Health Care Checkup: September 29, 2023

Health Care Checkup

September 29, 2023

THE BIG PICTURE: KEY CONGRESSIONAL & EXECUTIVE BRANCH DEVELOPMENTS

As the week draws to a close, it appears likely that the federal government will shut down over the weekend. The Senate is inching toward passing a stopgap spending measure to keep the government open and to allow more time for the passage of appropriations bills and negotiations to continue between the House and Senate over fiscal year 2024. However, the House failed this afternoon to pass its own short-term funding measure (known as a continuing resolution or “CR”), and it is clear that Speaker McCarthy does not plan to bring up the Senate version, which has much less support among the GOP caucus in the House. Barring any last-minute surprises, the government will officially shut down on Sunday, October 1. Then, the key questions become how long a stalemate lasts, whether McCarthy can bring a bipartisan measure to the House floor without threatening his hold on the speakership, and how Congress can find a compromise that allows the government to reopen. More to come.

On Thursday, the House Ways and Means Committee advanced two bills out of committee, mostly along party lines. H.R. 5688, the Bipartisan HSA Improvement Act of 2023, and H.R. 5687, the HSA Modernization Act of 2023, bolster high-deductible health plans and associated health savings accounts (HAS).

On Thursday, House Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ) and Senate Finance Committee Chair Ron Wyden (D-OR) sent a series of letters to the largest Medicaid Managed Care Organizations (MCOs) across the country as part of a new investigation seeking answers following reports of high rates of prior authorization denials for patients. This investigation follows an HHS Inspector General report, which found that MCOs denied, on average, one out of every eight prior authorization requests for service, more than double the denial rate in Medicare Advantage.

What to Expect Next Week: While Congress still has time to pass funding to keep the government open, there is a high likelihood that the government will shut down on Sunday due to Congress’ inability to pass either the 12 Appropriations bills to fund the government for FY24, or a continuing resolution (CR) to temporarily fund the government. If a government shutdown occurs, Congress will likely begin discussions and negotiations over how to pass a compromise CR to reopen the government and continue working on a longer-term spending deal for fiscal year 2024. How long a shutdown will last is anyone’s guess at this time. During a shutdown, operations at Federal agencies would significantly reduce or cease their operations. Jobs considered essential, such as some Congressional staffer positions, the military, and various positions within each agency, would continue to work throughout the shutdown. Read the Office of Personal Management (OMB) guidance for shutdowns here, and agency contingency plans here.

DEEP DIVE

Congressional:

Federal Government Appears Headed for Shutdown

It is increasingly likely that the federal government will shut down on Sunday, October 1. The Senate is moving forward on a stopgap spending bill to keep the government open through mid-November. See details below. This legislation could pass over the weekend. However, House Republican leadership has made clear that it does not plan to take up any Senate-passed measure which would not have the support of enough Republicans to pass the House. Today, the House failed to pass, in a 198-232 vote, a House revised stopgap funding bill or a continuing resolution (CR) under an amended version of H.R. 5525 that would fund the government through Oct. 31, with 21 Republicans joining all Democrats in voting no. The Houe CR bill proposed cuts in nondefense discretionary spending by 29.9% to $1.47 trillion and included most provisions from H.R. 2, the House Republicans’ border security package that Democrats have voiced strong opposition to. On Thursday, House Republicans passed three government appropriations bills: the Defense, Homeland Security, and State and Foreign Operations, but failed to pass the Agriculture bill. All three bills will likely face opposition in the Senate due to significant budget cuts and hardline GOP amendments included in the bills.

Also on Tuesday, the Senate released the text of a six-week CR that would fund the government through November 17, at current FY23 levels. The CR also includes a 3-month extension of the FAA, $6 billion in funding for disaster relief, and $6.14 billion for Ukraine aid. The Senate voted today to advance the bipartisan CR bill 76-22. GOP senators are actively discussing changes to make the measure more palatable for House Republicans as the House will likely reject the Senate CR due to the spending levels remaining at FY23 levels and the inclusion of funding for Ukraine aid and disaster relief. Health provisions included in the Senate CR bill were the following:

