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Health Care Reform Law | Regulatory Actions | Court Decisions | Requests for Proposal & Grant Offerings | Additional Health Care Reform Resources

This webpage provides links to (a) the Patient Protection and Affordable Care Act, as amended and supplemented by the Health Care and Education Reconciliation Act, (b) our summary of the health care reform law, (c) newly proposed or adopted regulations or other regulatory pronouncements relating to the health care reform law, (d) requests for proposal and grant offerings, and (e) additional health reform resources.

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Health Care Reform Law

• The Statute
• Health Reform Law Summary
  

Regulatory Actions

• FEHB  Program Carrier Letter re Affordable Care Act (ACA) Medical Loss Ratios (MLR) in the Federal Employees Health Benefits (FEHB) Program
  
  On April 10th, 2013, the U.S. Office of Personnel Management (OPM) Director of Healthcare and Insurance released an FEHB Program Carrier Letter outlining the ACA MLR procedures for FEHB insurance carriers and related entities.  The Carrier Letter may be found here.
  
  Under the ACA, all health insurance issuers—including FEHBP carriers—must submit MLR calculations to the Department of Health and Human Services (HHS) by June 1st.  If an issuer does not satisfy the MLR requirements, that is, the percentage of premiums spent on reimbursement for clinical services and activities that improve health care quality does not meet the minimum standards for a given plan year, then it must issue rebates to policyholders by August 1st each year.  OPM is the policyholder for FEHB plans.
  
  Notice of MLR Calculation and Rebate to OPM
  By June 1st, all FEHB carriers must provide notice to OPM’s Office of the Actuary about whether their ACA MLR calculation shows they may owe a rebate to OPM.  Carriers must include ACA MLR rebates from subcontractors or other legal entities providing services under the FEHB contract.  Carriers should notify OPM through the 2014 Rating Proposal, which includes a question about MLR rebates.  If a carrier owes an MLR rebate, it must follow the instructions on the ACA MLR Submission Template, attached to the Carrier Letter as Attachment A. 
  
  If a carrier owes an ACA MLR rebate to OPM, it must issue one check for each plan option that fails to meet the ACA MLR threshold.  Carriers are responsible for coordinating with their contractors and subcontractors to ensure OPM receives the ACA MLR information and any rebates owed by August 1st. 
  
  Starting with the 2015 reporting of 2014 plan information, the ACA MLR filing date will change from June 1st to July 31st and the ACA MLR rebate date will change from August 1st to September 30th to accommodate the premium stabilization program.  For the 2013 and 2014 reporting, the deadlines described above will apply. 
  
  Errors in MLR Calculations
  If a carrier discovers an error in its ACA MLR calculation that results in a rebate owed to OPM after June 1st and before August 1st, the carrier must immediately alert the Office of the Actuary via email and follow the Attachment A instructions to submit its rebate.  If a carrier discovers an ACA MLR calculation error after August 1st, it must follow the same procedure. 
  
  Enrollee Notice
  The Carrier Letter also contains a recommended cover letter for carriers to send to enrollees about how the ACA MLR rebate will apply to the FEHB program as Attachment B.  Carriers are to send this letter along with the standard rebate notice to enrollees. 
  
  
• HHS Issues Final Rule on the National Practitioner Data Bank
  
  On April 5, 2013, the Department of Health and Human Services issued a final rule to revise governance regulations and expand the National Practitioner Data Bank (NPDB).  The NPDB collects adverse licensure actions against physicians and dentists.  These actions are typically reported by malpractice insurers, state medical and dental boards, professional societies, provider organizations, and health insurers. 
  
  Under the final rule:
  
  
  • Provider organizations, medical/dental boards and other licensing bodies, Medicaid fraud control programs, state health agencies, quality improvement organizations, and certain law enforcement agencies have access to the practitioner data.  
  • Practitioners and provider organizations can search within the NPDB independently. 
  • HHS will transfer data from the Healthcare Integrity and Protection Data Bank (HIPDB) to the NPDB and cease operations of the HIPDB. Accordingly, regulations that previously implemented the HIPDB are removed, and become part of NPDB.
    
    
  The final rule revises existing regulations under sections 401-432 of the Health Care Quality Improvement Act of 1986 and section 1921 of the Social Security Act.  Section 6403 of the Patient Protection and Affordable Care Act, the statutory authority for this regulatory action, was designed to eliminate duplicative data reporting and access requirements between the HIPDB and NPDB.  The final rule becomes effective on May 6, 2013, and is available here. 
  
  
• CMS Responds to Technical Questions Regarding the Medical Loss Ratio Reporting and Rebate Requirements
  
  The Centers for Medicare and Medicaid Services (CMS) released technical guidance regarding the medical loss ratio (MLR) requirements found in Section 2718 of the Public Health Service Act (PHS Act), as added by the Patient Protection and Affordable Care Act (Affordable Care Act or ACA). The bulletin from CMS provides guidance in the form of questions and answers on the following topics: ACA fees, aggregation of data, and closed blocks of business. Specifically, the technical guidance provides that:
  
  
  • Health insurance issuers may exclude fees paid under the ACA, such as those under the risk adjustment program (§§ 1321(c)(1) and 1343), the Patient Centered Outcomes Research Institute (§ 6301), and the annual insurer fee (§ 9010), from premium in its MLR calculation;
  • Health insurance issuers may account for different MLR standards (such as in state markets with MLRs that change over time) when aggregating multiple years of data in MLR and rebate calculations;
  • CMS will not take enforcement action against health insurance issuers that fail to submit MLR reports if its only health insurance coverage is in grandfathered plans in small closed blocks of business (less than 1,000 life years nationwide) and subject to the provision of an attestation by the issuer's CEO and CFO that complies with the requirements set forth in this guidance; and
  • A health insurance issuer may notify CMS that its only health insurance coverage is in grandfathered plans in small closed blocks of business by registering with the MLR module of CMS's Health Insurance Oversight System, completing the "company issuer association" form, and checking the "small closed blocks of business" box.
    
    
  The full bulletin can be found here.
  
  
• CMS Releases Guidance on the Consumer Operated and Oriented Plan Program Contingency Fund
  
  The Centers of Medicare and Medicaid Services (CMS) released guidance on the Consumer Operated and Oriented Plan (CO-OP) Program Contingency Fund created by the American Taxpayer Relief Act of 2012 (ATR Act). The ATR Act rescinds ninety percent of the unobligated funds appropriated by the Patient Protection and Affordable Care Act (Affordable Care Act or ACA) for CO-OP loans. The ATR Act then transfers the remaining ten percent of the funds to a new CO-OP contingency fund, and directs the Secretary of Health and Human Services (HHS) to use the contingency fund to provide assistance to current CO-OP loan recipients. But only existing CO-OP loan recipients are eligible for loans from the contingency fund. CMS no longer has the authority to loan funds to new borrowers. The full bulletin from CMS can be found here.
  
  
• Department of Labor Releases a Self-Compliance Tool for Part 7 of ERISA
  
  The Department of Labor (DOL) released a self-compliance tool designed to assist those involved in operating a group health plan to understand the laws and related responsibilities found in the Affordable Care Act (ACA) provisions of Part 7 of ERISA.  The tool is a self-questionnaire that includes informal explanations of the statutes and the most recent regulations and interpretations of the law. It also includes citations to the underlying legal provisions. The DOL’s goal is to assist entities in compliance with the various ACA provisions that apply to group health plans and health insurance issuers that will soon become effective. The DOL tool can be found here.
  
  
• Patient Protection and Affordable Care Act; Exchange Functions: Standards for Navigators and Non-Navigator Assistance Personnel
  
  On April 3, 2013, HHS release a proposed rule aimed at creating conflict of interest, training and certification, and meaningful access standards applicable to "Navigators" and "Non-Navigator assistance personnel" who assist individuals attempting to access the Affordable Insurance Exchanges established by the ACA. The proposed rule makes three principal changes:
  
  
  • It prohibits states and Exchanges from prescribing licensing, certification, or other standards that would prevent application of title I of the ACA.
  • It amends 45 C.F.R. § 155.210(d) to clarify that a Navigator cannot be an issuer of, or a subsidiary of an issuer of, stop loss insurance, and cannot receive any consideration, directly or indirectly, from an issuer of stop loss insurance in connection with the enrollment of any individuals or employees in a Qualified Health Plan (QHP) or a non-QHP.
  • It adds a new provision at 45 C.F.R. 155.215 that would establish conflict-of-interest, training, and accessibility standards applicable to Navigators and non-Navigator assistance personnel in Federally-facilitated Exchanges, including State Partnership Exchanges.
    
    
  Comments on HHS's proposed rule are due by 5:00 p.m. Eastern time on May 5, 2013. The text of the rule is available here.
  
  
• HHS Rule Guarantees Full Funding For Newly Eligible Medicaid Beneficiaries
  
  On March 29, 2013, The Department of Health and Human Services (HHS) announced a final rule, effective January 1, 2014, that implements the provisions of the Affordable Care Act (ACA) relating to the Federal Medicaid Assistance Percentage (FMAP). The federal government will pay 100 percent of the costs of the "newly eligible" adult populations under states' Medicaid programs from 2014 through 2016. The federal government coverage will decrease to 90 percent by 2020, where it will remain permanently.
  
  Not all individuals enrolled in the eligibility group described in certain portions of the ACA will be "newly eligible" for FMAP purposes. The rule defines "newly eligible" as: those not under age 19 or such higher age as the state elects, those not eligible for full benefits under the ACA, or those eligible but not enrolled for such benefits or coverage under a waiver through a plan that has capped or limited enrollment. There is also an increased FMAP for expenditures for childless nonpregnant individuals in the new adult eligibility group.
  
  The rule also provides information to states expanding  Medicaid, describing the method states will use to claim the available matching rate for Medicaid expenditures of individuals with incomes up to 133 percent of the poverty rate and who are "newly eligible" and enrolled in the new eligibility group. It further clarifies the availability of increased FMAP for adults who are not newly eligible for those states that had coverage expansion in effect prior to the enactment of the ACA.
  
  HHS claims that the rule will provide more resources and flexibility for states to test ways of delivering Medicaid care, increase collaboration with states on audits that track down fraud, and specifically outline ways states can make Medicaid improvements without a waiver process.
  
  The full text of the rule is available here.
  
  
• CMS, EBSA, and IRS Jointly Issue Proposed Rule on 90-Day Waiting Period Limitation and Technical Amendments to Certain Health Insurance Requirements Under the Affordable Care Act
  
  On March 21, 2013, the Departments of the Treasury, Health and Human Services (HHS), and Labor jointly published a proposed rule implementing Public Health Service Act (PHSA) section 2708.  PHSA section 2708 prohibits group health plans and health insurance issuers from requiring otherwise eligible employees or their dependents to wait more than 90 calendar days before their employer-sponsored coverage becomes effective.  PHSA section 2708 does not require an employer to offer coverage to any particular employee or class of employees.  Section 2708 applies to both grandfathered and non-grandfathered group health plans as well as group health insurance coverage for plan years starting on or after January 1, 2014.  The full rule is available here. Comments are due by May 20, 2013. 
  
  Definition of "Waiting Period" 
  Some group health plans (both insured and self-insured) or health insurance issuers require a certain time period to pass before an otherwise eligible individual may receive health coverage.  The proposed rule adopts the same definition of "waiting period" as the 2004 HIPAA regulations—meaning that a "waiting period" is the period that must pass before coverage of an employee or dependent who is otherwise eligible to enroll under the terms of the group health plan becomes effective.  The proposed rule requires a group health plan or health insurance issuer offering group health insurance coverage to cap such a waiting period at 90 calendar days, beginning on the enrollment date and including all weekends and holidays.  If, however, an employee has the option to elect coverage that becomes effective on a date that is within the 90-day period, then the coverage complies with the waiting period rules.  This means that a group health plan or health insurance issuer does not violate the 90-day requirement simply because an individual chooses coverage beyond the end of that 90-day period, so long as coverage starting within the 90-day period is available. 
  
  Limitation on Eligibility Conditions
  The proposed rule limits eligibility conditions based solely on the lapse of a time period to be permissible for no more than 90 days.  Other conditions for eligibility are generally permissible, unless the condition is designed to avoid compliance with the 90-day waiting period restriction.   
  
  The proposed rule provides that, if a group health plan conditions eligibility on an employee regularly having a specified number of hours of service per period (or working full-time), and it cannot be determined that a newly-hired employee is reasonably expected to regularly work that number of hours per period (or work full-time), the plan may take a reasonable period of time to determine whether the employee meets the plan's eligibility condition, which may include a measurement period of no more than 12 months that begins on any date between the employee's start date and the first day of the first calendar month following the employee's start date, as provided for purposes of the employer shared responsibility requirements, commonly known as "pay or play."
  
  In the case of employer cumulative hours-of-service requirements, the proposed rule provides that a plan's waiting period begins once the employee satisfies the cumulative hours-of-service, and it still may not exceed 90 days.  The eligibility condition cannot have been designed to avoid compliance with the 90-day waiting period limitation, and it is not considered to be so designed if the cumulative hours-of-service requirement does not exceed 1,200 hours.
  
  Issuers Entitled to Rely on Eligibility Information from Plan Sponsors
  The proposed rule also allows health insurance issuers to rely on eligibility information given to them by employers (plan sponsors).  An issuer will not violate the proposed rule in administering the 90-day waiting period maximum if:
  1. the issuer requires the plan sponsor to make a representation regarding the terms of eligibility conditions or waiting periods imposed by the sponsor before an individual is eligible for coverage under the plan terms;
  2. the issuer requires the plan sponsor to update this representation with any changes; and
  3. the issuer has no specific knowledge of the imposition of a waiting period that would exceed the permitted 90 days. 
  
  Technical Amendments Regarding OPM Review of Exchange Plans and Multi-State Plans
  The proposed rule also provides technical amendments related to the Office of Personnel Management (OPM) nationally applicable external review process of insurance plans offered in the Affordable Insurance Exchanges, as established by the Affordable Care Act.  The Affordable Care Act requires OPM to contract with private health insurance issuers to offer at least two multi-state plans (MSPs) on each Exchange in the fifty states and the District of Columbia.  Group health plans and health insurance issuers must comply with either a State external review process or the Federal external review process under PHS Act section 2719, depending on whether the State external review process meets Federal regulatory requirements.  The proposed rule states that MSPs will be subject to the Federal external review process, not the State process.
  
  
• CMS Issues Final Rule on the Requirements for Long-Term Care Facilities; Notice of Facility Closure
  
  On March 19, 2013, CMS published a final rule in the Federal Register on the long-term care (LTC) facility closure notice requirements. The final rule adopts, with technical changes, the interim rule that CMS published on February 18, 2011. 

  In essence, the final rule places primary responsibility on individuals serving as administrators of a Skilled Nursing Facility (SNF) or Nursing Facility (NF) to timely report a facility's impending closure. The regulations also outline when Medicare and Medicaid reimbursement may be available during the closure process. The final rule is expected to allow for a smoother transition when a facility closes.    

  Under the final rule:

  • Any individual who is the administrator of a LTC facility must provide written notice of the closure and the plan for the relocation of residents at least 60 days prior to the impending closure.
  • If the Secretary terminates the facility's participation in Medicare or Medicaid, the administrator must give notice no later than the date the Secretary determines appropriate.
  • CMS must impose sanctions on the administrator of an LTC facility for failure to provide proper notice to specified parties, including CMS, that the facility is about to close.
  
  The final rule, which implements section 6113 of the Patient Protection and Affordable Care Act becomes effective on April 18, 2013. Click here to read the final rule.
  
  
• CMS Extends the Payment Adjustment for Low-Volume Hospitals and the Medicare-Dependent Hospital Program
  
  The Centers for Medicare and Medicaid Services (CMS) released a notice scheduled to be published in the Federal Register on March 7, 2013 that would extend the payment adjustment for low-volume hospitals and to the Medicare-dependent hospital (MDH) program under the hospital inpatient prospective payment system (IPPS) for fiscal year (FY) 2013. This complies with Sections 605 and 606, respectively, of the American Taxpayer Relief Act of 2012 (ATRA), which extends the temporary payment policies put into effect for FY 2011 and FY 2012 by the Affordable Care Act. Because this notice does not constitute substantive agency rulemaking, there will be no comment period. The full notice can be found here.
  
  
• CMS Announces Medicare Advantage and Prescription Drug Program MLR Proposed Rule—Largely Follows Commercial MLR Rules
  
  On February 15, 2013, CMS issued a proposed rule implementing the Affordable Care Act's (ACA) medical loss ratio requirement for Medicare Advantage and the Prescription Drug Program (PDP) as set forth in section 1103 of Title I, Subpart B of the Health Care and Education Reconciliation Act. The ACA requires Medicare Advantage Organizations (MAOs) and Part D sponsors (referring to stand-alone Part D, as opposed to MA-PD, contracts) to spend 85% of contract revenue (including any member premiums) on the provision of clinical services, prescription drugs, quality improving activities (as defined in the proposed rule) and direct benefits to beneficiaries via reduced Part B premiums. The MLR rule will be effective January 1, 2014. The proposed rule is scheduled for publication in the Federal Register on February 22, 2013, with comments due by April 23, 2013. Click to continue reading.
  
  
• CMS Explains the PPACA Exchange Record System
  
  On February 6, 2013, the Centers for Medicare & Medicaid Services ("CMS") published a notice about how the new system of records, intended to support the new health insurance exchanges, will operate. A "system of records" is a group of any records under the control of a federal agency from which information about individuals is retrieved by name or other personal identifier. Read more.
  
  
• CMS Proposes Rule to Reform Unnecessary, Obsolete, or Excessively Burdensome Regulatory Requirements
  
  On February 4, 2013, the Centers for Medicare & Medicaid Services (CMS) proposed a rule to reform Medicare regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. CMS claims that the rule will save the government nearly $676 million annually and $3.4 billion over five years. Among other things, the proposed rule would:
  • Permit registered dieticians to order patient diets independently, without requiring the supervision or approval of a physician or other practitioner;
  • Eliminate unnecessary requirements that ambulatory surgical centers must meet in order to provide radiological services; and
  • Get rid of a redundant data submission requirement and an unnecessary survey process for transplant centers. 
  
