HealthCare Roundtable e-News – February 13, 2023

 

Top News

CMS Releases Initial Guidance on Implementation of Medicare Prescription Drug Inflation Rebate Program

The Centers for Medicare & Medicaid Services (CMS) released (fact sheet) two guidance documents for implementation of the Inflation Reduction Act’s (IRA) inflation rebate provisions for Medicare Part B and Medicare Part D drugs. The guidance documents specify the initial requirements and procedures for implementation of the program. Under the IRA, drug companies will be required to pay rebates to Medicare when drug prices increase greater than the rate of inflation. As part of the initial guidance, CMS is seeking comment on the following topics:

  • The process to determine the number of drug units for rebatable drugs
  • Reduction of rebate amounts for certain Part B and Part D rebatable drugs in shortage and in cases of severe supply chain disruptions
  • The process to impose civil monetary penalties on manufacturers of Part D rebatable drugs that fail to pay rebates
  • Assuring accuracy of the inflation rebate payments

Comments on the guidance are due March 11, 2023.

 

Federal District Court Sides With Texas Medical Association in Challenge of No Surprises Act

Last Monday, a Federal District Court ruled in favor of the Texas Medical Association (TMA) that a final rule on the independent dispute resolution (IDR) process of the No Surprises Act conflicts with the Administrative Procedures Act. Last August, the Biden Administration issued a rule that directed arbiters to consider all factors listed in statute when determining the payment amount but still ensure these additional factors are not incorporated into the Qualifying Payment Amount. TMA and other provider groups maintain that the statute called for the IDRs to equally consider other factors listed in the statute. The Federal District Court agreed with the plaintiffs that the updated rule continues to favor insurers. This case marks TMA’s fourth lawsuit challenging implementation of the No Surprises Act and their second victory in court. On December 12, 2022, the Roundtable and 58 other stakeholders sent a letter to the Secretaries of HHS, Labor, and the Treasury, urging the Departments to stand firm against efforts to strike down the No Surprises Act.

 

Senate Judiciary Committee Passes Five Bipartisan Drug Pricing Reform Bills Out of Committee

Last week, the Senate Judiciary Committee advanced five bipartisan bills that aim to lower prescription drug costs by boosting generic and biosimilar competition. All five bills passed out of committee by voice vote. The bills focus on reforming the drug patent system and encouraging greater collaboration between the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (PTO). The pharmaceutical industry opposes bills aimed at reforming the patent system, and instead blames pharmacy benefit managers (PBMs) for withholding savings from insurers and patients. Specifically, the Pharmaceutical Research and Manufacturers of America (PhRMA) called out the Affordable Prescriptions for Patients Act, which it claims will slow research and development. According to a Democratic aide, the bills will likely pass the Senate.

Executive Action

On Tuesday, President Biden gave his first State of the Union Address to a divided Congress. President Biden revisited the Unity Agenda he laid out during his first State of the Union Address. His remarks highlighted steps Congress and the Administration have already taken towards the four goals identified last year, as well as new policies to continue advancing the agenda, which include accelerating progress to end cancer as we know it today, supporting America’s veterans and their families, caregivers, and survivors, tackling the mental health crisis, and beating the opioid and overdose epidemic.

Administrative Action

  • On Thursday, the Department of Health and Human Services (HHS) released a roadmap detailing their transition plan for the unwinding of the COVID-19 Public Health Emergency (PHE). The Department clarified policies that will be affected and those that are not. HHS highlighted there will be continued access to pathways for emergency use authorizations (EUAs) for COVID-19 products (tests, vaccines, and treatments) through the FDA, and major telehealth flexibilities will continue to exist for those participating in Medicare or Medicaid. Medicaid programs will continue to cover COVID-19 treatments without cost-sharing through September 30, 2024. 

  • The Centers for Medicare & Medicaid Services (CMS) announced that they are beginning to update their CMS Emergencies Page with resources to help providers and states as the COVID-19 public health emergency (PHE) declaration ends. The Biden Administration announced that it intends to allow the COVID-19 national emergency declaration to expire on May 11, 2023. CMS and states implemented numerous flexibilities to preserve access to essential health care during the PHE. The Consolidated Appropriations Act of 2023 extended several key telehealth and Acute Hospital Care at Home waivers beyond the end of the PHE, but other flexibilities are still set to expire with the PHE declaration. CMS states they will continue to update the resources on the emergencies page as the end of the PHE approaches.

  • On Thursday, the CDC and Prevention Advisory Committee on Immunization Practices (CDC ACIP) released updated vaccination schedules for children and adolescents as well as adults that include COVID-19 vaccines. CDC generally recommends healthy adults and children receive two doses of the vaccine followed by a booster dose, and immunocompromised individuals should receive three doses of the vaccine followed by a booster. The updated vaccination schedule has been approved by the American Academy of Pediatrics, American Academy of Family Physicians, and other leading medical associations. However, states and local governments are not mandated to require the complete vaccination schedule for students, so some school districts still may not require COVID-19 vaccinations.

Congressional Action

Recently, 74 House lawmakers sent a letter to Department of Health and Human Services (HHS) Secretary, Xavier Becerra and Centers for Medicare & Medicaid Services (CMS) Administrator, Chiquita Brooks-LaSure, urging Medicare to reconsider its determination of certain Alzheimer’s drugs, including the newly approved Leqembi. Representatives noted they are encouraged that CMS is open to reconsidering the National Coverage Determination (NCD) of monoclonal antibodies treating Alzheimer’s and other dementia, and hope Coverage with Evidence Development (CED) requirements for Food and Drug Administration (FDA)-approved monoclonal antibodies (mAbs) directed against amyloid for the treatment of Alzheimer’s disease will be reconsidered. 

Medicare

Health Affairs published an article on potential payment for comprehensive dementia care. More than 6.5 million older Americans are living with Alzheimer’s disease today, a number projected to double by 2050. The Alzheimer’s Association estimates that Medicare spent $146 billion on Alzheimer’s disease in 2022. 

Medicaid

  • On Wednesday, the Center for Health Care Strategies and Association for Community Affiliated Plans jointly released a new report reviewing how twelve states have utilized Medicaid managed care organizations (MCOs) to address the health-related social needs (HRSN) of beneficiaries. The report also notes that states are increasingly using value-based payment or community reinvestments to direct Medicaid funding from managed care organizations to providers and community-based organizations to support their SDOH-related activities. Finally, the report offers recommendations on how federal policymakers and the CMS can continue to support states and MCOs, which include continuing to use Medicaid funds to expand access to HRSN services, supporting accurate medical loss ratio (MLR) reporting and capitation rates, and allowing states to test new approaches to financing HRSN services and infrastructure.

  • Last month, the Medicaid and CHIP Payment and Access Commission (MACPAC) held its January policy meeting. The Commissioners discussed several issues related to Medicaid payment policy. Healthsperien was there to cover the January MACPAC meetings. Click here to access Healthsperien’s comprehensive summary. 

Research

recent survey commissioned by the Alliance for Women’s Health and Prevention (AWHP) found that 45 percent of American women skip preventative care services including check-ups, cancer screenings and vaccinations, often due to the cost of care. The poll found that the top two reasons that women skipped care were out-of-pocket costs (25 percent) and time restraints (23 percent). The study found that social determinants of health contribute to disparities in preventative care. The survey comes as the Affordable Care Act requirement that insurers cover preventive services that are “A” or “B” grade by the U.S. Preventive Services Task Force cost-free is at risk due to a pending district court decision in Braidwood v. Becerra.