DSH Cuts: The bill would delay scheduled cuts to the hospital disproportionate share program, set to take effect Oct. 1 for fiscal 2024 and run through fiscal 2027, to Medicaid payments for disproportionate share hospitals (DSH) that serve large numbers of low-income and uninsured patients.
Medicaid Improvement Fund: The measure would reduce funding in the Medicaid Improvement Fund to $6.36 billion from $7 billion.
Public Health Programs: The measure would extend funding for community health centers and other programs scheduled to expire Sept. 30, providing the following amounts:
$526 million for community health centers.
$40.8 million for the National Health Service Corps.
$19.7 million each for the Special Diabetes Program and the Special Diabetes Program for Indians.
$16.6 million for the Teaching Health Center Graduate Medical Education Program.
$3.7 million for the White House's new Office of Pandemic Preparedness and Response Policy
Pandemic Preparedness: The measure would provide a rate of operations of $3.7 million and transfer authority for the Salaries and Expenses account of the new Office of Pandemic Preparedness and Response Policy. The Pandemic and All-Hazards Preparedness Act (PAHPA), expiring Sept. 30, is not reauthorized in the CR.
Human Services Programs: The measure would extend the following programs:
The Stephanie Tubbs Jones Child Welfare Services Program and the Marylee Allen Promoting Safe and Stable Families Program.
The Sexual Risk Avoidance Education Program.
The Personal Responsibility Education Program.

Read the full bill here and the section-by-section here.

House Committee on Ways and Means Advances Health Savings Account Legislation

On Thursday, the House Ways and Means Committee advanced two bills to bolster high-deductible health plans and associated health savings accounts (HAS) mostly along party lines. The Bipartisan HSA Improvement Act of 2023, passed in a 28-14 vote, would allow plans to include the direct primary care payment model and pay for such care with HSA funds and plans to offer on-site health clinics. The HSA Modernization Act of 2023, passed in a 24-18 vote, would substantially raise HSA contribution limits. Democrats criticized the legislation, citing costs, and argued that boosting high-deductible health plans could result in delayed or missed care. The Joint Committee on Taxation estimated that the bills would cost a combined $71 billion over a decade by decreasing tax revenue. Read the post-markup press release here and the bills here.

House Judiciary backs substance use bill to schedule xylazine

On Thursday, the House Judiciary Committee advanced several pieces of legislation, including the Support for Patients and Communities Reauthorization Act (H.R. 4531) which reauthorizes several programs that treat and respond to the opioid crisis. During the markup, lawmakers stated that one of their top concerns was xylazine, a drug used in veterinary settings that has infiltrated the illicit drug market, often mixed with fentanyl. The House Energy and Commerce Committee advanced the same legislation in July, permanently scheduling xylazine, but after objections from Judiciary Democrats, the committee agreed to an amendment from Ranking Member Jerrold Nadler (D-NY) which would schedule xylazine for three years. On the Senate side, the Senate Health, Education, Labor and Pensions (HELP) Committee has yet to markup legislation to reauthorize the legislation. Read the bills included in the markup here.

Ranking Member Cassidy Opens Investigation into Hospital Revenue Generated by 340B Drug Program

On Thursday, Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, announced he is requesting information from Bon Secours Mercy Health and the Cleveland Clinic on how they spend 340B-tied revenue. Cassidy stated he is seeking information as part of an investigation as to how certain hospital systems may spend revenue generated from the 340B Drug Pricing Program, following multiple reports of certain 340B recipients announcing record-setting profits with no transparency on if and how much of that profit benefits patients. HELP Committee Chair Bernie Sanders (I-VT) did not join Cassidy’s request. Read the press release and letters here.

Pallone and Wyden Launch Investigation into Medicaid Managed Care Plan Prior Authorization Practices

Senate HELP Committee Republican Leader Calls for Information about Reforming CDC

On Tuesday, Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, announced a request for information from stakeholders on ways to reform the Centers for Disease Control and Prevention (CDC) and its practices. Specifically, Cassidy requests input on how the CDC can better coordinate with stakeholders, more effectively modernize public health data, and improve core public health activities, such as epidemiology, training programs, and its global health portfolio. Cassidy hopes to use stakeholder feedback to identify policies for potential legislation to modernize the CDC, so it is better prepared to respond to future public health threats. Many members have expressed interest in reforming the CDC, and conversations around this topic will likely increase ahead of the first confirmation vote for the CDC director, which will take place in January 2025. The deadline to submit feedback is Friday, October 20^th. Read the request here.

Neal Releases GAO Report on Transparency Gaps in Private Equity Nursing Home Ownership

On Tuesday, Ways and Means Committee Ranking Member Richard Neal (D-MA) released a report titled “Limitations of Using CMS Data to Identify Private Equity and Other Ownership” the Government Accountability Office (GAO) that shows transparency gaps in the data collected by the Centers for Medicare and Medicaid Services (CMS) to identify private equity and other owners in nursing homes. The GAO report estimated that about 5 percent of nursing homes were private equity owned in 2022, though it might be an underestimate. The American Investment Council, the leading private equity industry group, in a letter to CMS, stated concern that CMS’ proposal defines private equity inaccurately and that it is being unfairly targeted. Read the press release here, and the report here.

