Health Care Checkup: November 9, 2023

Health Care Checkup

November 9, 2023

THE BIG PICTURE: KEY CONGRESSIONAL & EXECUTIVE BRANCH DEVELOPMENTS

On Wednesday, the Senate Finance Committee unanimously advanced a bipartisan health care package in a 26-0 vote. The legislation, the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act, partially mitigates a Medicare payment cut for doctors, extends certain expiring Medicare and Medicaid provisions, aims to increase access to mental health care, and targets pharmacy benefit manager practices.

What to Expect Next Week: In the Senate, Leader Schumer is expected to file cloture on Thursday on a House bill to be used as a vehicle for a Senate supplemental. There continue to be ongoing conversations on the length of the CR, supplemental action, and border security provisions.

The House: The House continues to work on passing the remaining appropriations bills, with plans to bring the Labor-HHS-Education Supplemental to a vote next week. Work continues on plans for a CR to fund the government and avoid a government shutdown on November 18.

DEEP DIVE

Congressional:

Senate Finance Committee Advances Bipartisan Healthcare Package

Reform pharmacy benefit managers and increase access to biosimilars;
Expand mental health services under Medicare Part B;
Replace the statutory increase of 1.25% for Medicare physician fee schedule services furnished in 2024 with 2.50% for that year; and
Extend several Medicare programs.

Read the discussion draft here and the section-by-section and amendments here.

Senate HELP Committee Holds Hearing on AI in Healthcare

On Wednesday, the Senate Health, Education, Labor and Pensions (HELP) Committee Primary Health & Retirement Security Subcommittee held a hearing to examine policy considerations for artificial intelligence in health care. There was bipartisan consensus on the potential uses of AI in healthcare to improve healthcare outcomes and reduce cost and administrative burdens. Most Senators emphasized the need for Congress to enact guardrails to protect patient privacy, data, and bias without stifling innovation. Senators and witnesses also focused on the potential for biosecurity risks with AI and discussed policy solutions to protect against bioterrorism. Read the witness testimonies here.

Senate Confirms Monica Bertagnolli as NIH Director

On Tuesday, the Senate voted 62-36 to confirm Monica Bertagnolli to lead the National Institutes of Health (NIH). Bertagnolli's confirmation comes nearly two years after Francis Collins stepped down as head of the agency. Despite some Democratic concerns, Bertagnolli received bipartisan support overall, with 13 Republicans voting to confirm her nomination and two Democrats opposing: Senate HELP Chair Bernie Sanders (I-VT) and Senator John Fetterman (D-PA). See the vote here.

Senator Cassidy Continues Push to Reauthorize Expired SUPPORT Act Amid Calls from 300+ Groups to Take Action

On Wednesday, Senator Bill Cassidy (R-LA), ranking member of the Senate HELP Committee, released a statement bringing attention to the over 300 substance-abuse prevention and treatment, mental health, and other policy organizations that have called on the HELP Committee to take up and reauthorize the SUPPORT Act, which funds programs that bolster prevention, treatment, and recovery services for Americans with substance use disorders. The SUPPORT Act expired on September 30^th, but the committee’s chair, Bernie Sanders (I-VT), has not acted to reauthorize it. Cassidy stated, “Even if there are some differences in opinion on specific policies to include, we all agree the HELP Committee needs to get the SUPPORT Act reauthorization done.” Read the press release here.

House Energy & Commerce Republicans Threaten Subpoena to SAMSHA Administrator

On Wednesday, House Energy and Commerce Chair Cathy McMorris Rodgers (R-WA), Morgan Griffith (R-VA), and Brett Guthrie (R-KY) asked for more details on how the Substance Abuse and Mental Health Services Administration (SAMSHA) spent COVID-19 relief funds, in a letter sent to SAMHSA Administrator Miriam E. Delphin-Rittmon. The E&C Republicans said it is the second time they have asked for the accounting info, and the letter “serves as the final notice before the Committee will be forced to issue a subpoena.” Read the letter here.

Ways and Means Republicans Demand Biden Administration Follow the Law to End Surprise Medical Billing

On Thursday, in a letter signed by every Ways and Means Republican to Health and Human Services (HHS) Secretary Xavier Becerra, Treasury Secretary Janet Yellen, and Acting Labor Secretary Julie Su, Committee Republicans highlighted the problems with the Administration’s implementation of the No Surprises Act, and demand the Administration follow the law’s clear intent in implementing this historic patient protection legislation. In the letter, the Ways and Means Republicans wrote, “The statutory text of the law is unambiguous – despite that, the Departments failed to implement a final rule that accurately reflects the law, and this inconsistency has been proven in court four times where the Departments have lost each lawsuit.” Read the letter here.

