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The Rundown
- Debt limit negotiations continue as time runs short
- Congressional committees examine price transparency, 340B, site neutral payments, “anti-competitive hospital practices,” artificial intelligence, mental health, and healthcare access
- President Biden announces plan to nominate Dr. Monica Bertagnolli as NIH Director
- FTC issues proposed rule to strengthen regulation of healthcare data online
- The latest from our desks
- Virtual office hours TODAY - May 19
- Join the Duke Health Advocacy Network!
Federal Updates
The (debt) meetings are piling up. Progress?
Time marches on, negotiations continue, and the debt ceiling inches closer and closer every day. After the meeting last week between 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) -- produced no tangible results, though they all agreed a deal must be reached, several staffers were tasked with continuing the talks.
Now into week two of official negotiations, the number of people in the room and at the deal-making table shrunk to primarily representatives from the White House and Speaker McCarthy’s team. There are still serious sticking points, including the nature of spending reductions and increasing work requirements for certain benefits – but neither side has walked away.
If negotiations stall, several House Democrats are working on a backup plan with a procedural tool known as a discharge petition. The discharge petition could push a clean debt limit bill onto the floor separate from the spending negotiations. Its success depends on 218 supporters, which means Democrats would have to remain united and get some help from moderate House Republicans willing to cross the aisle and sign on. Think of this as an absolute 11th hour last resort. Right now, the focus for Republican members remains supporting the Speaker’s position.
In terms of other legislative priorities, the House-passed debt limit bill’s goal of reducing spending to FY22 levels is already influencing the House Appropriations Committee’s work on its versions of the twelve annual appropriations bills. The Committee has released its Agriculture and Homeland Security FY 2024 funding proposals and has marked up spending legislation for the Legislative Branch and Military Construction-Veterans' Affairs. Each bill contains some funding reductions influenced by the debt limit legislation.
Our office attended a White House virtual briefing with Vice President Kamala Harris this week where she outlined the administration’s position on preventing default on the United States’ debts. We are 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: a little bit of everything
Think of a topic in healthcare, any topic. Got it? Now, don’t tell us what it is, but there’s a very good chance that at least one congressional committee covered it in a hearing this week. There were markups of bills related to price transparency, site neutral policies, eliminating cuts to safety net hospitals, and 340B; there were also discussions about anticompetitive practices of hospitals, regulation of artificial intelligence, mental health access, and Medicare Advantage practices. What might await us next week? Well, let’s not get ahead of ourselves. Here’s a snapshot of some of the hearings we followed closely.
House Ways and Means Committee
On Tuesday, the House Ways and Means Committee held a hearing on “Healthcare Price Transparency: A Patient’s Right to Know.” Witnesses included representatives from small employers, a healthcare economist, a third-party healthcare price and quality evaluator, and a health system executive and former director of the Center for Medicare and Medicaid Innovation (CMMI). Discussion focused on the role of price transparency in aiding consumer choice of higher quality and lower cost healthcare services, as well as concerns that the Centers for Medicare and Medicaid Services (CMS) has not adequately enforced compliance violations of existing price transparency rules. The hearing comes as a fellow House committee (more below) is examining updated price transparency legislation and after CMS recently announced efforts to increase its enforcement of transparency requirements.
Despite recent CMS data suggesting that hospitals are now over 80 percent compliant with relatively new and existing regulations mandating consumer-friendly displays of shoppable services in a machine-readable file, price transparency has again become a hot-button issue for policymakers seeking additional cost savings in healthcare.
On Wednesday, the House Ways and Means Health Subcommittee also held a hearing entitled, “Why Health Care is Unaffordable: Anticompetitive and Consolidated Markets.” The hearing mainly focused on PBMs, vertical integration, and hospital consolidation.
In his opening statement, Chair Vern Buchanan (R-FL) said there are many facets contributing to consolidation and one of the reasons discussed at the hearing were site-neutrality policies in Medicare. Site neutral payment policies focus on paying the same for services regardless of the setting and have been targeting hospital outpatient departments (HOPDs) to be reimbursed the same as stand-alone physician offices, without taking into consideration that HOPDs tend to treat sicker and more complex patients, and they also must comply with more licensing and regulatory requirements. Our office is working diligently to address this issue.
Despite the focus on hospital consolidation, there were no hospitals or hospital associations represented at the hearing. However, the American Hospital Association (AHA) submitted a statement for the record stating that mergers and acquisitions are a vital tool to keep financially struggling hospitals open and allow hospitals and health systems to reduce costs, improve quality, and better serve patients where they live. AHA said that “hospitals and health systems have faced historic challenges in the last several years…They will need continued flexibility to seek strategic opportunities and partners as they work to recover from the pandemic, overcome massive increases in the cost of caring, adjust to changing patient and community demographics, adopt new care delivery and payment models, and innovate for the future.”
