The following is the latest health policy news from the federal government for October 27 – November 2. Some of the language used below is taken directly from government documents.
340B Remedy Payments
Late Thursday afternoon CMS published its final Medicare remedy for underpayments for 340B prescription drugs that was implemented in 2018 but rejected by the Supreme Court last year. According to the regulation, 340B remedy payments to hospitals will be made after this rule takes effect, which is 60 days after it is officially published in the Federal Register; publication is scheduled for November 16.
The final regulation includes CMS’s calculations of the payments for all participating 340B entities. Those entities will have until November 30 to submit to CMS any corrections of the data the agency used in those calculations.
To make these payments budget-neutral, CMS will reduce the outpatient prospective payment system conversion factor by 0.5 percent starting in calendar year 2026; originally, CMS proposed beginning this reduction in 2025. This reduction will remain in effect for 16 years – the length of time CMS projects that it will take for it to recoup the 340B remedy payments.
As noted, this regulation was only published late Thursday afternoon. We will be in touch with more information shortly. In the meantime, find additional information from this CMS fact sheet and this pre-publication version of the final regulation.
The White House
President Biden has issued an executive order on the “safe, secure, and trustworthy development and use of artificial intelligence” (AI). The executive order gives HHS one year to establish an AI safety program and, in cooperation with other federal departments, to create an AI task force within 90 days. That task force then has one year to create a national strategic plan. The executive order makes numerous other references to the use of AI in the health care field. Learn more from the administration’s executive order and an accompanying fact sheet.
No Surprises Act
HHS, along with the departments of Labor and Treasury and the Office of Personnel Management, has released a proposed rule revising the No Surprises Act’s federal independent dispute resolution (IDR) process. The proposed rule calls for changes in how payers and providers communicate with one another; in the open negotiation and IDR initiation processes; in the batching of claims for dispute resolution; and in IDR process eligibility and administrative fees. Learn more about what HHS and the other agencies have proposed from this HHS news release; this HHS fact sheet about the proposed rule; and this preview version of the formal Federal Register notice. The deadline for submitting comments will be 60 days after the proposed rule’s official publication, which is currently scheduled for November 3.
Centers for Medicare & Medicaid Services
- Late Thursday afternoon CMS published its final Medicare hospital outpatient prospective payment system rule for calendar year 2024. Learn more about the final rule from this pre-publication version of the final rule. As of this writing, CMS has not released a fact sheet summarizing this rule.
- Late Thursday afternoon CMS published its final Medicare physician fee schedule rule for calendar year 2024. Learn more about the final rule from this CMS news release; this CMS fact sheet on the final rule; and this pre-publication version of the final rule.
- CMS has published its final home health prospective payment system regulation that will govern calendar year 2024 payments and update other home health payment policies. The final regulation increases anticipated Medicare spending on home health by 0.4 percent (after CMS previously proposed a 2.2 percent decrease); finalizes changes in the home health quality reporting and value-based purchasing programs; and introduces many other changes. Learn more from this CMS fact sheet and this pre-publication version of the final rule.
- CMS has issued a final rule that updates payment rates and policies under the end-stage renal disease (ESRD) prospective payment system for calendar year 2024. This rule also updates requirements for the ESRD quality incentive program. Learn more from this CMS fact sheet and this preview version of the final rule, which is scheduled for publication on November 6.
- CMS has written to providers to inform them about three behavioral health services that Medicare will pay for that may improve outcomes for their Medicare patients: behavioral health integration services, psychotherapy for crisis, and opioid use disorder screening and treatment. Find that letter here.
- CMS has posted a summary of 2024 changes in Medicare payment systems. Find that summary here.
- CMS has posted a survey that it invites providers that participate in Medicare to take. The stated purpose of the survey, which should take about 15 minutes to complete, is to help improve providers’ experience with the Medicare program and billing resources. To take the survey, start here.
- CMS has posted a transcript, a recording, and a Q&A document from its October 12 skilled nursing facility/long-term care open door forum. To find them go here and scroll down to “Skilled Nursing Facility (SNF)/Long Term Care (LTC), Open Door Forum (ODF).”
- CMS has posted answers to frequently asked questions about the termination of CHIP eligibility for non-payment of premiums during extended continued eligibility but after January 1, 2024. Find the document here.
- CMS has posted Merit-Based Incentive Payment System (MIPS) Data Validation and Audit (DVA) Quality Template for PI Measures Phase 1 to assist eligible clinicians who have been selected for the MIPS DVA. To find the data go here, scroll down to “Full Resource Library,” and click on “Performance Year 2022 Data Validation and Audit (DVA) Template for PI Measures Phase 1” for a direct download of the file. For a submission template for the same data, click “Performance Year 2022 Data Validation and Audit (DVA) Quality Measures Phase 1 Submission Template” for a direct download of this template.
