The following is the latest health policy news from the federal government for October 13-19.  Some of the language used below is taken directly from government documents.

Congress

At this moment there is still no Speaker of the House of Representatives.  After 20 and then 22 House Republicans voted against Rep. Jim Jordan (R-Ohio) on Tuesday and Wednesday this week, Mr. Jordan has joined others, including senior Democrats, in supporting a plan to expand the powers of the temporary speaker, Rep. Patrick McHenry (R-NC).  Mr. Jordan remains the speaker designee, an option that will enable him to continue to seek support for that position and to call a speaker vote at any time.

Legislative work in the House has been at a standstill since October 3, when House Republicans voted to strip Rep. Kevin McCarthy (R-CA) of the speakership.  The House will not be able to proceed with legislative business unless members either elect a speaker or vote to expand the temporary speaker’s powers.  This standstill includes being unable to pass a spending bill to keep the federal government funded beyond November 17, when the current continuing resolution (CR) expires.

As you know, the current CR delays $8 billion in cuts to Medicaid DSH for the duration of the resolution.  Unless Congress passes another spending bill that includes another delay of those cuts, reductions to Medicaid DSH payments to states will take effect on November 18.

Centers for Medicare & Medicaid Services

  • CMS has announced 2024 premiums, deductibles, and coinsurance amounts for the Medicare Part A and Part B programs and the 2024 Medicare Part D income-related monthly adjustment amounts.  See the new amounts and learn more from this CMS news release and this CMS notice.
  • CMS has released its 2024 Star Ratings for Medicare Advantage (Medicare Part C) and Medicare Part D to help people with Medicare compare health and prescription drug plans ahead of Medicare Open Enrollment, which began on October 15.  Learn more about this year’s star ratings from this CMS news release and a CMS fact sheet on the 2024 Medicare Advantage and Part D Star Ratings.
  • CMS is accepting recommendations for proposed new ICD-10-PCS procedure codes for consideration at the March 2024 meeting of its ICD-10 Coordination and Maintenance Committee.  The deadline for submitting requests is December 1.  Learn more about what CMS seeks and how to submit recommendations from this CMS notice.
  • CMS has removed its restriction on the use of positron emission tomography, or PET scans, for diagnostic purposes for Medicare patients.  The primary anticipated use of PET scans is for diagnosing Alzheimer’s disease and possibly leading to the use of prescription medicines to treat that disease.  Until now, PET scans had only been authorized for Medicare reimbursement for use in clinical studies.  Learn more from this CMS memo explaining its removal of its previous national coverage determination (NCD) on the use of and Medicare reimbursement for PET scans.
  • CMS has published a bulletin describing an update for blood-clotting factor add-on payments.  Find it here.
  • CMS has published a document for state Medicaid programs on their evaluation of continued Medicaid eligibility for current beneficiaries.  The document presents various scenarios in the Medicaid eligibility determination process and the different options states can pursue in determining future eligibility for different types of current Medicaid beneficiaries based on different kinds of available information for reviewing eligibility.  Find the document here.
  • CMS has released two Health Equity Confidential Feedback Reports to post-acute care providers:  the Discharge to Community Health Equity Confidential Feedback Report and the Medicare Spending Per Beneficiary Health Equity Confidential Feedback Report.  To provide insight on outcome differences across social risk factors, the Health Equity Confidential Feedback Reports stratify these two post-acute-care quality reporting program measure outcomes by Medicare-Medicaid dual-enrollment status and patient race/ethnicity.  This data is meant to provide feedback to providers about their performance for certain populations that may have been historically disadvantaged and to identify opportunities for providers to focus more appropriately their internal quality improvement initiatives.  For more information about the reports and directions on how to find reports for individual providers, see this CMS notice.  In addition, CMS has posted two presentations on the use and interpretation of the reports:  a video presentation of a recent webinar and the webinar’s slides.

