POLICY BRIEFINGS

Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


THIS WEEK'S BRIEFING - MARCH 20, 2023

HELP Releases PAHPA RFI


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.



March 20, 2023: | Page 1 Page 2

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