Bipartisan leadership of the Senate Health, Education, Labor and Pensions (HELP) Committee is requesting input from public health officials, health care providers, and other stakeholders on policies the panel should consider as it works to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA). The law, which was originally passed in 2006, must be reauthorized every five years. Chairman Bernie Sanders (I-Vt.), Ranking Member Bill Cassidy (R-La.), Sen. Bob Casey (D-Pa.), and Sen. Mitt Romney (R-Utah) specifically ask for feedback on the effectiveness of existing programs, how to improve the ability of states and localities to respond to public health crises, any gaps in activities or authorities in the PAHPA framework, and ways to strengthen partnerships between the federal government, states and localities, the private sector, and non-government stakeholders. Authorization for most PAHPA programs expires at the end of the fiscal year on September 30. Comments should be submitted to [email protected] no later than March 29, 2023.

 

HELP to Hold Series of Round-Table Discussions

Senate HELP Chairman Bernie Sanders (I-Vt.) and Ranking Member Bill Cassidy (R-La.) informed committee members last week about their plans to hold the following series of closed, informal round-table discussions:

• March 23, on the need to improve apprenticeship programs • March 28, on patient access to complimentary medicine
• April 18, on the need to support the aging population
• April 20, on surprise medical billing patient protections
• April 26, on transparency in the cost of health care services

According to Sanders and Cassidy, the purpose of these meetings will be to expedite the HELP Committee’s work and to “see what kind of bipartisan consensus we might be able to achieve.”

 

CBO Scales Back Prior Health Care Cost Projections

The Congressional Budget Office (CBO) is predicting lower-than-previously-expected government health care costs for at least the next decade. In a response to an inquiry from the office of Sen. Sheldon Whitehouse (D-R.I.) last week, the government budget agency says that it overestimated projections for federal health care spending between 2010 and 2020. Mandatory outlays for these budget categories, which includes Medicare and Medicaid, were 9% less than predicted in 2010 – amounting to a total of $1.1 trillion less in money spent per beneficiary. CBO attributes this decline to lower than anticipated Medicare prescription drug costs and costs for Medicaid enrollees with disabilities and chronic conditions. While growth in Medicare spending per beneficiary increased at an average annual rate of 6.6% from 1987 to 2005, the growth slowed to 2.2% per year as of 2019.

 

JAMA Publishes Study on Provider Directories

Anew study published in the Journal of the American Medical Association last week reveals that more than 80% of physicians have inconsistent or incorrect entries listed in health insurance provider directories. The study covered all physicians in the publicly available directories of the five major national health insurers – UnitedHealth, Elevance, Cigna, Aetna, and Humana. Among those physicians listed in more than one directory, only 19.4% had consistent address and specialty information across all directories in which they were found. Approximately 28% had consistent practice location addresses and 68% had consistent specialty information. Consistency of information decreased as physician data was drawn from an increasing number of insurers. The information of physicians with only one practice location fared best – 85% saw consistent practice location addresses and 69% saw consistent specialty information across directories.

 

More Companies Announce Price Caps on Insulin Products

The three major insulin manufacturers in the U.S. – Sanofi, Eli Lilly, and Novo Nordisk – have all announced plans in recent weeks to significantly reduce the prices of their insulin products and cap patients’ monthly costs at $35. Together, the companies represent 90% of the nation’s insulin market. President Joe Biden praised the decisions but continued to urge Congress to pass legislation to ensure that all individuals can access insulin for no more than $35 per month.

 

Chairman Tester Calls on VA, Oracle Cerner to Fix Challenges with EHR System

During an oversight hearing last week, Senate Committee on Veterans’ Affairs Chairman Jon Tester (D-Mont.) urged the Department of Veterans Affairs (VA) and Oracle Cerner to resolve the challenges facing the Electronic Health Record Modernization (EHRM) program before expanding it to other hospitals and clinics. Oracle Cerner’s EHRM program has faced scrutiny for glitches that led to poor health outcomes and some deaths. At the same hearing, the Government Accountability Office (GAO) reported on issues with the VA’s EHRM program and made ten recommendations for the agency to address its concerns. To enhance transparency, Tester and Ranking Member Jerry Moran (R-Kan.) championed the recently enacted VA Electronic Health Record Transparency Act of 2021, which requires the VA to submit periodic reports to Congress on costs, performance metrics, and outcomes related to the EHRM. The EHRM program aims to replace the complex IT program that was in place at the department for 30 years to better integrate with the Department of Defense, Coast Guard, and other care providers. Currently, the program is only in use in five hospitals, 22 clinics, and 52 remote sites. House Committee on Veterans’ Affairs Chairman Mike Bost (R-Ill.) and House Committee on Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.) introduced the VA Electronic Health Record Modernization Improvement Act (H.R. 592), which would halt deployment of Oracle Cerner’s EHRM system until improvements are made to prevent harm to beneficiaries. The current contract between VA and Oracle Cerner expires in mid-May.

