The following is the latest health policy news from the federal government for April 8 – 20.  Some of the language used below is taken directly from government documents.

The White House

The Biden administration has announced a plan to expand health coverage for Deferred Action for Childhood Arrivals (DACA) individuals.  To this end, it announced that HHS will soon propose a rule amending the definition of “lawful presence,” for purposes of Medicaid and Affordable Care Act coverage, to include DACA recipients.  If finalized, the rule would make DACA individuals eligible for these programs for the first time.  Under the proposed rule, DACA individuals would be able to apply for coverage through the health insurance marketplace, where they may qualify for financial assistance based on income, and through their state Medicaid agency.  Learn more from this White House fact sheet.  HHS Secretary Xavier Becerra has released a letter on the same subject.

Congress

Congresswoman Yvette Clarke (D-NY) has introduced H.R. 2665, the Supporting Safety Net Hospitals Act, bipartisan legislation that would delay pending cuts to Medicaid disproportionate share hospital (Medicaid DSH) payments.  Currently, Medicaid DSH payments would be cut, beginning in 2024, by $8 billion a year through 2027.  The legislation proposes delaying implementation of the cuts until 2026.  Find the proposed bill here and ASH’s endorsement of the bill here.

Medicare Payment Regulations

  • CMS has published its proposed Medicare inpatient prospective payment system (IPPS) and long-term-care hospital (LTCH) regulation for FY 2024; the proposed regulation addresses how Medicare envisions paying for hospital inpatient and LTCH care in FY 2024.  Highlights include:
    • Proposed rate increases of 2.8 percent for inpatient care and 2.9 percent for LTCH care.
    • A reduction of approximately $160 million in Medicare disproportionate share payments (Medicare DSH) and uncompensated care payments.
    • Changes in CMS’s methodology for calculating rural wage indexes that would result in significant changes for some hospitals.
    • Several measures to support CMS’s health equity endeavors and a request for information about how CMS can better support safety-net hospitals.

Learn more about these and other aspects of CMS’s proposed regulation from this CMS news release; a CMS fact sheet; and the proposed rule itself.  The deadline for stakeholders to submit comments is June 9.

  • CMS has released its Notice of Benefit and Payment Parameters for 2024 final rule.  The final rule seeks to make coverage more accessible, expand access to behavioral health care, and make it easier and simpler for consumers to select a health plan in 2024.  The final rule also finalizes standards for issuers and marketplaces, agents, brokers, web-brokers, and assisters that help consumers with enrollment through marketplaces that use the federal platform.  Learn more about the final rule from this HHS news release and this CMS fact sheet.

