On July 9, 2021, the Biden Administration issued an executive order (EO), “Promoting Competition in the American Economy,” to address corporate consolidation, lack of competition and high prices for consumers, and low wages.[i] The health care portion of the EO focuses on improving competition to address health care prices and access to care in four [...] Read More
On May 28, 2021, the White House released the President’s fiscal year (FY) 2022 budget.[1] This full version of the budget follows the Administration’s “top-line” budget released in early April. For the Department of Health and Human Services (HHS), the administration is requesting $131.8 billion in discretionary.[2] In a statement about the budget request HHS [...] Read More
On April 30, 2021, the Biden administration released the final rule HHS Notice of Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager Standards. This is the second final rule released that includes policies for the health insurance exchanges in 2022. The first rule was released in the final days of the Trump administration [...] Read More
Budget Proposal Hearing Summaries from Appropriation Subcommittees April 15, 2021: House Subcommittee on Labor, Health & Human Services (HHS), Education, & Related Agencies · Chairwoman Rosa DeLauro (D-CT) lauded the proposal and noted the success of vaccination efforts (link) · Ranking Member Tom Cole (R-OK) believed this request spends too much on domestic programs at [...] Read More
On December 10, 2020, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) issued a press release, fact sheet, and an unpublished proposed rule announcing intended changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.[1] The proposed changes follow a request for information from December [...] Read More
On November 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a final rule that removes the existing legal safe harbor that protects rebates currently negotiated between pharmaceutical manufacturers and Medicare Part D prescription drug plans, either directly or through Pharmacy Benefit Managers (PBMs). To replace this rescinded [...] Read More
On November 20, 2020, the Health and Human Services’ Office of Inspector General (OIG) issued a fact sheet and final rule that removes potential regulatory barriers to care coordination and value-based care created by certain key healthcare laws and associated regulations, including the anti-kickback statute (AKS) and Beneficiary Inducements Civil Monetary Penalty (CMP).1 The changes [...] Read More
On September 18, 2020, the Centers for Medicare & Medicaid Services (CMS) released its long-awaited Specialty Care Models to Improve Quality of Care and Reduce Expenditures final rule (link) and the Health Resources and Services Administration (HRSA) released its Removing Financial Disincentives to Living Organ Donation final rule (link) and updated guidelines (link). These rules [...] Read More
The Department of Health and Human Services (HHS), in conjunction with the Departments of Labor and the Treasury, released a proposed rule for grandfathered group health plans and grandfathered group health insurance coverage. The agencies believe that the proposals in this rule would provide greater flexibility for these plans to make changes to some cost-sharing [...] Read More
On the evening of May 7, 2020, the Department of Health and Human Services (HHS) released the final rule for qualified health plans (QHPs) that operate on the health insurance Exchanges established by the Affordable Care Act (ACA), as well as several other types of plans operating off-exchange. Policies finalized in this rule address the [...] Read More