This week’s dose

Congress completed its measures on its last “to-pass” legislation in 2021, including a bill to increase the debt ceiling and the National Defense Authorization Act. Negotiations continued on the Build Back Better (BBB) ​​law. Senate Democrats continued to push for a resolution before the end of the year, although at the end of the week President Biden and Senate leaders acknowledged that the Senate would not consider the draft. law before January 2022.

Congress

Senate committees release BBB text, as negotiations and meetings with parliamentarians and are continuing. This week, Congress completed its actions on its final “to-pass” items of the year, including raising the debt limit and finalizing the annual defense clearance bill. At the same time, all eyes were on the Senate to see if Democrats would act on the Build Back Better (BBB) ​​law before the end of the year.

Since the House approved its version of the BBB on November 19, Senate Democrats have worked with the Senate Parliamentarian on issues related to the so-called “Byrd Rule,” which dictates the types of provisions that can move forward in legislation. considered as part of the budget reconciliation process. . In addition, negotiations are underway between the president, Democratic leaders and Senator Joe Manchin (D-WV) regarding his concerns about the size and scope of the legislation as well as specific provisions.

On December 11, the main Senate committees unveiled their draft BBB texts, including the Finance Committee and the Health, Education, Work and Pensions Committee (HELP) (drafts found here and here, respectively). Compared to the bill passed by the House, there have been notable health-related changes in the finance and AID projects. Some highlights of the changes to healthcare include, but are not limited to:

• Remove the 12.5% ​​reduction from the House bill to disproportionately distribute hospital payments (DSH) to hospitals in non-Medicaid expansion states.

• Eliminate regulatory requirements related to skilled nursing facility (SNF) staff-to-patient ratios that were included in the House bill.

• On Home and Community Services (HCBS) in Medicaid, removing many of the cited limitations for the use of funds and amending the improvement plan requirements to be defined by the Secretary of Health and Human Services (HHS ) and adding an additional $ 3 million in funds to the $ 22 million already allocated by the Chamber for the development of HCBS quality measures.

• The change to the permanent expansion of the Money Follows the Person event is scheduled to begin in 2022, rather than 2023 as passed by the House.

• With respect to postpartum Medicaid coverage, several of the state’s reporting requirements have been removed from the version adopted by the House.

• Protect low-income people who get coverage in 2025 (and had no other coverage for their health expenses) by requiring qualified health plans to cover up to three months of service before enrollment and requiring HHS to reimburse plans for these costs.

• Notable drug pricing provisions are as follows: Regarding the negotiation of the price of Medicare drugs, the Senate Finance Committee text clarifies how the maximum fair price of a prescription drug covered by Part B or Medicare D will be determined, with additional specifications for calculating the maximum fair price of insulin products. The updated text also makes changes to the timeline and baseline to determine how the inflation-based discounts for prescription drugs under Parts B and D will be calculated. Finally, it clarifies that generic prescription drugs could be exempt from inflation-based rebates if they experience supply chain disruptions or create access problems.

It is important to note that the Senate draft text is subject to further changes before a BBB package reaches the Senate floor, given the aforementioned negotiations with Senator Manchin – or any other Democratic senator who raises concerns about specific provisions – as well as upcoming decisions of the Parliamentarian.

Negotiations are ongoing, although President Biden and Democratic leaders conceded on the evening of Dec. 16 that the Senate would not act on BBB until the end of the year, following a decision by the parliamentarian according to which an immigration proposal in the package would violate the Byrd rule. . The Senate is expected to resume its sessions on January 3, 2022, with the House not returning until January 10.

Administration

Updates on the challenges of the Biden administration’s immunization mandates. On December 15, two federal courts issued orders that together have a significant impact on the authority of the Biden administration to implement and enforce the COVID-19 vaccine mandate issued by the Centers for Medicare and Medicaid (CMS).

The first order, issued by the United States Court of Appeals for the Fifth Circuit, has the effect of allowing the federal government to continue its efforts to implement the COVID-19 vaccine mandate issued by CMS in more than two dozens of states. The second order, issued by a federal court in Texas, prohibits the federal government from implementing CMS’s vaccination mandate in the state of Texas. The combined effect of yesterday’s orders, as well as recent actions by other federal courts, is that the Biden administration is currently authorized to implement the CMS vaccine mandate in 25 states, but has failed to do so. not done in 25 states, creating a patchwork approach to the mandate.

It’s still unclear how CMS will progress with the mandate, especially given the first initial compliance date of December 6. For more information, please see this Insight article.

HHS frees up $ 9 billion in relief fund payments for providers. On December 14, HHS announced the distribution of approximately $ 9 billion in Phase 4 payments from the Provider Relief Fund (PRF) to health care providers who suffered lost income and expenses related to the pandemic of COVID-19.

According to the agency’s press release, the average payment for small vendors is $ 58,000, for average vendors is $ 289,000, and for large vendors is $ 1.7 million. Phase 4 payments, which are distributed through HHS ‘Health Resources and Services Administration (HRSA), were scheduled to begin Dec. 16 for more than 69,000 providers in all 50 states, Washington, DC and eight territories (a state by state breakdown can be found here).

The remaining Phase 4 applications are currently under review by the HRSA and these payments will be made in 2022.

President Biden issues executive order reducing administrative burden and improving customer experience. On December 13, the President issued an executive order directing federal agencies to take action in six broad categories to reduce administrative burden and improve the customer experience for organizations and the public.

Quick shots

• The Senate Committee on Health, Education, Labor and Pensions (HELP) held a hearing to consider the appointment of Dr. Robert Califf as commissioner of the FDA.

• The special House subcommittee on the coronavirus crisis held a hearing to consider the need to accelerate global COVID-19 vaccination efforts.

• The Unified Fall 2021 Agenda, which details pending and upcoming regulatory measures that federal agencies plan to release in the short and long term, has been released by the Office of Information and Regulatory Affairs (OIRA), which is part of the Office of Management and Budget (OMB).

• CMS announced the availability of new Research Identification Files (RIFs) containing Next Generation ACO Model (NGACO) data for Performance Year 4.

• 2022 House and Senate calendars (House, Senate).