 

VHA to Cover Leqembi to Treat Alzheimer’s Disease

The Veterans Health Administration (VHA) announced last week that it will now cover LeqembiTM, a new monoclonal antibody treatment for veterans with early-stage Alzheimer’s disease. Developed by Eisai in partnership with Biogen, the Food and Drug Administration (FDA) approved the treatment under the accelerated approval pathway in January. However, the Centers for Medicare and Medicaid Services (CMS) only allows narrow coverage of the treatment, limiting it to Medicare beneficiaries in clinical trials. The Alzheimer’s Association requested that CMS reconsider its coverage policy, but the agency reiterated its position in a statement. Nevertheless, Chair of the House Energy and Commerce Committee Cathy McMorris Rodgers (R-Wash.) welcomed VHA’s announcement and called on CMS to reconsider its coverage policy. The FDA is expected to make a decision on full traditional approval of the drug in July.

 

Durbin Urges Increased Federal Coordination on Unauthorized Vapes

Sen. Dick Durbin (D-Ill.) is asking the Food and Drug Administration (FDA) and Department of Justice to better coordinate their work to prevent unauthorized vaping products from entering the market. “Every single day in America, children pick up vaping with unauthorized products that are on store shelves only because FDA has seemingly granted these illegal e-cigarettes a free pass,” his letter states. “I write to express my concern that the Biden administration has not taken more aggressive enforcement action to stop thousands of illegal e-cigarettes from flooding the market and addicting children.” He requests a response by April 7, 2023, to provide an update on interagency effort progression.

 

Hassan, Paul Introduce Bill to Speed Generic Approvals

Sens. Maggie Hassan (D-N.H.) and Rand Paul (R-Ky.) reintroduced the Increasing Transparency in Generic Drug Applications Act (S. 775) last week. The bill aims to lower the price of prescription drugs by streamlining the generic drug approval process to bring lower-cost competition to market faster. It would require the Food and Drug Administration to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why). The agency is currently unable to disclose the specific differences in inactive ingredients between a generic application and the reference product.

 

POLICY BRIEFINGS

 

McConnell Discharged from Hospital, Begins Physical Therapy

Sen. Mitch McConnell (R-Ky.) has been discharged from the hospital after being treated for a concussion. The Senate Minority Leader fell following a fundraising event at a D.C.-area hotel and suffered a fractured rib in addition to the concussion. He has started in-patient physical therapy at a rehabilitation facility. McConnell’s office did not state when he plans to return to the Senate.

The Senate has been significantly impacted by absences in recent months. In addition to McConnell, Sen. John Fetterman (D-Pa.) remains in treatment for depression, and Sen. Dianne Feinstein (D-Calif.) is expected to remain absent this week following her diagnosis with shingles in February. The last time all 100 members of the chamber attended a vote was August 7, 2022 for passage of the Inflation Reduction Act along party-lines.

 

MedPAC, MACPAC March Reports to Congress

The congressional advisory panels charged with advising lawmakers on issues affecting the Medicare, Medicaid, and CHIP programs released their annual March reports to Congress last week. The Medicare Payment Advisory Commission’s (MedPAC) report evaluates payment adequacy and makes recommendations concerning Medicare fee- for-service (FFS) payment policy in 2024 for seven FFS payment systems: acute care hospital, physician and other health professional, outpatient dialysis facility, skilled nursing facility, home health agency, inpatient rehabilitation facility, and hospice services. The report also includes a chapter on the current context of Medicare program payment policy and status reports on ambulatory surgical centers, the Medicare Advantage program, and on Medicare Part D. Notably, the MedPAC report recommends that Congress update the Medicare base payment rate for physician and other health professional services by 50% of the projected increase in the Medicare Economic Index. The Medicaid and CHIP Payment and Access Commission (MACPAC) report includes four chapters on the following topics: (1) Medicaid race and ethnicity data collection and reporting, (2) principles for assessing Medicaid nursing facility payment programs, (3) strengthening evidence under Medicaid drug coverage, and (4) the statutorily required review of hospital payment policy for the nation’s safety-net hospitals.