Department of Health and Human Services

  • HHS has announced that in the coming weeks it will issue an amendment to the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for medical countermeasures against COVID-19.  The PREP Act declaration has facilitated access to COVID-19 countermeasures such as vaccines, tests, and treatments.  The PREP Act declaration also has provided flexibilities and protections for individuals and entities that have been involved in providing these tools.  By issuing this amendment, HHS intends to permit pharmacies to continue their critical roles in the response to COVID-19 even after certain products transition to traditional health care pathways.  Among the planned changes that will be announced are extending immunity from liability for COVID-19 vaccines, seasonal influenza vaccines, and COVID-19 tests; extending coverage under selected federal agreements; ending coverage for certain activities, including  COVID-19 vaccination by non-traditional providers (e.g., recently retired providers and students) and COVID-19 vaccinations across state lines by licensed providers and pharmacists and pharmacy interns; and ending coverage for routine childhood vaccinations.  Some of the practices that will not change under the anticipated amended declaration are that it will have no immediate impact on government-distributed COVID-19 countermeasures; no change to coverage for certain prescribing and dispensing of COVID-19 oral antivirals; and no change of the Test to Treat program. Pharmacists and other providers prescribing tests in the Test to Treat program will continue to receive liability protection under the PREP Act.  Learn more from this HHS fact sheet.  HHS Secretary Xavier Becerra has shared information about these decisions in a letter to the nation’s governors.
  • HHS has announced its “HHS Bridge Access Program For COVID-19 Vaccines and Treatments Program” to maintain broad access to COVID-19 vaccines for millions of uninsured Americans.  The program will create a $1.1 billion public-private partnership to help maintain uninsured individuals’ access to COVID-19 care at their local pharmacies, through existing public health infrastructure, and at their local health centers.  The program will have two major components:  first, it will provide support for the existing public sector vaccine safety net, which is implemented through local health departments and  HRSA-supported health centers; and second, it will create a funded partnership with pharmacy chains that will enable those chains to continue offering free COVID-19 vaccinations and treatments to the uninsured through their networks or retail locations, as they have during the current COVID-19 public health emergency.  Learn more about the program from this HHS news release.
  • During the COVID-19 public health emergency, HHS’s Office of Civil Rights issued four notifications of enforcement discretion indicating that it temporarily would not enforce certain HIPAA requirements as they applied to the delivery of telehealth services.  With the coming end of the public health emergency, the Office of Civil Rights has published a notice announcing that it will resume enforcing those requirements once the emergency period ends but also is creating a 90-day transition period during which providers can bring their operations into compliance with HIPAA requirements.  Learn more from this Office of Civil Rights notice, which includes a link to a formal Federal Register notice.  Find additional information in this HHS news release.
  • In a release on a related subject, HHS has published an FAQ clarifying which telehealth and telephone services are valid for data submissions for the HHS-operated risk adjustment program in the 2023 benefit year in light of the end of the end of the COVID-19 emergency.  Find that FAQ here.
  • HHS and its Agency for Healthcare Research and Quality (AHRQ) have posted a new funding opportunity for multidisciplinary clinics that care for people with Long COVID to expand access to comprehensive, coordinated, and person-centered care, particularly for underserved, rural, vulnerable, or minority populations that are disproportionately affected by Long COVID.  The awards will help existing clinics develop and implement new or improved care delivery models, expand access and services offered, strengthen care coordination, and support the primary care community with Long COVID education and management.  Learn more from this AHRQ news release and this formal funding notice.  Letters of intent must be submitted by May 5 and the deadline for applications is June 12.
  • HHS and its cybersecurity task force have released the following new resources to help address cybersecurity concerns in the health care and public health sectors.  Those resources are:
    • Knowledge on Demand – a new online education platform that offers free cybersecurity training for health and public health organizations to improve cybersecurity awareness.
    • Industry Cybersecurity Practices 2023 Edition – a foundational publication that seeks to raise awareness of cybersecurity risks, provide best practices, and help the health care and public health sectors set standards in mitigating the most pertinent cybersecurity threats to the sector.
    • Hospital Cyber Resiliency Initiative Landscape Analysis – a report on domestic hospitals’ current state of cybersecurity preparedness, including a review of participating hospitals benchmarked against standard cybersecurity guidelines such as HICP 2023 and the National Institute of Standards and Technology Cybersecurity Framework.

Learn more about this HHS initiative and find links to the new resources in this HHS news release.

  • HHS’s Office of the Inspector General has updated its workplan for audits and evaluations in the month of April.  Find the updated workplan here.

Other Formal HHS Notices

  • HHS’s Office for Civil Rights has issued a Notice of Proposed Rulemaking to strengthen HIPAA privacy rule protections by prohibiting the use or disclosure of protected health information to investigate or prosecute patients, providers, and others involved in the provision of legal reproductive health care, including abortion care.  This notice of proposed rulemaking calls for extending additional privacy protections for providers, insurers, patients, and others to safeguard protected health information when that information otherwise would be disclosed or used to identify, investigate, sue, or prosecute someone for seeking, obtaining, providing, or facilitating lawful reproductive health care.  Reproductive health care would be defined to include, but not be limited to, prenatal care, abortion, miscarriage management, infertility treatment, contraception use, and treatment for reproductive-related conditions such as ovarian cancer.  Learn more from this HHS news release and this Federal Register notice.  The deadline for stakeholders to submit comments is June 16.
  • HHS’s Office of the National Coordinator for Health Information Technology (ONC) has published a Notice of Proposed Rulemaking for public comment on proposals to implement certain provisions of the 21st Century Cures Act and make several enhancements to the ONC Health IT Certification Program to advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information.  Proposals include implementing the Electronic Health Record Reporting Program as a new condition of certification for developers of certified health information technology; modifying and expanding exceptions in the information blocking regulations to support information sharing; revising several certification program certification criteria; adopting the United States Core Data for Interoperability (USCDI) Version 3 as a standard within the certification program and establishing an expiration date for USCDI Version 1 as an adopted standard within the certification program; and updating standards and implementation specifications adopted under the certification program to advance interoperability, support enhanced health IT functionality, and reduce burden and costs.  Learn more from this HHS news release; the proposed rule itself; and this ONC blog post.  The deadline for stakeholders to submit comments is June 20.