House Veterans’ Affairs Committee – Subcommittees on Health and Oversight and Investigations
On Wednesday, the House Veterans’ Affairs (VA) Subcommittees on Health and Oversight and Investigations held a joint hearing on “VHA Recruitment and Retention” to discuss challenges and opportunities to strengthening the Veterans’ Health Administration (VHA) workforce. Among the invited witnesses was Robyn Begley, American Hospital Association senior vice president of workforce and chief nursing officer, as well as CEO of the American Organization for Nursing Leadership. Begley spoke to the realities facing VHA partner hospitals and health systems that help fulfill Veterans’ community care needs, discussing how long-building structural changes in the healthcare workforce combined with the profound toll of the pandemic have left hospitals and health systems in the middle of a national staffing emergency that could jeopardize access to care. She also noted the shortages of nurses, doctors, and other health professionals, as well as the troubling increases in acts of violence directed toward healthcare workers.
The partnerships between VA medical facilities and academic medical centers like Duke are essential to improving access to quality care for Veterans across the country, as well as spurring innovations in research and care delivery that applies across populations. Maintaining and building upon these relationships will require investments in human capital and a strategic focus on developing a workforce with a diversity of experience and background that better reflects the communities it serves.
House Energy and Commerce Committee - Subcommittee on Health
The big one. On Wednesday, the House Energy and Commerce Health Subcommittee held a markup of 17 pieces of legislation covering issues from price transparency and Pharmacy Benefit Manager Reform to the 340B drug program and site neutral reimbursements for prescription medications. While there was mostly bipartisan agreement on advancing many of the bills, Republican and Democratic committee members were split on a proposal that would allow states to participate in value-based purchasing agreements for drugs and another introduced by Rep. Larry Buschon, MD (R-IN) to disclose additional information about how they use the 340B discount drug program.
In a collaborative effort between full Committee Chair Cathy McMorris Rodgers (R-WA) and full Committee ranking member Frank Pallone (D-NJ), the Transparent PRICE Act (H.R. 2691), which seeks to further codify certain hospital price transparency rules and increase penalties for hospitals deemed noncompliant, was amended to include several other measures announced for the markup. They include: increased funding for several public health programs, more transparency around the prices of diagnostic tests, business practices of PBMs, changes in ownership among Medicare providers, and delaying cuts to the Medicaid Disproportionate Share Hospital (DSH) program. The package also contains site-neutral drug policies for Medicare to pay the same amount for the drug regardless of whether it’s administered in a hospital or doctor’s office. Chair Rodgers initially offered but then withdrew an amendment that would have expanded the scope of the site neutral legislative proposal across ambulatory sites and services, noting that the Committee needed to do more background work on the impact of site neutral policies.
Our team connected with NC congressional delegation and committee contacts ahead of the hearing to share concerns about some of the proposals, including changes to 340B and the site neutral proposal. We will continue to work with Duke Health leaders and our national partners to inform the Committee’s work moving forward.
Senate Judiciary Committee – Subcommittee on Privacy, Technology, and the Law
On Tuesday, the Senate Judiciary Subcommittee on Privacy, Technology and the Law held a hearing on “Oversight of A.I.: Rules for Artificial Intelligence.” Witnesses included Samuel Altman, CEO, OpenAI, Christina Montgomery, Chief Privacy and Trust Officer, IBM, and Gary Marcus, Professor Emeritus, New York University. The hearing discussion largely underscored just how reticent and unprepared congressional leaders have been to tackle A.I. regulatory policy, despite increased warnings from experts that the rapidly emerging technology should have appropriate guardrails. The conversation also included suggestions for the creation of a new federal agency to oversee A.I. activities, which was not widely supported, A.I. data ownership, and the potential for A.I. technology to influence the 2024 election cycle.
There was also a brief exchange on the role of A.I. in healthcare delivery and the importance of protecting sensitive patient data. As these conversations are ramping up on the Hill, our team has been coordinating meetings with key congressional offices with Duke AI Health leadership and Duke Health leaders to position our work and expertise as resources for policymakers.
Senate Finance Committee – Subcommittee on Health Care
The Senate Finance Committee’s Subcommittee on Health Care held a hearing on Wednesday entitled, “Improving Health Care Access in Rural Communities: Obstacles and Opportunities.” The hearing featured witness testimony from health care systems across the country, including Mark Holmes, Director of UNC Chapel Hill’s Cecil G. Sheps Center for Health Services Research. With 1 in every 5 older Americans living in a rural community and the health care workforce shortage impacting rural areas, the issue of health care access in these communities directly impacts Duke Health as our health system experiences an increased number of visits from rural residents seeking health care that is unavailable closer to home. Committee Chairman Senator Ben Cardin (D-MD) spoke about the importance of telehealth for bringing healthcare resources to rural communities. Ranking Member Senator Steve Daines (R-MT) highlighted the issue of hospital closures, with 150 rural hospitals closing in the past 13 years.
