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Federal Health Policy Updates for the Week of April 19, 2021

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Federal Updates
 
The (debt) ceiling is the “oof”
Let’s talk about the debt ceiling. There are plenty of misconceptions about what it is and does given the name, but practically it “authorizes” the federal government to pay back money it has already or intends to borrow. It’s a congressional construct from World War I-era federal finance policies rather than a direct constitutional one (and in fact opponents of the debt ceiling point to a guarantee in the Constitution that the federal government will honor its debts and obligations as among the reasons to eliminate it). It was intended to make it easier for the federal government to borrow when needed and has served as a check at times on federal investment – but now, and within the past ten years in particular, it has acted as more of a political Sword of Damocles hanging over both parties.

After several recent suspensions and extensions, Congress will likely need to take action later this summer or in early fall to once again increase the federal debt ceiling. Congressional Republicans, whose votes will be needed under regular order in the Senate to pass a debt ceiling increase, are reportedly readying a strategy to demand spending cuts in exchange for their votes. This type of exchange is not unique – and it should be pointed out that Democrats have also not been immune to using debt ceiling debates for political advantage. However, history suggests that Congress should be very deliberate and cautious about what happens next. In 2011, a debt ceiling vote turned into a protracted political debate that threatened the country’s economic recovery and global credit rating. It led to the appointment of various fiscal commissions and ultimately the passage of legislation that placed indiscriminate, across-the-board caps and cuts on federal discretionary spending for much of the past decade that have just recently expired – and which impacted growth and investment in any number of agencies and programs, including those supporting biomedical research. Other, smaller debt ceiling skirmishes in recent years have been no less impactful on policy agendas. What used to be routine decidedly isn’t so anymore.

It’s still early, of course. There will be plenty of posturing and agreements may be reached well ahead of any vote, but it’s yet another issue which we will be monitoring closely that could have consequential implications for many Duke Health priorities, not to mention federal government operations and any hopes for near-term bipartisanship. What will it mean for the FY 2022 appropriations process? Will this be the issue that eventually cements plans for another round of reconciliation? Will it ultimately lead to reform of the filibuster? Are the past few paragraphs a D.C. conditioned overreaction?

Stay tuned.

One in, one in limbo: HHS nominees face committee confirmation
On Thursday, the Senate Finance Committee voted to advance the nomination of Andrea Palm for Deputy Secretary of Health and Human Services (HHS) by a 20-8 vote for consideration of the full Senate at a date to be determined. Palm is a former Obama administration HHS official and most recently served as director of Wisconsin’s Department of Health Services, leading the state’s COVID-19 response.
 
However, the vote to advance the nomination of Chiquita Brooks-LaSure for Administrator of the Centers for Medicare and Medicaid Services (CMS) ended in a tie, and the nomination is also now under a temporary procedural hold placed by Senate Finance Committee Member John Cornyn (R-TX).

The deadlock, unexpected when the vote was first scheduled, is the result of the Biden administration’s decision to rescind a Medicaid waiver given to Texas in the final days of the Trump administration. That waiver extended federal funds that reimburse hospitals for providing care for uninsured people without requiring Texas to adopt further Medicaid expansion. Finance Committee Republicans, including those who were planning to vote for Brooks-LaSure, joined in unison to vote against advancing her nomination to demonstrate their opposition to the administration’s decision, which they characterize as politically motivated to induce Texas and other states to formally expand Medicaid services. Senator Cornyn reportedly sought a meeting with the White House Thursday morning on the issue before the vote.

Senate Finance Committee Chair Ron Wyden (D-OR) indicated that the committee will still seek to advance Brooks-LaSure’s nomination and pledged to work with Senator Cornyn and the administration on the issue. Because of the tie vote in committee, Brooks-LaSure’s nomination will now require a discharge vote of the full Senate before it can advance for a final confirmation vote.

The confirmation processes for both nominees comes at a critical time as HHS is in the early stages of developing what many expect to be an interim final rule, subject to notice and comment procedures, for new surprise billing requirements mandated by the omnibus package passed by Congress last December. If eventually confirmed as CMS Administrator, Brooks-LaSure would also be tasked with overseeing the review of the efficacy of telehealth expansion in Medicare during the COVID-19 public health emergency.

As the Biden administration fully staffs its HHS leadership, we will closely monitor its activities on surprise medical billing, telehealth, and other priorities.

NIH reverses Trump-era fetal tissue research restrictions
On Friday, April 16, the National Institutes of Health (NIH) announced that the Biden administration is reversing Trump administration restrictions on the use of fetal tissue in biomedical research.

As a result, NIH will no longer convene the Human Fetal Tissue Research Ethics Advisory Board to review new external grants and proposals using fetal tissue. The advisory board only met formally one time after its inception and rejected 13 of 14 proposals submitted for ethics review at the recommendation of NIH researchers.

NIH will still require that researchers obtain consent from donors, do not pay for such tissue, and follow any applicable state laws governing fetal tissue research.