 

First of ARPA-H Hubs to be Located in D.C. Region

The Advanced Research Projects Agency for Health (ARPA-H) announced last week that the Washington, D.C. region will serve as one of its three headquarters across the country. A site solicitation has been opened to help choose the remaining two hubs for the new biomedical innovation agency, which will be announced by fall. ARPA-H leadership intends to fill each office with 85-100 staff personnel. The agency’s authorizing legislation specified that it cannot be situated on the campus of the National Institutes of Health in Bethesda, Maryland, but placed no further restrictions on location. ARPA-H’s first two program managers, Paul Sheehan and Ross Uhrich, were also announced last week. Sheehan currently serves as a program manager in the Defense Advanced Research Projects Agency’s Biological Technologies Office, and Uhrich is an assistant professor of surgery at Walter Reed National Military Medical Center.

 

CDC Releases Latest Maternal Mortality Data

The Centers for Disease Control and Prevention released new data last week showing a 40% increase in the number of maternal deaths across the U.S. in 2021. The total rate of pregnancy-related deaths reached 32.9 deaths per 100,000 live births, but this rate was 2.6 times higher for Black individuals – reaching 69.9 deaths per 100,000 live births – and 1.4 times higher for Hispanic people – reaching 26.6 deaths per 100,000 live births. The data from the National Center for Health Statistics reflects death certificate information for individuals who died during and up to 42 days after pregnancy. According to the report’s author, an initial review indicates that COVID-19 likely contributed to the increase in maternal mortality. The U.S. ranks far below most other wealthy nations in rates of pregnancy-related deaths.

 

Upcoming Congressional Hearings and Markups

 

Senate Health, Education, Labor, and Pensions Committee hearing “Taxpayers Paid Billions for It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine?” 10:00 a.m.; March 22

 

Senate Finance Committee hearing “The President’s Fiscal Year 2024 Health and Human Services Budget;” 10:00 a.m.; March 22

 

Senate Homeland Security and Government Affairs Committee hearing “Drug Shortage Health and National Security Risks: Underlying Causes and Needed Reforms;” 10:00 a.m.; March 22

 

Senate Commerce, Science, and Transportation Committee markup including S. 90, Informing Consumers About Smart Devices Act, and S. 127, Pharmacy Benefit Manager Transparency Act; 10:00 a.m.; March 22

 

Senate Appropriations Labor, Health and Human Services, Education, and Related Agencies Subcommittee hearing “A Review of the President’s FY 2024 Funding Request and Budget Justification for the Department of Health and Human Services;” 2:30 p.m.; March 22

 

House Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee member day hearing; 10:00 a.m.; March 23

 

House Homeland Security Subcommittee on Cybersecurity and Infrastructure Protection hearing “CISA 25: The State of American Cybersecurity from a Stakeholder Perspective;” 10:00 a.m.; March 23

 

House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies public witness hearing; March 23

 

House Energy and Commerce Subcommittee on Health hearing “Lowering Unaffordable Costs: Examining Transparency and Competition in Health Care;” 1:00 p.m.; March 28

 

House Energy and Commerce Subcommittee on Health hearing to discuss President Biden’s FY24 Budget Request; 10:00 a.m.; March 29

 

Recently Introduced Health Legislation

 

H.R.1570 – To enhance mental health and psychosocial support within United States development and humanitarian assistance programs; Sponsor: Wild, Susan [Rep.-D-PA-7]; Committees: House – Foreign Affairs

 

H.R.1565 -To amend title XVIII of the Social Security Act to remove the 96-hour physician certification requirement for inpatient critical access hospital services; Sponsor: Smith, Adrian [Rep.-R-NE-3]; Committees: House – Ways and Means

 

H.R.1557 – To require the Secretary of Health and Human Services to submit a report on the interoperability of medical devices; Sponsor: Miller-Meeks, Mariannette [Rep.-R-IA-1]; Committees: House – Energy and Commerce

 

H.R.1551 – To amend title XIX of the Social Security Act to implement a minimum work requirement for able-bodied adults enrolled in State Medicaid programs; Sponsor: LaTurner, Jake [Rep.-R-KS-2]; House – Energy and Commerce

 

H.R.1549 – To amend the Controlled Substances Act to prohibit the knowing possession of a pill press mold with intent to manufacture in violation of such Act a counterfeit substance in schedule I or II in a capsule, tablet, and other form intended for distribution, and for other purposes; Sponsor: Kustoff, David [Rep.-R-TN-8]; Committees: House – Judiciary; Energy and Commerce

 

H.R.1546 – To prohibit the use of funds to implement any obligations of the United States under the World Health Organization’s Global Pandemic Treaty; Sponsor: Jackson, Ronny [Rep.-R-TX-13]; Committees: House – Foreign Affairs

