The following is the latest health policy news from the federal government for the week of November 28 to December 1.  Some of the language used below is taken directly from government documents.

340B

  • HHS and its Health Resources and Services Administration (HRSA) have proposed revising the current 340B administrative dispute resolution process.  Since the current process was introduced in 2020 HRSA has encountered policy and operational challenges with its implementation and now proposes revising it and is soliciting comment on its proposed new approach.  Changes include changing the nature of the dispute resolution process, using different kinds of professionals to adjudicate disputes, moving the process closer to certain legislative requirements, and creating a process for reconsideration for those unhappy with decisions.  Learn more about how the proposed rule would change the administrative dispute resolution process from this HHS notice, which also includes a link to a more detailed Federal Register notice.  Comments are due by January 30.

Confidentiality of Substance Use Disorder Patient Records

  • HHS and its Office for Civil Rights and the Substance Abuse and Mental Health Services Administration (SAMHSA) have proposed changes in the Confidentiality of Substance Use Disorder Patient Records under 42 CFR part 2, which protects patient privacy and records for substance use treatment from unauthorized disclosures.  The proposed rule would increase coordination among providers of treatment for substance use and increase protections for patients concerning records disclosure to avoid discrimination in treatment and seeks to align current standards for the protection of patients’ substance use records with HIPAA requirements.  Among other provisions, the proposed rule would permit use and disclosure of part 2 records based on a single patient consent given once for all future uses and disclosures for treatment, payment, and health care operations and permit redisclosure of part 2 records in any manner permitted by HIPAA, with certain exceptions.  Learn more about the proposed rule from this HHS news release; from this HHS fact sheet; and from a pre-publication version of the proposed rule itself.  Comments are due 60 days after the rule’s formal publication, which is currently scheduled for December 2.

No Surprises Act

  • On Tuesday, November 29, an updated Notice of Initiation form for dispute resolution under the No Surprises Act was introduced on the Federal Independent Dispute Resolution portal.  Individuals using that portal for the first time after this update must clear their computer’s cache or open a private or incognito window to use the updated form.  For further information and instructions, see this CMS notice.

Centers for Medicare & Medicaid Services

  • CMS has written to states to remind them that with the passage of the Inflation Reduction Act, Medicaid and Children’s Health Insurance Program (CHIP) programs will be required to provide coverage for approved adult vaccines recommended by the CDC’s Advisory Committee on Immunization Practices (ACIP) without cost-sharing for certain enrollees beginning October 1, 2023.  Learn more from this CMS notice.
  • CMS has written to state survey agencies to encourage them to remind hospitals of their responsibility to protect staff and patients from violence and noting that it will continue to enforce the regulatory expectations that patients and staff have an environment that prioritizes their safety.  Find the CMS memo here.
  • CMS has issued a request for information soliciting public comment on issues related to essential health benefits under the Affordable Care Act, including the description of the essential health benefits, the scope of benefits covered in typical employer plans, the review of essential health benefits, coverage of prescription drugs, and substitution of essential health benefits.  Learn more from this pre-publication version of the formal request for information.  Comments are due 60 days after publication of the formal notice, which is scheduled for December 2.
  • CMS has updated its 2023 Supplemental Security Income (SSI) and spousal impoverishment standards, which affect eligibility for certain Medicaid  benefits, most notably long-term-care services and supports.
  • CMS has published new editions of its online newsletter MLN Connects, which reports on Medicare reimbursement matters.  Go here for articles on calendar year 2023 updates in ambulance, end-stage renal disease, and home health payments, reduced coinsurance for colorectal cancer screenings, 2023 bonus payments for health professional shortage areas, and more and go here for information about 2023 rates for distant telehealth services provided by Rural Health Clinics and Federally Qualified Health Centers, fees and codes for vaccine administration in 2023, billing for CLIA waived laboratory tests, and more.
  • CMS has published its expanded home health value-based purchasing (HHCBP) model newsletter for November.
  • CMS is working with a contractor to develop a “patient safety structural measure,” and as part of this project the contractor will convene groups of stakeholders to provide direction and input.  Among those groups, the contractor is creating an advisory panel to provide input on the development of a hospital-level structural measure assessing organizational policies and processes enacted and resources allocated to ensuring patient safety.  Learn more about the project, the specific skills and experiences sought among panel members, and how to submit applications to participate from this CMS notice.  The deadline for submitting nominations is December 21.
  • CMS has published an article about community care hubs – which it describes as “…community-focused entities supporting a network of CBOs [community-based organizations] providing services addressing health-related social needs…which centralize administrative functions and operational infrastructure” – on the Health Affairs blog.  Find it here.