Bipartisan Organ Transplant Legislation Signed into Law

Late last week, H.R. 2544, the Securing the U.S. Organ Procurement and Transplantation Network Act, was signed into law by President Biden. The legislation, which makes several reforms to the public-private organ procurement and transplantation process, passed Congress unanimously at the end of July. Senators Ron Wyden (D-OR), Chuck Grassley (R-IA), Ben Cardin (D-MD), Todd Young (R-IN), and Bill Cassidy (R-LA) celebrated the signing into law. Read the press release here.

Senate Passes Resolutions Recognizing Telehealth, Sickle Cell Disease, and Spinal Cord Injury Awareness

On Tuesday, the Senate passed by unanimous consent to pass three resolutions regarding Sickle Cell Disease Awareness Month (S Res 369), Telehealth Awareness Week (S Res 368) and National Spinal Cord Injury Awareness Month (S Res 367).

Veterans’ Health Bill Heads to the President After Passing the House and Senate

On Tuesday, the House passed by voice vote S. 2795, A bill to amend Title 38 of the United States Code, to extend and modify certain authorities and requirements relating to the Department of Veterans Affairs, The legislation extends from three to five years the authority for additional licensed health care professionals to perform medical disability examinations and extends through FY2028 the authorization for VA emergency preparedness for public health emergencies. The bill is expected to be signed into law by President Biden soon.

Rep. Miller, Colleagues Launch the Bipartisan Rural Health Caucus

Late last week, Rep. Carol Miller (R-WV) joined her colleagues in launching the Bipartisan Rural Health Caucus. The Congressional Bipartisan Health Caucus will promote and advance legislation and policy actions that help increase access to quality, affordable health care and mental health services for all rural Americans. The Caucus will highlight potential policy solutions, including stemming hospital closures, ensuring fair and adequate reimbursement rates, strengthening the health workforce, reducing health inequities, and expanding telehealth and other innovative care delivery models. Read the press release, and see the list of representatives in the Caucus here.

Notable Bills Introduced:

Wyden and Crapo Introduce Finance Committee PBM Bill

Today, Senate Finance Committee Chair Ron Wyden (D-OR), and Ranking Member Mike Crapo, (R-ID), introduced the Modernizing and Ensuring PBM Accountability (MEPA) Act, to increase transparency, accountability, and competition to pharmacy benefit manager practices (PBMs) in the pharmaceutical supply chain. The legislation would prohibit PBM compensation in Medicare from being tied to the sticker price of a drug, increase transparency by creating independent audit and enforcement measures, and provide relief to independent community pharmacies. The legislative text reflects the Chairman’s Mark that was reported out of the Finance Committee in July. Please see the press release here and read the bill here.

Senators Markey, Young, and Baldwin Introduce Bipartisan Bill to Combat Opioid-Related Infectious Diseases

On Tuesday, Senator Edward J. Markey (D-MA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Subcommittee on Primary Health and Retirement Security and a member of the U.S. Commission on Combating Synthetic Opioid Trafficking, along with Senators Todd Young (R-IN) and Tammy Baldwin (D-WI), today announced the reintroduction of the Eliminating Opioid-Related Infectious Diseases Act, bipartisan legislation that would reauthorize the Centers for Disease Control and Prevention’s (CDC) ongoing initiative to eliminate the risk of infectious disease caused by substance use disorder to continue through 2028. Read the press release here and the bill here.

Fitzpatrick, Trone Introduce Bipartisan Legislation to Allow Health Savings Accounts to Cover Mental Health Services

On Wednesday, Representatives Brian Fitzpatrick (R-PA) and David Trone (D-MD) introduced the bipartisan Opening Plans to Individuals and Offering New Services (OPTIONS) for Mental Health Act, legislation that will allow employers to provide families with first dollar coverage of mental health services up to $500 per family via Health Savings Accounts (HSAs). The bill will be marked up by the Ways and Means Committee today, September 28. Read the press release here and the bill here.

Mullin, Booker Introduce Bipartisan Prescription Information Modernization Act

On Tuesday, Senators Markwayne Mullin (R-OK) and Cory Booker (D-NJ) introduced the bipartisan Prescription Information Modernization Act, legislation that would enable the Food and Drug Administration (FDA) to implement a rule that allows drug manufacturers to transmit prescribing information electronically to reduce waste, improve efficiency, and ensure that healthcare professionals have access to the latest drug information. Read the press release here and the bill here.

