This I promise you
It’s going to seem tougher
Until they’re in sync
The Rundown
- Unfinished business dominates early 2022 agenda
- Califf HELP Committee nomination vote scheduled for next week
- Most favored nation model rescinded
- OSHA withdraws much of its healthcare workforce ETS
- Supreme Court to hear vaccine mandate challenges
- The latest from our desks
Federal Updates
Welcome back and keep your distance
The Senate returned this week with an ambitious opening agenda following a two-week holiday recess to regroup on a number of priorities. Then there was a disruptive snowstorm, more disagreements (or lack of discussion completely) on certain policy issues, recognition of the anniversary of the January 6th insurrection, passing of former Senate Majority Leader Harry Reid (D-NV), and the realities of the Omicron variant running rampant in D.C. The House is planning to return next week, but with all that’s going on (and not), some timelines are likely to get pushed.
- Build Back Better Act (BBBA) – We closed 2021 with a declaration from Senator Joe Manchin (D-WV) that he would not support the BBBA passed by the House in November and that it was hard for him to see a path forward on negotiations on the reconciliation package. This was a big blow to a major Biden administration agenda item and drew the ire of fellow Democrats in both chambers who felt that Manchin was reneging on a promise to help see the BBBA through the upper chamber. There hasn’t been much progress since, with negotiations and work by the Senate parliamentarian to help restructure the package on pause. Senate Majority Leader Chuck Schumer (D-NY) has said that despite the setback, the upper chamber will vote on various iterations of the BBBA until it passes, but those efforts will now take a temporary backseat to a long-stalled effort to adopt voting rights legislation.
- Voting rights and Senate rules – Leader Schumer is teeing up a vote on the John Lewis Voting Rights Advancement Act (H.R. 4) on Martin Luther King, Jr. Day on January 17th, daring Republicans to block a legislative effort designed to protect federal voting rights. Among other provisions, the legislation would reinvigorate anti-discrimination protections in the Voting Rights Act weakened by Supreme Court decisions. The support of at least 10 Republicans would be needed to meet procedural requirements for the bill to receive a final simple majority vote, which seems unlikely.
If the vote fails, Schumer has suggested a separate vote to change Senate filibuster rules to aid in the passage of voting rights legislation and potentially other priorities. The problem? Not all Senate Democrats agree on modifying the filibuster and even those that do have different ideas on the rule restructuring. What happens with these potential votes has implications beyond critical legislation. The Senate Democratic majority is already very fragile and absent greater cohesion the prospects for any number of other administration agenda items may hang in the balance.
- FY 2022 and FY 2023 federal appropriations – A second short-term continuing resolution (CR) was passed in early December to keep the federal government funded through February 18, 2022. Over the next few weeks, negotiations on a final FY 2022 spending package are expected to pick up, with an agreement on a final defense spending top line being among the first hurdles to clear. An omnibus is the desired goal for Democratic leaders, but the longer conversations drag on, the likelihood of another CR will increase.
Of course, most of this work may be happening during what would ordinarily be the kick off of the FY 2023 appropriations season with the release of the president’s budget in early February. With delays likely, it’s unclear when Congress will begin work on funding for the upcoming fiscal year.
What else might be on the docket in the mad dash to the November midterms? We anticipate that the Biden administration will renew the public health emergency (PHE) for another 90 days, but there is some uncertainty after that point. This likely means that advocacy and activity on any number of policies tied to the PHE, including those for telehealth, hospital at home, and other Medicare flexibilities, will pick up in the first quarter. There is also anticipated pandemic preparedness legislation, work on an update to the 21st Century Cures Act through Cures 2.0, and legacy legislation for a growing number of retiring congressional members.
Our office continues to advocate for Duke Health federal priorities and will stay closely engaged with the NC congressional delegation and our partners in regional and national coalitions as the federal agenda takes shape for 2022.
Califf vote scheduled in HELP Committee
On January 12, the Senate Health, Education, Labor and Pensions Committee will hold a vote to move forward on the nomination of Dr. Robert Califf to be Commissioner of the Food and Drug Administration. The Committee held its hearing to examine Dr. Califf on December 14, where he discussed priorities including emergency preparedness and response, consumer and patient protection, and modernization and innovation. Senate HELP Committee Ranking Member Richard Burr (R-NC) plans to support Dr. Califf’s nomination, who previously served as the vice chancellor for clinical and translational research at Duke University.
It’s official—Most Favored Nation Model rescinded
The Centers for Medicare and Medicaid Services (CMS) have officially rescinded the Most Favored Nation Model drug pricing rule proposed by the Trump Administration. This new model would have tested paying for certain Medicare Part B single source drugs and biologicals by matching them to the lowest price manufactures receive in other countries of similar status/GDP to the U.S. CMS had previously indicated that it did not plan to move forward with the rule and officially issued a final rule rescinding the policy on December 29, 2021.