Department of Health and Human Services

  • HRSA has announced a $350 million initiative to increase COVID-19 vaccinations.  This funding will support a six-week campaign through which health centers will administer updated COVID-19 vaccines through mobile, drive-up, walk-up, or community-based vaccination events, including by working with community-based organizations and other efforts, to increase the administration of COVID-19 vaccines.  All 1400 HRSA-funded health centers and health center look-alikes that received American Rescue Plan funding will be eligible.  Learn more from this HHS news release.
    • As part of the same campaign, the White House announced that HHS’s Administration for Community Living will award $125 million in grants to national organizations that serve people with disabilities and older adults to support community vaccination programs and efforts; that CMS will issue new guidance reminding nursing homes to educate their residents about the benefits of COVID-19 vaccinations and to offer the vaccines to their residents; and that it will launch a paid media effort to urge older Americans to talk with providers about seeking treatment if they contract COVID-19.  Learn more about these additional initiatives from this White House fact sheet. 
    • In addition, a CMS memo to state survey agencies reminds providers and suppliers, especially those delivering care in congregate care settings, to ensure that their patients and residents are protected against transmission of COVID-19 within their facilities and receive appropriate treatment when they test positive for the virus.
  • In support of its efforts to help address the current response to the pediatric surge in viral respiratory illnesses currently affecting hospital capacity, HHS has updated its “Pediatric Surge Resources” web page.  HHS also has updated its tip sheet for improving hospital pediatric surge and its tip sheet for improving regional pediatric surge.
  • HHS’s Office for Civil Rights has issued a bulletin to highlight HIPAA obligations for covered entities and business associates (“regulated entities”) under HIPAA rules when using online tracking technologies that collect and analyze information about how internet users are interacting with a regulated entity’s website or mobile application.  Some regulated entities regularly share electronic protected health information with online tracking technology vendors and some may be doing so in a manner that violates HIPAA rules.  HIPAA rules apply when the information that regulated entities collect through tracking technologies or disclose to tracking technology vendors includes electronic protected health information.  Learn more from this HHS news release and the Office for Civil Rights bulletin.
  • HHS has issued a new report addressing patients’ experience with Long COVID to provide information about its complexities and drive creative responses by government leaders, clinicians, patient advocates, and others.  The report offers short-term and longer-term recommendations drawn from patient experiences.  Learn more from this HHS news release and the report itself.
  • HHS has published its annual notification soliciting proposals and recommendations for developing new or modifying existing safe harbor provisions under section 1128B(b) of the Social Security Act, which is the federal anti-kickback statute.  That statute provides for criminal penalties for whoever knowingly and willfully offers, pays, solicits, or receives remuneration to induce or reward, among other things, referrals for or purchases of items or services reimbursable under any federal health care programs.  Learn more from this HHS explanation and also find a link there to a Federal Register notice.  Comments are due by January 27.
  • HRSA is seeking nominations of candidates for consideration for appointment to its Advisory Committee on Infant and Maternal Mortality, which advises the Secretary of HHS on department activities, partnerships, policies, and programs directed at reducing infant mortality, maternal mortality, and severe maternal morbidity and improving the health status of infants and women before, during, and after pregnancy.  Learn more about the committee, the qualities HRSA seeks in potential members, and how to submit nominations from this HRSA notice and also find a link there to a Federal Register notice.
  • HHS’s Agency for Healthcare Research and Quality (AHRQ) seeks surgical services teams to participate in its Safety Program for MRSA Prevention, a free 18-month program that seeks to reduce surgical site infections with a focus on MRSA.  Beginning in January of 2023, this program will combine evidence-based guidance with implementation strategies to address the attitudes, beliefs, culture, and barriers that often pose challenges to optimizing infection prevention practices.  Participation in this AHRQ program will provide surgical services teams with technical assistance, coaching, webinars, and tools to support their infection prevention program.  Learn more about the program, including dates and times for informational webinars that will share more about the program, from this AHRQ notice.
  • HHS’s Office of the Inspector General has published the report “Long-Term Trends of Psychotropic Drug Use in Nursing Homes” in which it attempts to ascertain the frequency with which such drugs are prescribed in nursing homes.