Daines, Smith Renew Push to Permanently Expand Telehealth Services During Telehealth Awareness Week

On Monday, Senators Tina Smith (D-MN) and Steve Daines (R-MT) reintroduced their bipartisan Expanded Telehealth Access Act to make pandemic-driven expanded access to certain telehealth services under Medicare permanent. To help reduce risks associated with visiting medical providers during the pandemic, the Centers for Medicare & Medicaid Services (CMS) expanded the types of health care providers who receive reimbursement for telehealth services. The Expanded Telehealth Access Act makes reimbursement eligibility permanent for physical therapists, audiologists, occupational therapists, and speech-language pathologists and permits the Secretary of Health and Human services to expand this list. Read the press release here, and the bill here.

Casey, Blackburn, Kaine, Cramer Introduce Legislation to Support People Living With Chronic Pain

On Tuesday, Senators Bob Casey (D-PA), Marsha Blackburn (R-TN), Tim Kaine (D-VA), and Kevin Cramer (R-ND) introduced legislation to close gaps in chronic pain research and help scientists propel chronic pain research forward. The Advancing Research for Chronic Pain Act would centralize current information and data to help clinicians and scientists more effectively research chronic pain conditions. The Advancing Research for Chronic Pain Act would direct the Centers for Disease Control and Prevention to utilize available research data to clarify the prevalence and characteristics of chronic pain; identify gaps in the available research data; develop standard definitions for population research on chronic pain; and create a centralized Chronic Pain Information Hub to aggregate and summarize available data, maintain a summary of complete, ongoing, and planned research, and translate findings to recommendations for clinicians and scientists. Read the press release here and the bill here.

Van Hollen, Blumenthal, Brown, Coons Introduce Bill to Protect Consumers Using Generic Medications

Late last week, Senators Chris Van Hollen (D-Md.), Richard Blumenthal (D-Conn.), Sherrod Brown (D-Ohio), and Chris Coons (D-Del.) announced the introduction of the Updated Drug Labeling for Patient Safety Act, legislation to allow all prescription drug manufacturers to revise medication labels to provide accurate, up-to-date warnings to consumers. Current federal law mandates that generic drug labels must match those approved by the Food and Drug Administration (FDA) for their brand-name equivalents. This bill will enable drug companies to update labels for generic medications independently – ensuring patients have the latest information about the potential side effects and risks associated with their prescriptions. Read the press release here and the bill here.

Rep. Schakowsky, Sen. Durbin Introduce Legislation to Protect Patients, Improve the Medical Device Recall Process

Late last week, Representative Jan Schakowsky (IL-09) and U.S. Senate Majority Whip Dick Durbin (D-IL) introduced bicameral legislation to improve the medical device recall process in order to protect patients. The Medical Device Recall Improvement Act would require the Food and Drug Administration (FDA) to establish an electronic format for medical device recall notifications to streamline communication between device manufacturers, FDA, hospitals, and health care professionals. It also would require manufacturers to include in recall notices information about how the recall could affect patients with medical devices and instruct hospitals and healthcare professionals to provide that information to patients. The legislation was inspired by Illinois constituents who had shared their personal stories about medical harms and other concerns related to recalled devices. Specifically, the Medical Device Recall Improvement Act would:

Require FDA to establish an electronic format for medical device recall notifications;
Require medical device manufacturers to use the electronic format to contact FDA and hospitals and health providers; and
Require medical device manufacturers to include information in recall notifications about the risks of the recalled device, and instruct hospitals and health providers to distribute the information to patients.

Read the press release here and the bill here.

Executive Branch:

Biden-Harris Administration Announces More Than $103 Million and Launches New Initiatives to Address Maternal Health Crisis

On Wednesday, as part of the Department of Health and Human Services (HHS) Maternal Health Day of Action, HHS Secretary Xavier Becerra announced that HHS is awarding more than $103 million to support and expand access to maternal health. HHS will also form a new task force to address maternal mental health conditions and co-occurring substance use disorders, and launch a national public education campaign, Talking Postpartum Depression, to provide information about and combat stigmatization associated with this significant public health issue. The actions are the latest steps by HHS and the Biden-Harris Administration to fulfill the President’s Unity Agenda, and continue implementation of the White House Blueprint for Addressing the Maternal Health Crisis. Read the press release here.

Biden-Harris Administration Awards More than $230 Million for Suicide Prevention, Behavioral Health Care Programs for At-Risk Communities

On Wednesday, the Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), awarded $232.2 million in grants for suicide prevention and behavioral health care for at-risk communities, including more than $200 million in new funding for states, territories, and Tribal nations and organizations to build local capacity for the 988 Suicide & Crisis Lifeline and related crisis services. Read the press release here.

