Health Care Checkup
March 31, 2023
THE BIG PICTURE
On Thursday, a federal judge in Texas, Reed O'Connor, struck down an Affordable Care Act (ACA) mandate that requires insurers to cover preventative care services recommended by the U.S. Preventive Services Task Force (USPSTF) with no cost-sharing. In his opinion, O’Connor wrote that the HHS’s enforcement of the preventive care mandate based on USPSTF’s recommendations were “unlawful.” O’Connor also ruled the ACA requirement that insurers and employers offer health plans that cover HIV-preventative measures unlawful. Key preventative services, such as mammograms and colonoscopies, are affected by O’Connor’s ruling. It is likely that the Biden Administration will appeal the ruling.

On Friday, the Department of the Treasury (Treasury) released the annual Social Security and Medicare Trustees Reports. The Medicare Hospital Insurance (HI) Trust Fund is projected to be depleted in 2031, which is three years later than projected in last year’s Medicare Trustees Report. Upon depletion, that fund’s reserves will only be able to pay 89% of total benefits. The press release from Treasury can be found here.

The House Energy and Commerce Subcommittee on Health held a hearing titled, “Lowering Unaffordable Costs: Examining Transparency and Competition in Health Care.” At the hearing, there was bipartisan agreement over the need for better enforcement of two Trump-era price transparency rules: the Hospital Price Transparency Rule and the Transparency in Coverage Rule. Several Members and witnesses called for heftier fines for non-compliance and argued that the regulations need to be strengthened and standardized. The Members also called for better oversight and reform of pharmacy benefit managers (PBMs). Mehlman Consulting’s summary of the hearing can be found here.

The U.S. Food and Drug Administration (FDA) approved the first non-prescription version of naloxone, a medication used to rapidly reverse the effects of an opioid overdose. An over-the-counter (OTC) version of this drug means that it can be sold at places such as grocery stores, gas stations, and online. In the FDA’s press release, it was noted that the timeline for availability and price of the product will be determined by the manufacturer.

A new study in the Journal of the American Medical Association (JAMA) found that the increased availability of telehealth and medications for opioid use disorder (OUD) during the COVID-19 pandemic was associated with a lowered risk of fatal drug overdose among Medicare beneficiaries.
What to Expect Next Week: Both the House and Senate will be out of session until Monday, April 17. Distribution of the Health Care Checkup will resume when Congress reconvenes. 
DEEP DIVE
Federal Judge in Texas Strikes Down Preventative Care Provisions in ACA
On Thursday, a federal judge in Texas, Reed O'Connor, struck down an Affordable Care Act (ACA) mandate that requires insurers to cover preventative care services recommended by the U.S. Preventive Services Task Force (USPSTF) with no cost-sharing. In his opinion, O’Connor wrote that the HHS’s enforcement of the preventive care mandate based on USPSTF’s recommendations were “unlawful.” O’Connor also ruled the ACA requirement that insurers and employers offer health plans that cover HIV-preventative measures unlawful. Key preventative services, such as mammograms and colonoscopies, are affected by O’Connor’s ruling. The plaintiffs in the case made the argument that the ACA’s requirement to cover preventative care services was a violation of their religious freedoms. It is likely that the Biden Administration will appeal the ruling.

Treasury Releases Annual Social Security and Medicare Trustees Reports
On Friday, the Department of the Treasury (Treasury) released the annual Social Security and Medicare Trustees Reports. The Medicare Hospital Insurance (HI) Trust Fund is projected to be depleted in 2031, which is three years later than projected in last year’s Medicare Trustees Report. Upon depletion, that fund’s reserves will only be able to pay 89% of total benefits. The press release from Treasury can be found here. The Social Security Report is available here, and the Medicare Trustees Report is available here. A fact sheet summarizing the reports can be found here.

Members Discuss PBMs, Market Consolidation, and Health Care Transparency at House E&C Health Subcommittee Hearing
The House Energy and Commerce Subcommittee on Health held a hearing titled, “Lowering Unaffordable Costs: Examining Transparency and Competition in Health Care.” At the hearing, there was bipartisan agreement over the need for better enforcement of two Trump-era price transparency rules: the Hospital Price Transparency Rule and the Transparency in Coverage Rule. Several Members and witnesses called for heftier fines for non-compliance and argued that the regulations need to be strengthened and standardized. The Members also called for better oversight and reform of pharmacy benefit managers (PBMs). Subcommittee Chair Brett Guthrie (R-KY) stated that rising health care costs have coincided with a “sharp rise” in consolidation within the health care industry. He noted that “There have been almost 1,800 hospital mergers between 1998 and 2021, leading to about 2,000 fewer hospitals throughout the country.” Due to these consolidation concerns, Members discussed the possibility of expanding site neutral payments to help eliminate the incentive for big health systems to buy up small, independent practices. Mehlman Consulting’s summary of the hearing can be found here.
 
Senate Finance Committee Delves into PBMs and the Prescription Drug Supply Chain at Hearing
Pharmacy benefit managers (PBMs) have been a recurring theme this Congress. On Thursday, the Senate Finance Committee held a hearing on PBMs and their impact on drug pricing. In his opening statement, Chair Ron Wyden (D-OR) stated that “In recent years, it’s increasingly apparent that PBMs are using their data, market power, and know-how to keep prices high and pad their profits instead of sharing the benefits of the prices they negotiate with consumers and the Medicare program.” Other Senators at the hearing expressed similar concerns. Ranking Member Mike Crapo (R-ID) stressed that we “should have frameworks, both within Part D and in other markets, that encourage low [drug] prices through meaningful competition.” It is expected that PBM reform will continue to be a popular topic this Congress.
 
FDA Approves First Over-the-Counter Naloxone Nasal Spray, which is used to Reverse Opioid Overdose
The U.S. Food and Drug Administration (FDA) approved the first non-prescription version of naloxone, a medication used to rapidly reverse the effects of an opioid overdose. An over-the-counter (OTC) version of this drug means that it can be sold at places such as grocery stores, gas stations, and online. In the FDA’s press release, it was noted that the timeline for availability and price of the product will be determined by the manufacturer. The FDA also advised that the switch from prescription to OTC may take months, and that other formulations of the drug will continue to be available by prescription. Additional information can be found here.

New Study Finds that Increased Use of Telehealth Services and Medications for Substance Use Disorder During the COVID-19 Pandemic Were Associated with Decreased Risk for Fatal Overdose
A new study in the Journal of the American Medical Association (JAMA) found that the increased availability of telehealth and medications for opioid use disorder (OUD) during the COVID-19 pandemic was associated with a lowered risk of fatal drug overdose among Medicare beneficiaries. Specifically, the study found that Medicare beneficiaries that “began a new episode of opioid use disorder-related care during the pandemic and received opioid use disorder-related telehealth services” had a 33% lower risk of a fatal overdose. The study also found that Medicare beneficiaries who received medication for OUD from an opioid treatment program had a 59% decreased risk of fatal overdose. More can be found here.
CONGRESSIONAL HEARINGS
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ADMINISTRATION ANNOUNCEMENTS
Centers for Medicare & Medicaid Services
 
Food and Drug Administration
 
Guidance Documents from the Centers for Disease Control and Prevention

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