Weekly Roundup: January 27, 2023

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Medicare Payment Advisory Commission Holds January Meeting
The Medicare Payment Advisory Commission (MedPAC) held its January public meeting to discuss a number of issues related to Medicare payment policy. Specifically, the Commission held sessions on:
  • Hospital inpatient and outpatient services; and supporting Medicare safety-net hospitals
  • Physician and other health professional services; and supporting Medicare safety-net clinicians
  • Outpatient dialysis services; hospice services; skilled nursing facility services; home health agency services; inpatient rehabilitation facility services
  • Status report on the Medicare Advantage program
  • Physician and other health professional services; and supporting Medicare safety-net clinicians
  • Medicare clinicians and outpatient behavioral health services
  • Mandated report: Updates on telehealth use and beneficiary and clinician experiences
  • Status report on Medicare Part D
  • Addressing high prices of drugs covered under Medicare Part B
Healthsperien was there to cover the January MedPAC meetings. Click here to access Healthsperien’s comprehensive summary.
Ways and Means Health Subcommittee Leadership Announced
Yesterday, it was announced (subscription required) that Rep. Vern Buchanan (R-FL) will serve as the chair of the Ways and Means Health Subcommittee as well as vice chair of the full panel. The Health Subcommittee has jurisdiction over Medicare, government payments for health care, health delivery systems, and health research, as well as health care tax law. Buchanan also chairs Republicans’ Healthy Future Task Force alongside Energy and Commerce Health Subcommittee Chair Brett Guthrie (R-KY). The task force has developed legislative proposals aimed at addressing the opioid crisis, modernizing health care, and reducing costs. Buchanan plans to bolster telehealth access, “save and strengthen Medicare” and prioritize preventive care. Today, it was announced that Rep. Lloyd Doggett (D-TX) will serve as the ranking member of the Ways and Means Health Subcommittee. Doggett anticipates bipartisan work with Buchanan on telehealth.
FDA Proposal Partially Lifts Blood Donation Restrictions for Men Who Have Sex with Men
Today, the Food and Drug Administration (FDA) released a draft policy that partially lifts long-standing restrictions that prevented men who have sex with men (MSM) from donating blood. The draft policy updates the donor history questionnaire to identify more targeted human immunodeficiency virus (HIV) risk factors, rather than assessing the abstinence of MSM and their partners. In addition to previous questions on injection drug use and other factors, new questions will ask whether the individual has had new or multiple sexual partners in the past three months, and if they recently took pre- or post-exposure prophylaxis (PrEP or PEP). MSM and others without those risk factors will be allowed to donate blood. The proposal comes after decades of FDA policies that prohibited MSM from donating blood. In 1985, following the initial outbreak of HIV/AIDS in the U.S., FDA issued a lifetime ban on donations from MSM. In 2015 the ban was lifted for MSM who had abstained for one year, and in 2020 the abstinence requirement was dropped to three months.
CMS Releases New Guidance on Medicaid Unwinding Process for States
The Centers for Medicare and Medicaid Services (CMS) released a State Health Official (SHO) letter implementing new Medicaid unwinding requirements included in the Consolidated Appropriations Act, 2023. Specifically, the guidance implements the uncoupling of the increased Federal Medical Assistance Percentage (FMAP) and maintenance of effort (MOE) requirements of the Family First Coronavirus Relief Act (FFCRA – passed in 2020) from the COVID-19 Public Health Emergency (PHE). The guidance addresses changes to the conditions that states must meet to receive the FMAP, outlines new reporting requirements, and describes enforcement authority for CMS to ensure state compliance. Of note, the guidance clarifies that the following requirements remain in place during the FMAP phase down, which will occur from April 1, 2023 through December 31, 2023:
  • States may not impose eligibility standards, methodologies, or procedures that are more restrictive than those in effect on January 1, 2020.
  • States must continue to ensure that the amounts in their Medicaid premium schedule do not exceed the amounts that were in place as of January 1, 2020. However, states may increase the premium amount imposed on an individual, based on if the individual moves into a new eligibility category with a different premium amount.
  • States must continue to provide coverage, without cost sharing, for any services and treatments for COVID 19, including vaccines, specialized equipment, and therapies.