  The proposed rule supports President Obama's call on federal agencies to modify and streamline regulations on business. The proposed rule is scheduled to be published in the February 7, 2013 Federal Register. Comments are due by 5 p.m. on April 8, 2013. The full rule is available here, and a press release regarding the proposed rule is available here. 
  
  HHS, Treasury, and DOL Propose Rule Regarding Coverage of Contraceptive Services Under the ACA
  
  

  On February 1, 2013, the Department of Health and Human Services, the Department of the Treasury, and the Department of Labor (collectively, the "Departments") released a proposed rule regarding coverage of certain preventive health services mandated by the Patient Protection and Affordable Care Act (ACA). Section 2713 of the Public Health Service Act (PHSA), as added by the ACA, requires that non-grandfathered group health plans and health insurance issuers offering non-grandfathered or individual health insurance coverage provide benefits for certain preventive health services without the imposition of cost sharing.  These services include preventive care and screenings for women as provided for in the comprehensive guidelines supported by the Health Resources and Services Administration (HRSA). The guidelines issued by HRSA include all FDA-approved contraceptive methods, sterilization procedures, and patient education and counseling for all women with reproductive capacity (collectively, "contraceptive services"), as prescribed by a health care provider.

  The proposed rule builds on previous guidance allowing for the exemption from the contraceptive services requirement for group health plans established or maintained by religious employers (and group health insurance coverage provided in connection with such plans). Specifically, the proposed rule amends the criteria for the religious employer exemption to ensure that an otherwise exempt employer plan is not disqualified because the employer's purposes extend beyond the inculcation of religious values or because the employer serves or hires people of different religious faiths. It also establishes accommodations for health coverage established or maintained by eligible organizations, or arranged by eligible organizations that are religious institutions of higher education, with religious objections to contraceptive coverage.

  The proposed rule is scheduled to be published in the February 6th Federal Register. Comments on the proposed rule are due no later than 60 days after the date of publication in the Federal Register. A link to the full rule can be found here.
  
  
• IRS Releases Proposed Rule and Notice of Public Hearing on Shared Responsibility Payment for Not Maintaining Minimum Essential Coverage
  
  

  On January 30, 2013, the Internal Revenue Service released a proposed rule relating to the individual requirement to maintain minimum essential coverage, as established by the Patient Protection and Affordable Care Act. The proposed rule offers guidance regarding liability for the shared responsibility payment where a nonexempt individual does not maintain minimum essential coverage. 

  The proposed rule was published in the Federal Register on February 1, 2013. Comments on the proposed rule must be received by May 2, 2013. A public hearing has been scheduled for May 29, 2013.  The proposed rule can be found here, and IRS Q&As issued with respect to the individual shared responsibility requirement can be found here.
  
  
• IRS Adopts Final Rule Regarding Health Insurance Premium Tax Credit Eligibility for "Related Individuals"
  
  

  On January 30, 2013, the Internal Revenue Service released a final rule relating to the determination of whether individuals are eligible for a premium tax credit where they are eligible to enroll in eligible employer-sponsored coverage by reason of their relationship to an employee (Related Individuals). Specifically, the final rule provides guidance for determining whether such coverage is affordable for purposes of determining Related Individuals' eligibility for a premium tax credit. For taxable years beginning before January 1, 2015, an eligible employer-sponsored plan is affordable for Related Individuals for purposes of determining eligibility for a premium tax credit if the portion of the annual premium the employee must pay for self-only coverage does not exceed 9.5% of the taxpayer's household income. 

  The final rule was published in the Federal Register on February 1, 2013. The full rule can be found here. 
  
  
• HHS Releases Proposed Rule to Implement Certain Exchange Functions
  
  

  On January 30, 2013, the Department of Health and Human Services (HHS) released for public inspection a proposed rule that would implement certain functions of Affordable Insurance Exchanges (Exchanges), consistent with the Patient Protection and Affordable Care Act (ACA). 

  The proposed rule sets forth standards and processes pursuant to which an Exchange will determine eligibility for and grant certain exemptions from the ACA requirement that nonexempt individuals maintain coverage constituting "minimum essential coverage" or make a shared responsibility payment. The proposed rule also provides standards by which the Secretary of HHS, in coordination with the Secretary of the Treasury, may designate as minimum essential coverage certain types of coverage that are not statutorily designated as minimum essential coverage. It designates certain types of existing health coverage as minimum essential coverage, and it also provides substantive and procedural requirements that must be met in order for other types of coverage to be designated as minimum essential coverage. 

  The proposed rule was published in the Federal Register on February 1, 2013. Comments on the proposed rule are due by 5 p.m. on March 18, 2013.  The full rule can be found here.
  
  
• CMS Issues Bulletin Clarifying Status of Employer Prescription Drug Coverage that Supplements Medicare Part D Coverage Provided Through an Employer Group Waiver Plan
  
  On January 25, 2013, CMS issued a bulletin providing guidance on how the requirements of Title XXVII of the Public Health Service Act (PHS Act, Part 7 of the Employee Retirement Income Security Act (ERISA), and Chapter 100 of the Internal Revenue Code (collectively, "federal health coverage requirements") apply when a Medicare-authorized Employer Group Waiver Plan supplements standard Medicare Part D prescription drug coverage. First, retiree-only plans are exempt from the federal health coverage requirements.  These plans include employment-based prescription drug plans (PDPs) and employment-based Medicare Advantage Prescription Drug plans (MA-PDs) that cover less than two current employees. Second, coverage through an insured Employer Group Waiver Plan that offers non-Medicare supplemental drug coverage as part of an MA-PD plan qualifies as an excepted benefit and is not subject to the federal health coverage requirements. Finally, coverage through a self-insured Employer Group Waiver Plan that offers non-Medicare supplemental drug coverage as part of an MA-PD plan is technically subject to the federal health coverage requirements. However, CMS, the Department of Labor, and the Department of the Treasury released an FAQ on January 24, 2013 that provides an enforcement safe harbor for such plans. This safe harbor FAQ can be found here. The CMS bulletin can be found here.
  
  
• Consumer Operated and Oriented Plan (CO-OP) Funding Slashed by Fiscal Cliff Legislation
  
  

  Section 644 of the American Taxpayer Relief Act of 2012 ("ATRA," more commonly referred to as the recently enacted "fiscal cliff" legislation), makes changes to section 1322 of the Affordable Care Act (ACA § 1322). ACA § 1322 directed the Secretary of Health and Human Services to establish a Consumer Operated and Oriented Plan (CO-OP) in each state as an alternative to for-profit insurance carriers in individual and small group markets. CO-OPs must reinvest any profits or government funding to reduce premiums, expand enrollment, or increase benefits. Additionally, CO-OP members select their board of directors from among their enrolled membership.

  ATRA Section 644, which was enacted "to provide assistance and oversight to qualified nonprofit health insurance issuers that have been awarded loans or grants under section 1332," directs the Secretary of Health and Human Services to establish a fund for the CO-OPs. Section 644 then upholds the funds already allocated under ACA § 132, but otherwise rescinds 90% of ACA § 1322's unobligated funds. Originally, Congress had appropriated $6 billion for the CO-OP program, but later reduced that amount to $3.8 billion. CMS has awarded more than $2 billion in loans to CO-OPs in twenty-four (24) states. But some estimate that many CO-OPs will default on planning or solvency loans. Now, as a result of ATRA, more than $1.4 billion in additional funding has been cut.
  
  
• CMS Releases HHS Risk Adjustment Model Algorithm Instructions
  
  The Centers for Medicare and Medicaid Services (CMS) released the HHS Risk Adjustment Model Algorithm Instructions, which is intended as a supplement to the draft HHS notice of benefit and payment parameters published on December 7, 2012.  Section 1342 of the Affordable Care Act provides for permanent risk adjustment programs to transfer funds from plans with relatively lower-risk enrollees to plans with relatively higher-risk enrollees. This new draft provides HHS risk adjustment model instructions for benefit year 2014. The plan would: calculate a plan average risk score for each covered plan based upon the relative risk of the plan's enrollees, and apply a payment transfer formula in order to determine risk adjustment payments and charges between plans within a risk pool within a market within a state. The proposed risk adjustment addresses (1) the newly insured population, (2) plan metal level differences and permissible rating variation, and (3) the need for risk adjustment transfers that net to zero. The draft provides the algorithm used to develop and calculate risk scores. Click here for the draft.
  
  
• CMS Releases Proposed Rule to Consolidate Eligibility, Notices, Appeals, and Cost-sharing Maximums for Medicaid, CHIP, and Exchanges
  
  On January 14, 2013, the Centers for Medicare & Medicaid Services released a proposed rule, titled, Medicaid, Children's Health Insurance Programs, and Exchanges: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Exchange Eligibility Appeals and Other Provisions Related to Eligibility and Enrollment for Exchanges, Medicaid and CHIP, and Medicaid Premiums and Cost Sharing. Click here to read our summary of the rule.
  
  
• Summary of Treasury, IRS Proposed Regulations Regarding Employer Shared Responsibility Requirement
  
  

  On December 28, 2012, the Department of the Treasury and the Internal Revenue Service (collectively, the "Service") issued a proposed rule ("Proposed Rule") regarding the employer shared responsibility provisions – the so-called "pay or play" provisions – set forth in section 4980H of the Internal Revenue Code of 1986, as amended ("Code"). Read more.

• OPM Releases Proposed Rule on Establishment of Multi-State Plan Program for Affordable Insurance Exchanges
  
  The Office of Personnel Management (OPM) published in the December 5, 2012 Federal Register a proposed rule that would implement the Multi-State Plan Program (MSPP). Section 1334 of the Affordable Care Act (ACA) creates the MSPP to foster competition among plans competing in the individual and small group health insurance markets on the Affordable Insurance Exchanges on the basis of price, quality, and benefit delivery. The ACA directs OPM to contract with private health insurance issuers to offer at least two multi-state plans on each of the Exchanges in the 50 states and the District of Columbia. Comments with respect to the proposed rule are due on or before January 4, 2013.  The first open enrollment period for MSPP plans begins on October 1, 2013 for coverage starting in January 2014. Click here to read our summary of the rule.
  
  
• IRS Releases Guidance on Branded Prescription Drug Fee for 2013 Fee Year
  
  On November 29, 2012, the IRS released Notice 2012-74, which provides guidance with respect to the branded prescription drug fee for the 2013 fee year. The branded prescription drug fee, which is imposed by section 9008 of the Affordable Care Act, is an annual fee on covered entities engaged in the business of manufacturing or importing branded prescription drugs. The Notice focuses on (1) the submission of Form 8947, "Report of Branded Prescription Drug Information," (2) the time and manner for notifying covered entities of their preliminary fee calculation, (3) the time and manner for submitting error reports for the dispute resolution process, and (4) the time for notifying covered entities of their final fee calculation. Please click here for the text of the Notice.
  
  
• CMS Issues Proposed Rules on Rate Review, Risk Pools, Guaranteed Availability and Renewability, and Fair Premiums Under Patient Protection and Affordable Care Act (Comments due by Dec. 26, 2012)
  
  The Centers for Medicare and Medicaid Services (CMS) published in the Federal Register on Monday, November 26, 2012 a notice of proposed rulemaking (NPRM) seeking comments on, inter alia, the implementation of  the Patient Protection and Affordable Care Act's (PPACA) policies related to guaranteed availability, guaranteed renewability, rate review, single risk pools, and fair health insurance premiums. Click here to read our summary of the rule.
  
  
• CMS requests quality management information for Exchanges
   
  The Centers for Medicare & Medicaid Services (CMS) on November 27, 2012 published a request for input on quality management for health plans operating under the new health insurance Exchanges. It is seeking information on existing quality measures and rating systems, strategies and requirements for quality improvement, purchasing strategies to promote care redesign and patient safety, and methodologies to measure health plan value. Responders are invited to make recommendations on the most effective ways to enhance and align the quality reporting and display requirements for Qualified Health Plans starting in 2016. Details can be found here.
  
  
• CMS Formally Recognizes NCQA and URAC as Accrediting Entities for QHPs
   
  On November 23, 2012, the United States Department of Health and Human Services (HHS) published a Federal Register notice announcing that the National Committee for Quality Assurance (NCQA) and URAC were recognized accrediting entities for purposes for fulfilling the accreditation requirement for certification of qualified health plans (QHPs).    
  
  Section 1311(c)(1)(D)(i) of the Patient Protection and Affordable Care Act (PPACA) requires health plans to be accredited by a recognized accrediting entity in order to be certified as QHPs and operate in the Affordable Insurance Exchanges, including the federally-facilitated and State Partnership Exchanges. The ACA requires all states to establish an Affordable Insurance Exchange on or before January 1, 2014. If a state does not establish an exchange or elects not to have an exchange approved by January 1, 2013, HHS will create and operate a federally-facilitated exchange within the state.  An issuer must demonstrate that each plan offered on an Exchange is a QHP. 
  
  This notice follows HHS's final rule published July 20, 2012, titled "Patient Protection and Affordable Care Act; Data Collection to Support Standards Related to Essential Health Benefits; Recognition of Entities for the Accreditation of Qualified Health Plans." That rule finalized 45 C.F.R. § 156.275, "Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers" (Exchange Rule), which set forth the requirements for recognition as an accrediting entity.
  
  HHS's recognition of NCQA and URAC is the first phase of a two-phase process by HHS for recognizing accrediting entities.  Recognized accrediting entities shall accredit QHPs on the Exchange's required timeline based upon the local performance standards codified in 45 C.F.R. 156.275(a)(1). HHS's recognition of NCQA and URAC as accrediting entities in phase-one is effective until it is rescinded or the interim phase-one process is replaced by the phase-two process. 
  
  On November 26, 2012, HHS published a new proposed rule that would amend the phase-one recognition process and allow additional accrediting entities to apply for recognition. Within 60 days of receiving the complete application, HHS would be required to publish notice in the Federal Register identifying the applicant accrediting entity, along with a summary by HHS of whether the applicant meets the criteria for recognition, and provide a minimum 30-day public comment period. After close of the public comment period, HHS would publish the names of accrediting entities that are recognized and that are not recognized to provide QHP accreditation. Applicants that are not recognized may reapply for recognition following the same application procedure.
  
  HHS plans to adopt a criteria-based review for the phase-two process through further rulemaking.

• CMS Proposed Rule on Affordable Care Act Standards for Essential Health Benefits, Actuarial Value and Accreditation
  
  The Patient Protection and Affordable Care Act (PPACA) requires all health plans offered through Health Insurance Exchanges (Exchanges) and small group and individual products offered outside of the Exchanges to offer a core package of items and services, known as essential health benefits, and to meet specified actuarial value levels. On November 20, 2012, the U.S. Department of Health and Human Services (HHS) issued a proposed rule for the purpose of clarifying and elaborating on the requirements for offering essential health benefits and for meeting actuarial value levels. The proposed rule also sets a timeline for qualified health plans (QHPs) to be accredited in the Exchanges and a process for recognition of additional accrediting entities for purposes of certifying QHPs. The comment period expires December 26, 2012. Click here to read our summary of the rule.
  
  
• CMS issues guidance to states on new Medicaid benchmark benefit coverage options
   
  In a November 20, 2012 letter to state Medicaid directors, CMS provides guidance on the use of Alternative Benefit Plans for the new eligibility group for low-income adults, the relationship between Alternative Benefits Plans and Essential Health Benefits, and the relationship of section 1937 of the Social Security Act, adopted in 2005, to other provisions of Medicaid law. Beginning in 2014, provisions of the Affordable Care Act will expand Medicaid eligibility for lower-income adults. The enactment of Section 1937 gave states greater flexibility in structuring Medicaid benefit packages, including the option to offer Alternative Benefit Plans, based on "benchmark", "benchmark-equivalent," or "Secretary-approved" plans. In addition, under the Affordable Care Act, Alternative Benefit Plans must include coverage of defined Essential Health Benefits in ten benefit categories consistent with HHS regulations. The new guidance outlines CMS's plans for implementing the new Essential Health Benefits requirements in the context of Medicaid Alternative Benefit Plans. The notice states that a new proposed regulation will be issued shortly.  States may submit Medicaid Plan Amendments to the CMS beginning in 2013, and these amendments must address eligibility, services covered, and fee-for-service methodology for the proposed Alternative Benefit Plans. More information can be found here.
  
  
• Agencies Release Proposed Regulations Regarding Incentives for Nondiscriminatory Wellness Programs in Group Health Plans
  
  On November 20, 2012, the Department of the Treasury, the Department of Labor, and the Department of Health and Human Services (collectively, the "Departments") issued proposed regulations regarding nondiscriminatory wellness programs in group health coverage and reflecting changes made to wellness programs as part of the Patient Protection and Affordable Care Act (Affordable Care Act or ACA). Click here to read our summary of the rule.
  
  
• OPM Releases Draft Multi-State Plan Program Application
  
  On September 20, 2012, the Office of Personell Management (OPM) has released the draft Multi-State Plan Program Application for the purpose of soliciting comments from health issuers who wish to offer individual and small group coverage through Multi-State Plans (MSPs) made available on the Affordable Insurance Exchanges and from any other interested parties.  Comments are due by October 22, 2012.

• HHS Adopts Enforcement Safe Harbor for Certain Plan Determination Notices from Non-Federal Governmental Plans
   
  On August 17, 2012, the Department of Health and Human Services (HHS) published a notice containing an enforcement safe harbor with respect to the content of the adverse benefit determinations and final internal adverse benefit determinations issued to participants and beneficiaries in group health plans that are non-federal governmental plans (and health insurance coverage offered in connection with such plans). Generally, ERISA plans, including non-federal governmental plans, must provide information in adverse benefit determinations and final internal adverse benefit determinations regarding, among other things, (i) the private right of action under ERISA section 502(a) and (ii) the services the EBSA provides to participants and beneficiaries. This requirement can lead to inaccurate disclosures for non-federal governmental plans because the ERISA private right of action is not available to participants or beneficiaries in these plans and the EBSA does not provide services to these participants or beneficiaries. For this reason, HHS has announced that it will not enforce the requirements that non-federal governmental plans provide notice of the ERISA private right of action or contact information for the EBSA or a State Department of Insurance. The HHS notice is available here.
  

• HHS Publishes Interim Final Rule with Comment Period Regarding Operating Rules for Health Care Electronic Funds Transfers and Remittance Advice Transactions
  
  On August 10, 2012, the Department of Health and Human Services (HHS) published an interim final rule with comment period implementing parts of section 1104 of the PPACA, which requires the adoption of operating rules for the health care electronic funds transfers (EFTs) and remittance advice transaction. The purpose of the interim rule is to cut down on the cost of billing and insurance related tasks by automating many of these tasks through the electronic transfer of information, including through electronic fund transfers. Secretary Sebelius has announced that this new rule will cut red tape for doctors, hospitals and health plans and, in combination with a previously issued regulation, save up to $9 billion over the next ten years. The interim final rule is available here.

• DOL, HHS and Treasury Issue FAQ About Affordable Care Act Implementation Part X
  
  On August 7, 2012, the Department of Labor (DOL) issued a new FAQ about Affordable Care Act implementation (FAQ Part X) jointly prepared by the Departments of Health and Human Services (HHS), labor and Treasury (together, the "Departments:) regarding implementation of the summary of benefits and coverage ("SBC") provisions of the PPACA. The FAQ clarifies that Medicare Advantage plans are Medicare benefits not subject to the SBC requirement and that the Departments will not take any enforcement action against a group health plan because it does not provide an SBC with respect to a Medicare Advantage benefit package. The FAQ is available here.
  

• HHS Releases an Issue Brief on Access to Women's Preventive Services under the PPACA
   
  On July 31, 2012, the Department of Health and Human Services (HHS) published an issue brief estimating that 47 million women will have guaranteed access to women's preventive services with zero cost-sharing under the PPACA. Generally, HHS guidelines requiring non-grandfathered health insurance plans to cover certain preventive services for women without cost sharing under the PPACA take effect for plan years beginning on or after August 1, 2012.
  
  The issue brief breaks down the 47 million women who will have guaranteed access to services at no cost by state and racial group. The issue brief is available here.
  

• HHS Issues Final Rule Establishing Data Collection Standards
   
  On July 20, 2012, the Department of Health and Human Services (HHS) issued a final rule establishing data collection standards necessary to implement aspects of PPACA section 1302, which directs the HHS Secretary to define essential health benefits. The final rule outlines the data on applicable plans to be collected from certain issuers to support the definition of essential health benefits and establishes a process for the recognition of accrediting entities for purposes of certification of qualified health plans. The final rule can be found here.
  
  
• CCIIO Technical Guidance (CCIIO 2012-0005); Questions and Answers Regarding the Medical Loss Ratio Reporting and Rebate Requirements
  (July 17, 2012)

• Treasury and IRS Publish Additional Non-Substantive Corrections to Final Regulations on the Health Insurance Premium Tax Credit
   
  On July 13, 2012, the Department of the Treasury (Treasury) and the Internal Revenue Service (IRS) published additional minor, non-substantive corrections to the final regulations regarding the health insurance premium tax credit codified in section 36B of the Internal Revenue Code by the PPACA (as amended) that were originally published on May 23, 2012. These corrections are in addition to the non-substantive corrections made on July 12, 2012. The corrections are available here.

• Treasury and IRS Publish Non-Substantive Corrections to Final Regulations on the Health Insurance Premium Tax Credit
   
  On July 12, 2012, the Department of the Treasury (Treasury) and the Internal Revenue Service (IRS) published a few minor, non-substantive corrections to the final regulations regarding the health insurance premium tax credit codified in section 36B of the Internal Revenue Code by the PPACA (as amended) that were originally published on May 23, 2012. The corrections to the preamble to the final regulations are available here and the corrections to the final regulations themselves are available here.

• CCIIO and CMS Issue Information to Facilitate States' Selection of Benchmark Plans to Establish Essential Health Benefits
   
  On July 3, 2012, the Center for Consumer Information and Insurance Oversight (CCIIO) and the Centers for Medicare & Medicaid Services (CMS) issued a document that provides information to facilitate States' selection of the benchmark plans that would serve as the reference plans for the essential health benefits (EHB). It updates a prior publication released on January 25, 2012 and complements the bulletin on the EHB released on December 16, 2011. The document provides an updated list of the three largest small group insurance products ranked by enrollment for each State, as well as lists of the three largest nationally available Federal Employee Health Benefit Program plans, a benchmark option under the intended approach outlined in the bulletin.  It also provides the single largest Federal Employees Dental and Vision Insurance Program dental and vision plans respectively, based on enrollment. The document is available here.

• HHS Releases Bulletin on the Transitional Reinsurance Program
   
  On May 31, 2012, the Department of Health and Human Services (HHS) released a bulletin titled "Bulletin on the Transitional Reinsurance Program: Proposed Payment Operations by the Department of Health and Human Services." Section 1341 of the PPACA provides that a transitional reinsurance program will be established in each State to help stabilize premiums for coverage in the individual market from 2014 through 2016. All health insurance issuers, and TPAs for self-insured group health plans, will be required to submit contributions to support reinsurance payments to issuers that cover high-cost individuals in non-grandfathered individual market plans.
  
  The bulletin specifies the processes and timeframes HHS will employ to identify, calculate, and disburse reinsurance payments for the HHS-operated program. The bulletin is available here.
  
  
• CCIIO Technical Guidance (CCIIO 2012-004); Questions and Answers Regarding the Medical Loss Ratio Reporting Requirements (May 30, 2012)

• HHS Releases Non-Substantive Corrections to final Insurance Exchange Guidance
   
  On May 29, 2012, the Department of Health and Human Services (HHS) published non-substantive technical and typographical corrections to the final insurance exchange guidance originally published on March 27, 2012. The corrections are effective as if included in the original final rule (i.e., they become effective on May 29, 2012). The corrections are available here.
  
  
• CCIIO Technical Guidance (CCIIO 2012-003); Questions and Answers Regarding the Medical Loss Ratio Reporting Form
  (May 24, 2012)

• Treasury and IRS Issue Final Regulations on the Health Insurance Premium Tax Credit
   
  On May 23, 2012, the Department of the Treasury (Treasury) and the Internal Revenue Service (IRS) issued final regulations on the health insurance premium tax credit enacted by the PPACA (as amended). The health insurance premium tax credit is codified in section 36B of the Internal Revenue Code, which provides a tax credit for certain individuals who purchase health insurance coverage through an Affordable Insurance Exchange (Exchange).
  
  The final regulations provide guidance to individuals who enroll in qualified health plans through Exchanges and claim the premium tax credit, and to Exchanges that make qualified health plans available to individuals and employers. The final regulations are effective on May 23, 2012. They are available here.
  
  
• Memo to Insurance Companies: Guidance for Medical Loss Ratio Notices of Rebates (May 15, 2012)
  
  
• Memo to Insurance Companies: Guidance for Medical Loss Ratio Annual Reporting Form (May 15, 2012)
  
  
• CCIIO Technical Guidance (CCIIO 2012-002); Questions and Answers Regarding the Medical Loss Ratio Interim Final Rule
  (May 13, 2011)

• Treasury and IRS Issue Proposed Regulations and Notice of Public Hearing Regarding the Disclosure of Return Information
   
  On April 27, 2012, the Department of the Treasury (Treasury) and the Internal Revenue Service (IRS) issued proposed regulations and a notice of public hearing regarding the disclosure of return information under section 6103(l)(21) of the Internal Revenue Code, as enacted by PPACA (as amended). Section 6103(l)(21) permits the disclosure of return information to assist Exchanges in performing those functions set forth in PPACA section 1311 for which income verification is required (including determinations of eligibility for the insurance affordability programs described in PPACA), as well as to assist State agencies administering a State Medicaid program under title XIX of the Social Security Act, CHIP, or a basic health program under PPACA section 1331 (if applicable).
  
  The proposed regulations define certain terms and describe certain additional items of return information that will be provided, upon written request, in addition to those items specifically prescribed by statute under Code section 6103(l)(21). Comments on the proposed regulations are due by July 30, 2012. A public hearing has been scheduled for August 31, 2012. The proposed rules and notice of public hearing are available here.

• CCIIO issues additional MLR guidance
  
  On April 20, 2012, the Center for Consumer Information & Insurance Oversight (CCIIO) issued a new set of questions and answers (Q&As) on medical loss ratio (MLR) requirements under PPACA. Among other things, the Q&A clarifies that exchange user fees paid to a State or Federal Exchange are to be included in licensing and regulatory fees subtracted from the premium for the purpose of MLR calculations. In addition, the Q&A provides guidance related to specific plan types, small employer groups, the method for counting employees, "premium holidays," reinsurance and reporting requirements, the effect of state MLR requirements, mini-med policies, and rebates. For further information, you may access the new guidance here.
  
  
• CCIIO Technical Guidance (CCIIO 2012-002); Questions and Answers Regarding the Medical Loss Ratio Regulation
  (April 20, 2012)
  
  
• IRS Issues Proposed Regulations Relating to the PPACA PCORI Fee
   
  On April 17, 2012, the Internal Revenue Service (IRS) issued proposed regulations relating to what is commonly referred to as the PCORI fee.  Section 6301(a) of the PPACA amended section 1181(b) of the Social Security Act to authorize the establishment of the Patient-Centered Outcomes Research Institute (PCORI), an institute designed to advance research and evidence synthesis to increase the quality and relevance of evidence concerning the manner in which diseases, disorders and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored and managed. PCORI is funded in part by fees assessed on the issuers of certain health insurance policies and plan sponsors of certain self-insured health plans.
  
  The proposed regulations implement and provide guidance on the PCORI fee. Comments on the proposed regulations should be submitted by July 16, 2012. The IRS will hold a public hearing on the proposed regulations on August 8, 2012. The proposed regulations are available here.
  

• HHS Issues Proposed Rule to Streamline Health Care Administrative Transactions
   
  On April 17, 2012, the U.S. Department of Health and Human Services (HHS) issued a proposed rule establishing new requirements for administrative transactions that would improve the utility of the existing HIPAA standards for electronic health care transactions and reduce administrative burden and costs. The proposed rule is the third in a series of regulations under PPACA section 1104, which requires HHS to issue a series of regulations over five years that are designed to streamline health care administrative transactions, encourage greater use of standards by health care providers, and make existing standards work more efficiently.
  
  The proposed rule:
  
  
  • Providers for the adoption of a standard for a national unique health plan identifier (HPID) that would be used to identify health plans in covered transactions;
  • Providers for the adoption of an "other entity" identifier (OEID) to be used for entities that are not health plans, health care providers, or "individuals," that need to be identified in standard transactions;
  • Specifies the circumstances under which an organization covered health care provider must require certain noncovered individual health care providers who are prescribers to obtain and disclose a National Provider Identifier (NPI); and
  • Proposes to change the compliance date for the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) for diagnosis coding, including the Official ICD–10–CM Guidelines for Coding and Reporting, and the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD–10–PCS) for inpatient hospital procedure coding, including the Official ICD–10–PCS Guidelines for Coding and Reporting, from October 1, 2013 to October 1, 2014.
    
    The proposed rule is available here. Comments are due by May 17, 2012. An HHS fact sheet is available here.
    

• CMS issues Medicare Advantage and Medicare Prescription Drug Benefits Program guidance
  
  On April 12, 2012, the Centers for Medicare & Medicaid Services issued new regulations, appearing in the Federal Register, implementing changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs. The new regulations, issued as a final rule with comment period, specifically "implement new statutory requirements; strengthen beneficiary protections; exclude plan participants that perform poorly; improve program efficiencies; and clarify program requirements." The new provisions address a range of issues, including:
  
  
  • the Coverage gap discount program;
  • Transparency requirements for entities providing pharmacy benefits management services;
  • Filing of Part D appeals with the Independent Review Entity;
  • Plan performance ratings;
  • Additional benefits for fully-integrated dual eligible special needs plans;
  • Clarification of durable medical equipment coverage limits;
  • Use of daily cost-sharing rates in drug utilization management and fraud, abuse, and waste control programs; and
  • Use of National Provider Identifier and standardized technology for accessing covered Part D drugs.

The regulations also address concerns with pharmacy-related conditions of participation for long-term care facilities. The new regulations largely will enter into effect on June 1, 2012. Because CMS has invited comment on specified issues, comments on those issues will be accepted through June 11, 2012. Click here to access the new guidance [PDF].

• On Monday, April 2, 2012, the U.S. Office of Personnel Management ("OMB") published in the Federal Register final regulations which amend existing Federal Employees Health Benefits (FEHB) and the Federal Employees Health Benefits Acquisition Regulation (FEHBAR) provisions related to premium rate-setting methods for community rated plans. With "minor changes" to a June 29, 2011 interim final rule, see 76 Fed. Reg. 38282, the new regulations replace the prior similarly sized subscriber group (SSSG) rate-setting method with a medical loss ratio (MLR) calculation.

  The updated MLR requirements impose obligations on all community-rated plans, except those subject to "traditional" community rating requirements under state law. The revised MLR regulations, like those embodied in the Patient Protection and Affordable Care Act (PPACA), are designed to offer "a more modern and transparent calculation while still ensuring that the FEHB Program is receiving a fair rate." In addition, OPM anticipates that the MLR requirement "will result in a more streamlined process for plans and increased competition and plan choice for enrollees."

  The final regulations make four changes to the prior interim final rules:

  • In response to public comments, the final rules do not contain any provision barring consideration of a prior year's MLR in determining that of the current plan year. According to OPM, this change is geared toward providing OPM "flexibility to determine a fair and accurate MLR for each plan in each year."
  • The new rules provide a deadline for publication of the FEHPleB-specific MLR requirement. Specifically, the regulations require promulgation of the applicable FEHB-specific MLR threshold 8 months prior for plan year 2013, and twelve calendar months in advance for plan years 2014 and beyond. See 48 C.F.R. § 1602.170-14(b).
  • The new regulations include technical changes to certification requirements, applicable to carriers using the MLR methodology, based on changes in timing. Under the new provisions, carriers using the MLR methodology must first submit a "Certificate of Accurate Cost or Pricing Data or Community-Rated Carriers," followed by later submission of a "Certificate of Accurate MLR Calculation." See 48 C.F.R. § 1515,406-2(b).
  • The new regulations specifically provide that OPM will issue a separate credibility adjustment, apart from that defined by the U.S. Department of Health & Human Services (HHS). See 48 C.F.R. § 1602.170-14(c).

OPM declined to permit plans making MLR rebates under the PPACA health reform law to include any rebate required under that law for the FEHBP to be included as a reduction in premium under the FEHBP-specific MLR calculation. It also declined to permit plans to determine FEHBP MLR results based on a composite of multiple years' experience. OPM will expect plans to follow CMS guidelines for determining how to treat expenditures under the FEHBP MLR rule.

The new rules go into effect on May 2, 2012. For more information, click here to find the final regulations, as published in the Federal Register [PDF].

• Memo to Insurance Companies: Medical Loss Ratio Annual Reporting Procedures (March 20, 2012)
  
  
• HHS releases set of PPACA guidance
  
  On March 16, 2012, the Department of Health & Human Services (HHS) released several rulemakings finalizing regulations on several issues under PPACA. The rulemakings include:
  
  
  • Final rule on PPACA reinsurance, risk corridor, and risk adjustment standards: These regulations adopt final standards devised to mitigate adverse selection and to promote premium stabilization, as the new Insurance Exchange program begins implementation. Published in the Federal Register on March 23, 2012, the regulations are slated to go into effect on May 22, 2012.
  • Final rule and interim final rules on Medicaid eligibility changes: This rulemaking imposes new and revised policy and procedural requirements related to eligibility, enrollment, renewals, public availability of program information, and coordination in the Medicaid and CHIP programs, pursuant to PPACA. Also published in the Federal Register on March 23, 2012, the rule's provisions will go into effect on January 1, 2014. Because some of the rulemaking's provisions were issued as interim rules, comments are being accepted. The deadline for comment submission is May 7, 2012.
  • Final rules on student health insurance coverage under PPACA: This rulemaking contains final regulations pertaining to student health insurance coverage, based on provisions enacted as part of PPACA. These regulations were also published in the Federal Register on March 21, 2012, and it's provisions will go into effect on April 20, 2012.
  • Advance NPRM on PPACA preventive service regulations: This rulemaking, published in the Federal Register on March 21, 2012, provides an outline for the current Administration's approach to dealing with questions related to women's preventive service coverage in forthcoming amendments to existing regulations under PPACA on the same issue. Specifically, the Advance NPRM addresses the issue of coverage "sponsored or arranged by a religious organization that objects to the coverage of contraceptive services for religious reasons and that is not exempt" under regulations previously issued. The Advance NPRM includes a request for comments, with a comment deadline of June 19, 2012.
  • Notice on Early Retiree Reinsurance Program (ERRP): This notice, also published in the Federal Register on March 21, 2012, serves as an announcement of the timeline for use of reimbursement funds by plan sponsors participating in the ERRP.  Specifically, the notice establishes a December 31, 2014 deadline for such reimbursement fund use.

• HHS releases final Insurance Exchange guidance
  
  On March 12, 2012, the Department of Health and Human Services released the anticipated final rule on insurance exchange establishment and standards for plan, individual, and employer participation. The new regulations will go into effect 60 days after publication in the Federal Register, slated for March 27, 2012.  Because some of the provisions are being issued as interim final rules, comments will be accepted until 45 days after publication. Click here for the rulemaking [PDF]. In addition, click here for fact sheet describing the new rulemaking.
  
  
• CMS issues Electronic Health Record (EHR) Incentive Program NPRM
  
  On February 23, 2012, the Centers for Medicare & Medicaid Services (CMS) issued an NPRM containing Stage 2 criteria for participation in the EHR Incentive Program. Comments on this proposed rule will be due 60 days after publication in the Federal Register, slated for March 7, 2012. Click here to access the NPRM [PDF].

• EBSA releases proposed extension of information collection related to Internal Claims and Appeals and External Review Procedures
  
  On February 22, 2012, the Employee Benefits Security Administration (EBSA) released a notice regarding information collection related to PPACA provisions on internal claims and appeals and external review procedures for non-grandfathered plans. The notice requests comments with respect to the proposed information collection's relationship to prior amendments (1) providing that plans are not required to include diagnosis and treatment codes on notices of adverse benefit determination and final internal adverse benefit notification, and (2) changing the method for determining who is eligible to receive a notice in a culturally and linguistically appropriate manner. Comments will be accepted through April 23. Click here to access the notice.