HHS Newsletters

Provider Relief Fund

  • April 28 is the deadline for recipients of Provider Relief Fund Phase 4 payments to submit a request for an extension for reporting on their expenditure of these funds.
  • April 30 is the deadline for Provider Relief Fund participants to return any unused funds from their Phase 4 payments.  Go here to learn more about Provider Relief Fund repayment and debt collection.
  • HHS has published an updated post-payment notice on Provider Relief Fund distributions and American Rescue Plan rural distribution reporting requirements.  Key updates include the addition of reporting periods 8 and 9, including the applicable payment received period and period of availability dates, and additional guidance concerning the use of these payments for lost revenues incurred within the period of availability up to June 30, 2023, which is the end of the quarter in which the COVID-19 public health emergency ends.  Find the notice here.

Centers for Medicare & Medicaid Services

  • CMS has updated its national fee schedule for Medicare Part B vaccine administration.  Learn more from this CMS notice.
  • CMS has updated its calendar of FY 2024 Medicare area wage index geographic reclassification deadlines.  Find the updated deadlines here.
  • CMS has posted a guide for organizations seeking to register to perform the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for Merit-based Incentive Payment System (MIPS) Survey for the 2023 performance period.  Find that guide here.
  • CMS has announced a new opportunity for states to increase care for individuals who are incarcerated during the period immediately prior to their release.  The agency’s new Medicaid Reentry Section 1115 Demonstration Opportunity would permit state Medicaid programs to cover services that address various health concerns, including substance use disorders and other chronic health conditions.  The program would permit states to cover a package of pre-release services for up to 90 days prior to the individual’s expected release date that could not otherwise be covered by Medicaid due to a longstanding statutory exclusion that prohibits Medicaid payment for most services provided to most people imprisoned in county or state facilities.  Learn more from this CMS news release and this CMS letter to state Medicaid directors.
  • CMS has contracted with Yale New Haven Health Services Corporation’s Center for Outcomes Research and Evaluation to develop a measure of equity of emergency care capacity and quality.  The measure will be an electronic clinical quality measure (eCQM), and to support this endeavor, the Yale group is creating a technical expert panel to advise it during the process of developing the measure.  The panel is expected to bring diverse perspectives and expertise to its work of advising on conceptual, technical, and implementation considerations of this measure.  Learn more about the project, the role of the technical expert panel, the qualities CMS seeks in panel members, the time commitment involved, and how to submit nominations from this CMS notice.  The deadline for submitting nominations is April 28.
  • CMS did not accurately report on the Care Compare site one or more deficiencies related to health, fire safety, and emergency preparedness for an estimated two-thirds of nursing homes, the HHS Office of the Inspector General has concluded in a new report.  Go here for a summary of the report and a link to the complete document.
  • CMS has approved the state of Washington’s request to amend its section 1115 Medicaid waiver to expand its definition of transportation for individuals who receive the state’s Medicaid Alternative Care and Tailored Supports for Older Adults long-term services and supports benefit packages.  This change will expand the transportation services covered by the state’s Medicaid program to permit transportation in accordance with participants’ service plan so eligible participants may gain access to community services, activities, and resources as defined by their service plan.  Learn more from CMS’s approval letter and the waiver application document.
  • CMS has approved a Medicaid state plan amendment for Illinois that will enable that state to provide more Medicaid funding for eligible children receiving Medicaid-covered health care services in schools.   Learn more from this CMS news release and this CMS letter approving the state plan amendment, which includes information about the Illinois program.
  • CMS has posted materials from its Medicare home health prospective payment system CY 2023 behavior change recap, 60-day episode construction overview, and payment rate development webinar.  Those materials include an updated presentation; audio (passcode: =u.#r7XD); and a transcript of the webinar.
  • CMS has published ownership data for all Medicare-certified hospice and home health agencies, enabling the public to review detailed information on the ownership of more than 6000 hospices and 11,000 home health agencies certified by the agency to participate in Medicare.  Learn more from this HHS news release and gain access to this data through CMS’s data web site.

Food and Drug Administration

The FDA has amended its emergency use authorizations for the Moderna and Pfizer COVID-19 bivalent vaccines to simplify the vaccination schedule for most individuals.  This action includes authorizing the current bivalent vaccines to be used for all doses administered to individuals six months of age and older and for an additional dose or doses for certain populations, including individuals ages 65 and older and those who are immunocompromised as booster vaccines.  The monovalent Moderna and Pfizer COVID-19 vaccines are no longer authorized for use in the U.S.  Learn more from this FDA announcement.