House Republicans Face Opposition Over Spending Cuts in Labor-HHS-Education Spending Bill

House Republicans face major challenges with their remaining government-funding bills, including the Labor-HHS-Education spending bill (H.R. 5894), as spending cuts and abortion restrictions draw opposition from more moderate members. The Labor-HHS-Education spending bill has proposed a $60.3 billion or 29% cut overall. Rep. Brian Fitzpatrick (R-PA), a key moderate who co-chairs the Problem Solvers Caucus, stated the Labor-HHS bill was “totally ridiculous” and “probably the worst” of all appropriation bills. Rep. Robert Aderholt (R-Ala.), chair of the Labor-HHS-Education subcommittee, stated he is still optimistic and will try to resolve issues with moderates like Fitzpatrick but admitted that passing the bill is a “big lift.”

Notable Bills Introduced:

Sens. Welch, Sanders, and Rep. Balint Introduce Bill to Support EMS Providers

On Wednesday, Senators Peter Welch (D-Vt.) and Sen. Bernie Sanders (I-Vt.) introduced the Emergency Medical Services Reimbursement for On-scene Care and Support (EMS ROCS) Act. Representative Becca Balint (D-VT) introduced companion legislation in the House. The bill would provide Medicare reimbursement for care provided by EMS on-scene when transportation to the hospital is not needed. Read the press release here and the bill here.

Reps. Miller-Meeks, Barragán, Chavez-DeRemer, Manning, Malliotakis, Schneider, Kean, and Spanberger Introduce the DRUG Act

On Wednesday, Representatives Mariannette Miller-Meeks (R-IA), Nanette Diaz Barragán (D-CA), Lori Chavez-DeRemer (R-OR), Kathy Manning (D-NC), Nicole Malliotakis (R-NY), Brad Schneider (D-IL), Tom Kean, Jr. (R-NJ), and Abigail Spanberger (D-VA) introduced the Delinking Revenue from Unfair Gouging (DRUG) Act, legislation that bans spread pricing, patient steering, and implements de-linking policies in the commercial insurance market. Read the press release here and the bill here.

Senators Rosen and Cassidy Introduce Bipartisan Legislation to Lower Costs for Caregivers

On Wednesday, Senators Jacky Rosen (D-NV) and Bill Cassidy (R-LA) introduced the Lowering Costs For Caregivers Act, which would allow people to use their tax-free health savings accounts and flexible spending accounts on medical expenses for their parents. Currently, adult children may not take advantage of these tax-free accounts to cover expenses they incur on behalf of their aging parents unless their parents are classified as dependents for tax purposes. Read the press release here and the bill here.

Senators Peters and Moore Capito Reintroduce Bipartisan Bill to Help Prevent Diabetes & Lower Health Care Costs

On Tuesday, Senator Gary Peters (D-MI) and Shelley Moore Capito (R-WV) reintroduced bipartisan legislation that would improve health outcomes and reduce healthcare costs for individuals at risk for diabetes, while saving long-term costs for Medicare. Peters’ Preventing Diabetes in Medicare Act would extend Medicare coverage for medical nutrition therapy services to Americans with pre-diabetes and risk factors for developing type-2 diabetes. Under current law, Medicare will only cover medical nutrition therapy services for individuals who have already been diagnosed with diabetes or renal disease. Read the press release here and the bill here.

Senators Warner and Kaine Introduce Bipartisan Bill to Expand Access to Telehealth Treatment for Substance Use Disorder

On Monday, Senators Mark Warner (D-VA) and Tim Kaine (D-VA) joined Senators Sheldon Whitehouse (D-RI), Lisa Murkowski (R-AK), and Marsha Blackburn (R-TN) in introducing the Telehealth Response for E-prescribing Addiction Therapy Services (TREATS) Act, legislation that would increase access to telehealth services for individuals with substance use disorder (SUD). During the COVID-19 pandemic, the Drug Enforcement Administration (DEA) temporarily removed an in-person exam requirement for providers to prescribe SUD treatment, which is set to expire at the end of next year. The TREATS Act would make this flexibility permanent. Read the press release here and the bill here.

Senators Hassan and Murkowski Introduce Bipartisan Bill to Grow Addiction Care Workforce Through Student Loan Debt Relief Program

On Monday, Senators Maggie Hassan (D-NH) and Lisa Murkowski (R-AK) introduced bipartisan legislation to reauthorize and double the Substance Use Disorder Treatment and Recovery Loan Repayment Program, which provides student loan repayment for health care workers who focus on addiction treatment and recovery in underserved areas. This legislation would reauthorize the program that expired on September 30, double its authorization from $25 to $50 million, and make the loan payments tax-exempt. Read the press release here.

Senators Warner, Thune, Cortez Masto, and Young Introduce Bipartisan Legislation to Reduce Health Care Reporting Requirements for Employers

Last week, on November 2, Sens. Mark R. Warner (D-VA), John Thune (R-SD), Catherine Cortez Masto (D-NV), and Todd Young (R-IN) today introduced bipartisan legislation that would protect Americans’ privacy and remove reporting requirements in the Patient Protection and Affordable Care Act (ACA) by allowing certain communications to be electronically filed. The Paperwork Burden Reduction Act would codify the current IRS policy by allowing the 1095-B to be provided electronically and would extend this to 1095-C, limiting unnecessary physical paperwork. Read the press release here and the bill here.

