April showers brought
A May of finger-pointing
That’s not the rhyme, guys
The Rundown
- Unwound: COVID-19 PHE comes to an end
- The default in our stars: no sign of debt limit agreement, but talks continue
- Congressional committees examine drug access, PBMs, PAHPA, and healthcare workforce diversity
- DEA formally extends PHE tele-prescribing rules for controlled substances
- The latest from our desks
- Save the date: virtual office hours on May 19
- Join the Duke Health Advocacy Network!
Federal Updates
Unwound: COVID-19 PHE comes to an end
No one reading today will likely forget where they were or what they were doing over three years ago when the COVID-19 public health emergency (PHE) was first declared in the United States. It was a time of great unknowns, and despite the cautious optimism of some public health officials that this newly emerged bio-threat could be effectively contained, there was also this unshakeable feeling that we had a long road ahead of us. For some, that meant facing the frontlines, learning in real time at the bedside or in the lab about what we were up against. For many others, it was doing everything possible to support those efforts, each other, to adjust, to just keep moving forward. That’s who we are. That’s Duke Health. There was no choice – just do.
Yesterday, that PHE declaration officially came to an end, following an announcement from the Biden administration earlier this year that it intended to formally move away from the emergency phase of the pandemic to one of mitigation and management. COVID-19 is here to stay, and the shift back to “normal” will be continuous and evolving, despite the finality of a policy declaration.
What happens now? Some things won’t change right away. Many of the PHE-related telehealth flexibilities have been extended through December 31, 2024, and the 118th Congress is expected to consider legislation before that end date to make any number of those flexibilities permanent. The Medicare Acute Care Hospital at Home program has also been extended through the end of 2024. The Food and Drug Administration will still be able to issue emergency use authorizations (EUAs), and the Drug Enforcement Administration has announced an extension of its tele-prescribing rules for controlled substances (more below). For others, the end of the PHE marks changes in other relied-upon flexibilities, including: the ability for CDC to track COVID cases, COVID-related food assistance, federal responsibility for vaccines and testing, an immigration policy to deny asylum claims for public health reasons, rules around virtual supervision of residents, and some hospital reporting requirements.
The Centers for Medicare and Medicaid Services (CMS) have published a number of resources to help hospitals, providers, and insurers navigate the PHE’s end, including a recently updated FAQ document. Our team has worked closely with Duke Health leadership and counsel’s office over the past few months to share updates and assist in preparing for the PHE’s end.
It’s hard not to be reminded of the place from which we came when we take notice of where we are today – and as importantly, recognize that some of the same systemic flaws and inequities that made this emergency even more difficult to address persist. There is still work ahead, for our team, for all of us – and we must continue to “just do” with the same sense of purpose and resolve as we did when we measured our time not in days or weeks, but just moment to moment. Reflection is worthwhile, as is rest and celebration. The end of one thing marks the beginning of another and so much opportunity to be better prepared now and for next time.
The (de)fault in our stars? Policymakers no closer to debt limit deal – but still talking
While no one really expected Tuesday’s initial meeting between the White House and congressional leadership about raising the debt ceiling to produce an agreement, there was some hope that the characterization of those talks afterward would be a little more encouraging than, “well, it happened.” Then again, that’s just the world of negotiations. You never take the first offer, but at some point, some actual offers/counteroffers will need to be made.
The good news? The parties are still talking and President Biden and the “big four” -- House Speaker Kevin McCarthy (R-CA), House Minority Leader Hakeem Jeffries (D-NY), Senate Majority Leader Chuck Schumer (D-NY), and Senate Minority Leader Mitch McConnell (R-KY) -- are planning to meet again early next week. The challenge will be trying to find a way to get past the focus on the order of operations and understand in principle both sides have concerns about similar issues. No one wants default, or to bear the responsibility of what might happen as a result, and both Democratic and Republican leaders have expressed interest in more thoroughly examining federal spending. If there is a deal to be made, it will be found somewhere in that mix. And it will likely need to be made quickly. We’re fewer than three weeks out from a potential default date. Building consensus for legislation takes time – and the sound of that ticking clock is getting louder.