OSHA withdraws much of its healthcare worker ETS
The Department of Labor’s Occupational Safety and Health Administration (OSHA) announced just before the new year that it had officially withdrawn most of its original COVID-19 healthcare worker emergency temporary standard (ETS) issued on June 21, 2021. Only the ETS’s recordkeeping requirements authorized by a separate provision in the OSHA Act remain in place.
The healthcare worker ETS, which by rule can only be enforced for six months without additional permanent rulemaking by the administration, applied broadly across many healthcare settings to protect employees and patients from COVID-19 exposure. It is unrelated to OSHA’s separate vaccine and testing mandate ETS for private employers with more than 100 employees.
While the administration and OSHA have indicated that they continue to work on permanent COVID-related safety standards for healthcare workers, the decision to withdraw the ETS amid a growing surge of the Omicron variant has been met with derision by labor unions and some policymakers.
Many labor attorney groups are reportedly advising their healthcare clients to continue to operate as if the ETS is still in place, and OSHA officials have said that in the absence of the healthcare standard, the agency will “vigorously enforce” OSHA’s general duty clause and rules covering personal protective equipment and respiratory protection such as the use of N95 respirators. The general duty clause requires employers to provide a workplace that is free of known, fatal hazards that can be feasibly mitigated.
We will continue to monitor activity and updates from OSHA and the Biden administration on COVID-19 workplace safety standards.
Supreme Court to hear limited arguments on federal vaccine mandates
We know that we said we were retiring use of the word “unprecedented” for the foreseeable future, but the Supreme Court’s decision to hear limited oral arguments today on emergency applications related to district court decisions on both the OSHA and CMS federal vaccine mandates is worthy of the descriptor.
Traditionally, the Court will act on emergency applications to stay (or temporarily delay) certain actions or decisions without oral argument. Occasionally, an emergency application will then be converted to a full hearing on the merits with argument – but the Court in this case isn’t likely to rule on the merits of the mandates at all. Instead, what the Court is expected to decide is whether the two mandates can be enforced while lower appellate courts continue to work through the various challenges.
Sound complicated? It is, but it is also an attempt to provide at least some short-term certainty amid a pandemic entering a new phase with a highly-transmissible variant spreading throughout the country. Let’s take a quick look at the emergency applications in question.
- OSHA vaccine and testing mandate for private employers with 100 or more employees – The OSHA mandate was temporarily stayed nationwide by a Louisiana federal district court in November. In December, the 6th Circuit Court of Appeals issued a ruling lifting the stay. The applicants are asking the Supreme Court to again temporarily block the OSHA mandate pending other appellate decisions across the country on the basis that OSHA lacks the explicit statutory authority to issue such a mandate.
- CMS vaccine mandate for employers that receive Medicare and Medicaid funding – The short of it is that separate federal court decisions have resulted in 25 states being enjoined from implementing the CMS vaccine mandate and 25 states, including North Carolina, not subject to a pause in implementation. The question is whether to extend the stay to everyone or lift it completely pending appellate decisions. Opponents of lifting the stay argue that CMS acted outside of its general statutory authority by issuing the mandate without a formal notice and comment period. CMS originally indicated that it would not enforce the mandate anywhere pending a decision from the Supreme Court but reversed course on December 28 and announced that the states not under a stay order would still need to comply under a slightly adjusted timeline.
While the immediate futures of the two vaccine mandates are in play, the Court’s decision may also be a bellwether for limits on the Biden administration’s ability to utilize federal emergency powers and rulemaking to address the ongoing public health emergency. The Court has allowed state-issued vaccine mandates to move forward, but these applications will be a true test of federal authority.
From our desk(s): Duke Health GR this week
This week, the Duke Health Government Relations team was pleased to join our colleagues in the Duke State Relations office for a policy presentation during the Department of Psychiatry & Behavioral Sciences’ Grands Rounds. We appreciate these opportunities to connect directly with our Duke Health colleagues, share more about our work, as well as learn about the priorities and issues of importance for various departments and their team members – and we’d love to engage more with you, too. If you are interested in having our team join yours for a brief conversation about our work, please contact us at govrelations@dm.duke.edu.
Our office continues to monitor implementation of new federal surprise billing rules established by the No Surprises Act and have been working closely with health system leadership and the finance team to share updates and communicate concerns and questions to agency officials and congressional offices. Litigation is pending to have the Biden administration revisit some facets of the new rules, including the independent dispute resolution process. Links to updated guidance and resources from CMS are now posted on under the surprise billing information article on our website.
We are also monitoring legislation recently introduced in the Senate by Senators Collins (R-ME) and Lujan (D-NM) to amplify neuroscience priorities at the FDA. The Neuroscience Center of Excellence Act (S. 3427) would create a coordinated initiative at the FDA to enhance the research and development of therapeutics for neurological diseases and disorders. Our team is connecting with partners and stakeholders to learn more about the legislation and how it is being positioned in the second session of the 117th Congress. We will provide updates as they become available.
Finally, as Duke Health and our community continues to be impacted by the COVID-19 Omicron variant, our office is connecting Duke Health leadership with NC delegation members to ensure they have real-time information and an on-the-ground perspective to help inform the federal response.