Department of Health and Human Services

  • HHS’s Health Resources and Services Administration (HRSA) has updated the Provider Relief Fund web page to reflect that reporting period 5 has now passed and to offer guidance to providers that seek to submit a request to report late for reporting period 5 due to extenuating circumstances.  The deadline for submitting requests to report late for reporting period 5 is October 27.
  • HHS’s Office of the Inspector General (OIG) has issued a favorable opinion about an employer’s proposal to pay bonuses to its employed physicians based on net profits derived from certain procedures performed by the physicians.  Find that opinion here.
  • The HHS OIG has published the inflation update of the annual cap on patient engagement tools and supports furnished to a patient by a value-based enterprise participant under federal safe harbor law.  Find  the annual update here.
  • The HHS OIG has updated its workplan for audits and reviews it will perform in October.  Find the updated plan here.
  • An HHS OIG audit has concluded that the Strategic National Stockpile was not positioned to respond effectively to the COVID-19 pandemic.  Learn more from this summary of the audit and the complete audit report.
  • HHS is inviting written comments from the public on the current “Healthy People 2030” objectives and written comments proposing additional new core, developmental, or research objectives or topics to be included in Healthy People 2030.  Healthy People 2030 objectives present a picture of the nation’s health at the beginning of the decade, establish national goals and targets to be achieved by 2030, and monitor progress over time.  Learn more from this HHS notice.  The deadline for submitting comments is November 20.
  • HHS’s Office for Civil Rights has issued two resource documents to help explain to patients the privacy and security risks to their protected health information when using telehealth services and ways to reduce these risks.  The first resource is for health care providers on “Educating Patients about Privacy and Security Risks to Protected Health Information when Using Remote Communication Technologies for Telehealth” and the second is a resource for patients called “Telehealth Privacy and Security Tips for Patients.”   Learn more about the two new documents and find links to the documents themselves from this HHS news release.
  • HHS’s Health Resources and Services Administration (HRSA) has awarded more than $81 million in one-time funding to all current Health Center Program operational (H80) award recipients and to health center look-alikes that previously received American Rescue Plan funding in support of its HHS Bridge Access Program for COVID–19 Vaccines and Treatments.  Learn more about the funding and why it was awarded from this HHS announcement and find a link to the grant recipients here.
  • HHS and its Administration for Strategic Preparedness and Response (ASPR) have awarded more than $500 million in grants for its next-generation vaccine candidates for Project NextGen; these grants are intended to launch planning for Phase 2b clinical trials and technologies that advance innovative next-generation vaccine and therapeutics platforms for the prevention and treatment of COVID-19.  Learn more about the funding and why it was awarded and find a list of award recipients in this HHS news release.
  • HHS’s Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public to inform its review on “Updating the Framework for AHRQ’s National Healthcare Quality and Disparities Report (NHQDR),” which is currently being conducted by the AHRQ’s Evidence-based Practice Centers Program.  The agency is particularly interested in information that has not yet been published because of studies that may not be complete at this time or for which results have not yet been published.  Learn more about what AHRQ seeks and how to submit information from this agency notice.  The deadline for submitting information is November 17.

HHS Newsletters

Food and Drug Administration

  • The FDA has published final guidance titled “Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements.”  The guidance addresses certain requirements that apply to blood establishments that collect blood and blood components.  Specifically, the guidance explains the conditions under which the FDA does not intend to take regulatory action for a blood establishment’s failure to comply with certain requirements in FDA’s regulations regarding donation suitability, donor eligibility, and quarantine hold for source plasma.  FDA expects that the compliance policy described in the guidance will increase the availability of blood and blood components while maintaining the health of blood donors and the safety of blood and blood components.  This guidance finalizes the draft guidance of the same title dated May 2022 and supersedes the guidance “Alternative Procedures for Blood and Blood Components During the COVID–19 Public Health Emergency; Guidance for Industry” from April of 2020.  Learn more from this FDA notice and the guidance document itself.  The FDA invites comments on the new guidance; see the notice for how to submit comments.
  • The FDA has published a list of guidance documents that its Center for Devices and Radiological Health intends to publish during FY 2024 and previously issued final guidance for which the agency is interested in receiving external feedback about whether these guidance documents should be revised or withdrawn.  Find the list and an explanation of this process here.  Comments are due by December 11.

Government Accountability Office (GAO)

The GAO has submitted testimony to the House and Commerce Committee’s Health Subcommittee on performance-based and geographic adjustments to Medicare physician payments.  This statement summarizes GAO’s previously issued reports on Medicare’s quality payment program and the two tracks it established to create incentives for Medicare providers and on geographic adjustments to physician payments.  Find a summary of the GAO testimony here and its full submission here.

Stakeholder Events

CMS – Making Care Primary (MCP) Office Hours – October 24

The CMS Innovation Center’s Making Care Primary (MCP) Model team will answer questions about the forthcoming model in an Office Hours webinar on Tuesday, October 24 at 2:00 (eastern).  A link to register for the event will be sent via listserv once available.  In addition to the live Q&A, participants will be able to submit questions in advance upon registering.  Go here to learn more about the model and applying to participate in it.