Centers for Disease Control and Prevention

The CDC seeks nominations for membership on the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment.  This committee consists of 18 experts in fields associated with public health, epidemiology, laboratory practice, immunology, infectious diseases, substance use disorder, behavioral science, health education, healthcare delivery, state health programs, clinical care, preventive health, medical education, health services and clinical research, health equity, and health care financing.  Learn more about the role of the committee and how to nominate candidates from this CDC notice, which includes a link to a Federal Register notice.  The deadline for submitting applications is October 1.

Medicare Payment Advisory Commission (MedPAC)

MedPAC’s commissioners held their latest public meeting last week.  The issues addressed during the meeting were:

  • addressing the high prices of drugs covered under Medicare Part B
  • reforming Medicare’s wage index systems
  • aligning fee-for-service payment rates across ambulatory settings
  • a mandated report evaluating a prototype design for a post-acute care prospective payment system
  • assessing post-sale rebates for prescription drugs in Medicare Part D
  • assessing the need for Medicare safety-net payments for skilled nursing facilities and home health agencies
  • a mandated report on telehealth in Medicare
  • congressional request for information on behavioral health in Medicare

Go here to see summaries of these issues and find links to the presentations offered during the meeting.

Medicaid and CHIP Payment and Access Commission (MACPAC)

MACPAC’s commissioners held their latest public meeting last week.  The issues addressed during this meeting were:

    • recommendations for automatic adjustments to Medicaid disproportionate share (Medicaid DSH) allotments
    • integrating care for dually eligible beneficiaries
    • access to Medicaid coverage and care for adults leaving incarceration
    • access to covered dental benefits for adult Medicaid beneficiaries
    • Medicaid unwinding update on state implementation and coordination with providers and community organizations
    • proposed rule on Medicaid DSH third-party payer policy
    • access to home- and community-based services
    • denials and appeals in Medicaid managed care

For a summary of the meeting and links to the presentations delivered during the session, go here.

  • MACPAC has published an issue brief comparing the demographics, health status, quality of care, experiences and satisfaction with provided care, provider concordance, and perceived unfair treatment and discrimination of adults covered by Medicaid by race and ethnicity.  Find that report here.

Congressional Research Service

  • The Congressional Research Service has updated its report on the effects of terminating the COVID-19 public health emergency and national emergency declarations.  Find that report here.
  • The Congressional Research Service has published a brief review of the Supreme Court’s Dobbs decision discussing Congress’s authority to regulate reproductive health services and examining the regulation of medication abortion.  Find that report here.

Stakeholder Events

CMS – National Stakeholder Call – April 25

CMS Administrator Chiquita Brooks-LaSure and her leadership team will hold a national stakeholder call on Tuesday, April 25 at 1:00 (eastern) to review the agency’s recent accomplishments and its progress toward advancing the agency’s strategic plan.  Go here to register to participate.

CMS – Medicaid and CHIP Continuous Enrollment Unwinding Webinar – April 26

CMS will hold a webinar on the unwinding of Medicaid and CHIP continuous enrollment and what providers need to know and how to prepare for that unwinding on Wednesday, March 22 at noon (eastern).  During the webinar, CMS officials will review recently released CMS unwinding resources to help partners with their outreach efforts and respond to questions about Medicaid renewals and terminations, Medicaid to marketplace transitions, Medicaid to Medicare transitions, communication and outreach strategies, and more.  Go here to register to participate.  CMS will offer the same webinar on May 24 and June 28.  Go here and scroll down for materials from previous webinars on Medicaid unwinding.

CMS Quality Conference – May 1-3

The 2023 CMS Quality Conference, “Building Resilient Communities:  Having an Equitable Foundation for Quality Health Care,” will be held virtually on Monday, May 1 through Wednesday, May 3.  The conference will feature expert speakers who will address improving quality, equity, and innovation and discuss how advocates, providers, researchers, and champions in health care quality improvement can develop and spread solutions to address America’s most pervasive health system challenges.  Go here to learn more about the conference and how to register to participate.

FDA – Considerations for Buprenorphine Initiation and Maintenance Care Public Meeting – May 10-11

In partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Reagan-Udall Foundation for the FDA, the FDA has announced a virtual public meeting on Wednesday and Thursday, May 10-11, on considerations for buprenorphine initiation and maintenance care.  The meeting is for stakeholders, including people who use drugs, their families and community, harm reduction programs, health professionals from inpatient and outpatient settings, academic researchers, and federal partners and will explore real-world experiences and scientific evidence for buprenorphine initiation strategies as well as medication dosing and management during continued treatment across different care settings.  Go here for additional information about the two-day public meeting and how to register to participate.