 

H.R.1539 – To amend the Richard B. Russell National School Lunch Act to require schools to provide fluid milk substitutes upon request of a student or the parent or guardian of such student, and for other purposes; Sponsor: Carter, Troy [Rep.-D-LA-2]; Committees: House – Education and the Workforce

 

H.Res.224 -Raising awareness of the racial disparities in the impact of colorectal cancer on the Black community; Sponsor: Watson Coleman, Bonnie [Rep.-D-NJ-12]; Committees: House – Energy and Commerce

 

S.775 – A bill to provide for increased transparency in generic drug applications; Sponsor: Hassan, Margaret Wood [Sen.- D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.786 – A bill to amend the Internal Revenue Code of 1986 to treat certain amounts paid for physical activity, fitness, and exercise as amounts paid for medical care; Sponsor: Thune, John [Sen.-R-SD]; Committees: Senate – Finance

 

S.793 – A bill to amend title XVIII of the Social Security Act to add physical therapists to the list of providers allowed to utilize locum tenens arrangements under Medicare; Sponsor: Lujan, Ben Ray [Sen.-D-NM]; Committees: Senate – Finance

 

S.799 – A bill to amend title XVIII of the Social Security Act to provide Medicare coverage for all physicians’ services furnished by doctors of chiropractic within the scope of their license, and for other purposes; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate – Finance

 

H.Res.232 – Recognizing the importance of sleep health and expressing support for the designation of the week of March 12 through March 18, 2023, as “Sleep Awareness Week”; Sponsor: Raskin, Jamie [Rep.-D-MD-8]; Committees: House – Energy and Commerce

 

H.R.1575 – To require the Secretary of Health and Human Services to award grants to pregnancy-help organizations; Sponsor: Fulcher, Russ [Rep.-R-ID-1]; Committees: House – Energy and Commerce

 

H.R.1580 – To amend the Controlled Substances Act with respect to the scheduling of fentanyl-related substances, and for other purposes; Sponsor: Johnson, Mike [Rep.-R-LA-4]; Committees: House – Energy and Commerce; Judiciary

 

H.R.1582 – To amend the Internal Revenue Code of 1986 to treat certain amounts paid for physical activity, fitness, and exercise as amounts paid for medical care; Sponsor: Kelly, Mike [Rep.-R-PA-16]; Committees: House – Ways and Means

 

H.R.1587 – To provide for appropriate cost-sharing for individuals 26 years of age or younger for insulin products covered under private health plans and Medicaid; Sponsor: Landsman, Greg [Rep.-D-OH-1]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

 

H.R.1597 – To amend the Controlled Substances Act with respect to a penalty for illicit fentanyl and fentanyl-related substances; Sponsor: Newhouse, Dan [Rep.-R-WA-4]; Committees: House – Judiciary; Energy and Commerce

 

H.R.1610 -To amend title XVIII of the Social Security Act to provide Medicare coverage for all physicians’ services furnished by doctors of chiropractic within the scope of their license, and for other purposes; Sponsor: Steube, W. Gregory [Rep.-R-FL-17]; Committees: House – Energy and Commerce; Ways and Means

 

S.801 – A bill to address research on, and improve access to, supportive services for individuals with Long COVID; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.803 – A bill to amend the title XVIII of the Social Security Act to preserve access to rural health care by ensuring fairness in Medicare hospital payments; Sponsor: Warner, Mark R. [Sen.-D-VA]; Committees: Senate – Finance

 

S.818 – A bill to promote affordable access to evidence-based opioid treatments under the Medicare program and require coverage of medication assisted treatment for opioid use disorders, opioid overdose reversal medications, and recovery support services by health plans without cost-sharing requirements; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Finance

 

S.838 – A bill to amend title XVIII of the Social Security Act to improve access to mental health services under the Medicare program; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Finance

 

S.842 – A bill to amend titles XVIII and XIX of the Social Security Act to provide for coverage of dental and oral health services, vision services, and hearing services under the Medicare and Medicaid programs; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Finance

 

S.845 – A bill to allow for expedited approval of generic prescription drugs and temporary importation of prescription drugs in the case of marginally competitive drug markets and drug shortages; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.853 – A bill to direct the Secretary of Veterans Affairs to establish the Zero Suicide Initiative pilot program of the Department of Veterans Affairs; Sponsor: Rosen, Jacky [Sen.-D-NV]; Committees: Senate – Veterans’ Affairs

 

S.862 – A bill to address health workforce shortages through additional funding for the National Health Service Corps, and to establish a National Health Service Corps Emergency Service demonstration project; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions