Insights

On May 10, 2024, the Centers for Medicare & Medicaid Services (“CMS”) published a Final Rule that, for the first time, imposes national minimum nurse staffing requirements for nursing homes. Specifically, the standard adopted by CMS requires minimum staffing of 3.48 hours per resident day (“HPRD”), as discussed in more detail below. CMS estimates that the new requirements will cost facilities $43 billion over the next 10 years, which is more than the $40.6 billion cost that CMS estimated for Proposed Rule of 3.0 HPRD. Some industry sources estimate that less than 25% of nursing facilities across the country currently meet the full scope of staffing standards laid out in CMS’ Final Rule due to a myriad of factors including labor shortages and increasing wage pressures. Indeed, the impact and cost of these staffing requirements will vary significantly by state. For example, CMS reported that at least one state will need to increase certain staff by nearly 96% to meet the minimum standards, while other states already meet the requirements.

On Friday April 26th, the Office of Civil Rights (“OCR”) at the U.S. Department of Health and Human Services (“HHS”) released regulations under Section 1557 of the Affordable Care Act[1] (“Section 1557”), the nondiscrimination provision of the Affordable Care Act (the “Final Rule”). Promulgated almost two years after OCR’s proposed rule for Section 1557, the Final Rule restores critical protections for LGBTQI+ and pregnant individuals and significantly expands the scope of activity that is subject to Section 1557’s nondiscrimination provisions, in both instances by removing limitations to the scope of Section 1557 that went into effect during the Trump Administration.

In the latest sign that federal enforcers remain focused on increasing antitrust enforcement, last Thursday, the Justice Department (DOJ), Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) revealed an online portal, HealthyCompetition.gov, to encourage the public to submit reports on potential anticompetitive and monopolistic conduct in the healthcare sector.  The initiative seeks to address concerns that such behavior may affect healthcare affordability and quality, and employee wages. 

On November 2, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released the calendar year (“CY”) 2024 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Final Rule (“CY 2024 OPPS/ASC Final Rule”). The final rule with comment period finalizes payment rates and policy changes affecting Medicare services furnished in hospital outpatient and ambulatory surgical center (“ASC”) settings for CY 2024.

On September 1, 2023, the U.S. Department of Health and Human Services, through the Centers for Medicare & Medicaid Services (“CMS”) issued a much anticipated and contested proposed rule that seeks to establish minimum staffing level requirements for nursing homes.  The proposed rule represents the first time the federal government has proposed comprehensive nationwide nursing home staffing requirements, although various states have already enacted their own staffing requirements.

On Friday, February 3, DOJ announced in a press release that it has withdrawn support for three joint DOJ-FTC policy statements that explicitly describe certain “safety zones” applicable to information sharing among competitors and the formation of certain competitor collaborations (including healthcare provider joint ventures and accountable care organizations (ACOs)) that the antitrust agencies did not intend to prosecute. See 1993 Policy Statement, 1996 Policy Statement, 2011 Accountable Care Organizations. The FTC has not yet withdrawn its support for these statements and the DOJ does not apparently plan to issue new guidance, which may result in the agencies applying differing standards and, at a minimum, creates more uncertainty about how the agencies will evaluate conduct covered by these guidance documents.

On December 29, President Joe Biden signed into law the Consolidated Appropriations Act, 2023 (P.L. 117-164) (the “Act”)—an approximately $1.7 trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes.  

On January 4, in its most recent effort to expand federal support for addressing health-related social needs (HRSNs), the Centers for Medicare & Medicaid Services (CMS) issued guidance to clarify an existing option for states to address HRSNs through the use of “in lieu of” services and settings policies in Medicaid managed care. This option is designed to help states offer alternative benefits that take aim at a range of unmet HRSNs, such as housing instability and food insecurity, and to help enrollees maintain their coverage and improve health outcomes. 

On October 14, 2022, President Biden signed an Executive Order (EO) directing the Secretary of the Department of Health and Human Services (HHS) to consider new healthcare payment and delivery models the Center for Medicare & Medicaid Innovation (CMMI)—part of the Centers for Medicare & Medicaid Services (CMS) and created by the Affordable Care Act—can test to lower drug costs and promote access to innovative drug therapies for Medicare and Medicaid beneficiaries. The EO specifies the HHS Secretary should include models that may lead to lower cost-sharing for commonly used drugs and support value-based payment initiatives that promote high-quality care. The Secretary’s report, describing any models selected, must be submitted within 90 days of the EO’s issuance.  

Crowell & Moring and Crowell Health Solutions hosted a HealthTech roundtable with discussions focused on value-based care, health equity, data privacy, artificial intelligence, and other trends in health care technology in the Washington, D.C. office on October 27. The sessions featured numerous experts from health technology companies, advocacy organizations, and trade associations, all of whom have extensive experience advising on health care policy and business issues. Policy makers, thought leaders, health care innovators, and business executives also joined the conversation.

This is an update to our January 6, 2022 alert on the CMS vaccine mandate.

This is an update to our November 5, 2021 alert on the CMS vaccine mandate.

On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule requiring health care workers at facilities enrolled with Medicare and Medicaid to be fully vaccinated as a condition of participation. Under the rule, if providers want to continue participating in Medicare, all applicable staff must have at least started the vaccination process by December 5, 2021. By January 4, 2022, all applicable facility staff must have all required vaccine doses, not including the 14-day incubation period after the final dose.

After 100 days in office, President Joe Biden has made it clear that he is not afraid to go it alone to pursue policy to match his campaign rhetoric and promises. The first 100 days of the administration were marked by a significant number of executive orders, a historic economic stimulus package passed with only Democratic support in Congress, and sweeping proposals that – if enacted – could transform everyday life for a significant number of Americans.

The American Rescue Plan Act of 2021, or COVID-19 bill, was signed into law by President Biden on March 11, 2021.  It passed the U.S. House originally on February 27, 2021, by a vote of 219 to 212, was amended by and passed the U.S. Senate on March 6, 2021, by a vote of 50 to 49, and the amended and reconciled bill was passed by the U.S. House on March 10, 2021 by a vote of 220 to 211.  The 242-page bill provides a total of $1.9 trillion in economic stimulus related to the COVID-19 crisis and includes stimulus checks for Americans, renewed unemployment benefits, employment related provisions, tax related provisions, education related provisions, child benefits related provisions and provisions related to the COVID-19 pandemic at large and health care in general.  The purpose of this Client Alert is to provide a summary of the health care provisions of the new law.

Today, President Biden signed an executive order and published a presidential memorandum seeking to improve access to the health insurance markets created by the Affordable Care Act, reverse certain Trump Administration healthcare policies, and to protect access to reproductive health services. The action comes on the seventh business day since the administration took office, a day dedicated to addressing broad healthcare issues, as opposed to the more acute pandemic measures that were taken on days one and two. Although not sweeping policy changes, President Biden signals ownership of the Affordable Care Act, which he as President Obama’s vice president shepherded, and rings in a new era of leadership that seeks to strengthen the law rather than repeal and replace it. The following is a summary and link to each of today’s actions:

The U.S. Congress passed a combined COVID-Relief and Omnibus Spending Bill on Monday, December 21, 2020.  The Consolidated Appropriations Act of 2021—both funded the U.S. government for FY 2021 and included a variety of COVID-19-related relief measures. The COVID-19 bill includes about $900 billion in new federal spending. It also repurposes $429 billion in unused CARES Act funding for the Federal Reserve Main Street Lending Program. The combined appropriations-COVID-19 stimulus relief package is the second largest in the nation’s history behind the CARES Act passed earlier this year.

While the healthcare industry is evolving from fee-for-service to quality-based payment, the Stark Law (42 U.S.C. § 1395) and the Anti-Kickback Statute (42 U.S.C. § 1320a–7b) have remained stuck in the past. These two fraud and abuse laws have impeded the continued development and utilization of value-based arrangements that reward high quality health care and improved health outcomes. The Stark Law, for example, was created to combat the exchange of financial incentives in return for referring patients for designated health services (DHS) – an exchange that can incentivize the provision of unnecessary care under a fee-for-service payment system. However, with the healthcare industry’s recent shift toward value-based payments, overutilization is no longer the problem it used to be. The Stark Law and Anti-Kickback Statute are misaligned with the current health care industry payment landscape and as result have impeded forward progress toward value-based care.

The Department of Health and Human Services (HHS) released on Friday the initial terms and conditions related to the distribution of the first tranche of the $100 billion Public Health and Social Services Emergency Fund. Rather than await the submission of applications by eligible healthcare providers, HHS has instead begun a rapid delivery of an initial $30 billion in relief funding to providers and suppliers that are enrolled in Medicare and received Medicare fee-for-service reimbursement in 2019. These eligible entities are being allotted a portion of the initial $30 billion distribution based on their proportionate share of the approximately $484 billion of Medicare fee-for-service reimbursements made in 2019. Subsequent distributions will be targeted at providers particularly impacted by the COVID-19 outbreak, rural providers, and providers of services with lower shares of Medicare fee-for-service reimbursement or who predominantly serve the Medicaid population, e.g., nursing homes, pediatric hospitals and pediatricians, and OB-GYNs.  Funds will also be used to reimburse providers for COVID-19 care for uninsured Americans.