Lots of work to do
On your marks, it’s time to sprint
It’s almost August
The Rundown
- Supreme Court to hear case challenging cuts to 340B program
- President Biden issues an executive order focused on promoting competition, including provisions targeting hospital consolidation and hospital price transparency rules
- House appropriators propose increases for NIH and other Duke Health priorities
- The FY 2022 Physician Fee Schedule proposed rule is released
- Infrastructure debate continues as we approach the upcoming August recess
- The latest from our desks
Federal Updates
Supreme Court to hear challenge to 340B site-neutral regulations
The Supreme Court has announced that it will review a challenge from the Association of American Medical Colleges, the American Hospital Association, and others to a Trump administration policy in which Medicare cut reimbursements by nearly 30 percent to hospitals that receive drug manufacturer discounts through the 340B discount drug program.
The hospital and health care associations initially prevailed in U.S. Federal District Court on the argument that the cuts were not made according to statutory requirements that must be followed for changes to payments. However, the U.S. Court of Appeals for the District of Columbia sided with the administration’s interpretation of the underlying statute used to authorize the cuts.
The case will likely be heard during the Supreme Court’s fall session.
Expansive executive order on competition includes health care, hospital provisions
On July 9, President Biden issued an executive order designed to promote competition in the American economy. The order, described as a “whole-of-government” effort, is comprised of 72 initiatives directing federal agencies to prioritize specific competition-related issues from health care and financial services to technology and agriculture.
While the executive order does not have the force of law or formal rulemaking, it is a strong signal of the administration’s executive priorities and serves as guideposts for agencies to act under their current authorities.
Specifically, the health competition provisions include encouraging the Department of Justice and Federal Trade Commission (FTC) to review and revise their merger guidelines as concerns persist over the impact of hospital consolidations. They also direct the Department of Health and Human Services (HHS) to support the enforcement of existing price transparency rules while also prioritizing those related to surprise billing that were passed by Congress in December 2020.
The order further directs HHS to standardize health care plan options in the federal Health Insurance Marketplace to aid in comparison shopping for individuals and families; increases support for generic and biosimilar drugs; directs the Food and Drug Administration to work with states and tribes to import lower cost prescription drugs from Canada; encourages the FTC to ban “pay for delay;” and reiterates the administration’s support for legislation to allow Medicare to negotiate drug prices and the creation of a public health care insurance option.
House Committee Approves Health Care Spending Bill
At the time of this writing, the House Appropriations Committee was set to pass its FY 2022 Labor-HHS-Education spending bill, which proposes robust funding for several of Duke Health’s priorities. Top highlights include:
- The National Institutes of Health (NIH) would receive $49 billion, an increase of $6.5 billion above the FY 2021 enacted level. According to the Committee, the bill includes an increase of $3.5 billion for existing NIH Institutes and Centers, which supports an increase of no less than 5 percent for each Institute and Center to support a wide range of biomedical and behavioral research, as well as targeted investments in several high-priority areas. In addition, $3 billion would establish the Advanced Research Projects Agency for Health (ARPA-H).
- The Centers for Disease Control and Prevention (CDC) would receive $10.6 billion, an increase of $2.7 billion above the FY 2021 enacted level. This would include $25 million for firearm injury and mortality prevention research, double the FY 2021 enacted level.
- The Agency for Healthcare Research and Quality (AHRQ) would receive $380 million, an increase of $42 million above the FY 2021 enacted level.
- The Substance Abuse and Mental Health Services Administration (SAMHSA) would receive $9.16 billion, an increase of $3.14 billion above the FY 2021 enacted level. This includes $100 million for the National Child Traumatic Stress Initiative, an increase of $28 million above the FY 2021 enacted level. This funding supports work done by the National Child Traumatic Stress Network (NCTSN), which is administered by SAMHSA and coordinated by the UCLA-Duke University National Center for Child Traumatic Stress (NCCTS).
- Title VII health professions programs at the Health Resources and Services Administration (HRSA) would receive $665.4 million, an increase of $175.8 million above the FY 2021 enacted level, with significant increases in funding for the Behavioral Health Workforce Education and Training Program. Title VIII Nursing Workforce Development programs would receive $314.4 million, an increase of $50 million above the FY 2021 enacted level.
The Senate has not yet introduced its bill, and passage of a final spending bill is not anticipated until much later in the year. It is likely that a continuing resolution will be needed to keep the government funded past October 1.
