HealthCare Roundtable e-News – February 21, 2023

 

Top News

Roundtable Submits Statement on Role of PBMs in Ensuring Access to Affordable Drug Benefits

Last Thursday, the Roundtable submitted a statement for the Senate Committee on Commerce, Science, and Transportation full committee hearing on increasing federal oversight of pharmacy benefit managers (PBMs). According to experts who testified at the hearing, there is bipartisan support for greater transparency and accountability of PBMs, who serve as the drug supply chain middlemen. Committee members and witnesses discussed the role of PBMs in determining drug prices and highlighted the impact on patients. The hearing specifically addressed how S.127 – Pharmacy Benefit Manager Transparency Act of 2023, reintroduced by Senate Commerce Chair Maria Cantwell (D-WA) and Sen. Chuck Grassley (R-IA), proposes to bring transparency into PBM business practices. The bill would prohibit PBMs from using ‘deceptive and unfair pricing schemes’, imposing arbitrary claw back payments made to pharmacies, and require them to report to the Federal Trade Commission (FTC) how much money they make through spread pricing and pharmacy fees.

The Roundtable’s statement emphasized our members’ support of efforts to constrain health care cost growth, and highlighted the role that PBMs play in maintaining affordable drug costs for Roundtable members’ active and retired populations. Our members rely on the ability of PBMs to negotiate with all parties in the prescription drug supply chain for the best possible price. The Roundtable expressed concern about the potential impact that S. 127, if enacted, would have on our members’ access to affordable prescription drug benefits.

 

HHS Secretary Becerra Selects Three Models for Testing By CMS Innovation Center

Last week, the Centers for Medicare & Medicaid Services (CMS) announced that Secretary of the Department of Health and Human Services (HHS) Xavier Becerra selected three new models for testing by the CMS Innovation Center. The announcement comes in response to President Joe Biden’s Executive Order 14087, “Lowering Prescription Drug Costs for Americans.” In a report, Secretary Becerra detailed how the three models addressed the themes outlined in the executive order and meet the criteria for affordability, accessibility, and feasibility of implementation. The models are:

  • The Medicare High-Value Drug List Model: Part D plans would be encouraged to offer a low, fixed co-payment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs that treat chronic conditions. The out-of-pocket costs for these generic drugs will be capped at a maximum of $2 per month per drug.

  • The Cell and Gene Therapy Access Model: State Medicaid agencies would assign CMS to coordinate and administer multi-state, outcomes-based agreements with manufacturers for certain cell and gene therapies, helping Medicaid beneficiaries gain access to high-cost specialty drugs for illnesses like sickle cell disease and cancer.

  • The Accelerating Clinical Evidence Model: CMS would develop payment methods for drugs approved under accelerated approval to encourage timely confirmatory trial completion, potentially reducing Medicare spending on drugs with no confirmed clinical benefit.

Executive Action

On Thursday, Politico shared that the Biden Administration is developing plans to preserve free access to COVID-19 tests, treatments, and vaccines for individuals who are uninsured after the end of the national public health emergency (PHE). The Administration anticipates that after the PHE ends on May 11, COVID-19 care will begin commercializing in the latter half of the year. Individuals with private insurance, Medicare, and Medicaid will likely continue to be able to access care and an existing federal program will continue providing free vaccinations to uninsured children. While the plan is still in development, Administration officials anticipate they will be able to use existing COVID-19 response funding to continue providing care into 2024, giving the Administration time to develop longer-term solutions.  

Administrative Action

  • Last Monday, the Department of Health and Human Services (HHS) hosted a call to discuss the end of the public health emergency (PHE). Based on current data, HHS is expecting that this will be the last renewal of the PHE and it will end on May 11, 2023. The call included representatives from the Office of the Secretary, Centers for Medicare & Medicaid Services (CMS), Food and Drug Administration (FDA), Centers for Disease Control and Prevention, and Substance Use and Mental Health Services Administration (SAMHSA) to discuss the impact of the end of the COVID-19 PHE on current flexibilities and policies.