• Agencies release new guidance on PPACA provisions
  
  Two rulemakings released on February 22, 2012 aim at providing more transparency and assistance in carrying out various of the provisions under PPACA. First, the Centers for Medicare & Medicaid Services (CMS) has issued a final rule on the review and appeal process for Section 1115 Medicaid program demonstrations. The resulting regulations impose requirements designed to ensure transparency and public notice in the demonstration process. Second, the Treasury Department and Department of Health and Human Services have jointly issued regulations on the application, review, and reporting process for seeking waivers for state innovation. These regulations, which go into effect on April 27, 2012, can be accessed by clicking here [PDF]. Further information on both of these rulemakings, as well as a discussion on the new round of Affordable Insurance Exchange Establishment Grants, can be found in a CMS press release.

• New guidance issued on Essential Health Benefits
  
  On February 17, 2012, the Department of Health and Human Services released additional guidance on its website related to PPACA provisions on Essential Health Benefits (EHB). This guidance includes a new FAQ, which supplements prior guidance on the Centers for Medicare & Medicaid Services' likely approach to defining EHB in forthcoming regulatory actions. Click here for the new guidance [PDF].
  
  
• Agencies issue final rules related to women's preventive services coverage
  
  On February 15, 2012, the U.S. Department of Health & Human Services, the Internal Revenue Service, and the Employee Benefits Security Administration collectively published final rules on women's preventive services in the Federal Register. These rules finalized earlier issued interim regulations on the exemption for religious employers from contraceptive services coverage requirements and create a temporary enforcement safe harbor, during which the agencies will consider changes to the regulations. Click here to access this rulemaking [PDF].

• HHS issues proposed rules on the National Practitioner Data Bank
  
  On February 15, 2012, new rules revising existing regulations were published in the Federal Register. Promulgated under section 6403 of PPACA, the new rules would consolidate regulations on the collection and disclosure of all relevant data banks in one CFR part. Comments on this NPRM are due on April 16, 2012. Click here to directly access the proposed rules [PDF].

• Agencies issue Summary of Benefits and Coverage guidance
  
  On February 14, 2012, long anticipated guidance on the Summary of Benefits and Coverage (SBC), required under PPACA, was published in the Federal Register. The guidance includes two rulemakings:
  • Guidance for compliance and notice of availability of Templates, Instructions, and Related Materials.
  • Final SBC rule
  Additional guidance, including final templates, instructions, and related materials, as referenced in the Federal Register notice, is available at www.dol.gov/ebsa/healthreform. For a summary and more information on this guidance, you may also visit HHS.gov, which contains an HHS news release on the rulemaking.

• CMS issues proposed rule on reporting and returning of Medicare overpayments
  
  On February 14, 2012, the Centers for Medicare & Medicaid Services released a new notice of proposed rulemaking on the reporting and return of Medicare overpayments, issued under section 6402(d) of PPACA. The new rules would require such reporting and return by the later of 60 days after identification of the overpayment, or the due date of any corresponding cost report. Comments will be due by April 17, 2012. Click here to access the NPRM [PDF].
  
  
• CCIIO Technical Guidance (CCIIO 2012-001); Questions and Answers Regarding the Medical Loss Ratio Interim Final Rule
  (February 10, 2012)

• IRS issues guidance on automatic enrollment, employer shared responsibility, and waiting periods
  
  On February 9, 2012, the Internal Revenue Service (IRS) released new guidance on automatic enrollment, employer shared responsibility, and waiting periods under provisions of the PPACA health reform law. This guidance, issued in the form of an FAQ as Notice 2012-17, addresses these three issues, as well as the different approaches under consideration for future related regulatory actions. Click here to access the IRS notice [PDF]. You may also visit the Department of Labor website for substantially identical guidance.

• IRS temporary regulations and NPRM to affect insurance issuers participating in CO-OP program
  
  On February 7, 2012, the Internal Revenue Service (IRS) published temporary regulations authorizing the IRS to prescribe certain procedures were published in the Federal Register. Specifically, the temporary regulations allow the IRS to prescribe procedures for recognizing exemptions from Federal income tax with an effect on qualified nonprofit health insurance issuers participating in the Consumer Operated and Oriented Plan (CO-OP) program, created by PPACA. The temporary regulations can currently be found in the Federal Register [PDF]. In addition, an NPRM, with comments due April 9, 2012, which cross-references the temporary regulations, can be found at gpo.gov [PDF].

• CMS issues final rule Medicare Advantage and Prescription Drug Benefits Program rule
  
  On January 11, 2012, CMS released a new final rule implementing and finalizing rules addressing reporting requirements for gross covered retiree plan-related prescription drug costs and retained rebates by Retiree Drug Subsidy sponsors. The rule also addresses CMS's waiver authority. The rule will go into 60 days after publication in the Federal Register, slated for January 12, 2012. Click here for this rulemaking [PDF].

• DOL delegates authority added by PPACA to EBSA
  
  On January 9, 2012 an order of the Department of Labor (DOL) was published in the Federal Register, delegating authority and assigning certain responsibilities to the Employment Benefits Security Administration (EBSA). The order specifically delegates DOL's authority under Sections 45R and 4980H of the Internal Revenue Code (both of which were added through the Affordable Care Act) to EBSA. This delegation includes the authority for defining the term "seasonal worker." Click here for the order [PDF].
  
  
• HHS releases Electronic Funds Transfer rules
  
  On January 5, 2012, the Department of Health & Human Services released new rules regarding Electronic Funds Transfers (EFT). The interim rule with comment period, promulgated pursuant to PPACA "administrative simplification" provisions, aims to create streamlined standards for submissions from health plans to banks when paying provider claims electronically, as well as standards for Remittance Advice notices. The new rules entered effect on January 10, 2012 and have a compliance date of January 1, 2014. Comments are due by March 12, 2012. Click here for rulemaking, accessed through the Federal Register [PDF].

• CMS issues proposed "sunshine" rule
  
  On December 19, 2011, the proposed "sunshine" rule, pursuant to provisions of the Affordable Care Act, was published in the Federal Register. Issued by the Centers for Medicare & Medicaid Services, this proposed rule imposes transparency and reporting requirements on certain drug and medical supply manufacturers covered by Medicare, Medicaid, or CHIP, requiring them to report annually on payments or transfers made to physicians or teaching hospitals. In addition, it requires such manufacturers and group purchasing organizations to report on certain ownership and investment interests. Comments on this proposed rule are due by February 17, 2012. Click here for the proposed rule [PDF].

• Essential Health Benefits Bulletin released by Department of Health and Human Services
  
  On December 16, 2011, the Department of Health and Human Services issued its Essential Health Benefits Bulletin (EHHB), which, pursuant to the Affordable Care Act, outlines proposed policies related to the package of essential health benefits to be offered by individual and small group markets. The EHHB is designed to provide states with flexibility in carrying out requirements under the Affordable Care Act. Click here for the EHHB in its entirety [PDF]. In addition, click here for a CCIIO summary of key aspects of the bulletin.

• Consumer Oriented and Operated Plan Program rule released
  
  On December 13, 2011, the Department of Health and Human Services published in the Federal Register a final rule related to the establishment of the Consumer Operated and Oriented Plan (CO-OP) Program. This program, established under the Affordable Care Act, makes available loans in every state for the creation of "consumer-governed, private, nonprofit health insurance issuers to offer qualified health plans in the Affordable Insurance Exchanges." The final rule will go into effect on February 13, 2012. The first round of grant awards is anticipated for January 2012, with subsequent quarterly application deadlines to follow through the end of 2012. Click here for the final rule in its entirety [PDF].
  
  
• CMS issues ERRP reimbursement announcement
  
  On December 13, 2011, the Centers for Medicare & Medicaid Services announced that, based on projected funding estimates for the Early Retiree Reinsurance Program (ERRP), it would be exercising its authority under 45 C.F.R. § 149.45(a) to deny ERRP reimbursement requests for claims incurred after Dec. 31, 2011. Click here for notice of this announcement [PDF].

• DOL releases MEWA guidance
  
  On December 5, 2011, the Employee Benefits Security Administration (EBSA) released several rulemakings designed to implement provisions of the Affordable Care Act related to multiple employer welfare arrangements (MEWAs). Section 521 of ERISA, enacted under Section 6605 of the Affordable Care Act, authorizes the Secretary of the Department of Labor (DOL) to issue a cease and desist order if it appears that a MEWA is fraudulent, creates an immediate danger to public safety or welfare, or can be reasonably expected to cause significant, imminent, and irreparable injury. It also authorizes the Secretary to issue a summary seizure order if it appears that a MEWA is in a financially hazardous condition.
  
  Accordingly, EBSA has released two proposed rulemakings and two notices to implement the DOL's MEWA authority. First, EBSA has released a proposed rule (1) establishing the procedures for issuance of an ex parte cease and desist or summary seizure order, and (2) establishing procedures for use by ALJs and the Secretary when a MEWA or other person challenges a temporary cease and desist order. Click here for the proposed rule.
  
  Second, EBSA released a proposed rule implementing the registration and reporting requirements for MEWAs under the Affordable Care Act. The proposed rules apply to MEWAs and certain other entities that offer or provide health benefits for employees of two or more employers. Click here for this rulemaking. Both rulemakings will be published in the December 6, 2011 issue of the Federal Register, and comments are due March 5, 2012 (90 days after publication).
  
  Consistent with the two above rulemakings, EBSA has also released two notices of proposed revisions to Form M-1 (Report for MEWAs and Certain Entities Claiming Exception) and Form 5500 (Annual Return/Report filed by administrators of employee benefit plans). These form revisions will update filing requirements for MEWAs pursuant to the Affordable Care Act provisions and proposed rules. Click here for the notice of proposed revisions of the Form M-1. In addition, the proposed revised Form M-1 itself can be found by clicking here. Click here for the notice of proposed revisions to the Form 5500. For further information, you may also wish to view the concurrently issued fact sheet and news release.

• OMB receives hospice services final rule for regulatory review
  
  On December 5, 2011, the OMB received for regulatory review a final rule of the Centers for Medicare & Medicaid Services (CMS) on requirements for long term care facilities with respect to hospice services. According to the relevant announcement, long-term care facilities will be required to have an agreement with hospice agencies when hospice care will be provided. In addition, the final rule will include quality of care requirements. Click here for the announcement of OMB review.

• Centers for Medicare & Medicaid Services releases final MLR rules
  
  On December 4, 2011, the anticipated rules related to Medical Loss Ratio (MLR) requirements under the Affordable Care Act were released by the Centers or Medicare & Medicaid Services (CMS). Under the final rule, health insurance companies are generally required to spend at least 80 percent of premiums on provision of care. Insurance companies that fail to do so will be required to provide rebates to beneficiaries. The final rule provides, among other things, that rebates received will be tax-free and also includes a number of provisions geared at transparency about the MLR requirements. The final rule also phases down the special circumstances adjustment to mini-med plan MLRs but retains the ex-patriate plan multiplier adjustment. This final rule provides for a comment period, with comments due by January 6, 2012. The modifications to the MLR rules included in the final rule will go into effect on January 1, 2012. Click here for the final rule.
  
  Relatedly, CMS concurrently issued an interim final rule with request for comments on MLR rebate requirements for non-federal governmental plans in group markets. Under the interim final rule, issuers of such plans are to distribute entire MLR rebates to the group policyholder, and the group policyholder is required to use the portion of rebates attributable to the premium paid by subscribers of such plans for the benefit of subscribers. This interim final rule likewise will go into effect on January 1, 2012. Comments are due 60 days after publication in the Federal Register, which is slated for December 7, 2011. Click here for this rulemaking.
  
  Finally, in light of the MLR rule updates, the Department of Labor (DOL) issued Technical Release No. 2011-04 regarding MLR rebates issued to policyholders who are group health plans under ERISA. According to the guidance, if a group health plan is entitled to a rebate, such rebates may constitute plan assets, requiring the policyholder to comply with ERISA fiduciary provisions for handling the rebates. If the plan sponsor is the policyholder, then the plan's portion of the rebate, if any, may depend on provisions of the plan or the manner of cost-sharing under the policy. The guidance, however, does not expressly address when an MLR rebate becomes an ERISA plan asset or whether an issuer delivering a rebate could be an ERISA fiduciary. Click here for the Technical Release.

• ACO guidance published in Federal Register
  
  On November 2, 2011, the ACO and Shared Savings Program guidance, originally released on October 20, was published in the Federal Register. The interim final rule with comment period addressing Shared Savings Program waivers can now be found by clicking here. These regulations go into effect on November 2, 2011, with comments due by January 3, 2012. The final rule on the Shared Savings Program and ACOs, which enters into effect on January 3, 2012, can now be found by clicking here. Finally, the notice announcing testing of the Advance Payment Model for ACOs is now available by clicking here.
  
  Finally, in addition to the CMS guidance on ACOs, the Federal Trade Commission and the Department of Justice released the final version of their joint policy statement addressing enforcement of antitrust law in the ACO and Shared Savings program context. The final policy statement was published in the Federal Register on October 28, 2011, and can be found by clicking here.

• CMS releases set of Medicare payment systems guidance
  
  On November 2, 2011, the Centers for Medicare & Medicaid Services (CMS) released several rulemakings on the public inspection desk related to Medicare payment systems and related revisions to existing regulations. First, CMS released a final rule with comment period revising the Medicare hospital outpatient and ambulatory surgical center payment systems. In addition, this rule contains revisions to the Hospital Value-Based Purchasing Program, provisions on exceptions to the physician self-referral prohibition, and patient notification requirements in provider agreements. The new regulations will be effective January 1, 2012, with comments on the final rule due by March 2, 2012. This rulemaking can currently be found here.
  
  Second, CMS released a final rule containing updates to the End-Stage Renal Disease (ERSD) prospective payment system for 2012. This rule also finalizes prior guidance in the form of an interim final rule. In addition to the ERSD-related updates, this rule revises the ambulance fee schedule regulations and durable medical equipment regulations. This rule likewise goes into effect on January 1, 2012. It can currently be found by clicking here.
  
  Finally, CMS released an additional final rule with comment period revising the Part B physician fee schedule and payment policies so as to conform with changes in medical practice and the relative value of services. These regulations also go into effect on January 1, 2012, and comments are due 60 days after the date of issuance for public inspection (i.e. 60 days from November 2, 2011). This final rule can be found by clicking here.

• HHS announces extension of Temporary Certification Program
  
  On November 2, 2011, the Department of Health and Human Services (HHS) released a notice announcing the extension of the Temporary Certification Program. This program helps make Certified Electronic Health Record (EHR) Technology available for adoption and use for participants in the Medicare and Medicaid EHR Incentive Programs. Originally set to expire on December 20, 2011, the Temporary Certification Program will be extended to align with the effective date of forthcoming rules adopting new standards and rules regarding meaningful use of EHR technology. The notice announcing the extension can presently be found by clicking here.
  
  
• CMS announces new Medicare premiums and deductibles for 2012
  
  On November 1, 2011, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register several notices setting forth new Medicare premium and deductible rates for the upcoming year. First, CMS announced new inpatient hospital deductibles and hospital and extended care services coinsurance amounts for Medicare Part A. Click here for this announcement. Second, CMS announced Medicare Part B monthly actuarial rates, premium rates, and annual deductibles. Click here for this notice. Finally, CMS announced Medicare Part A premiums for uninsured aged and certain disabled individuals who have exhausted other entitlement. Click here for this notice. The new rates will enter into effect as of January 1, 2012.

• Centers for Medicare & Medicaid Services releases final ACO rule and additional guidance
  
  On October 20, 2011, the Centers for Medicare & Medicaid Services released the final rule on the Medicare Shared Savings Program, in addition to further related guidance, for Accountable Care Organizations (ACOs). The Shared Savings Program is an initiative geared toward more coordinated care among providers. The program enables ACO providers and suppliers to receive traditional fee-for-service payments under Medicare Parts A and B, and to become eligible for additional payments if they meet program quality standards and savings requirements. According to the Department of Health and Human Services (HHS), the final rule includes broader incentives and a streamlining of the program in comparison to the earlier proposed rule. The regulations will go into effect 60 days after publication in the Federal Register, which is slated for November 2, 2011. Click here for the final rule.
  
  In addition to the final Shared Savings Program rule, CMS has released (1) a notice announcing testing of the Advance Payment Model for ACOs, and (2) an interim final rule with comment period on waivers of application of the physician self-referral law, anti-kickback statute, and certain civil monetary penalty provision to ACOs. The first notice provides information for interested physician-owned and rural providers participating in the Shared Savings Program, with background about the model and the application process. Click here for the notice. Click here for the interim final rule on waiver provisions, issued jointly with the HHS Office of Inspector General. Comments on the interim final rule are due 60 days after publication in the Federal Register, also slated for November 2, 2011.
  
  
• CMS issues regulatory reduction guidance
  
  On October 18, 2011, CMS issued three new rulemakings, all with a purpose of regulatory reduction and the elimination of burdensome and unnecessary regulations. The rulemakings include:
  
  
  • Final rule on Medicare Changes to the Ambulatory Surgical Centers Patients Rights Conditions for Coverage. This rule "revises the ambulatory surgical centers (ASCs) conditions for coverage (CfC) to allow patient rights information to be provided to the patient, the patient's representative, or the patient's surrogate prior to the start of the surgical procedure."
  • Proposed rules on Reform of Hospital and Critical Access Hospital Conditions of Participation for both Medicare and Medicaid.
  • Proposed rules on Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction. This proposed rule targets regulatory areas for reduction and revision, including but not limited to conditions for coverage for end-stage renal disease facilities, conditions for coverage for ambulatory surgical centers, revocation and deactivation of Medicare enrollment and billing privileges rules, intermediate care facilities for the intellectually disabled, obsolete provisions related to claims determinations and appeals, the ambulatory surgical center infection control program, e-prescribing, physical and occupational therapist qualifications, and organ donation.

All three rulemakings are slated for publication in the Federal Register on October 24, 2011.

• IOM Issues Report, Essential Health Benefits: Balancing Coverage and Costs
  
  The Patient Protection and Affordable Care Act (ACA) requires that healthcare benefits offered to individuals and small groups include a package of "essential health benefits" (EHB). The ACA provides some parameters and guidance for what EHB should include, but stops well short of defining EHB. On October 7, 2011, the Institute of Medicine (IOM) issued a 314-page report that undertakes to answer the question, "How, exactly, should one go about deciding what to include as essential in a health insurance plan?" That is, the IOM report describes how the federal government should go about defining EHB. The chief concern relating to EHB's definition, as the report's preface notes, is that "[i]f the package of benefits is too narrow, health insurance might be meaningless; if it is too broad, insurance might become too expensive."
  
  The IOM panel made two key decisions that framed the rest of the defining process. First, it decided that a "typical employer" should be a small rather than a large employer, and made a small employer's business profile basic to the cost criteria for definitions of EHB. And second, the panel opted for a definition of "essential" that establishes a set of basic requirements and that does not encompass every service included in the 10 statutorily mandated service categories or every service included in a typical employer plan.
  
  These antecedent definitions make up much of the platform on which the panel rests Chapter 5, "Defining the EHB," which spells out steps for arriving at a definition in Recommendation 1:
  
  By May 1, 2012, the Secretary should establish an initial essential health benefits (EHB) package guided by a national average premium target.
  
  
  1. The starting point in establishing the initial EHB package should be the scope of benefits and design provided under a typical small employer plan in today's market. To specify the initial EHB package, this scope of benefits should then be modified to reflect
     • The 10 general categories specified in Section 1302(b)(1) of the Affordable Care Act (ACA); and
     • The criteria specified in this report for the content of specific elements and aggregate EHB package (see Summary Figure S-2).
  2. Once a preliminary EHB list is developed as described in (A), the package should be adjusted so that the expected national average premium for a silver plan with the EHB package is actuarially equivalent to the average premium that would have been paid by small employers in 2014 for a comparable population with a typical benefit design.
  3. The Secretary should sponsor a public deliberative process to assist in determining how the adjustments to the EHB package should be made.
  4. Initial guidance by the Secretary on the contents of the EHB package should list standard benefit inclusions and exclusions at a level of specificity at least comparable to current best practice in the private and public insurance market.
  
  Other salient points in the IOM report include a discussion of how to define "medical necessity" (Chapter 5), a recommendation that HHS establish a research framework for collecting and analyzing data in order to evaluate EHB implementation (Chapter 7), and support for potential waivers from the federally defined EHB to states whose alternative EHB definitions are consistent with the ACA and with the criteria specified in IOM's report (Chapter 8).
  
  
• The Institute of Medicine has released a report at the request of the Department of Health and Human Services regarding criteria and methods to develop an essential benefits package
  
  An October 6 news release issued concurrently with the report states that essential benefits should be based on what small businesses typically offer. Click here for news release; click here for the "Report in Brief."
  
  
• OMB to review rule on Medicare Shared Savings Program: Accountable Care Organizations
  
  On October 6, 2011, OMB received for review a CMS final rule designed to implement provisions of PPACA related to Medicare payments to providers and suppliers participating in Accountable Care Organizations (ACOs). The new rules will enable such providers and suppliers to receive traditional Medicare fee-for-service payments under Parts A and B, and to become eligible for other payments based on applicable quality and savings standards. OMB's announcement of its review of this rule can be found here.
  
  
• CMS issues proposed rule to revise Medicare Parts C and D regulations
  
  On October 3, 2011, the Centers for Medicare & Medicaid Services (CMS) released on the Federal Register's Electronic Public Inspection Desk a new proposed rule designed to implement revisions to the Medicare Advantage (MA) program (Part C) and prescription drug benefit program (Part D) regulations. The revisions address a number of goals, namely: "to implement new statutory requirements; strengthen beneficiary protections; exclude plan participants that perform poorly; improve program efficiencies; and clarify program requirements." In addition, CMS is considering revisions to the long term care facility conditions of participation requirements for pharmacy services. Comments on the proposed rule will be due 60 days after publication in the Federal Register, which has been slated for Tuesday, Oct. 11. Among the revisions considered, highlights include:
  
  
  • Implementation of Affordable Care Act with regard to the consolidation of prior guidance on the Coverage Gap Discount Program and implementation of Pharmacy Benefit Manager reporting requirements under Part D;
  • Implementation of MIPPA provision related to benzodiazepines and barbiturates as Part D drugs;
  • Provisions for beneficiary reinstatement into cost plans when good cause for failure to pay premiums can be established;
  • Provision of uniform ID cards for MA plan enrollees and guidance related to the determination of creditable coverage for the retiree drug subsidy;
  • A process for Independent Review Entity (IRE) reconsideration of Part D coverage determinations;
  • Procedures and standards for the exclusion of poor performers in the Parts C and D programs;
  • Measures to reduce costs, including the elimination of the requirement to purchase print advertising announcing non-renewal of cost contractors, implementation of hospital-acquired conditions and present-on-admission indicator policy for MA plans, changes to rules regarding agent/broker compensation, and cost-sharing associated with trial fills of prescription drugs;
  • And further codification and clarification of prior guidance under Parts C and D.
    The proposed rule can currently be accessed here.
    
    
• Comment period for Exchange guidance extended to Oct. 31, 2011
  
  HHS has announced the extension of the comment period for both the proposed rule implementing the Affordable Insurance Exchange program and also the proposed rule implementing standards for States and insurance issuers related to reinsurance, risk adjustment, and risk corridors. Further information can be found at
  http://www.gpo.gov/fdsys/pkg/FR-2011-09-30/pdf/2011-25202.pdf.

• CMS issues information request related to PPACA state "Basic Health Program" option
  
  On September 9, 2011, CMS issued on the Public Inspection desk a notice seeking information related to a state's option to establish a Basic Health Program under PPACA § 1331, rather than provide health coverage through the Affordable Insurance Exchange program. In addition to detailing PPACA provisions related to this program, the information request solicits responses to specific questions targeted at informing CMS's process of developing standards for the establishment and operation of a state Basic Health Program. Comments responses to the information collection request are due by 5 p.m. 45 days after publication in the Federal Register, which is slated for Sept. 14, 2011. Click here to access the notice [PDF].

• CMS issues final rule amending definitions of "individual market" and "small group market"
  
  On September 6, 2011, a CMS final rule on rate increase disclosure and review and definitions of "individual market" and "small group market" was published in the Federal Register. This final rule amends a May 23, 2011 final rule in light of comments received and amends the definitions of "individual market" and "small group market" for rate review purposes "to include coverage sold to individuals and small groups through associations even if the State does not include such coverage in its definitions of individual and small group market." In addition, the rule also includes updates to standards related to disclosure of unreasonable premium increases. This rule goes into effect on Nov. 1, 2011, click here to access [PDF].

• CMS issues notice regarding Bundled Payments for Care Improvement Initiative applications
  
  On August 25, 2011, CMS posted in the Federal Register a notice requesting applications for the Bundled Payments for Care Improvement initiative. This initiative has been established to explore "episode-based payment for acute care and associated post-acute care, using both retrospective and prospective bundled payment methods." Letters of intent are due by Sept. 22 for Model 1, and by Nov. 4 for Models 2 through 4. Click here to access the notice [PDF].
  
  
• Summary of Benefits and Coverage guidance issued by CMS
  
  On August 22, 2011, HHS, IRS, and EBSA jointly published in the Federal Register new guidance related to disclosure of summary of benefits and coverage information for group health plans and health insurance coverage in the group and individual markets pursuant to PPACA. Comments on this rulemaking are due by Oct. 21, 2011. The Federal Register version of this proposed rule can be accessed by clicking here [PDF]. In addition to the proposed rule, further related guidance has been released by EBSA. Such guidance includes a Summary of Benefits and Coverage (SBC) template, a sample completed SBC, instructions for SBC completion for both group health plans and individual health insurance coverage, a guide for coverage examples calculations, a glossary, and "Why this matters" guidance. These items may be found on the EBSA website.
  
  
• IRS issues guidance on annual fee for branded prescription drug manufacturing and importing
  
  On August 15, 2011, the IRS issued new guidance related to provisions of PPACA enacting an annual fee for entities engaged in the manufacturing or importing of branded prescription drugs. The new guidance was issued in the form of both temporary regulations and a proposed rule. Both rulemakings are slated for publication in the Federal Register on August 18, 2011. Comments on the proposed rule and requests for public hearing are due within 90 days of publication in the Federal Register. For further information, please see the proposed rule and temporary regulations respectively here and here.
  
  
• Agencies release second round of "Affordable Insurance Exchange" guidance
  
  On August 12, 2011, several rulemakings were released related to the insurance exchange program enacted under PPACA. The first of these is an HHS proposed rule on exchange functions in the individual market, eligibility rules, and standards for employer participation in the SHOP program for small businesses. CMS also released a proposed rule implementing PPACA provisions related to Medicaid eligibility, aiming to promote better coordination of Medicaid and CHIP with the insurance exchange program. Finally, an IRS proposed rule lays out requirements related to the premium tax credit available to individuals participating in the exchange program. Comments on all three rulemakings are due within 75 days of publication in the Federal Register, slated for August 17, 2011. These three rulemakings can be found respectively on the Public Inspection Desk here and here, and here. Concurrent with the new exchange guidance, HHS has also announced new recipients of its Exchange Establishment grants. Further information about this announcement is available here.
  
  
• Preventive care guidance and rulemakings issued
  
  On August 1, 2011, new guidance and regulations related to preventive care, promulgated under PPACA, were issued by the responsible federal agencies. Specifically, the Internal Revenue Service (IRS), jointly with the Employee Benefits Security Administration (EBSA) and Health and Human Services Department (HHS), released an amendment to the interim final regulations implementing the rules for group health plans and health insurance issuers relating to coverage of preventive services under PPACA. This amendment was published in the Federal Register on August 3, 2011, with comments are due by September 30. This rulemaking can be accessed directly here. Along with this amendment, the IRS issued a separate notice of proposed rulemaking, adopting by cross reference the language of the above joint amendment. This notice of proposed rulemaking is likewise available here. Under the concurrent guidance issued by the Health Resources and Services Administration (HRSA), coverage for women's preventive services will be required of all new health plans, beginning August 1, 2012, at no additional cost to the patient. More information about the HRSA guidelines and PPACA's provisions on preventive care can be found here.
  
  
• CCIIO announces grant opportunity
  
  The CMS Center for Consumer Information & Insurance Oversight (CCIIO) website has posted a link to the announcement of a grant opportunity available to participants in the Consumer Operated and Oriented Plan (CO-OP) program. The CO-OP program is designed to increase competition in the insurance market by encouraging the creation of private, non-profit consumer-based health insurance plans. Click here for further information about the grant and the application process. Voluntary letters of intent to apply for funding are requested as soon as possible, and first round applications are due October 17, 2011.
  
  
• OMB receives interim rule on preventive services for review
  
  On July 28, 2011, OMB received for regulatory review a CMS interim final rule on preventive services under PPACA. Further information can be found here.

• PPACA-related information collection requests issued by CMS
  
  Two information collection requests were published in the July 29, 2011 Federal Register, both concerning aspects of PPACA.
  • The first has a number of components. First, it would extend reporting requirements for programs established under PPACA to provide consumer assistance in resolving problems related to health coverage. Second, it seeks to create a database to store and track consumer inquiries to the agency on health coverage issues. Third, it would revise the existing information collection related to cooperative agreements to support state-operated insurance exchange programs. Comments are due 30 days after publication in the Federal Register. The notice may be found online here.
  • The second concerns a nationwide survey of health insurers to better understand the effect of PPACA insurance market reforms on premiums and coverage for certain benefits. Comments are due in 30 days. It may be found here.

• Corrections issued for interim final rules on group health plan internal claims and appeals and external review processes
  
  On July 26, 2011, corrections to interim final rules jointly issued by the Internal Revenue Service, Employee Benefits Security Administration, and Department of Health and Human Services were published in the Federal Register. The corrections can be accessed here.

• OMB receives proposed rules from CMS for regulatory review
  
  On July 26, OMB received for review two additional proposed rules being promulgated under PPACA. The first proposed rule, concerning "Uniform Explanation of Benefits, Coverage Facts, and Standardized Definitions," addresses standards applicable to group health plans and health insurance issuers in providing coverage and benefits information, as well as sets forth standard definitions of terms used in policies. Further information may be found here. The second proposed rule addresses aspects of the "Affordable Insurance Exchanges," including provisions on individual eligibility requirements and standards for verification of employer-sponsored health coverage, employer appeals, and employer SHOP participation. Additional information is available here.

• CMS issues proposed rule on Consumer Operated and Oriented Plans (CO-OP) program
  
  On July 20, 2011, the proposed rule on the CO-OP program was published in the Federal Register. This program involves the creation of private, non-profit consumer-based health insurance plans, designed to elevate competition in the insurance market. Comments are due by September 16, 2011. The proposed rule can be found in its entirety here.

• CMS issues proposed rule on payment policies under the physician fee schedule and other revisions to Medicare Part B for CY 2012
  
  The July 19, 2011 issue of the Federal Register published a proposed rule on various changes to payment policies, reflecting changing practices and new requirements under PPACA. Comments are due by August 30, 2011. The proposed rule may be accessed here.
  
  
• CCIIO Technical Guidance (CCIIO 2011-004); Questions and Answers Regarding the Medical Loss Ratio Interim Final Rule
  (July 18, 2011)

• CMS issues proposed rule revising payment systems for hospital outpatient care and ambulatory surgical centers and proposing other Medicare changes
  
  This CMS proposed rule was published in the July 18, 2011 issue of the Federal Register. In addition to payment system revisions, the proposed rule seeks to revise Hospital Outpatient Quality Reporting Program requirements, ASC Quality Reporting System Requirements, Hospital Inpatient Value-Based Purchasing Program provisions, Medicare Electronic Health Record Incentive Program requirements, exceptions to physician self-referral rules, and patient notification requirements. Comments are due August 30, 2011. This proposed rule can be accessed here.

• Department of Health and Human Services releases Affordable Insurance Exchange proposed regulations
  
  A set of two proposed rules governing a host of requirements for implementation of Affordable Insurance Exchanges was released by the Department of Health & Human Services on July 11, 2011. The exchange program is a key component of the health law reforms promulgated under PPACA. Together, the new proposed rules provide guidance for the operation of the anticipated exchange program, which aims to create a competitive marketplace for information about and purchase of affordable private health insurance by individuals and small businesses. The exchange program is currently set to go into effect on January 1, 2014. The proposed regulations separately address a number of issues regarding program requirements and implementation:

  • The first proposed rule sets forth core federal standards for creation and operation of exchanges on a state-by-state basis. In addition, the proposed rule addresses requirements for employer participation in the Small Business Health Options Program (SHOP) and establishes certification requirements for health plan participation in the exchange program. As a general matter, the proposed rule aims to promote flexibility for states in choosing how to design and implement exchange programs under the regulations. Comments are due 75 days after publication in the Federal Register, which is slated for July 15. Click here to view the proposed rule online.
  • The second proposed rule focuses on premium rate stabilization and sets forth standards for both states and health plans for achieving this goal. Specifically, the proposed state-based reinsurance program is designed to adjust for uncertain risks by making payments in the individual market where costs are particularly high. In addition, a temporary federal risk corridor program aims to limit both issuer losses and gains. Finally, a state-based risk adjustment program will make payment to health insurers with especially high-risk beneficiaries. Comments on this proposed rule are also due 75 days after publication in the Federal Register, set for July 15. Click here to view the proposed rule online.

• CMS issues proposed rule revising policy on clinical diagnostic laboratory tests
  
  On June 29, 2011, the Centers for Medicare & Medicaid Services released a proposed rule retracting earlier policy under the Medicare 2011 Physician Fee Schedule final rule. Under the new proposed rule, a signature from a physician or qualified non-physician practitioner is no longer required for requisition for clinical diagnostic laboratory tests paid under the Clinical Laboratory Fee Schedule. Comments on the proposed rule are due 60 days from the date of issuance. Click here to access the proposed rule [PDF].
  
  
• HHS issues notice of availability of proposed data collection standards for race, ethnicity, primary language, sex, and disability status
  
  On June 29, 2011, the Department of Health and Human Services (HHS) issued a notice pursuant to the Affordable Care Act proposing new draft standards for HHS data collections. According to a concurrently issued press release, the new standards will aid the Department in better understanding health disparities across various characteristics. Comments on the notice are due August 1, 2011. Click here to access the notice [PDF].
  
  
• Amendment to 2010 interim final rule on internal claims and appeals and external review processes under Affordable Care Act issued
  
  On June 22, 2011, the Internal Revenue Service (IRS), Employee Benefits Security Administration (EBSA), and Department of Health and Human Services (HHS) jointly issued an amendment to a 2010 interim final rule on appeals procedures under the Affordable Care Act. The amendments to the 2010 regulations under the new interim rule address:
  • Expedited notification of benefit determinations involving urgent care;
  • Notice requirements for internal claims and appeals;
  • Deemed exhaustion of internal claims and appeals processes;
  • Form and manner of notice for internal claims and appeals;
  • The duration of the transition period for State external review processes;
  • Scope of the Federal External Review Process;
  • Clarification regarding requirement that external review decision be binding; and
  • Other technical guidance.
  In light of the amendment, additional technical guidance has been published by the involved agencies. The amendment was published in the June 24, 2011 issue of the Federal Register, click here to access [PDF]. Comments are due by July 25, 2011.

• CMS issues proposed rule on Conditions of Participation for Community Mental Health Centers
  
  On June 16, 2011, the Centers for Medicare & Medicaid Services released a proposed rule setting forth conditions of participation (CoPs) for Community Mental Health Centers (CMHCs). The CoPs will consist of health and safety standards designed to better ensure quality of care for Medicare beneficiaries receiving health services at CMHCs. In the past, no such conditions of Medicare participation have been required by the agency for CMHCs. The proposed standards specifically address areas including "(1) personnel qualifications; (2) client rights; (3) admission, initial evaluation, comprehensive assessment, and discharge or transfer of the client; (4) treatment team, active treatment plan, and coordination of services; (5) quality assessment and performance improvement; and (6) organization, governance, administration of services, and partial hospitalization services." Comments on the proposed rule are due by Aug. 16, 2011. For more information, click to access the proposed rule [PDF].
  
  
• CMS extends deadline on Pioneer Accountable Care Organization Model applications
  
  The Centers for Medicare & Medicaid Services has issued a notice extending the deadline for submission of Pioneer Accountable Care Organization (ACO) Model applications to August 19, 2011.& In addition, letters of intent are now due June 30, 2011. Click here for the notice [PDF].
  
  
• New accountable care model information from CMS
  
  CMS has announced details on two new "accountable care organization" approaches under the Medicare program.
  