That time of year: The 2022 Medicare Physician Fee Schedule and Quality Payment Program proposed rule is out
The Centers for Medicare and Medicaid Services (CMS) released the 2022 Medicare Physician Fee Schedule and Quality Payment Program proposed rule on July 13. It includes updates to payment rates for physicians and other health care professionals, expands the use of telehealth, clarifies evaluation and management (E/M) policies, solicits comment on how CMS can better collect and analyze data on disparities in health care, and proposes policies for the 2022 performance year of the quality payment program, among many other provisions.
Regarding telehealth, the rule proposes continuing to cover some telehealth benefits until the end of 2023 to give CMS time to decide whether those services should become permanent. It also would require some in-person mental health visits to complement tele-behavioral health visits.
Our team is reviewing the provisions in the proposed rule and will work in coordination with our professional associations and internal stakeholders to develop feedback. The public comment period closes September 13 at 5:00pm.
Is two weeks enough? Infrastructure debate hits critical point
The sprint to the August recess is officially underway, with the House and the Senate trying to complete work on several pending policy issues before they return to their respective states and districts through Labor Day. While the House remained in recess this week, only conducting business at the Committee level, the Senate returned with several big polices awaiting action, including how to move forward on an infrastructure bill.
In a July 9th “Dear Colleague” letter, Senate Majority Leader Chuck Schumer (D-NY) outlined his plan for the Senate’s schedule, including his commitment to pass President Biden’s American Jobs and Families Plans and the FY 2022 Budget Resolution, which would include reconciliation instructions. As reported last week, Schumer is planning for the Senate to continue these discussions along two tracks. The first track, focused on a bipartisan infrastructure framework, involves Senate committees working with the White House and the bipartisan infrastructure group to turn their recent agreement into actual legislation. On the second track, the Senate Budget Committee unveiled an overall limit of $3.5 trillion for the upcoming FY 2022 Budget Resolution that would incorporate the remaining elements of the American Jobs and Families Plans, including provisions related to climate change, health care, and the caring economy (e.g., elder care, home care, child care, and other education and safety net programs).
Neither track is an easy lift, especially in an evenly divided Senate where the only agreement so far is on a broadly outlined framework. When you add that to drafting an actual bill with details, asking for and receiving a Congressional Budget Office (CBO) score, and ensuring enough Senators to support passage of the bills, it’s easy to see how one, or both, of these tracks could get derailed.
Schumer plans to hold a vote on the first track’s bipartisan framework next week. We continue to monitor the release of proposals and negotiations and are working with our partners, associations, other stakeholders, and Duke leadership to advocate for robust infrastructure investment in academic medical and research institutions
From our desk(s): Duke Health GR this week
Over the last two weeks, Dr. Gabriela Maradiaga Panayotti, Associate Professor in the Department of Pediatrics, and Dr. Viviana Martínez-Bianchi, Associate Professor in the Department of Family Medicine and Community Health, met with Rep. David Price (D-NC-04) and staff for Senators Richard Burr (R-NC) and Thom Tillis (R-NC) about the Latinx Advocacy Team & Interdisciplinary Network for COVID-19 (LATIN-19). They shared how they co-founded the group to address health disparities within the Latinx community as a result of the COVID-19 pandemic.
On Thursday, Duke Health participated in the 340B Health Hill Day to share updates and concerns with the offices of Senators Burr and Tillis and with Rep. Deborah Ross (D-NC-02) about the 340B Drug Discount Program. Recently, several drug manufacturers have been taking actions that appear to fall outside the scope of the program, possibly jeopardizing patient access to drugs provided at a discount. Specifically, some manufacturers are refusing to offer drugs to safety-net providers at the discounted prices that federal law requires, while others are demanding claims data that go beyond the scope of the 340B statute. Duke Health Government Relations continues to urge our representatives to support giving HRSA, which oversees the program, more authority to enforce the law.
In addition, our office coordinated a response to a request for information from Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) to inform the development of an Advanced Research Projects Agency for Health (ARPA-H). ARPA-H has been proposed by the Biden Administration “to develop breakthroughs to prevent, detect, and treat diseases like Alzheimer's, diabetes, and cancer.” Reps. DeGette and Upton are pursuing authorization as part of their Cures 2.0 bill and requested feedback on specific questions to inform this effort.
Our team also coordinated with health system leadership to add Duke Health to a national health system and health care professional sign-on letter to Congress in support of at least $5 billion to establish and strengthen hospital-based violence intervention programs.
Finally this week, our office connected our transplant experts with the office of Senator Tillis to share Duke Health’s concerns about an organ transplantation proposal in the FY 2022 Inpatient Prospective Payment System (IPPS) proposed rule. Duke Health submitted public comments noting that the proposed rule would have widespread and unintended consequences for patients, as “undermining the financial viability of organ procurement efforts is likely to reduce organ availability and lead to increased wait times for transplantation, resulting in greater acuity and possibly death.”
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