Federal Health Policy Update for Thursday, June 30

The following is the latest health policy news from the federal government as of 2:45 p.m. on Thursday, June 30.  Some of the language used below is taken directly from government documents.

White House

The White House has unveiled its “White House Blueprint for Addressing the Maternal Health Crisis.”

Monkeypox Update

• The White House has announced the first phase of its national monkeypox vaccine strategy, a part of its monkeypox outbreak response.  The major components of the strategy include expanded efforts to vaccinate those most at risk, expanded testing supply and availability, and greater engagement with community leaders and stakeholders.  Learn more about the White House’s plan from this fact sheet.
• HHS has announced an enhanced nationwide vaccination strategy to mitigate the spread of monkeypox.  The strategy includes vaccinating and protecting those at risk of monkeypox, prioritizing vaccines for areas with the highest numbers of cases, and providing guidance to state, territorial, tribal, and local health officials to aid their planning and response efforts.  HHS will provide 296,000 doses of monkeypox vaccine.  Of that amount, 56,000 doses will be made available immediately and an additional 240,000 doses will be made available in the coming weeks.  HHS expects more than 750,000 additional monkeypox vaccine doses to be made available over the summer and an additional 500,000 doses will undergo completion, inspection, and release throughout the fall, totaling 1.6 million doses available this year.  The vaccine will be allocated using a four-tier distribution strategy that prioritizes jurisdictions with the highest case rates of monkeypox.  Within each tier, doses of the vaccine will be allocated based on the number of individuals at risk for monkeypox who also have pre-existing conditions.  Learn more from this HHS news release.
• The CDC has activated its Emergency Operations Center to serve as its command center for monitoring and coordinating the emergency response to monkeypox and mobilizing additional CDC personnel and resources.  Learn more from this CDC announcement.
• The CDC has posted an updated map showing the distribution of 351 confirmed cases of monkeypox in the U.S. as of June 29.

Centers for Medicare & Medicaid Services

• CMS has issued updates to guidance on minimum health and safety standards that long-term-care facilities (nursing homes) must meet to participate in Medicare and Medicaid.  Among the issues addressed in the guidance are staffing; infectious disease prevention; mental health and substance abuse challenges; admissions, transfers, and discharges; resident rights; timely investigations; and others.  Learn more from this CMS news release; an accompanying CMS fact sheet; and revised CMS guidance to long-term-care surveyors.
• The latest edition of MLN Connects, CMS’s online newsletter covering Medicare reimbursement issues, includes items about new billing codes for Pfizer COVID-19 vaccines for infants and children; updated resources for hospital price transparency; updated information about Medicare provider enrollment; and a No Surprises Act fact sheet for patients.  For these items and more, see the new issue of MLN Connects.
• CMS has published program year 2021 Open Payments data to disclose the financial relationships between applicable manufacturers and group purchasing organizations and certain health care providers.  This data includes 12.1 million records and $10.9 billion in publishable payments or transfers of value made to covered health care providers during program year 2021.  It also includes newly submitted or updated records from previous program years.  Learn more about the Open Payments program, to whom it applies, and how it works from this CMS news release and find the searchable Open Payments database here.
• CMS has approved Washington state’s extension of Medicaid and CHIP coverage for 12 months after pregnancy, as authorized by the American Rescue Plan; the coverage ordinarily extends only for 60 days.  This brings to 15 the number of states that have extended postpartum coverage to 12 months.  Learn more from this HHS news release.
• CMS has published an analysis of Medicaid and CHIP enrollment during the pandemic and the delivery of services to that population during the COVID-19 public health emergency.  Learn more from the CMS report “Medicaid and CHIP and the COVID-19 Public Health Emergency.”