The guidance describes in detail new requirements from the CAA, 2023, to include:
  • Compliance with federal renewal requirements
  • Attempting to ensure beneficiaries have up to date contact information
  • Contacting an individual with more than one modality
The guidance also details on new reporting requirements for states, including reporting of monthly data related to the redetermination process and a detailed table of the reporting elements required. Finally, CMS outlines that it will be monitoring state progress and describes the corrective action measure tools it has to ensure compliance.
Healthsperien Releases Summary on 2024 Medicare Advantage and Part D Proposed Rule
Last month, CMS released their annual Medicare Advantage (MA) and Part D Proposed Rule for 2024 (fact sheet) which governs requirements for MA and Part D plans. Healthsperien developed a comprehensive section-by-section summary of the rule, covering a wide range of critical topics, including changes to utilization management, Star Ratings, plan marketing, behavioral health, and the Medication Therapy Management program. The rule also proposes several changes to better incorporate health equity into Medicare plan requirements. Healthsperien’s summary can be used as a resource to inform comment development on the rule, with responses due to CMS by February 13th.
Execution Action
  • Recently, the Biden-Harris Administration announced that more than 16.3 million people, a 13 percent increase over last year and new overall record, selected an Affordable Care Act (ACA) Marketplace health plan nationwide during the 2023 Marketplace Open Enrollment Period (OEP). The OEP ran from November 1, 2022 – January 15, 2023 for most Marketplaces. Of the total plan selections, 22% are new to the Marketplaces for 2023, and 78% had active 2022 coverage and made a plan selection for 2023 coverage or were automatically re-enrolled.
Administrative Action
  • Last Thursday, the Department of Health and Human Services (HHS) released a report entitled, “Marking the 50th Anniversary of Roe: Biden-Harris Administration Efforts to Protect Reproductive Health Care,” which outlines actions HHS has taken in light of the Dobbs decision, which overturned Roe v. Wade. HHS’ actions have been centered on six core priorities: 1) Protecting Access to Abortion Services 2) Safeguarding Access to Birth Control 3) Protecting Patient Privacy 4) Promoting Access to Accurate Information 5) Ensuring Non-discrimination in Healthcare Delivery 6) Evidence-Based Decision Making at FDA.
  • The U.S. Food and Drug Administration (FDA) announced draft industry guidance, Action Levels for Lead in Food Intended for Babies and Young Children, on action levels for lead in processed foods that are intended for babies and children under two years of age. The draft guidance could help reduce potential health effects from dietary exposure to lead.  FDA will consider comments on the draft guidance by March 27, 2023. The guidance addresses the lead levels for processed foods, such as food packaged in jars, pouches, tubs, and boxes.
  • To increase internal efficiency and transparency, the Centers for Disease Control and Prevention (CDC) is undergoing organizational changes (subscription required) under Director Rochelle Walensky, including the creation of a new Office of Health Equity led by Leandris Liburd, new Office of Public Health Data, Surveillance, and Technology led by Jennifer Layden, new Global Health Center, and new position for an internal director for external communications to manage public and private partnerships.
Congressional Action
  • On Tuesday, House Speaker Kevin McCarthy named the members of the Select Subcommittee on the Coronavirus Pandemic formed earlier this month. The panel will operate under the newly renamed Committee on Oversight and Accountability. This panel has until January 2, 2025 to conduct an investigation into the pandemic and submit: 1) findings on the origins of the coronavirus pandemic 2) the use of taxpayer funds and relief programs to address it 3) the efficacy of laws and regulations to address the pandemic and prepare for future pandemics 4) the development and implementation of vaccine policies or federal employees and military service members, among other issues. In addition, Energy and Commerce Chair Cathy McMorris Rodgers (R-WA) announced that Rep. Brett Guthrie (R-KY) will serve as the Chair of the Health Subcommittee. His priorities are to focus on price transparency, address the fentanyl crisis, and expand telehealth access, among other initiatives.