House and Senate Introduce Bipartisan, Bicameral Healthcare Workforce Resilience Act to Alleviate Healthcare Sector Workforce Challenges

Last week, on November 2, Representatives Brad Schneider (IL-10), Yadira Caraveo (CO-08), Don Bacon (NE-02), and Tom Cole (OK-04) led 27 colleagues in introducing the bipartisan Healthcare Workforce Resilience Act to enable skilled immigrant nurses and physicians to secure robust permanent legal status in the United States. Senate Majority Whip Dick Durbin (D-IL), Chair of the Senate Judiciary Committee, along with U.S. Senator Kevin Cramer (R-ND) introduced the same bill in the Senate. The bill would designate 40,000 Congressionally authorized visas for foreign-born healthcare workers from pre-existing unused visas - 15,000 for foreign-born physicians and 25,000 for foreign-born nurses. Read the press releases here and here, and the bill here.

Executive Branch:

CMS Announces Proposed Rule on 2025 Medicare Advantage and Medicare Part D

On Monday, CMS released the 2025 Medicare Advantage (MA) & Part D Proposed Rule. The proposed policies build on existing Biden-Harris policies to strengthen beneficiary protections and guardrails to promote healthy competition and ensure MA plans best meet the needs of beneficiaries. In addition, these proposed policies would promote access to behavioral health care providers, promote equity in coverage, and improve supplemental benefits. The provisions include:

Improving access to behavioral health care by adding a new facility type that includes several behavioral health provider types to MA network adequacy requirements.
New guardrails to plan compensation for agents and brokers, including standardized plan compensation, to ensure that the use of compensation creates incentives to enroll individuals in the MA plan that is intended to best meet their health care needs.
Policies to increase the utilization and appropriateness of supplemental benefits, such as new requirements related for MA plans to send a personalized notification mid-year to alert beneficiaries of unused benefits, as well as new requirements to ensure benefits offered as special supplemental benefits for the chronically ill (SSBCI) are backed by evidence.
Streamlining enrollment options for individuals with both Medicare and Medicaid by providing more opportunities for integrated care.
New requirements to conduct an annual health equity analysis of the plans’ prior authorization policies and procedures and to publicly post the analyses to improve transparency on the effects of prior authorization on underserved communities.
More flexibility for Part D plans to more quickly substitute lower-cost biosimilar biological products for their reference products.

There is a 60-day comment period, with comments due by January 5, 2024. Read the Press Release, Fact Sheet, and Proposed Rule.

DEA Responds to Adderall Shortage

Late last week, the Drug Enforcement Agency, in response to widespread shortages of Adderall, announced it will make changes to respond to drug shortages and prevent them from happening in the future by making changes to its quota process. In the letter, the DEA said 17 out of 18 manufacturers have committed to use their allotted quota amounts and increase production of stimulant medication. In response to the shortages, the DEA said it will require manufacturers to submit their anticipated production timelines for producing medications in advance of receiving their quota allotments and apply for those allotments quarterly instead of annually. Read the letter here.

FTC Challenges More Than 100 Drug Patents as Improperly Listed in the FDA’s Orange Book

On Monday, the Federal Trade Commission (FTC) announced it has challenged more than 100 patents held by manufacturers of brand-name asthma inhalers, epinephrine autoinjectors, and other drug products as improperly or inaccurately listed in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.” The FTC sent a notice letter to 10 entities representing eight distinct corporate parents, with patent-listing dispute notifications also provided to the FDA. Each entity has 30 days to withdraw or amend the challenged listings, or to “certify under penalty of perjury that the listings comply with applicable statutory and regulatory requirements.” “Wrongfully listed patents can significantly drive up the prices Americans must pay for medicines and drug products while undermining fair and honest competition,” FTC Chair Lina M. Khan said Tuesday in the agency’s statement about the effort.

Legal & Other:

Federal Court Rejects HRSA Attempt to Narrow Drug Discount Program

On Monday, a U.S. District Court in South Carolina ruled that the Health Resources and Services Administration (HRSA) exceeded its authority by limiting the definition of a 340B patient to someone who receives the prescription from the participating doctor or hospital, in a case between Genesis HealthCare Inc. and HRSA. The court’s order follows a legal battle between Genesis and HRSA over the interpretation of the term “patient” under the 340B statute and HRSA’s attempts to enforce its interpretation of the term “patient” on Genesis. Judge Bryan Harwell noted that while the statute requires a covered entity to have an ongoing relationship with a patient in order to use 340B drugs, HRSA can’t further limit the use of 340B only to drugs that pertain to care that the covered entity initiated. Read the court docket here.