Department of Health and Human Services

• HHS has launched a new web site, ReproductiveRights.gov, to provide information about reproductive rights and resources for exercising those rights in the wake of reversal of Roe v. Wade and how those who feel those rights are being violated can file a complaint with the federal government.  Find the site here.
• In the wake of the Supreme Court ruling in Dobbs v. Jackson Women’s Health Organization, HHS’s Office for Civil Rights has issued new guidance to help protect patients seeking reproductive health care and their providers.  In general, the guidance addresses how federal law and regulations protect individuals’ private medical information relating to abortion and other sexual and reproductive health care and addresses the extent to which private medical information is protected on personal cell phones and tablets and provides tips for protecting individuals’ privacy when using period trackers and other health information apps.  Learn more from the following resources:
  • an HHS news release
  • guidance on the HIPAA privacy rule and disclosures of information relating to reproductive health care
  • guidance on protecting the privacy and security of health information when using personal cell phones and tablets
• In response to the COVID-19 emergency, HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) in April of 2020 issued an exemption to opioid treatment programs from the requirement to perform an in-person physical evaluation of any patient who will be treated by such programs with buprenorphine if a program physician, primary care physician, or authorized health care professional under the supervision of a program physician determines that an adequate evaluation of the patient can be accomplished via telehealth.  Based on positive response to this practice, SAMHSA is extending this flexibility for one year from the formal end of the COVID-19 public health emergency.  Learn more from SAMHSA’s guidance.
• HHS and the Department of Defense have entered into an agreement to purchase 105 million doses of Pfizer’s COVID-19 vaccine for a fall vaccination campaign, with options for up to 300 million doses.  Learn more from this HHS news release.  Also, the FDA has recommended that the fall vaccinations include a component that addresses the omicron variant.  The FDA explains this recommendation in this statement.
• HHS’s Agency for Healthcare Research and Quality has released a new statistical brief, “Expected Payers and Patient Characteristics of Maternal Emergency Department Care, 2019.”  Find it here.
• HHS has introduced four new and updated questions in its Provider Relief Fund FAQ; they can be found on pages 3, 7, 44, and 66.

Food and Drug Administration

• The FDA has announced its authorization of an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated AstraZeneca monoclonal antibody Evusheld (tixagevimab co-packaged with cilgavimab), which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals.  Learn more from this FDA announcement.
• The FDA has authorized an extension to the shelf-life from 24 months to 30 months for specific lots of the refrigerated Regeneron monoclonal antibodies, casirivimab and imdevimab, administered together as REGEN-COV.  Because of the high frequency of the omicron variant and its subvariants, REGEN-COV is not currently authorized for use in the U.S. but the FDA urges providers to retain their supply in case the nature of the COVID-19 variants in the U.S. changes in the near future.  Learn more from this FDA announcement.

Medicare Payment Advisory Commission (MedPAC)

MedPAC has submitted testimony at a House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations hearing on the Medicare Advantage program.  Among the subjects addressed in the testimony are MedPAC’s concerns about Medicare Advantage, coding intensity, the Medicare Advantage quality bonus program, and encounter data.  The testimony also includes MedPAC recommendations.  Find the MedPAC testimony here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

MACPAC has submitted written comments in response to CMS’s proposed rule addressing the implementation of certain Medicare provisions in the Consolidated Appropriations Act of 2021 and other revisions related to Medicare enrollment and eligibility rules.  The letter primarily addresses selected provisions of the 2021 law affecting dually eligible (Medicare and Medicaid) beneficiaries.  Find the MACPAC letter to CMS here.

Government Accountability Office (GAO)

Concerned about the large numbers of Medicare beneficiaries disenrolling from Medicare Advantage plans during their last year of life in favor of traditional Medicare, the GAO has examined the performance of Medicare Advantage plans to learn if the financial incentives for those plans have led participants to question the quality and accessibility of care.  The GAO also evaluated the effectiveness of CMS in attempting to monitor this situation.  Learn more from the GAO report “Medicare Advantage:  Continued Monitoring and Implementing GAO Recommendations Could Improve Oversight.”  This report also was submitted as testimony to the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations for a hearing on Medicare Advantage.

In general, states are not permitted to direct Medicaid managed care plans’ payments to providers, but in 2016 CMS issued regulations establishing certain circumstances under which states may direct managed care payments to providers; these payments are often referred to as state directed payments.  The regulations generally require annual CMS approval of implementing state directed payments and required states to phase out payments that states had been directing managed care plans to make but that CMS no longer considered allowable; the latter are typically referred to as pass-through payments.  In 2021 CMS issued additional guidance and revised its review process.  In a new report, the GAO looks at how states are using the state directed payments option and the effectiveness of CMS’s oversight of how this is done and the efforts of states to eliminate pass-through payments.  Learn more in the GAO report “Medicaid: State Directed Payments in Managed Care.”

Stakeholder Events

National Advisory Council for Healthcare Research and Quality – July 21

The National Advisory Council for Healthcare Research and Quality, which advises the Secretary of the Department of Health and Human Services and the Director of Agency for Healthcare Research and Quality (AHRQ) on matters involving to AHRQ’s mission, will meet on Thursday, July 21 at 12:30 p.m. (eastern).  Council members will meet in person but the public is invited only virtually.  Learn more about the council, the agenda for the meeting, and how to participate in the meeting from this Federal Register notice.