Centers for Disease Control and Prevention

  • The CDC has awarded $3.2 billion in grants to help state, local, and territorial jurisdictions strengthen their public health workforce and infrastructure.  The $3.2 billion includes $3 billion to recruit, retain, and train the health care workforce, including critical frontline public health workers such as epidemiologists, contact tracers, laboratory scientists, community health workers, and data analysts; $140 million to strengthen and revitalize public health infrastructure; and $65 million to provide training, evaluation, and other technical assistance to jurisdictions as they work to strengthen the services they provide and rebuild their workforce.  Learn more about the funding and find a link to a list of the grants awarded and additional information about these programs from this CDC news release.
  • The CDC has published its “CDC Clinical Practice Guideline for Prescribing Opioids for Pain—United States, 2022.”  The 2022 document updates and expands upon 2016 guidelines and provides evidence-based recommendations for clinicians who provide pain care, including those prescribing opioids.  Find the updated document here.
  • The CDC is inviting comments on proposed new recommendations for perinatal hepatitis C virus infection testing to identify infants who may go on to develop chronic hepatitis C.  An informational webinar on the new recommendations will be held on Tuesday, December 6 and comments are due by January 27.  Learn more about the issue, the recommendations, and how to participate in the webinar from this CDC notice, which also includes a link to a Federal Register notice.
  • The CDC’s Advisory Committee on Immunization Practices has recommended PRIORIX, a drug approved by the FDA in June as a combination vaccine against measles, mumps, and rubella, as an additional option to prevent those diseases.  Find its explanation of this decision here.
  • The CDC has published an analysis of the effectiveness of Paxlovid in preventing hospitalization for patients with COVID-19.  The study found that among U.S. adults diagnosed with COVID-19, including those with previous infection or vaccination, persons who were prescribed Paxlovid within five days of diagnosis had a 51 percent lower hospitalization rate within 30 days after diagnosis than those who were not prescribed Paxlovid.  Learn more from this CDC report.
  • The CDC is seeking comments and suggestions to update the CDC Framework for Program Evaluation in Public Health and associated resources such as checklists and self-study guides.  The CDC Evaluation Framework has guided the CDC and other evaluators for two decades but evaluation has evolved since publication of the framework in 1999, so the CDC seeks to update the framework to align with changes in evaluation, public health, and federal policies and practices.  Learn more about the CDC Framework for Program Evaluation and the nature of the comments the agency seeks from this CDC announcement, which also links to a Federal Register notice.  Comments are due by January 30.

Food and Drug Administration

  • The FDA has revoked its authorization for emergency use for bebtelovimab, which it previously authorized for use in treating COVID-19, because the drug is not expected to neutralize omicron subvariants BQ.1 and BQ.1.1, which now account for more than half of all COVID-19 cases in the U.S.  Learn more about this FDA action, and the agency’s recommended alternative treatments for COVID-19, from this FDA announcement.

National Institutes of Health

  • The NIH has established a web site on which individuals may report the results of self-administered COVID-19 tests.  Learn more from this NIH news release and find the new web site here.

Stakeholder Events

MACPAC – December 8-9

Members of the Medicaid and CHIP Payment and Access Commission will hold their next public meetings on Thursday, December 8 and Friday, December 9.  The agenda and information about participating in the meeting are not yet available but when they are they will be posted here.

MedPAC – December 8-9

Members of the Medicare Payment Advisory Commission will hold their next public meeting on Thursday, December 8 and Friday, December 9.  The agenda and information about participating in the meeting are not yet available but when they are they will be posted here.

Center for Medicare and Medicaid Innovation – Value-Based Insurance Design Model Health Equity Incubation Program Webinar – December 9

CMMI will hold a webinar on leveraging value-based insurance design flexibilities to improve equity in housing stability and quality through its Value-Based Insurance Design Model Health Equity Incubation Program on Thursday, December 9 at 3:00 (eastern).  Go here for more information about the webinar and here to register (registration is required).

FDA – Cardiovascular and Renal Drugs Advisory Committee – December 14

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet virtually on Wednesday, December 14 at 9:00 (eastern).  For information on the meeting’s agenda, the docket the committee has created for the meeting, how to submit comments and papers, and how to join the meeting, see this Federal Register notice.

HHS – New Technology Town Hall – December 14-15

HHS will hold a new technology town hall meeting on Wednesday, December 14 and Thursday, December 15, with both virtual sessions to begin at 9:00 (eastern), to discuss FY 2024 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system.  Interested parties may present comments, recommendations, and data regarding whether the FY 2024 new medical services and technologies applications meet the substantial clinical improvement criterion.  Learn more about the meeting and its purpose and how to participate from this Federal Register notice.