CMMI – AHEAD Model Webinar – October 26

With the upcoming launch of its Advancing All-Payer Health Equity Approaches and Development Model (AHEAD) Model, CMMI officials and others will share more information about the model’s hospital global budget and primary care investment goals and how they fit within the model’s other core elements during a webinar that will be held on Thursday, October 26 at noon (eastern).  To learn more about the webinar and register to participate, go here.

CMS – Medicaid and CHIP – October 25 and December 6

HHS and CMS are holding a series of monthly webinars on Medicaid and CHIP renewals to educate partners.  Topic covered vary each month.  Go here to register for upcoming webinars.

  • October 25 at 12:00 pm (eastern)
  • December 6 at 12:00 pm (eastern)

Recordings, transcripts, and slides from past webinars can be found on the CMS National Stakeholders Calls web page.

CDC – Protecting Infants from RSV Webinar – October 26

The CDC will hold a webinar on protecting infants from respiratory syncytial virus (RSV) on Thursday, October 26 at 2:00 (eastern).  During this call, presenters will give a comprehensive overview of the CDC’s new recommendations to prevent severe RSV disease in infants, including clinical guidance and considerations for administering RSV immunizations to infants and pregnant people during weeks 32 through 36 of pregnancy.  Learn more about the webinar and how to participate from this CDC notice.  Continuing education credits are available.

CMS – Patient-Focused Listening Sessions on Medicare Drug Price Negotiations – October 30-November 15

CMS will host a series of patient-focused listening sessions this fall as part of the Medicare Drug Price Negotiation Program.  The virtual public listening sessions will provide an opportunity for patients, beneficiaries, caregivers, consumer and patient organizations, and other interested parties to share input relevant to drugs selected for the first round of negotiations.  Learn more about the listening sessions, the schedule for these sessions, the individual drugs to be discussed at each, and how to participate from the CMS drug listening session web page.

FDA – Webinar on Laboratory-Developed Tests – October 31

The FDA will host a webinar on its proposed rule governing laboratory-developed tests, or LDTs, on Tuesday, October 31 at 1:00 (eastern).  Learn more about the webinar, what it will cover, and how to participate from this FDA announcement.

CMS – Provider Compliance Focus Group – November 2

The Provider Compliance Group within CMS’s Center for Program Integrity will hold a focus group to address medical review and prior authorization on Thursday, November 2 at 1:00 (eastern).  During the focus group CMS will seek provider input on what it can do better to communicate, improve its processes, and eliminate unnecessary requirements.  Learn more about the focus group and how to register to participate from this CMS announcement.  The deadline for registering is October 26.

MedPAC – Public Meetings – November 2 and 3

The Medicare Payment Advisory Commission (MedPAC) will hold its next public meeting on Thursday, November 2 and Friday, November 3.  An agenda and information about how to join the meeting are not yet available but when they are they will be posted here.

MACPAC – Public Meetings – November 2 and 3

The Medicaid and CHIP Payment and Access Commission (MACPAC) will hold its next public meeting on Thursday, November 2 and Friday, November 3.  An agenda and information about how to join the meeting are not yet available but when they are they will be posted here.

CMS – Burden Reduction Conference – November 15

CMS will convene leadership from the federal government, health provider organizations, and the patient advocacy community to focus on opportunities across the health care enterprise to reduce administrative burden, strengthen access to quality care, and make it easier for clinicians to provide that care during a day-long virtual conference it will hold on Wednesday, November 15 beginning at 9:00 (eastern).  Go here to learn more about the conference and find a link for registration.

CMS – Healthcare Common Procedure Coding System Public Meeting – November 28-30

CMS will hold virtual public meetings from November 28 through November 30 to discuss its preliminary coding, Medicare benefit category, and payment determinations for new revisions to the HCPCS Level II code set for non-drug and non-biological products.  Learn more about the meeting, why it is being held, its agenda, how it will be conducted, and how to register from this formal CMS notice.

CMS – Town Hall Meeting on FY 2025 Applications for New Medical Services and Technologies Add-On Payments – December 13-14

CMS will hold a virtual town hall meeting on Wednesday, December 13 and Thursday, December 14 during which organizations representing hospitals, physicians, manufacturers, and other interested parties may present comments, recommendations, and data to CMS’s clinical staff about whether individual services or technologies represents a substantial clinical improvement.  The meeting will include a discussion of the substantial clinical improvement criteria for the FY 2025 applications for new technology add-on payments.  Learn more about the meeting, why it is being held, what it will address, and how to participate from this CMS notice.