Senate HELP Committee
On Wednesday, the Senate Health, Education, Labor and Pensions Subcommittee on Primary Health and Retirement Security held a hearing entitled, “A Crisis in Mental Health and Substance Use Disorder Care: Closing Gaps in Access by Bringing Care and Prevention to Communities”. Witnesses discussed positive impacts of models in communities, and recommendations for the committee such as “decriminalization of the prescribing of methadone for OUD by addiction specialist physicians.”
Senate Homeland Security and Government Affairs – Permanent Subcommittee on Investigations
On Wednesday, the Senate Homeland Security and Government Affairs Permanent Subcommittee on Investigations held a hearing on “Examining Denials and Delays in Medicare Advantage.” Witnesses included the widow of a Medicare Advantage (MA) enrollee and representatives from the Department of Health and Human Services’ Office of Inspector General, Kaiser Family Foundation, Greater Wisconsin Agency on Aging Resources, and Marquette University College of Nursing. Discussion included concerns among witnesses and Committee members that some Medicare Advantage plans inappropriately restrict beneficiary access to medically necessary covered services. Meaningful enforcement of new CMS rules to better align MA coverage policies with Traditional Medicare and stronger congressional oversight were among the solutions suggested to address MA plan restrictions.
Our team, in partnership with Duke Health experts, has been meeting with NC congressional delegation offices to highlight our concerns and experiences with a variance of MA practices and claim denials, urging greater oversight and alignment with Medicare.
President Biden announces plan to nominate Dr. Monica Bertagnolli as NIH Director
This week President Biden announced his intent to nominate Dr. Monica Bertagnolli as Director of the National Institutes of Health (NIH). Dr. Bertagnolli currently serves as the Director of the National Cancer Institute. Before starting her tenure as NCI Director, Dr. Bertagnolli served as the Richard E. Wilson Professor of Surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer Treatment and Sarcoma Centers at Dana-Farber Cancer Institute.
In his statement, President Biden called Dr. Bertagnolli “a world-class physician-scientist whose vision and leadership will ensure NIH continues to be an engine of innovation to improve the health of the American people.”
The position of NIH director is a confirmable position, and she will have to be advanced by the Senate Health, Education, Labor and Pensions Committee where she is expected to face questions on several topics including the origins of COVID and NIH’s role in lowering drug prices.
FTC issues proposed rule to strengthen regulation of healthcare data privacy online
On Thursday, the Federal Trade Commission (FTC) issued a proposed rule updating its enforcement interpretation of the Health Breach Notification Rule, which that lays out health companies’ responsibilities when hackers access health data to include policing companies’ use of such data for marketing.
The proposed rule is intended “better explain” how the Health Breach Notification Rule applies to health apps and other digital health tools that don’t fall under HIPAA, the federal health privacy law that governs data protection by health plans and providers.
If finalized, the proposed rule would clarify that health apps, including those offering health services and supplies, such as fitness, sleep, diet, and mental health products and services would be subject to regulations requiring them to notify customers if their identifiable data is accessed by hackers or business partners or shared for marketing without patient approval.
The move by the FTC comes after it first cited the Health Breach Notification Rule in a settlement earlier this year with GoodRx, which was accused sharing data with Google and Meta – and while Congress is ramping up its work on potential data privacy legislation.
The proposed rule will have a 60-day comment period that begins after its publication in the Federal Register, which is expected as soon as next week.
From our desk(s): Duke Health GR this week
We coordinated a meeting for Dr. Michael Pencina, director of Duke A.I. Health, to meet with the office of Rep. Deborah Ross (D-NC-02) to discuss the role of A.I. in healthcare and Duke’s leadership role in building frameworks for his governance and evaluation. Rep. Ross is a member of the House Space, Science, and Technology Committee, which has some jurisdiction over A.I. issues.
Our team worked closely with colleagues at the Association of American Medical Colleges (AAMC) and reached out to CMS independently in support of extending COVID-19 waivers and flexibilities for virtual supervision of residents and outpatient hospital billing for remote services provided to patients in their homes that allows hospitals to receive payment for telehealth services provided by hospital employed physical therapists, occupational therapists, speech-language pathologists, or clinical staff providing Diabetes Self-Management Training or Medical Nutrition. The current extension runs through the end of 2023 and is likely to be addressed in the CY 2024 Physician Fee Schedule. CMS has released a new FAQ document with these updates included.
Our office also attended meetings for advocacy on Accountable Care Organizations, the Undiagnosed Diseases Network, and the Gun Violence Prevention Research Roundtable to receive updates, share information, and discuss strategy.
Join us TODAY – 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. Join us below!
Date: Friday, May 19, 2023
Time: 10:00 a.m.
To access the link to the event, click here.
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Join the Duke Health Advocacy Network!
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