In the near term, the limbo of this process is already impacting other legislative priorities. We reported last week that the House-passed debt limit bill will likely influence how the House Appropriations Committee begins work on its versions of the twelve annual appropriations bills, resulting in recommended cuts of up to 20 percent for non-defense discretionary spending, including funding for biomedical research. The House Armed Services Committee has also pumped the breaks on its work on the FY 2024 National Defense Authorization Act (NDAA), an annual defense policy bill that, among other priorities, authorizes medical research funded by the Department of Defense.
Our team is continuing to work with Duke Health leadership and the NC congressional delegation to emphasize the critical importance of federal support for health systems, the healthcare workforce, research, and our communities.
Heard on the Hill: Prescription drugs, PBMs, PAHPA, and workforce diversity
This week saw a new House subcommittee take a deeper dive into policies impacting prescription drugs, the House Energy and Commerce Committee focusing on the Pandemic All-Hazards Preparedness Act (PAHPA), the continuation of a Senate Health, Education, Labor, and Pensions (HELP) Committee markup of drug access and Pharmacy Benefit Manager (PBM) legislation, and a field hearing today on increasing diversity in the healthcare workforce.
House Ways and Means Subcommittee on Health
On Wednesday, the House Ways and Means Subcommittee on Health held a hearing on “Examining Policies that Inhibit Innovation and Patient Access.” Witnesses included a patient advocate and representatives from a professional research association, pharmaceutical research, and academia. The discussion largely focused on policies designed to increase access to new drugs and therapeutics and the federal government’s role in spurring innovation and market access. Several committee members and witnesses were critical of provisions in the Inflation Reduction Act, passed by the 117th Congress, that were developed to increase consumer access to prescription medication, including the ability for Medicare to negotiate certain drug prices.
House Energy and Commerce Subcommittee on Health
Yesterday, the House Energy and Commerce Subcommittee on Health held a hearing entitled, “Preparing for and Responding to Future Public Health Security Threats.” The hearing was the official start of the legislative process for reauthorizing certain key programs and authorities originally established in the Pandemic and All Hazards Preparedness Act (PAHPA) ahead of their September 30, 2023, expiration date.
Rep. Richard Hudson (R-NC-09), who is leading PAHPA reauthorization efforts for the majority, said he has received feedback though several efforts, including a bipartisan Request for Information (RFI) from stakeholders to which Duke Health responded. He stressed that this is not a COVID-19 response bill but a reauthorization bill to ensure that our nation is prepared for all public health security threats, including natural disasters, cyber-attacks, and bio threats alike.
Energy and Commerce House Oversight and Investigations Subcommittee
The Energy and Commerce Oversight and Investigations Subcommittee also held a hearing on “Examining The Root Causes Of Drug Shortages: Challenges In Pharmaceutical Drug Supply Chains.” In his statement, full Committee Ranking Member Frank Pallone (D-NJ) said that drug shortages are not a new issue but are currently at a five-year high and can last anywhere from a year to over a decade, with 15 critical drugs in shortage for over ten years. He noted the recent disruptions in the availability of children’s pain medication and medication to treat conditions like ADHD, which can result in delayed care, ineffective treatment, and increased hospitalizations. He emphasized the need to prevent drug shortages, including building a robust and resilient drug supply chain, which is not only critical to our health and well-being but also to national security and the economy.