  • Recently, the Department of Health and Human Services (HHS) stated (subscription required) that they chose six organizations to begin developing qualified health information networks to facilitate patient healthcare data sharing nationwide. The six organizations: Epic, CommonWell Health Alliance, Health Gorilla, Kno2, eHealth Exchange, and KONZA, will begin pre-production testing and project planning with HHS, but each pledged to go live as qualified networks later this year. To become qualified networks, each of the organizations must meet the Trusted Exchange Framework and Common Agreement (TEFCA) standards HHS finalized last year. If successful, this initiative will allow providers and public health agencies to quickly send and receive health information, which HHS believes will lead to better patient care and outcomes.

  • Last Monday, the Department of Health and Human Services (HHS) issued a proposed rule (proposed rulefact sheet) that would require nursing homes to disclose to the Centers for Medicare and Medicaid (CMS) and states additional ownership and management information. In addition, the rule would provide definitions of “private equity company” and “real estate investment trust,” which would assist nursing homes in reporting data and lead to the disclosure of nursing home owners who are private equity companies or real estate investment trusts. This rule marks a continuation of President Biden’s initiative to improve the quality and care available at nursing homes. HHS asserts that through transparent facility ownership and oversight, nursing home residents and their families can make informed decisions related to care. 

Medicare

CMS released a proposed National Coverage Determination (NCD) to expand coverage for power seat elevation equipment on certain power wheelchairs to Medicare individuals. If finalized, the equipment would be covered by Medicare for individuals with a Group 3 power wheelchair, which are designed to meet the needs severely disabled Medicare beneficiaries. The proposed NCD is open for public comment for 30 days and closing on March 17, 2023. 

Medicaid

On Wednesday, Sellers Dorsey in collaboration with Medicaid Health Plans of America (MHPA) and the Association for Community Affiliated Plans, released their 2022 State of Medicaid Managed Care Report. The report details the evolution of the Medicaid Managed Care industry from its inception to the present, highlighting key legislative and regulatory changes, case studies from innovative states and individual plans, and data on enrollment, growth and beneficiary outcomes. The report also notes that enrollment has continued to grow through the COVID-19 public health emergency and maintenance of eligibility requirements. 

Litigation

Last Friday, CMS announced that effective immediately, certified Independent Dispute Resolution (IDR) entities should not issue any new, out-of-network surprise billing payment determinations until further guidance is issued. Certified IDR entities have also been instructed to recall any payment determinations issued after February 6, 2023. CMS noted this comes as a direct result of a court ruling in Texas Medical Association, et al. v. United States Department of Health and Human Services, which vacated certain portions of the Federal IDR process applicable to all surprise billing payment disputes. The Departments will provide specific directions to certified IDR entities for resuming the issuance of payment determinations that are consistent with the court’s judgment and order.

Research

  • On Tuesday, the Consumer Financial Protection Bureau (CFPB) released a report showing a significant reduction in the number of Americans with medical debt on their credit report. From the first quarter of 2020 to the first quarter of 2022, 8.2 million individuals eliminated medical debt on their credit reports. The Biden Administration pointed to efforts to strengthen the Affordable Care Act, lower health care costs as drivers of the decrease, as well as the CFPB’s actions to highlight inaccurate reporting of debt in collections. The CFPB report also shows that while progress has been made in reducing medical debt for Americans, it still accounts for more than 50% of debt in collections exceeding the number of debt collections from all other sources combined.

  • The National Academies of Science, Engineering, and Medicine published a new report titled, “Advancing Antiracism, Diversity, Equity, and Inclusion in STEMM Organizations: Beyond Broadening Participation.” The report, published on Tuesday, stresses that higher education and scientific institutions must go beyond increasing the number of people from underrepresented racial and ethnic groups in clinical trials, and in addition, change their culture. The authors argue that cultural changes are necessary to create an environment where students, scientists, and clinicians from various backgrounds feel included and welcomed. The report includes a multitude of broad recommendations, including different frameworks to approach culture change and steps that can be taken at the individual, group, and organization levels.