  -- First, the CMS Innovation Center is now accepting applications for the "Pioneer ACO Model," which will provide a faster path for mature ACOs that have already begun coordinating care for patients. Organizations interested in applying to the Pioneer ACO Model must submit a letter of intent on or before June 10, 2011. Applications must be received on or before July 18, 2011. The Pioneer ACO Request for Application, the Letter of Intent form and the Application form may be accessed at http://innovations.cms.gov/areas-of-focus/seamless-and-coordinated-care-models/pioneer-aco. The Innovation Center will hold an Open Door Forum to review the Pioneer ACO Model Request for Application on June 7, 2011.
  
  The Pioneer ACO Model is designed for health care organizations and providers that are already experienced in coordinating care for patients across care settings. It will allow these provider groups to move more rapidly from a shared savings payment model to a population-based payment model on a track consistent with, but separate from, the Medicare Shared Savings Program. The government says it is designed to work in coordination with private payers by aligning provider incentives, which will improve quality and health outcomes for patients across the ACO, and achieve cost savings for Medicare, employers and patients.
  
  The payment models being tested in the first two years of the Pioneer ACO Model are a shared savings payment policy with generally higher levels of shared savings and risk for Pioneer ACOs than levels currently proposed in the Medicare Shared Savings Program. In year three of the program, participating ACOs that have shown a specified level of savings over the first two years will be eligible to move a substantial portion of their payments to a population-based model.
  
  Pioneer ACOs will be expected to improve the health and experience of care for individuals, improve the health of populations, and reduce the rate of growth in health care spending. Participating ACOs will be held financially accountable for the care provided to their aligned beneficiaries. In addition, CMS will publicly report the performance of Pioneer ACOs on quality metrics, including patient experience ratings, on its website.
  
  -- Second, the CMS Innovation Center is seeking public comments on whether it should offer an Advance Payment Initiative that would allow certain ACOs participating in the Medicare Shared Savings Program access to a portion of their shared savings up front, helping providers make the infrastructure and staff investments crucial to successful ACOs. The advance payment would be made in the form of a monthly payment for each aligned Medicare beneficiary. Advance payments would be recouped through the ACOs' earned shared savings. ACOs would need to provide a plan for using these funds to build care coordination capabilities, and meet other organizational criteria.Public comments are sought by June 17th, 2011.
  
  More information about the Advance Payment ACO Model can be found at: http://innovations.cms.gov/areas-of-focus/seamless-and-coordinated-care-models/advance-payment/. The Innovation Center will accept comments on the Advance Payment ACO Model, if submitted prior to June 17, 2011. Comments should be submitted via email to: advpayACO@cms.hhs.gov.
  
  CMS will also be offering ACO Accelerated Development Learning Sessions to provide the executive leadership teams from existing or emerging ACO entities the opportunity to learn about essential ACO functions and ways to build capacity needed to achieve better care, better health and lower costs through integrated care models. Four sessions will be offered in 2011. Each will include a focused curriculum on core competencies for ACO development, such as improving care delivery to increase quality and reduce costs; effectively using health information technology and data resources; and building capacity to assume and manage financial risk. Additionally, the Accelerated Development Learning Sessions will not discuss elements of or specific requirements for participation in any CMS ACO program, including the Medicare Shared Savings Program.
  
  Individuals wishing to attend the June Accelerated Development Learning Session in person may register at https://acoregister.rti.org.
  
  
• CMS Rules on Premium Increases (May 19, 2011) – HHS has issued a final rule requiring independent review at the state level for proposed premium rate increases of 10 percent or more for individual and small group health insurance plans. HHS will serve in a backup role in states that don't have the resources or authority to review rates. Starting September 2012, the 10-percent threshold will be replaced by state-specific thresholds that reflect the insurance and health care cost trends in each state. The final rule clarifies that HHS will work with states in developing these thresholds. The rule requires insurance companies to provide consumers with information about the reasons for certain rate increases and post the justification for those hikes on their website as well as on the HHS Affordable Care Act website. The regulation issued today finalizes proposed rules issued in December 2010. The final rule has several additions to the proposed rule, including a requirement that states provide an opportunity for public input in the evaluation of rate increases subject to review. HHS is also requesting comment from the public on applying the rule to individual and small group coverage sold through associations.
  
  
• CCIIO Technical Guidance: Deadline for Submission of 2011 First Quarter MLR Data by Issuers of "Mini-med" and Expatriate Plans (May, 19, 2011)
  
  
• CCIIO Technical Guidance: Submission of 2011 Quarterly Reports of MLR Data by Issuers of "Mini-med" and Expatriate Plans (April 26, 2011)
  
  
• Accountable Care Organizations Regulations, Centers for Medicare & Medicaid Services, HHS (March 31, 2011) – CMS has issued the long-awaited proposed Accountable Care Organizations (ACO) regulations implementing section 3022 of the Affordable Care Act, which contains provisions relating to Medicare payments to providers of services and suppliers participating in ACOs. Under these provisions, providers of services and suppliers can continue to receive traditional Medicare fee-for-service payments under Parts A and B while being eligible for additional payments based on meeting specified quality care and financial savings requirements. Comments on the proposed regulations are due 60 days from the publication of the regulations in the Federal Register, which is currently slated for April 7, 2011.
  
  Several other Federal agencies have also released content related to the ACO regulations:
  • CMS and HHS OIG jointly issued a notice with comment period outlining proposals for waivers of the Stark law, the anti-kickback statute, and certain provisions of the civil monetary penalty law in connection with the Medicare Shared Savings Program. The joint notice is available here.
  • The FTC and the DOJ jointly issued a "Proposed Statement of Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program." This statement is available here.
  • The IRS issued a notice requesting comments regarding the need for guidance on participation by tax-exempt organizations in the Medicare Shared Savings Program through ACOs. The IRS notice is available here.

  Lastly, CMS has provided several fact sheets related to ACOs that can be accessed here.

• IRS Issues Guidance on Mandatory Form W-2 Informational Reporting of Employer-Sponsored Health Coverage
  On March 29, 2011, the IRS issued Notice 2011-28 , which provides interim guidance to employers regarding the new Form W-2 reporting requirement for employer-sponsored group health coverage. This requirement was added to the Internal Revenue Code by last year's health reform legislation, the Patient Protection and Affordable Care Act of 2010, Pub. L. No. 111-149. The IRS has requested comments, which are due by June 27, 2010, on this interim guidance. Click here for more.
  
  
• Consumer Disclosure Notices of Proposed Health Insurance Rate Increases, Department of Health & Human Services (March 7, 2011) – HHS has published proposed consumer disclosure notices that insurers would be required to complete when proposing rate increases of more than 10 percent. The disclosure notices then would be published on the Health and Human Services Department website while insurers' proposed increases are reviewed. HHS published its notice of information collection request for the rate increase disclosures in the March 1, 2011 Federal Register.
  
  
• Student Health Insurance Coverage, Centers for Medicare & Medicaid Services, HHS (Feb. 11, 2011) – This proposed rule seeks to extend key consumer protections under the Patient Protection and Affordable Care Act, as amended, to students enrolled in student health plans by clarifying that "student health insurance coverage" would be defined as "as a type of individual health insurance coverage," but, pursuant to section 1560(c) of the Affordable Care Act, certain Public Health Service Act and PPACA requirements would be inapplicable to this type of individual health insurance coverage. Section 1560(c) states:

  [N]othing in this title (or an amendment made by this title) shall be construed to prohibit an institution of higher education (as such term is defined for purposes of the Higher Education Act of 1965) from offering a student health insurance plan, to the extent that such requirement is otherwise permitted under applicable Federal, State, or local law.

  For example, the proposed rule would ultimately prohibit lifetime limits on coverage, but issuers of student health insurance coverage would be provided a slightly different transition period from the transition period provided in the interim regulations prohibiting annual and lifetime limits that were issued on June 28, 2010. HHS officials are seeking comments on what provisions of PPACA may be found inapplicable pursuant to section 1560(c), such as provisions governing the choice of medical providers and the application of the new medical loss ratio rules.
  
  Comments are due by April 12, 2011. This proposed rule would apply to policy years beginning on or after January 1, 2012.

• Planning and Establishment of Consumer Operated and Oriented Plan Program; Request for Comments Regarding Provisions of Consumer Operated and Oriented Plan Program, Office of Consumer Information and Insurance Oversight (Feb 2, 2011) - HHS's OCCIO requests comments regarding regulatory implementation of section 1322 of PPACA prior to rulemaking. Section 1322 of PPACA requires the Secretary to establish the Consumer Operated and Oriented Plan (CO-OP) program to foster the creation of "qualified nonprofit health insurance issuers" that will offer qualified health plans in the individual and small group markets. Under the CO-OP program, the Secretary will make loans to assist in funding start-up costs for qualified nonprofit issuers and will award grants to assist such issuers in meeting State solvency requirements. Comments are due by March 4, 2011.
  
  
• HHS publishes mini-med plan waivers. The Office of Consumer Information and Insurance Oversight has posted a summary and list of waivers it has granted through January 26, 2011 for mini-med health plans that do not provide the scope of coverage required under PPACA's three year phase out of mini-med plans. By 2014, health plans will be required to phase out annual dollar limits on benefits.
  
  
• Delay of PPACA Nondiscrimination Provisions Applicable to Insured Group Health Plans, IRS (Jan. 10, 2011) – PPACA, as amended, establishes certain nondiscrimination rules that prohibit insured group health plans, in part, from discriminating in favor of highly compensated individuals. The IRS issued Notice 2011-1 (Notice) in order to delay the application of PPACA's nondiscrimination rules to insured group health plans until further guidance is issued at an unspecified later date. Specifically, the Notice states that the Treasury Department and the IRS, as well as the Departments of Labor and Health and Human Services, have determined that compliance with these requirements should not be required (and thus, any sanctions for failure to comply do not apply) until after regulations or other administrative guidance of general applicability have been issued.
  
  The Notice also solicits public comment on numerous issues, including what information should be included in future guidance on the topic. Comments are due no later than March 11, 2011.

• Corrections to the Medical Loss Ratio Interim Final Rule. The HHS Office of Consumer Information and Insurance Oversight has published "technical corrections" to the interim final rule that appeared in the December 1, 2010 Federal Register implementing medical loss ratio requirements under the Patient Protection and Affordable Care Act.
  
  
• Information Collection for Early Retiree Reinsurance Program, HHS Office of Consumer Information and Insurance Oversight (Dec. 23, 2010) -- HHS published an information collection notice for the PPACA Early Retiree Reinsurance Program in the Federal Register outlining information requirements anticipated for the new program under which employers who submit documentation of actual costs of health care benefits can receive federal reinsurance subsidieis under section 1102 of PPACA and 45 CFR part 149.
  
  
• Rate Increase Disclosure and Review, HHS Office of Consumer Information and Insurance Oversight (OCIIO) (December 23, 2010) – HHS published its notice of proposed rulemaking (NPRM) to implement rules for health insurance issuers regarding the disclosure and review of unreasonable premium increases under revised section 2794 of the Public Health Service Act. The proposed rule would establish a rate review program to ensure that all rate increases that meet or exceed an established threshold are reviewed by a State or HHS to determine whether the rate increases are unreasonable.
  
  
• Affordable Care Act Implementation FAQs Part 5, Dept. of Labor, HHS, Dept. of Treasury (December 22, 2010) – HHS has posted a fifth iteration of PPACA implementation FAQs on its website. These recently issued FAQs address both the implementation of PPACA's market reform provisions, as well as the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA). Specifically, the fifteen questions in the fifth set of FAQs touch upon the following: (1) value-based insurance design in connection with preventive care benefits; (2) automatic enrollment in health plans; (3) disclosure under Public Health Service Act section 2715(d)(4); (4) dependent coverage of children to age 26; (5) preexisting condition exclusions for children in the individual market; (6) grandfathered health plans; (7) MHPAEA; and (8) nondiscrimination based on a health factor and wellness programs.
  
  All five PPACA implementation FAQs are available here.
  
  
• IRS Delays Implementation of PPACA's Extension of Nondiscrimination Rules to Insured Plans
  
  On December 22, the Internal Revenue Service (IRS), with the approval of the Departments of Treasury, Labor and Health and Human Services, announced that insured health plans will not be required to comply with the Patient Protection and Affordable Care Act (PPACA) provision extending nondiscrimination rules to insured plans until after regulations or other administrative guidance of general applicability has been issued. Section 2716 of the Public Health Service Act, added by PPACA, provides that insured group health plans must satisfy certain specific nondiscrimination requirements contained in the Internal Revenue Code (Code), as well as "rules similar to the rules contained in" other provisions of the same requirements. Prior to PPACA, these nondiscrimination rules applied only to self-insured group health plans. The IRS acknowledged that there were "fundamental concerns" about the ability of plans to comply with PPACA Section 2716 without guidance, particularly on the question of what the term "rules similar" would entail, and so a delay in implementation was required. The IRS stated that they "anticipate" that any such guidance will not apply until plan years beginning a specified period after issuance of the guidance. The IRS requested further comments on what such guidance should contain, and included a list of specific implementation questions, with all comments due by March 11, 2011.
  
  
• CCIIO Technical Guidance: Process for a State to Submit a Request for Adjustment to the Medical Loss Ratio Standard of PHS Act Section 2718 (December 17, 2010)
  
  
• Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements under the Patient Protection and Affordable Care Act, Office of Consumer Information and Insurance Oversight, HHS (Nov. 22, 2010): The Department of Health and Human Services (HHS) has released an interim final rule on health insurer medical loss ratios under PPACA. The interim regulation certifies the draft rule proposed by the National Association of Insurance Commissioners this past October.

  Substantively, the interim regulation requires health insurers in the individual and small group market to spend 80 percent of consumers' premiums on direct care for patients and efforts to improve health care quality. Insurers in the large group market are required to spend 85 percent of consumers' premiums. Beginning in 2012, if insurers fail to meet the ratio requirements, they will be required to provide a rebate to their customers by August 1 each year. The rule also expressly allows for a State to require a higher medical loss ratio than that required under the interim regulation.

  Insurers must also submit an annual report to HHS, which will be made available to consumers, explaining the company's ratio of incurred loss to earned premium and the nature of the incurred loss. Specifically, insurers are required to report "all of the elements of revenue and expenditures that will be needed to calculate the amount of rebates." To that end, the report must include the amount of premium revenue received, the reimbursement amount for clinical services provided to enrollees under the health insurance plan, the amount spent on activities that improve health care quality for enrollees, the amount spent on all other "non-claims" costs, and the amount spent on Federal and State taxes and licensing or regulatory fees.

  A fact sheet entitled "Medical Loss Ratio: Getting Your Money's Worth on Health Insurance" has been posted on Healthcare.gov and can be accessed here. This interim final regulation is effective January 1, 2011; comments are due no later than 60 days after the regulation's publication in the Federal register, which is currently set for December 1, 2010.
  

• Medicare Program; Request for Information Regarding Accountable Care Organizations and the Medicare Shared Savings Program, CMS (November 17, 2010) – CMS has published a request for comments to aid with its development of rulemaking for the establishment of the Shared Savings Program. The Shared Savings Program is authorized under section 3022 of PPACA, which promotes the formation and operation of accountable care organizations (ACOs). Additionally, CMS is seeking information to help develop potential payment and service delivery models that complement the Shared Savings Program for testing by the Center for Medicare and Medicaid Innovation (CMMI) – a new department within CMS that was established by PPACA. Comments are due by December 3, 2010.
  
  
• Affordable Care Act Implementation FAQs, Dept. of Labor, HHS, Dept. of Treasury (October 28, 2010) – HHS has posted a fourth iteration of PPACA implementation FAQs on its website. These recently issued FAQs address the implementation of PPACA's market reform provisions. Specifically, the three questions in the fourth set of FAQs touch upon (1) grandfathered health plans' compliance with disclosure requirements relating to statements in plan materials disclosing that the plan believes it is a grandfathered plan under PPACA; (2) the eligibility of an insurance policy for grandfathered status where the insurance policy existed prior to March 23, 2010 with an option, but individual's can elect the option after March 23, 2010 and the election of the option results in a cost-sharing amount in excess of the limits under the grandfather rule; and (3) whether a certain type of health plan violates the lifetime dollar limit on "essential health benefits."
  
  All four PPACA implementation FAQs are available here.
  
  
• Draft Regulation for Uniform Definitions and Standardized Methodologies for Calculation of the Medical Loss Ratio for Plan Years 2011, 2012 and 2013 per Section 2718 (b) of the Public Health Service Act, National Association of Insurance Commissioners (Oct. 14, 2010) – Thirteen state regulators of the NAIC have approved a draft regulation entitled "Patient Protection and Affordable Care Act Medical Loss Ratio Regulation." The draft regulation will be subject to a vote by the entire NAIC during their Fall National Meeting which will take place between October 18 to October 21. If approved at the meeting, HHS will then have to certify the regulation in order for it to take effect.
  
  The NAIC continues to receive letters suggesting how the final medical loss ratio should work. On October 14, Senator John Rockefeller, chairman of the Senate Committee on Commerce, Science and Transportation, sent a letter to NAIC urging the NAIC to reject any last minute efforts by insurers advocating for allowing the national, rather than state level, aggregation of large group medical loss ratio data when applying the medical loss ratio requirements.
  
  In relation to the establishment of the regulatory provisions governing medical loss ratios, the NAIC sent a letter on October 13 to the Secretary of HHS expressing the need for a transitional period for health insurance companies to comply with the medical loss ratio limits in order to prevent the destabilization of markets in certain states. AHIP had sent the NAIC a letter on the same day also recommending, amongst other things, a transition strategy to address the implementation of the medical loss ratio requirements.
  
  
• Interim Relief with Respect to Form W-2 Reporting of the Cost of Coverage of Group Health Insurance Under § 6051(a)(14), IRS (October 12, 2010) – The IRS has announced that employers will not need to report the cost of coverage under an employer-sponsored group health plan in 2011. If an employer would like to report this information, the draft W-2 form includes the necessary codes for employers to provide this cost information. The IRS also announced that it will provide related guidance later this year.
  
  Additional information from the IRS relating to PPACA's tax provisions can be found here.
  
  
• FAQs About the Affordable Care Act Implementation Part II, Dept. of Labor, HHS, Dept. of Treasury – As a follow-up to the "FAQs" posted by the Department of Labor (DOL) on September 20, 2010, the DOL has jointly released a second set of "FAQs." The questions and answers included in this second installment relate to grandfathered health plans, dental and vision benefits, rescissions, preventive health services, and a clarification relating to policy year and effective date for individual health insurance policies. The DOL explains that "the ongoing guidance the Departments are providing reflects our approach to implementation, which emphasizes assisting (rather than imposing penalties on) plans…."
  
  
• Memorandum on the Deadlines for the Secretary of Health and Human Services in the Patient Protection and Affordable Care Act from Enactment to January 1, 2011; Congressional Research Service (Oct. 1, 2010) – The Congressional Research Service has drafted a memorandum on the deadlines specific to the Secretary of HHS in PPACA through January 1, 2011. The memorandum largely consists of a table of the relevant requirements in PPACA along with the corresponding public actions taken by the Secretary through September 23, 2010. The introduction to the memo cautions that actions taken by the Secretary through September 23, 2010, but that were not the subject of public notification in the Federal Register or on agency websites, would not be included in the table.
  
  
• Questions and Answers on Enrollment of Children Under 19 Under the New Policy That Prohibits Pre-Existing Condition Exclusions, HHS (Sept. 24, 2010) – The Department of Health and Human Services has posted guidance on its website relating to the June 28, 2010 interim final regulations that prohibit new group health plans and health insurance issuers in both the group and individual markets from imposing pre-existing condition exclusions on children under 19 for the first plan year (in the individual market, policy year) beginning on or after September 23, 2010. The guidance provides seven questions and answers that address, in part, what types of health plans and insurance issuers are affected by the regulations, whether enrollment for children under 19 can be limited to certain time periods, and what types of actions can be implemented to mitigate adverse selection concerns. The webpage also includes two letters from the Secretary of HHS to America's Health Insurance Plans and to Blue Cross and Blue Shield Association responding to concerns of adverse selection.
  
  
• Medicare, Medicaid, and Children's Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers, CMS (Sept. 23, 2010) – Citing to numerous provisions in the Patient Protection and Affordable Care Act, as amended, the proposed rule seeks to establish several new requirements to limit fraud and abuse, e.g.,
  
  
  • screening procedures for providers and suppliers under Medicare, Medicaid, and CHIP programs that would vary in degree based on the risk of fraud, waste, and abuse and may include such screening procedures as criminal background checks and fingerprinting;
  • an application fee each "institutional provider of medical or other items or services or supplier" that would be used to cover the cost of screening as well as other program integrity efforts;
  • temporary moratoria that may be imposed in six month increments in situations where necessary to prevent or combat fraud, waste, and abuse under Medicare, Medicaid, and CHIP programs such as (1) highly disproportionate number of providers or suppliers in a category relative to the number of beneficiaries or a rapid increase in enrollment applications within a category with respect to a particular provider or supplier type or particular geographic area; (2) a State has imposed a moratorium on enrollment in a particular geographic area or on a particular provider of supplier type; or (3) CMS, in consultation with the HHS OIG or the DOJ identifies a significant potential for fraud, waste or abuse in the Medicare program in a particular geographic area or on a particular provider of supplier type;
  • guidance for States regarding procedures to terminate providers if terminated by Medicare or another state's Medicaid plan or CHIP;
  • provides an approach and requests comments on the provisions of PPACA that require providers and suppliers to establish compliance programs; and
  • requirements for suspension of payments pending a "credible allegation of fraud" in both the Medicare and Medicaid programs. The definition of "credible allegation of fraud" would include "an allegation from any source, including but not limited to fraud hotline complaints, claims data mining, patterns identified through provider audits, civil false claims cases, and law enforcement investigations." Allegations would be considered to be credible if they have an "indicia of reliability."
    
    Comments are due by November 16, 2010.
    
    
• The Federal Trade Commission, the Centers for Medicare & Medicaid Services (CMS), and the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) have announced that they will be holding a public workshop regarding legal issues relating to Accountable Care Organizations (ACOs) on October 5, 2010. ACOs are integrated health care delivery systems designed to lower costs and improve quality by allowing physicians to work in groups and receive payments for shared savings.

  A variety of legal regimes—such as the antitrust laws, the physician self-referral prohibition, the Federal anti-kickback statute, and the civil monetary penalty (CMP) law—will apply to ACOs, and the agencies seek to explore how these laws will affect ACOs. The stated goals of the workshop will be (1) to assess how the variety of possible ACO structures in different health care markets could affect the prices and the quality of health care services; (2) to determine whether and, if so, how the requirements of the laws mentioned above could or should be addressed in the regulations that CMS is developing for the Medicare Shared Savings Program; and (3) to evaluate whether and, if so, to what extent any safe harbors, exceptions, exemptions, or waivers from the applicable laws may be warranted.

  The agencies intend to address these goals by holding several moderated panel discussions. The FTC will hold two morning sessions that will explore the antitrust issues associated with ACOs. The first will address circumstances under which collaboration among independent health care providers in an ACO permits member providers to engage in joint price negotiations with private payers without running the risk of engaging in illegal price fixing under the antitrust laws. The second session will explore ways to encourage formation of multiple ACOs among otherwise independent providers so that competition among ACOs in any given geographic market will drive improved quality and affordability of health care. CMS and OIG will also have a panel discussion as well as a listening session regarding how ACOs will interact with the physician self-referral prohibition, the anti-kickback statute, and the CMP law.

  In preparation for these discussions, the agencies are seeking public comment on topics such as: (1) the intersection of the various business models envisioned for ACOs with both the antitrust laws and the fraud and abuse laws; (2) the types of contractual and financial relationships under existing or planned ACOs that might trigger or implicate the antitrust laws, the physician self-referral prohibition, the anti-kickback statute, and the CMP law; (3) whether the public believes that the incentive payments or shared savings to ACOs, or the distribution of these payments to the physicians or other providers and suppliers in the ACO, would trigger or implicate the physician self-referral prohibition, the anti-kickback statute, and/or the CMP law; and (4) any potential impediments, including the inadequacy of current safe harbors, to the success of ACOs as presently constrained by the various laws.
  

• IRS Issues Guidance Explaining 2011 Changes to Flexible Spending Arrangements, (Sept. 3, 2010) – The IRS issued a notice providing guidance on § 9003 of the Patient Protection and Affordable Care Act. Section 9003 revised the definition of medical expenses in employer-provided accident and health plans including flexible spending arrangements (FSAs) and health reimbursement arrangements (HRAs) and the definition of qualified medical expenses in Health Savings Accounts (HSAs) and Archer Medical Savings Accounts (Archer MSAs). Purchases made after January 1, 2011 for over-the-counter-drugs can only be reimbursed from such accounts with a prescription. However, insulin, durable medical devices, eye glasses, and contact lenses may still be reimbursed from such accounts without a prescription so long as such items meet the definition of "medical care" in § 213(d)(1) of the Internal Revenue Code.
  
  
• Availability of Interim Procedures for Federal External Review and Model Notices Relating to Internal Claims and Appeals and External Review Under the Patient Protection and Affordable Care Act; Notice, IRS, Dept. of the Treasury; Employee Benefits Security Admin., Dept. of Labor; Office of Consumer Information and Insurance Oversight, HHS (August 26, 2010) – On July 23, 2010, the Departments published interim final regulations implementing the Public Health Service (PHS) Act §2719, as added by PPACA. Those regulations address plans and issuers in States that do not have an applicable State external review process, and they address when plans and issuers must comply with an applicable State external review process and when plans and issuers must comply with the Federal external review process.
  
  This Notice provides and announces the availability of additional guidance in relation to the Federal external review process as well as the publication of model notices that can be used to satisfy the disclosure requirements under the interim regulations. In particular, this notice details two ways for non-grandfathered self-insured plans that are not subject to a State external review process to satisfy an interim enforcement safe harbor. This notice also announces the future publication of the requirements of an interim enforcement safe harbor for issuers in the individual market and the small and large group health insurance markets at http://www.hhs.gov/ociio/. Additionally, this notice provides that model language for the following types of notices will be posted at http://www.dol.gov/ebsa and http://www.hhs.gov/ociio/: 1) a notice of adverse benefit determination; 2) a notice of final internal adverse benefit determination; and 3) a notice of final external review decision.
  
  
• NAIC Approved Form for MLR Financial Reporting Requirements (Aug. 17, 2010) — The National Association of Insurance Commissioners (NAIC) Executive Committee/Plenary approved final implementation of the Medical Loss Ratio (MLR) Blanks Proposal to implement a provision of the Patient Protection and Affordable Care Act (PPACA). Blanks are the actual forms submitted by insurance companies to report financial information to state regulators. Regulators will then review this data to calculate MLR and any rebate required under the new federal law.
  
  
• Planning and Establishment of State-Level Exchanges, Office of Consumer Information and Oversight, HHS (August 3, 2010) (request for comments regarding Exchange-related provisions in Title I of PPACA) – HHS is soliciting comments on a series of questions regarding state insurance Exchange implementation. Notably for insurers, HHS requests comments on the factors Exchanges should consider in reviewing justifications for premium increases from insurers seeking certification ass as qualified health plans. Other questions focus on certification of Qualified Health Plan s (QHPs), such as what factors would be most imprtant important in establishing standards for rating of health plans, how Exchanges can help consuemrs consumers understand the quality and cost implications of plan choices, whether Medicare Advantage plan rating measures would be appropriate for QHPs, how much flexibility would be desireable desirable for state specific requirements above minimum Federal quality or threshold requirments requirements, and what payment structures or other strategies could be used by plans to improve practices by plan providers. Other topics on which comments are sought include premium reating rating areas, improving the consumer expeire9ience experience with the Exhanges Exchanges, participation of small employers in the Exchange, and establishment of risk adjustment, reinsurance and risk corridors. HHS asks for comments on the progress states are making in planning for the Exchanges and required resources for Exchange development, on implementation tasks and milestones for tracking state progress, on the desirability of uniformity across states in aspects of exchange operation, and on the kind of systems state exchanges will need for data reporting, payment flow, tracking spending, providing transparency, and facilitating audits, and whether there would be benefit from a federal IT solution for Exchange operations. Questions also address how the Federal government should go about setting up an Exchange to be available in states that do not set up their own. HHS also asks about Exchange eligibility and enrollment, including coordinating enrollment between Medicaid, CHIP and the Exchanges. Comments are requested by October 4, 2010.
  
  
• Pre-Existing Condition Insurance Plan Program, Office of Consumer Information and Oversight, HHS (July 30, 2010) -- Section 1101 of the Patient Protection and Affordable Care Act (PPACA) requires the establishment of a temporary high risk health insurance pool program to provide affordable health insurance coverage to uninsured individuals with pre-existing conditions. Theses regulations set forth guidelines with respect to the administration, eligibility, and benefits, amongst other things, of these Pre-Existing Condition Insurance Plans or "PCIPs" that the Federal government will administer either directly or through contracts with States or non-profit entities.
  
  The following is required for an individual to be eligible to enroll in a PCIP: (1) Is a citizen or national of the United States or is lawfully present in the United States as determined in accordance with section 1411 of the Affordable Care Act; (2) has not been covered under creditable coverage, as defined in section 2701(c)(1) of the Public Health Service Act as of the date of enactment, during the 6-month period prior to the date on which he or she is applying for coverage through the PCIP; and (3) has a pre-existing condition, as determined in a manner consistent with guidance issued by the Secretary. We further provide in § 152.14(a)(4) that an individual must be a resident of a State that falls within the service area of a PCIP.
  
  The benefits and excluded services under the PCIPs will parallel the coverage under the Federal Employees Health Benefits Plan.
  
  Interim final rule effective on July 30, 2010; Comment period open until September 28, 2010.
  
  
• Questions and Answers on Enrollment of Children Under 19 Under the New Policy That Prohibits Pre-Existing Condition Exclusions, Office of Consumer Information and Insurance Oversight, HHS (July 27, 2010) – This set of Q&As assist health insurance issuers with implementation of the new requirement, addressed in interim final regulations published on June 28, 2010, that children under 19 may not be denied coverage because of a pre-existing condition for policy years beginning on or after September 23, 2010. The guidance permits restriction of enrollment to annual open enrollment periods, when permitted by state law. It also discourages states from using federal Medicaid or CHIP funds as "premium assistance" to pay for individual health insurance for children with pre-existing conditions as a way of transferring risk for these children to the private marketplace. Also, "child-only" insurance plans may be grandfathered from the pre-existing condition bar.
  
  
• Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Internal Claims and Appeals and External Review Processes Under PPACA, IRS, Dept. of the Treasury; Employee Benefits Security Admin., Dept. of Labor; Office of Consumer Information and Insurance Oversight, HHS (July 23, 2010) – The Patient Protection and Affordable Care Act (PPACA) added section 2719 of the Public Health Service (PHS) Act, and these regulations implement section 2719. With the exception of grandfathered plans (see section 1251 of PPACA), these regulations set forth certain processes that group health plans must incorporate relating to internal claims and appeals, and these regulations provide that individual health issuers must initially incorporate the internal claims and appeals processes set forth in applicable State law with any necessary updates to bring such processes in accord with standards established by HHS. Additionally, these regulations provide rules for determining whether a State or Federal external review process is applicable as well as guidance regarding each process. Interim final regulations effective September 21, 2010; Comment period open until September 21, 2010.
  
  
• Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services Under PPACA, IRS, Dept. of the Treasury; Employee Benefits Security Admin., Dept. of Labor; Office of Consumer Information and Insurance Oversight, HHS (July 19, 2010) – The Patient Protection and Affordable Care Act added section 2713 of the Public Health Service (PHS) Act, and these regulations implement section 2713. These implementing regulations require that both a group health plan and a health insurance issuer offering group or individual health insurance coverage provide certain preventive benefits without the imposition of cost-sharing requirements (such as co-payment, coinsurance, or deductible) when the benefits are provided by an insurer's in-network providers. More information with respect to what preventive benefits are required to be covered can be found here. Interim final regulations effective September 17, 2010; Comment period open until September 17, 2010.
  
  
• Patient Protection and Affordable Care Act: Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, and Patient Protections, Final Rule and Proposed Rule, IRS, Employee Benefits Security Admin., HHS (June 28, 2010) – The Patient Protection and Affordable Care Act as amended adds sections 2701 through 2719A to the Public Health Service Act, and these regulations, collectively being referred to by the Government as the "Patient Bill of Rights," implement several of these provisions. Generally, the rules established through these regulations will apply to most plans on or after September 23, 2010.
  
  These new rules include, in part and with some exception such as with "grandfathered" plans: a) a prohibition on preexisting condition exclusions for enrollees under 19 and then for all enrollees regardless of age beginning January 1, 2014; b) impose restrictions on health plan annual dollar-value coverage limits; c) a prohibition on rescission of coverage except in instances of fraud or an intentional misrepresentation of a material fact; and d) other patient protections including an enrollee's ability to choose any participating primary care provider as the enrollee's primary care physician and the ability for an enrollee to seek and receive emergency services without prior authorization if enrolled in a plan that provides coverage for emergency services..
  
  The Government has also released a brief fact sheet highlighting portions of these regulation. Interim final regulations effective August 27, 2010; Comment period open until August 27, 2010.
  
  
• Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011: CMS (June 25, 2010) – This proposed regulation implements numerous sections of the Patient Protection and Affordable Care Act. A list of the provisions implemented by this regulation can be accessed here. Section 4104 is among the provisions implemented by these regulations and requires Medicare to cover 100% of the costs for certain preventive services such as the initial preventative physical examination, annual wellness visits, and various screening tests. The proposed regulation also implements Section 5501 which increases payments to providers for primary care services. Comment period open until 60 days after the date the regulation is published in the Federal Register.
  

• Group Health Plans and Health Insurance Coverage Relating to Status as a Grandfathered Health Plan under the Patient Protection and Affordable Care Act, Interim Final Rules, Department of Health & Human Services, Department of Labor and Internal Revenue Service (June 17, 2010) – Section 1251 of the Affordable Care Act, as modified by section 10103 of the Affordable Care Act and section 2301 of the Reconciliation Act, provides that certain group health plans and health insurance coverage existing as of March 23, 2010 (the date of enactment of the Affordable Care Act), are subject only to certain provisions of the Affordable Care Act. The statute and these interim final regulations refer to these plans and health insurance coverage as grandfathered health plans. The agencies have published interim final regulations addressing numerous issues regarding grandfathered plans, including events whose occurrence would result in the loss of grandfathered status. The public comment period is scheduled to end on August 16, 2010.

  The government also released a Fact Sheet and a Questions & Answers document.
  

• Correction of Errors in Proposed Rule with Changes to Hospital Inpatient Prospective Payments Systems (June 5, 2010)
  

• Medicare Program; Supplemental Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Supplemental Proposed Fiscal Year 2011 Rates – Supplement to Proposed Rule, CMS, HHS (June 2, 2010) -- Proposed rule supplement would implement certain statutory provisions relating to Medicare payments to hospitals for inpatient services contained in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010. It would also specify statutorily required changes to the amounts and factors used to determine the rates for Medicare acute care hospital inpatient services for operating costs and capital-related costs, and for long-term care hospital costs. Comment period open until July 2, 2010.
  
  
• CMS's Preliminary Questions & Answers re Medicare "Accountable Care Organizations" Shared Savings Program, CMS (May 27, 2010) – CMS has released some basic information on accountable care organizations such as possible organizational forms and how such organizations could qualify for shared savings. CMS hopes to establish the program by January 1, 2012 and will announce by June 11, 2010 details on holding a listening session to hear stakeholder ideas on accountable care organizations later on this summer.
  
  
• Medicare Program; Medicare Coverage Gap Discount Program Model Manufacturer Agreement, CMS, HHS (May 26, 2010) – Section 3301 of the Patient Protection and Affordable Care Act as amended establishes the Medicare Coverage Gap Discount Program which will be effective January 1, 2011. CMS has released the draft model manufacturer agreement that it intends to revise based on a public meeting that was held on June 4, 2010 and any comments received. The agreement will then be used as a standard agreement between all Medicare Part D drug manufacturers and HHS. The manufacturer agreement, in part, requires the manufacturer to provide a 50% discount from the "negotiated price" for coverage gap claims by applicable Medicare beneficiaries. Comment period open until June 21, 2010.
  