Senate Health, Education, Labor, and Pensions (HELP) Committee
After a somewhat contentious markup hearing last week related to disagreements over procedure and amendments, the Senate HELP Committee met again yesterday to continue its markup of drug access and Pharmacy Benefit Manager legislation. There were no comments or additional changes related to the Ensuring Timely Access to Generics Act of 2023 (S. 1067) or the RARE Act (S. 1214), both of which were unanimously reported favorably. The Committee approved an amendment to the Expanding Access to Low-Cost Generics Act of 2023 (S. 1114) that would clarify the FDA’s responsibility in its review of inactive ingredients in generic drugs and favorably reported the bill. The Committee approved seven amendments to the Pharmacy Benefit Manager Reform Act (S. 1339), including requiring reporting of certain drug price increases and another that requiring a study on access to medication for opioid overdose reversal. The Committee favorably reported the bill.
Senate HELP Committee – Field Hearing
Later this morning, the Senate HELP Committee will hold a field hearing at Morehouse College in Atlanta, Georgia focused on improving health workforce diversity and addressing health workforce shortages. The Committee will be joined by leadership and students from Historically Black Colleges and Universities (HBCUs) and representatives from the Association of American Medical Colleges (AAMC).
DEA officially extends PHE tele-prescribing rules for controlled substances
This week, the Drug Enforcement Administration (DEA), in conjunction with the Substance Abuse and Mental Health Services Administration (SAMHSA), officially published in the Federal Register its intention to extend public health emergency (PHE) rules for the tele-prescribing of controlled substances through November 11, 2023.
For patients and providers that have an established relationship, the eased PHE rules will be extended for another year through November 11, 2024.
The extension of the PHE rules is intended to give the DEA more time to finalize post-PHE tele-prescription rules first proposed in February of this year, which would allow the continuation of tele-prescribing of controlled substances in certain circumstances but includes a requirement for an in-person evaluation before a provider can begin prescribing substances via telehealth. While the in-person requirement is intended to address potential patient safety concerns, the DEA received over 38,000 public comments, many raising concerns about existing provider-patient relationships and potential impact of the proposed rules for patients in rural and underserved communities.
Our team, working with health system leadership and experts, submitted comments in response to the proposed rules on behalf of Duke Health on March 31, urging a temporary extension of PHE flexibilities and asking the DEA to weigh patient safety and health equity concerns when developing final rules.
From our desk(s): Duke Health GR this week
On Tuesday, Dr. Catherine Kuhn, Associate Dean for Graduate Medical Education (GME), participated in an Association of American Medical College's (AAMC) congressional briefing, “From The Match® to Medicine: The Post-Medical School Path for Doctors, and the Role of Medicare-Supported GME.” Dr. Kuhn spoke about Duke's GME program and the unique resident training opportunities available at Duke Health. While in DC, Julie Rose from our team organized and joined Dr. Kuhn and Dr. Hubert Haywood, Senior Assistant Resident at Duke, in meetings with the offices of Senator Ted Budd (R-NC) and Reps. Greg Murphy, MD (R-NC-03), Valerie Foushee (D-NC-04), and Richard Hudson (R-NC-09) to further emphasize the importance of funding GME programs.
This week a member of our team participated in the White House Health Community Engagement Call and shared information with Duke Health leadership on the White House Call to Action During Mental Health Month on actions organizations are taking to support mental health research.
A member of our team participated in a national coalition working group, which includes representatives of health systems, associations, and industry, on data privacy in healthcare to develop advocacy strategies for expected data privacy legislation in the 118th Congress.
Save the Date – Virtual “Office Hours” on May 19
Duke Health (federal) Government Relations is once again partnering with our Duke State Relations colleagues to hold our second open, virtual "office hours" in May. Open to members of the Duke Health Advocacy Network, these “office hours” are not formal presentations but instead an opportunity to talk about some of things on deck for us to learn more about the issues that are at the forefront for you and your work. Our sincere thanks to those who joined us for our inaugural office hours on April 21st. We hope to see you again in May!
Date: Friday, May 19, 2023
Time: 10:00 a.m.
A link to access the event will be published in the Duke Health Advocacy Network Teams Channel
Not yet a member of the Duke Health Advocacy Network? No problem! Learn more about how to join below.
Join the Duke Health Advocacy Network!
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