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 Senate returned this week to focus on nominations and voting rights legislation but not the Build Back Better (BBB) bill. The chamber provided no more clarity on the path forward for on this massive domestic investment priority. The House remained in recess with plans to return on Monday, January 10. In addition, both chambers somberly commemorated the events of January 6, 2021.

Congress

Senate Turns Focus to Voting Rights

While Senator Joe Manchin (D-WV) effectively side-lined BBB in its current form prior to the holidays, Senate Majority Leader Chuck Schumer (D-NY) kept hope alive by expressing strong interest in continuing negotiations.

Without clarity on BBB, the Senate shifted focus to voting rights legislation this week, with Majority Leader Schumer declaring the Senate will vote before Martin Luther King Day. The Freedom to Vote Act has support from all 50 Democratic senators, but no Republicans. The John Lewis Voting Rights Advancement Act has 223 Democratic cosponsors in the House and 48 in the Senate, but both pieces of legislation will require 60 votes to overcome an anticipated filibuster. Therefore, this key Democratic priority may jump-start conversations over changing the filibuster.

Congress Faces Upcoming Budget Deadline

Congress is yet again facing an upcoming deadline to fund the federal government along with key programs. The current continuing resolution (CR) funding the government expires on February 18, 2022. Democrats would like to see a comprehensive funding bill pass rather than another short-term extension, as agencies are currently operating under Trump Administration funding levels. There is also some interest in an emergency supplemental funding bill to provide relief for tornado-ravaged parts of the South and Midwest, and the fires that destroyed parts of Colorado. The supplemental could also become an opportunity to include an extension of the monthly child tax credit that expired at the end of 2021, and COVID-19 relief items.

Looking ahead, the Biden Administration is scheduled to release its FY 2023 Presidential budget proposal next month, though there is some uncertainty around timing. While the President’s Budget is non-binding and isn’t implemented as written, it typically kicks off the congressional budget process and provides the Administration’s recommendations and priorities for federal funding levels across the policy spectrum.

Administration

CMS Releases 2023 MA/Part D Technical Rule

The Center’s for Medicare and Medicaid Services proposed technical policy changes to the 2023 Medicare Advantage (MA) and Part D programs for 2023. The proposed rule would require pharmacy price concessions be used to lower out-of-pocket prescription drug costs for Medicare beneficiaries and seeks to improve health equity in both Medicare Advantage (MA) and Part D.

The proposed rule would also set maximum out-of-pocket limits for dual-eligibles in MA plans and revise timeframes associated with care and provider access for beneficiaries under MA during disasters and emergencies. Finally, the rule contains provisions on past performance considerations for new contracts, network adequacy requirements for MA plans, greater marketing and communications oversight, and more.

If finalized, the proposed changes would be effective January 1, 2023, meaning that Part D plans would need to account for these changes in bids submitted for contract year 2023.

HHS Releases Notice of Benefit and Payment Rule

This week, the Department of Health and Human Services released the 2023 Notice of Benefit and Payment proposed rule, which would require every state issuer participating in the federal exchange to offer at least one standardized plan option at each metal level in which it offers plans. The agency also announced that it plans to conduct network adequacy reviews in every state using healthcare.gov and will refine the Affordable Care Act Essential Health Benefits process as a part of the Administration’s move toward advancing healthcare equity. The agency is accepting comments on the proposed rule for the next 30 days.

CMS Rescinds MFN Rule

The Centers for Medicare and Medicaid Services (CMS), posted a final rule in late December, rescinding the November 2020 Most Favored Nations (MFN) Model interim final rule and removed the associated regulatory text.

The MFN rule would have created a mandatory, seven-year payment model for the 50 highest-cost drugs and biologics in Medicare Part B to replace the current reimbursement formula for these drugs. Instead of adding a 6 percent administration fee to the average sale price (ASP) of the drug, the new reimbursement system would have been based on international pricing information from 22 different countries.

Following significant pushback from industry stakeholders as well as several court challenges, the agency announced that it will no longer implement the rule, which was scheduled to take effect January 1, 2022.

CMS Ends the SIP Component of the PCF Model

The Seriously Ill Population (SIP) component of Primary Care First (PCF) was designed to have advanced primary care practices, including providers whose clinicians are enrolled in Medicare and who typically provide hospice or palliative care services, coordinate care for high need, seriously ill beneficiaries. CMS has determined that the proposed SIP outreach method, which was designed to comply with statutory beneficiary privacy protections, is unlikely to result in sufficient beneficiary uptake to allow for model evaluation.

Quick Hits

• The Child-Tax Credit quietly expired at the end of 2021, with the final payments issued on December 15. The program, which was enacted through the American Rescue Plan, began in July 2021, and issued monthly payments of $300 per child under 6, and $250 per older child. Provisions to extend the federal program are included in the Build Back Better Act, which has yet to pass the Senate.

• An all-time high of individuals enrolled in healthcare coverage through the Affordable Care Act’s insurance marketplaces in 2021. Enrollment topped 13.6 million individuals in mid-December, with nearly a month left in the enrollment period. Open enrollment for the federal marketplace was extended through January 15 by the Biden Administration, though some states extend through the end of January.

• House Speaker Nancy Pelosi (D-CA) invited President Joe Biden to deliver the State of the Union address to Congress on March 1, 2022. This is a historically late date when compared to past events. This delay would potentially give President Biden additional time to see progress on key Democratic policy priorities.

• Congresswoman Pramila Jayapal (D-WA) and over 50 members of the House of Representatives sent a letter to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure asking the agency to end the Global and Professional Direct Contracting model by July 1, 2022.

• Key provisions of the No Surprises Act, the federal surprise billing protection law, took effect January 1, 2022. CMS posted additional guidance shortly before the holidays elaborating on, among other things, the Independent Dispute Resolution processes.

• Meanwhile, a group of 26 Republican Senators, led by Senators Roger Marshall, MD (R-KS) and Bill Cassidy, MD (R-LA) sent a letter to HHS Secretary Xavier Becerra, asking the agency to revise their interim final rule on the “No Surprises Act” to more specifically consider numerous historical and financial factors in the independent dispute resolution process.

• The American Society of Anesthesiologists, American College of Emergency Physicians and American College of Radiology sued the US Department of Health and Human Services, among others, on December 22nd in the Northern District of Illinois federal district court challenging aspects of the dispute resolution process outlined in the No Surprises Act implementing regulations.

Next Week’s Diagnosis

Both the House and Senate will be returning to Washington next week. Former Senate Majority Leader Harry will lie in state in the Capitol Rotunda. Ongoing consideration of both potential voting rights legislation and the confirmation of Food & Drug Administration (FDA) Commissioner nominee Robert Califf are also expected to occur.