Biden-Harris Administration Announces More Than $200 Million To Support Youth Mental Health

Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), the Health Resources and Services Administration (HRSA), and the Administration for Children and Families (ACF), announced $206 million in grant awards towards youth mental health. The awards will help expand access to mental health services for students in schools, bolster the behavioral health workforce, and improve access to mental health prevention and treatment for children and youth in communities across the country. Read the press release here.

Medicare Advantage and Medicare Prescription Drug Programs to Remain Stable in 2024

On Tuesday, the Centers for Medicare & Medicaid Services (CMS) announced that average premiums, benefits, and plan choices for Medicare Advantage and the Medicare Part D prescription drug program will remain stable in 2024. The average monthly plan premium for all Medicare Advantage plans, which includes Medicare Advantage-Prescription Drug plans, is projected to change from $17.86 in 2023 to $18.50 in 2024 (an increase of $0.64). CMS is releasing this information, including 2024 premiums and deductibles for Medicare Advantage and Medicare Part D prescription drug plans, ahead of the upcoming Medicare Open Enrollment, beginning October 15, 2023. Read the press release here.

ARPA-H Announces First Regional Hubs, New Cancer Research Programs

On Tuesday, the Biden administration's new biomedical research agency, the Advanced Research Projects Agency for Health (ARPA-H), announced its first two hubs will land in the Dallas and Boston areas. The agency is using a "hub-and-spoke" model rather than centering all activity in one city. Part of the agency's charter was that it would not be located in Washington, D.C. The agency also revealed $115 million in funding for three new cancer research programs, plus a nationwide network for health innovation deployment. Read the press release here.

FDA Finalizes Cybersecurity Guidance for Devices

On Tuesday, the Food and Drug Administration finalized guidance updating the cybersecurity information device makers should submit to its Center for Devices and Radiological Health or Center for Biologics Evaluation and Research for premarket review of devices that have cybersecurity considerations. The recommendations are intended to help manufacturers meet their obligations under section 524B of the Federal Food, Drug, and Cosmetic Act, enacted in December 2022 as part of the Consolidated Appropriations Act of 2023, which defines “cyber device” as one that includes a device or software that can connect to the internet and be vulnerable to cybersecurity threats. Read the FDA guidance here.

CDC Advisors Recommend Maternal RSV Vaccine

Late last week, Centers for Disease Control and Prevention vaccine advisers voted to recommend the use of the first-ever maternal vaccine to prevent respiratory syncytial virus, or RSV, in young babies by a vote of 11-1. The shot from Pfizer, Abrysvo, would be administered to pregnant people at 32 to 36 weeks of gestation. Approximately 75 percent of RSV-related hospitalizations occur in the first six months of life, according to data from Pfizer. The CDC also signed off on a monoclonal antibody to prevent RSV in kids ages 8 months and under and approved a vaccine for older adults in June.

Legal & Other:

Clashing Campaigns Over Hospital Site-Neutral Payment Bills

On Monday, in a clash with hospital groups, a health policy coalition group, Consumers for Quality Care, launched campaigns around site-neutral payments, which would cut Medicare pay to hospitals. Families USA and Public Citizen, two groups commonly aligned with Democrats on health policy issues, formed a coalition with three dozen other advocacy organizations to encourage Congress to take on hospital pricing. The group is pushing for Congress to codify federal rules that hospitals post their prices online and support site-neutral payment policies. In contrast to the coalition, the American Hospital Association (AHA) also launched a new TV ad campaign, followed by digital ads, urging Congress to reject site-neutral policies. The AHA campaign is part of a larger campaign from hospitals pushing back against changes to site-neutral payments that have advanced in House and Senate panels. The industry has argued it would take billions out of the system, negatively impacting hospitals and providers. House Energy and Commerce Chair Cathy McMorris Rodgers (R-WA) has argued cutting payments to hospitals to bring them in line with payments to independent clinics would help tackle consolidation and high costs in the healthcare industry.

Insurers Announce They Are Working to Reduce Barriers to COVID-19 Vaccines

On Wednesday, insurance companies stated they resolved access issues for the latest COVID-19 vaccines after the Department of Health and Human Services alerted them of coverage denials soon after the vaccine’s rollout last week. In a letter to HHS Secretary Xavier Becerra, Prominent insurers stated the commercialization hiccups should now be resolved, and they plan to "proactively educate consumers" on where they can find vaccines in-network without cost-sharing.