  
• Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Dependent Coverage of Children to Age 26, IRS, Dept. of the Treasury, Employee Benefits Security Admin., Dept. of Labor, HHS (May 13, 2010) – Section 1004 of the Patient Protection and Affordable Care Act as amended adds Section 2714 to the Public Health Service Act, which requires that a plan or issuer that provides dependent coverage to children to provide such coverage until children reach 26 years of age. According to the regulations, a plan or issuer may no longer define dependent for purposes of eligibility upon consideration of such factors as financial dependency on the primary subscriber, residency with the primary subscriber, student status, employment, or eligibility for other coverage. Interim final regulations effective July 12, 2010; Comment period open until August 11, 2010.
  
  
• Revised Payment Files for the 2010 Medicare Physician Fee Schedule Database (MPFSDB) and Retroactive Provisions under the Patient Protection and Affordable Care Act (Pub. L. 111-148) (the Affordable Care Act, CMS Medicare Learning Network (May 10, 2010)
  
  
• Systems Changes Necessary to Implement the Patient Protection and Affordable Care Act (PPACA) Section 6404 - Maximum Period for Submission of Medicare Claims Reduced to Not More Than 12 Months, CMS Medicare Learning Network (May 7, 2010)
  
  
• Health Care Reform Insurance Web Portal Requirements, HHS (May 5, 2010) – Section 1103(a) of the Patient Protection and Affordable Care Act as amended by Section 10102(b) of the same act requires the establishment of a website through which any small business or individual may identify affordable health coverage options in any state. Interim final regulation effective May 10, 2010; Comment period open until June 4, 2010.
  
  
• Early Retiree Reinsurance Program -- Interim Final Rule, Department of Health & Human Services (May 5, 2010) – Section 1102(a)(1) of the Patient Protection and Affordable Care Act appropriates $5 billion for a temporary program running through the end of 2013 to provide reimbursement to participating employment-based plans for a portion of the cost of health benefits for early retirees and their spouses, surviving spouses and dependents. These interim final regulations became effective on June 1, 2010.
  
  
• Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Fiscal Year 2011 Rates; Effective Date of Provider Agreements and Supplier Approvals; and Hospital Conditions of Participation for Rehabilitation and Respiratory Care Services Medicaid Program: Accreditation Requirements for Providers of Inpatient Psychiatric Services for Individuals Under Age 21 – Proposed Rule, Centers for Medicare & Medicaid Services, HHS (May 4, 2010) – CMS proposes to revise the Medicare IPPS for operating and capital-related costs of acute care hospitals for discharges on or after October 1, 2010; update the rate of increase limits for hospitals paid on a reasonable cast basis; update policy and rates for long-term care hospitals; modify the Medicare conditions of pariticpatino for hospitals relating to the types of practitioners who may provide rehabilitation and respiratory care services; changes affecting the determination of the effective date of provider agreements and supplier approvals under Medicare.; and to offer psychiatric providers increased flexibility in obtaining accreditation to participate in the Medicaid program. Comment period open until June 18, 2010.
  
  
• Medicaid Prescription Drug Rebates, CMS Letter to State Medicaid Directors (April 22, 2010)
  
  
• Medical Loss Ratios – Request for Public Comment, Department of Health & Human Services, Department of Labor and Internal Revenue Service (April 14, 2010) – The Patient Protection and Affordable Care Act requires health insurers to report their expenditures of premiums on clinical care, quality improvement and other administrative expenses. Rebates to insured individuals are required for insurers whose expense ratio for clinical care and quality improvement do not reach specified thresholds. The agencies have requested comments on implementation of the medical loss ratio requirements.
  
  
• New Option for Coverage of Individuals Under Medicaid, CMS Letter to State Medicaid Directors (April 9, 2010)

Court Decisions

• Colorado federal court issues a temporary order enjoining HHS, DOL and Treasury from enforcing contraceptive mandate against Catholic owned company.  On July 27, 2012, in Hercules Industries, Inc. v. Sebelius, the U.S. District Court for the District of Colorado issued a temporary order enjoining the Departments of Health and Human Services (HHS), Labor (DOL) and Treasury from enforcing what has come to be known as the contraceptive mandate against a Catholic-owned air-conditioning company until the company's challenge that the mandate infringes on constitutional and statutory rights is resolved.  Generally, HHS guidelines requiring non-grandfathered health insurance plans to cover certain preventive services for women without cost sharing under the PPACA take effect for plan years beginning on or after August 1, 2012.  Under HHS guidelines, coverage for preventive services for women includes, among other things, coverage of certain contraceptive methods.  Exemptions exist for religious organizations, such as churches, and a temporary enforcement safe harbor exists delaying the effective date to August 1, 2013 for nonprofit organizations with religious objections to contraceptive coverage, but no relief has been provided for other business entities that object to certain contraceptive methods for religious reasons.  The injunction only applies to the company in question, but the ultimate determination of the case, and any succeeding challenges to that decision, could have broad ramifications for the contraceptive mandate.
  
  
• Supreme Court Decision on Constitutionality of Health Reform Law, June 28, 2012.
  
• 11th Circuit Ruling On PPACA Constitutionality. The Eleventh Circuit Court of Appeals has ruled that the PPACA health reform law's individual mandate is unconstitutional, but that the mandate provision is "severable" from the rest of the law, so no other part of the law is struck down. The court also rejected the challenge by state attorneys general to the expanded coverage mandates imposed on states electing to participate in the Medicaid program.
  
  
• Florida federal court issues order to stay declaratory judgment against health reform law. On March 3, 2011 Federal District Judge Vinson issued an order that will stay his prior ruling that the individual coverage mandate of PPACA is unconstitutional and that the entire law is therefore invalid, in response to a motion for clarification by the federal government. The judge conditioned the stay upon the government filing an appeal of his declaratory judgment ruling within seven days of his March 3 order and seeking an expedited appellate review, either in the Court of Appeals or in the Supreme Court.
  
  
• Mississippi Federal Court Dismisses Suit Challenging PPACA's Minimum Essential Coverage Provision on Jurisdictional Grounds, (Feb. 3, 2011) – The District Court for the Southern District of Mississippi dismissed a lawsuit brought by Mississippi's Lieutenant Governor along with ten individuals residing in Mississippi who do not have health insurance. The lawsuit challenged the constitutionality of the "minimum essential coverage" provision, or individual mandate, in PPACA. Specifically, Plaintiffs alleged that the minimum essential coverage provision: 1) exceeds the power granted to Congress by the Commerce Clause of Article I of the United States Constitution; 2) constitutes an unconstitutional taking pursuant to the Fifth Amendment to the United States Constitution; 3) violates substantive due process rights guaranteed by the Fifth and Fourteenth Amendments; and 4) violates the Tenth Amendment. Additionally, the Plaintiffs further contend that the tax penalty is an unconstitutional capitation or direct tax.
  
  The Plaintiffs argued, in part, that they had standing to bring the claims they asserted, and therefore the Court had jurisdiction to hear the lawsuit, because the minimum essential coverage provision (1) constitutes a concrete threat of injury insofar as it will force them to purchase health insurance or be subject to a financial penalty, and (2) the provision will force them to manage their financial affairs to prepare for the provision's requirements. In response, the Defendants filed a motion to dismiss the lawsuit claiming that the Court did not have jurisdiction to hear the case, because the Plaintiffs did not have standing to bring the suit.
  
  In ruling on the Defendants' motion to dismiss, the Court agreed with the Defendants jurisdictional challenge and found that the Plaintiffs' lacked standing to challenge the minimum essential coverage provision, because the allegations in the Plaintiffs' complaint were insufficient to show a "certainly impending" injury. For example, the Court explained that the ten private individuals did not sufficiently allege that (1) the minimum coverage provision would apply to them and (2) that they would incur the tax penalty for non-compliance in the event the provision would apply to them. However, because the Plaintiffs' complaint was dismissed without prejudice, the Plaintiffs may amend their complaint and file it again within 30 days from the date of the opinion.

• The United States District Court for the Northern District of Florida Declares the Patient Protection and Affordable Care Act Unconstitutional. (January 31, 2011) – The United States District Court for the Northern District of Florida ruled on a suit brought by the Florida Attorney General and joined by twenty-five other states, among others, challenging the constitutionality of PPACA. While numerous challenges to the law's constitutionality were brought, the Court specifically ruled on Plaintiffs' claims alleging (1) that PPACA violates the Spending Clause and principles of federalism under the Ninth and Tenth Amendments to the extent that the law expands the Medicaid program to cover certain new classes of individuals and render the states responsible for the actual provision of health services thereunder, and (2) that Section 1501 of PPACA, commonly known as the Minimum Essential Coverage Provision or the Individual Mandate Provision, exceeds Congress's authority under the Commerce Clause.
  
  After finding that the Medicaid expansion complained of by the Plaintiffs did not violate the Constitution, the Court declared the Individual Mandate provision unconstitutional as Congress lacked the authority to enact the provision under the Commerce clause. The Court's conclusion is in align with the Eastern District of Virginia's ruling on December 13, 2010, but in conflict with the Eastern District of Michigan's and the Western District of Virginia's rulings in October and November of last year.
  
  However, unlike the Eastern District of Virginia, the Court here found that the Individual Mandate Provision was inextricably tied to the entire legislation, and therefore, could not be severed. In particular, the Court concluded:
  
  

  [N]otwithstanding the fact that many of the provisions in the Act can stand independently without the individual mandate (as a technical and practical matter), it is reasonably "evident"… that the individual mandate was an essential and indispensable part of the health reform efforts, and that Congress did not believe other parts of the Act could (or it would want them to) survive independently. I must conclude that the individual mandate and the remaining provisions are all inextricably bound together in purpose and must stand or fall as a single unit.

  As a result, the Florida Court has declared that the entire Act is unconstitutional and, therefore, void.
  
  
• The United States District Court for the Eastern District of Virginia Issued a Declaratory Judgment Today Finding PPACA's Minimum Essential Coverage Provision Exceeds the Constitutional Boundaries of Congressional Power. The Attorney General of Virginia brought suit on behalf of the Commonwealth of Virginia challenging the constitutionality of Section 1501 of PPACA, commonly known as the Minimum Essential Coverage Provision or the Individual Mandate. This provision requires that every United States citizen, unless specifically excepted, maintain a minimum level of health insurance coverage for each month beginning in 2014, or the individual will have to pay a penalty.
  
  The Court found that the penalty operated, in fact, as a penalty rather than a tax necessitating that Congress's authority to enact the penalty would have to be tied to a valid exercise of the Commerce Clause and the associated Necessary and Proper Clause, rather than the General Welfare Clause. However, the Court found that Congress had lacked the power under the Commerce Clause "to compel an individual to involuntarily engage in a private commercial transaction, as contemplated by the Minimum Essential Coverage Provision." The Court went on to state that this dispute "is not simply about regulating the business of insurance—or crafting a scheme of universal health insurance coverage—it's about an individual's right to choose to participate."
  
  The Court ordered that Section 1501 be severed from the remainder of PPACA, but declined to issue an injunction. The ruling does not address any of the remaining PPACA provisions. The issue will now go up on appeal.
  
  
• Michigan court upholds PPACA "Individual Mandate". A Michigan federal district court judge on October 7, 2010 denied an injunction and dismissed the plaintiffs' challenge to the "Individual Mandate" under the Patient Protection and Affordable Care Act (PPACA). The plaintiffs were a "public interest" law firm acting on behalf of its members and four individuals who asserted they do not have private health insurance and object to "being compelled to purchase heatlh care coverage". They claimed that they were being forced by the Individual Mandate to direct into saving for health insurance to be purchased in 2014 monies they would now be spendig in other preferred ways, even though the mandate and its penalties only become effective in 2014 and that Congress lacked the power to regulate "inactivity" – i.e., not buying health insurance. The court ruled that the plaintiffs did have standing and that the case was sufficiently "ripe" for resolution. On the merits, though, the court upheld Congress's power under the Constitution's interstate commerce clause to impose the penalty under PPACA for violation of the Individual Mandate to have health insurance. The court observed that the plaintiffs' "inaction" as regards purchase of health insurance effectively meant that they would purchase health care services in some other way, since they would no doubt be at some point participants in the health care services market. The federal government could regulate that choice, the court said, given the impact those choices can have on the operation of the health care marketplace. Because it upheld the law on interstate commerce clause grounds, it did not reach the separate argument by the government that the mandate penalty was enforceable under the federal government's separate taxing authority.
  
  
• The United States District Court for the Northern District of Florida denied the Department of Health & Human Services ("HHS") motion to dismiss this action against the PPACA with respect to the individual mandate and the state coercion count. In this case, the plaintiffs contended that the PPACA violates the Constitution in the following ways: (1) the individual mandate and concomitant penalty exceed Congress's authority under the Commerce Clause and violate the Ninth and Tenth Amendments; (2) the individual mandate and penalty violate substantive due process under the Fifth Amendment; (3) "alternatively," if the penalty imposed for failing to comply with the individual mandate is a tax, it is an unconstitutional capitation or direct tax; (4) the PPACA coerces and commandeers the states with respect to Medicaid by altering and expanding the program in violation of Article I and the Ninth and Tenth Amendments; (5) it coerces and commandeers with respect to the health benefit exchanges in violation of Article I and the Ninth and Tenth Amendments; and (6) the employer mandate interferes with the states' sovereignty in violation of Article I and the Ninth and Tenth Amendments.
  
  First, the court determined that the individual mandate penalty was not a "tax" and, thus, HHS could not rely on Congress's taxing authority under the General Welfare Clause to justify the penalty. Second, the court held that HHS's jurisdictional challenges fail. The court then turned to the plaintiff's arguments for failure to state a claim upon which relief could be granted under Federal Rule of Civil Procedure 12(b)(6). In Count VI, the plaintiffs objected to PPACA's employer mandate, which requires the states, as large employers, to offer and automatically enroll state employees in federally-approved insurance plans or face substantial penalties. The court found that because the employer mandate regulates the states as participants in the national labor market the same way as it does private employers, and because the Supreme Court has held that adversely affecting the state fisc does not interfere with state sovereignty, the employer mandate does not violate the Constitution as a matter of law. In Count V, the plaintiffs claimed that the creation of health benefit exchanges, which states may create and operate, is really not a choice because the PPACA forces them to operate the exchanges under threat, in violation of the Ninth and Tenth Amendments. The court held that because the health benefit exchanges are voluntary and do not compel states to regulate the private conduct of their citizens, the PPACA gives the states a choice and is a type of "cooperative federalism." In Count III, the plaintiffs objected to the individual mandate penalty as an unconstitutional capitation or direct tax. The court found that Congress did not intend the individual mandate penalty to be a tax so it dismissed this count as moot. In Count II, the plaintiffs alleged that the individual mandate violates their rights to substantive due process under the Fifth Amendment. The court also dismissed this count because there was a "rational basis" for justifying the individual mandate.
  
  In Count IV, the state plaintiffs objected to the fundamental changes in the nature and scope of the Medicaid program. Specifically, the state plaintiffs claimed that the drastic expansion would force them to "run [their] budgets off a cliff." In light of the current state of the law, the judge found that there was little support for the plaintiffs" coercion theory, but the law did not necessarily preclude this argument. The court acknowledged that the plaintiffs are placed in an extremely difficult situation of either accepting sweeping changes to Medicaid or being withdrawn from the system entirely. Finally, in Count I, the plaintiffs challenged the individual mandate as exceeding Congress's power under the Commerce Clause. The court held that the plaintiffs had stated a plausible cause of action, as the government "has never required people to buy any good or service as a condition of lawful residence in the United States."

Requests for Proposal and Grant Offerings

• Solicitation for State Proposals to Operate Qualified High Risk Pools, Department of Health & Human Services (April 2, 2010)
  
  
• Solicitation for Federal High Risk Pool Third Party Administrator, Department of Health & Human Services
  
  
• Affordable Care Act (ACA) School-Based Health Centers Capital Program, Health Services and Resources Administration (June 30, 2010) (funding opportunity)
  
  
• Affordable Care Act (ACA) Nursing Assistant and Home Health Aide Program, Health Services and Resources Administration (June 18, 2010) (funding opportunity)
  
  
• Affordable Care Act (ACA) Nurse Managed Health Clinics, Health Services and Resources Administration (June 17, 2010) (funding opportunity)
  
  
• Affordable Care Act: State Health Care Workforce Planning Grants, Health Services and Resources Administration (June 17, 2010) (funding opportunity)
  
  
• ACA: Expansion of Physician Assistant Training Program, HRSA (June 17, 2010) (fuindng opportunity)
  
  
• Affordable Care Act: Personal and Home Care Aide State Training Program, HRSA (June 17, 2010) (funding opportunity)
  
  
• Affordable Care Act (ACA) Maternal, Infant and Early Childhood Home Visiting Program (June 10, 2010) (funding opportunity)
  

Additional Health Care Reform Resources

• "Risk Sharing Among Plans Under the Affordable Care Act's Reinsurance, Risk Corridor, Risk Adjustment Programs," Bloomberg BNA Health Insurance Report, Vol. 18, No. 18 (May 2, 2012). Author: Brian J. O'Sullivan.
  
  
• Upcoming Rules Pursuant to the Patient Protection and Affordable Care Act, Congressional Research Service (January 13, 2011)
  
  
• Health Care Reform Regulations Arrive – Now What? What You Need to Know Right Now About Health Care Reform Regulations (So Far) - Crowell & Moring Labor & Employment Law Alert, June 30, 2010
  
  
• "The Early Retiree Reinsurance Program: $5 Billion Will Last About Two Years," Notes, Vol. 31, No. 7- ebri.org, Employee Benefit Research Institute (July 2010). Author: Paul Fronstin.
  
  
• Testimony of: Lewis Morris, Chief Counsel, Office of Inspector General, U.S. Department of Health & Human Services - House Committee on Ways and Means, Subcommittee on Health and Oversight (June 15, 2010)
  
  
• Health Insurance Market Reforms under PPACA: The Future is Now, Christine Rinn, HOOPS presentation (April 26, 2010)
  
  
• The Reformed New World of Health Insurance Exchanges, Arthur Lerner, HOOPS presentation (April 26, 2010)
  
  
• Attacks on Health Reform and Developing Litigation Issues, Chris Flynn and Jeff Poston, HOOPS presentation (April 26, 2010)
  
  
• Health Care Reform Law: Implications for Insurers and Health Plans, Arthur Lerner, AHLA Health Care Reform Law conference (May 12, 2010)