  • Senate Majority Leader Chuck Schumer (D-NY) announced Senate Democratic committee memberships for the 118th Congress. All memberships have been agreed upon by the Democratic Conference and are subject to ratification by the full Senate. All members of the 117th Senate Finance Committee will remain on the committee for the 118th Congress. Sen. Sanders is the new Chairman of the Senate HELP Committee. He is replacing Sen. Murray, who is the new Chairwoman of the Senate Appropriations Committee. Sen. Sanders is the new Chairman of the Senate HELP Committee. He is replacing Sen. Murray, who is the new Chairwoman of the Senate Appropriations Committee. Sen. Markey is the newest member of the HELP Committee. He is replacing Sen. Jacky Rosen (D-NV). Sen. Markey is the newest member of the HELP Committee. He is replacing Sen. Jacky Rosen (D-NV).
  • On Tuesday, the Center for Medicare and Medicaid Innovation (CMMI) Director Liz Fowler, Ph.D., announced CMMI’s plans to release up to four new alternative payment models in 2023. The new models will focus on advancing primary care and enabling states to assume the total cost of care. These new models align with CMMI’s goals of increasing the participation of specialist physicians in value-based care and advancing health equity efforts.
  • Recently, Amazon announced its expansion into the generic drug market with a new subscription service—RxPass—targeting consumers with common health conditions like high blood pressure, acid reflux, or anxiety. The new subscription service is available to Amazon Prime members from Amazon Pharmacy to provide Prime members with affordable access to approximately 50 generic medications delivered free to their home for $5 a month. Amazon Pharmacy stated RxPass is designed for people with chronic conditions who require multiple prescription medications and pay for them out-of-pocket. The program does not accept insurance, including Medicare or Medicaid. The service begins immediately in all states except California, Louisiana, Maryland, Minnesota, New Hampshire, Pennsylvania, Texas, and Washington due to state-specific requirements
  • Late last week, the National Partnership for Healthcare and Hospice Innovation (NPHI), along with LeadingAge, the National Association for Home Care & Hospice (NAHC), and the National Hospice and Palliative Care Organization (NHPCO), released a comprehensive set of program integrity reform recommendations. These recommendations follow concerns expressed by industry leaders about the rapid entry of newly created hospice organizations in several states, and the corresponding adequacy of Medicare certification, accreditation, and enforcement processes. The national hospice organizations urged Congress and the Centers for Medicare and Medicaid Services (CMS) to act to ensure that only well-qualified advanced illness care providers are permitted to care for and support beneficiaries and their families at the end of life. The organizations produced 34 specific recommendations, which can be found here.
  • On Tuesday, the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation (HHS ASPE) released a new report projecting the estimated cost savings of the new monthly insulin cost caps. Beginning this month, Medicare beneficiaries will only pay $35 for a month’s supply of insulin. HHS estimates that if the cap were in place in 2020, 1.5 million Medicare beneficiaries would have saved an average of $500 on insulin costs for the year. This would have resulted in a total of $734 million in Part D savings and $27 million in Part B savings for beneficiaries.
  • The Centers for Medicare and Medicaid Services (CMS) approved a section 1115 demonstration amendment that will improve access to care for individuals following release from jail, prison, or youth correctional facilities. This first-of-its-kind approval will allow California Advancing and Innovating Medi-Cal (CalAIM) to cover pre-release services to incarcerated individuals 90 days prior to their release, which builds upon past congressional, administrative, and executive actions. As part of this approval, California will increase and sustain provider payment rates and Medicaid managed care payment rates in obstetrics, primary care, and behavioral health as a condition of the approval of authority to receive Designated State Health Program (DSHP) funding.
  • The Federal Communications Commission (FCC) released new guidance to allow states and their partners to use automated calls and text messages to Medicaid enrollees to inform them about the redetermination process. The FCC issued this guidance in response to a request from Health and Human Services Secretary Xavier Becerra to clarify that states, local governments, managed care organizations, and other government contractors can use pre-recorded and automated messages to contact beneficiaries without violating the Telephone Consumer Protection Act.
  • On Tuesday, the Bipartisan Policy Center (BPC) released a report that found that enabling workers who are not licensed behavioral health specialists to provide more services could help address the healthcare workforce shortage. BPC explained that the workforce shortage has severe implications for access to treatment, rates of diagnoses, and causes of hospitalizations. The report includes two recommendations for the federal government to address shortages of behavioral health workers.
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