McDermott+Consulting is pleased to provide the McDermottPlus Check-Up, your regular update on health care policy from Washington, DC.

This Week’s Dose

The House and Senate were both in session this week, with little discussion on healthcare policy. Instead, the focus in the Senate was on voting rights legislation, which failed to advance after Senators Kyrsten Sinema (D-AZ) and Joe Manchin (D-WV) opposed changing Senate voting rules. President Joe Biden also hosted a two-hour press conference on the anniversary of his presidency. 

Congress

President Biden Speaks on BBB. In his first press conference in over 10 months, President Joe Biden spoke to the unclear fate of the Build Back Better Act (BBB), noting that the White House remains open to passing key pieces of the bill. Many have interpreted his remarks to acknowledge that the broad BBB package that passed the House is not going to move forward in totality, but there may be a path to using the reconciliation instructions to create a smaller package of permanent provisions that could garner the support of 50 Democrats. This puts Senator Joe Manchin (D-WV) firmly in control of what such a package could include. Other provisions would then need to be pursued through other legislative vehicles, but given that it is an election year, if items don’t make the cut for a revised package, it is hard to see how they would move forward near term.  At the same time, it is not clear that consensus can be reached among Democrats on a smaller BBB package either. Progressives, among others, have demonstrated similar inflexibility on further compromise.  Timing on next steps for the BBB remains unclear.

Administration

FDA Sends PDUFA, GDUFA to Congress, MDUFA Pending. The U.S. Food and Drug Administration (FDA) failed to send the Medical Device User Fee Act (MDUFA) agreement to congressional lawmakers prior to the January 15th deadline, following months of disagreement between the medical device industry and the agency. The other agreements, including the Prescription Drug User Fee Act (PDUFA) and Generic Drug User Fee Act (GDUFA) were sent to Capitol Hill earlier this month. MDUFA has been delayed in the past, most recently in 2012. The FDA has not commented on which specific provisions are causing the delay. Both industry and FDA remain optimistic about reaching a deal in coming weeks. These user fee agreements are important to watch as other healthcare policies could hitch a ride as they advance.

Departments Host Listening Session on Provider Nondiscrimination Rulemaking. On January 19, the Departments of Health and Human Services, Labor, and Treasury held a listening session on an anticipated rulemaking implementing Provider Nondiscrimination legislation.  Originally passed as part of the Affordable Care Act, the provision prohibits health plans from discriminating against any health care provider who is “acting within the scope of that provider's license or certification under applicable State law.” The Section does not require payers to contract with any provider who is willing to accept the terms and conditions of participation and nothing prevents a payer from varying reimbursement rates based on quality or performance measures. To date, no agency has issued implementing regulations (the Departments regarded the law as “self-implementing”), but the three Departments responsible for enforcing the law  issued FAQs that some stakeholders regarded as a lax enforcement posture. Because of this, stakeholders from the advanced practice provider (non-physician clinicians) community successfully sought a provision in the No Surprises Act (section 108) that requires the Departments to issue regulations through notice and comment rulemaking. The No Surprises Act provision required the Departments to issue proposed regulations by January 1, 2022, and to issue final regulations six months later; the Departments failed to meet this first deadline notwithstanding the statutory command.  The listening session was an opportunity for stakeholders to share their perspectives on how the nondiscrimination provision should be implemented in the forthcoming rulemaking. The provision remains controversial with advanced practice providers lining up on one side, and physicians and payers generally lining up on the other.

CMS Hosts National Stakeholder Call on 2021 Accomplishments and 2022 Goals. On January 18, the Centers for Medicare and Medicaid Services (CMS) held a National Stakeholder Call to highlight 2021 accomplishments and 2022 goals and objectives, including efforts to advance health equity and an ongoing emphasis on data and science-informed decisions. The agency also noted that they will be undertaking ongoing efforts to streamline the Medicare enrollment process and eliminate delays in coverage.

Quick Hits

• On January 19, COVIDTests.gov- the website where individuals can order free COVID-19 at-home tests went live. Up to four tests per residential address may be requested.

• The U.S. Centers for Disease Control (CDC) released new data this week, showing a significant decline in the number of uninsured individuals across the country. Secretary of the U.S. Department of Health and Human Services (HHS) Xavier Becerra shared the data showing a drop in the uninsured for the third quarter of 2021 when compared to the same quarter of 2020. Reports from state-based exchanges in California and Minnesota also showed a record number of Affordable Care Act plan enrollees.

• This week, Center for Medicare and Medicaid Innovation (CMMI) Director Liz Fowler noted that the Innovation Center will be focusing on models that lower Medicare beneficiary costs going forward. She cited pilots focused on reducing drug costs as an example of the new strategic direction for the center.

• The White House appears to be aiming to release the FY 2023 President’s Budget in March, a month after the statutory deadline. This timeframe would allow for the budget proposal to be released following the President’s State of the Union Address, which he is scheduled to deliver to Congress on March 1. The Office of Management and Budget (OMB) has not commented on the budget’s delay or expected release.

• On January 13, the Supreme Court released two emergency opinions that change the landscape of the three federal vaccine rules. With these rulings, the CMS Rule is now enforceable in every state including Texas where an injunction was lifted to align with this ruling on January 19, across the full spectrum of the facilities covered by the rule. In sum:

• A 5-4 Supreme Court majority let CMS enforce its vaccine mandate nationwide, impacting specified health care facilities.

• A 6-3 majority blocked the U.S. Occupational Safety and Health Administration (OSHA) from enforcing its vax-or-test Emergency Temporary Standard (ETS) applicable to large employers.

• The third federal vaccine rule – the federal contractor vaccine mandate – remains subject to multiple legal challenges and, at this time, the government is blocked from enforcing the mandate nationwide. The Supreme Court has not yet weighed in on this mandate.

Both the House and Senate will be in session next week. We expect details to continue to emerge on the potential for another COVID relief package along with further details on negotiations for the next appropriations package. As a reminder, the current continuing resolution expires February 18th.