HELP hearing on foreign influence in research
On Thursday, April 22, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on foreign influence in research, with witnesses from NIH, the HHS Office of National Security, the HHS Office of Inspector General, and the Government Accountability Office. Senators lauded the nation’s scientific enterprise and stressed the need for trust and transparency in research to ensure federal investments are well spent and national security is protected.

Senator Richard Burr (R-NC), who is the Ranking Republican of the HELP Committee, noted that some foreign actors are actively engaged in efforts to subvert biomedical research in the United States but that he is committed to working with the federal government and academic centers to protect the nation’s research enterprise.

Senate Republicans make infrastructure pitch
Also on Thursday, a group of Senate Republicans, led by Senator Shelley Moore Capito (R-WV), unveiled a $568 billion infrastructure proposal in an effort to open negotiations with the Biden administration on potential bipartisan infrastructure legislation.

In size and scope, the proposal is roughly a quarter of the Biden administration’s American Jobs Plan and defines infrastructure more narrowly, focusing on more “traditional” items, including roads and bridges, public transit systems, and rail, as well as wastewater infrastructure, airports, and broadband infrastructure. It does not include any dedicated funding to support the nation’s research infrastructure nor any direct funding for hospital and clinical research infrastructure as proposed by House Energy and Commerce Committee Democrats in the LIFT America Act (H.R. 1848).

While the Republican proposal was quickly dismissed by some in Democratic leadership as not going far enough, there is a small contingent of Senate Democrats who are open to finding an agreement on an initial targeted bipartisan infrastructure bill as a “down payment” on the Biden administration’s broader goals.

Our office will be monitoring the release of proposals and legislation closely. We’ll also be working with our partners, associations, other stakeholders, and Duke leadership to advocate for robust infrastructure investment in academic medical and research institutions, hospitals, clinical and research laboratories, and technological investments supporting the delivery of and greater access to healthcare.

House Democratic committee leaders reintroduce drug pricing legislation
On Thursday, House Ways and Means Committee Chair Richard Neal (D-MA), House Energy and Commerce Committee Chair Frank Pallone (D-NJ), and House Education and Labor Chair Bobby Scott (D-VA) reintroduced the Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3).

Among other provisions, the legislation would seek to lower prescription drug costs by:

  • Authorizing the HHS Secretary to negotiate better prescription drug prices in Medicare and make those negotiated prices available to commercial health insurance plans;
  • Capping Medicare beneficiaries’ out-of-pocket spending on prescription drugs at $2,000 per year;
  • Requiring drug manufacturers to pay back rebates to the federal government if they increase prices faster than inflation; and
  • Reinvesting federal cost-savings in the NIH and the Food and Drug Administration to support research and development of new breakthrough treatments and cures, as well as making investments in combatting the opioid crisis.

Estimates from the Congressional Budget Office in 2019 suggest the legislation could result in federal savings of approximately $456 billion over 10 years, as well as $42 billion in savings for the Medicare program due to anticipated better health outcomes for Medicare beneficiaries with increased access to drugs at lower prices.

The legislation passed the House in the 116th Congress but was not taken up by the Republican-controlled Senate. Even if passed by the House again, the bill would face an uphill fight under regular order in the Senate with such a narrow Democratic majority. Key provisions in the legislation may ultimately be included in the Biden administration’s healthcare infrastructure plans.

From our desk(s): Duke Health GR this week
Our work continues to build support among the NC congressional delegation for Dear Colleague Letters (DCLs) that prioritize various funding requests for specific programs, including funding for the NIH, Title VII and Title VIII workforce programs, the MISSION Zero Military-Civilian Partnership for Trauma Readiness Program, and the Department of Defense’s Peer-Reviewed Reconstructive Transplant Research Program. Many of these letters will close in the coming week, and we will share with you whom in the NC delegation joined to offer their support for various priorities.

In addition to monitoring the Senate HELP Committee hearing focused on biomedical research and foreign influence/research security, our office met with staff for Committee Ranking Member Burr to discuss Duke Health priorities and initiatives, including our health system’s support of the Lincoln Community Health Center, Black maternal health, RADx-UP, the ABC Science Collaborative, healthcare workforce, and research relief. Additionally, we plan to follow up soon with majority and minority HELP staff on a proposal to support early educational and training opportunities for medical professionals training at qualified institutions and programs.
 
We also continue to participate in critical issue coalitions – informing national policy and advocacy strategies – and joined a telehealth policy summit organized by the Alliance for Connected Care, engaged with the leadership of the Senate Telehealth Working Group on federal expansion of telehealth services beyond the current public health emergency, and met with faculty on emerging projects and policy issues.
 
Want to Join Team Advocacy?
Thanks to the PDC and our partners in the Duke State Relations office, Duke Health physicians and providers can engage with policymakers through the PDC Provider Advocacy Network.

By enrolling in the Phone2Action advocacy tool, individuals can join a powerful, collective voice on priority healthcare issues debated in Raleigh and Washington, D.C., including telehealth, workforce, drug pricing, and many more.

Learn more here. (NOTE: You must register and use a non-Duke email address to receive action alerts.)