- CMS has posted the Plan Year 2024 Public Use Files (PUFs) for the Quality Rating System (QRS) and QHP Enrollee Survey to the CMS Marketplace Quality Initiative (MQI) website. The Plan Year 2024 PUFs include the Enrollee Survey PUF for Plan Year 2024, Plan Year 2024 Nationwide QRS PUF, and Plan Year 2024 Quality PUF. The Nationwide QRS PUF outlines underlying measure data as well as star ratings for all eligible QHP issuers that received QRS star ratings. The Quality PUF includes star ratings assigned to plans. Find the files and links to additional files here.
Department of Health and Human Services
- HHS has published a proposed rule that would establish disincentives for health care providers found by the HHS Office of Inspector General (OIG) to have committed information-blocking: when a provider knowingly and unreasonably interferes with the access, exchange, or use of electronic health information except as required by law or covered by a regulatory exception. This proposed rule would establish penalties applicable to certain health care providers determined by OIG to have committed information-blocking that also are Medicare-enrolled providers or suppliers. The rule also proposes a process through which information would be shared with the public about health care providers that the OIG determines have committed information-blocking. Learn more about the proposed rule, including the penalties it proposes, from this HHS news release and this Federal Register notice. The proposed rule also is the subject of an article in the blog of HHS’s Office of the National Coordinator for Health Information Technology. The deadline for submitting comments is January 2.
- HHS has issued a toolkit designed to promote collaboration and spur action to improve the health and well-being of adolescents across the U.S. This toolkit outlines a vision, key principles, eight goals, and a set of initial action steps. Learn about this effort’s goals, some of which address health care, and how HHS proposes that stakeholders go about achieving them from this HHS news release; a new web page established by HHS to support the program; and the publication “Take Action for Adolescents: A Call to Action for Adolescent Health and Well-Being.”
Centers for Disease Control and Prevention
The CDC’s National Institute for Occupational Safety and Health has launched “Impact Wellbeing,” a new campaign to provide hospital leaders with evidence-informed resources to improve workplace policies and practices that reduce burnout, normalize help-seeking, and strengthen professional well-being. The project seeks to support hospital leaders, and in turn their health care workforce, by providing actionable steps to fine-tune quality improvements, establish new workflows, and help staff feel safe seeking help. Learn more about the program and find links to the project’s initial resources from this CDC news release and the program’s new web page.
Food and Drug Administration
- The FDA has approved the first over-the-counter test for the detection of fentanyl in urine. The test is for use in drawing preliminary results only. Learn more from this FDA news release.
- The FDA has advised providers who administer the 2023 Moderna COVID-19 vaccine to individuals from six months through 11 years of age to ensure that they are administering the correct volume of the vaccine. The FDA issued this advice after learning that some providers are not recognizing that the single dose vial of Moderna COVID-19 vaccine for use in individuals six months through 11 years of age contains more than a single dose of the vaccine for children and that some providers may be withdrawing the entire contents of the vial to administer to patients. Find the FDA notice here.
CMS – Hospital/Quality Initiative Open Door Forum – November 7
CMS will hold a hospital/quality initiative open-door forum on Tuesday, November 7 at 2:00 eastern). One of the subjects to be discussed during the forum will be the final outpatient prospective payment system regulation for 2024. Go here to register to participate.
CMS – Rural Health Open Door Forum – November 8
CMS will hold a rural health open door forum on Wednesday, November 8. Go here to register to participate.
HRSA – Organ Procurement and Transplantation Network Modernization Initiative Update – November 9
HHS’s Health Resources and Services Administration (HRSA) will provide an update on its Organ Procurement and Transplantation Network (OPTN) Modernization Initiative on Thursday, November 9 at 1:00 (eastern). During this meeting the OPTN board of directors also will seek input on these efforts. For more information about the event and how to register to participate, go here. The deadline for registering is November 7.
CMS – Physicians, Nurses, and Allied Health Professionals Open Door Forum – November 15
CMS will hold a physicians, nurses, and allied health professionals open door forum on Wednesday, November 15 at 2:00 (eastern). Go here to register to participate.
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.
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 – Long-Term Services and Supports Open Door Forum – November 28
CMS will hold a long-term services and supports open door forum on Tuesday, November 28 at 2:00 (eastern). Go here to register to participate.
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 – Inpatient Rehabilitation Facility Prospective Payment System: Coverage Requirements Webinar – November 29
CMS will hold a webinar on inpatient rehabilitation facility prospective payment system coverage requirements on Wednesday, November 29 at 1:30 (eastern). During the webinar CMS will review inpatient rehabilitation facility prospective payment system coverage requirements from pre-admission to discharge and provide a refresher on existing payment requirements and answer common payment system questions. Go here to register to participate.
CMS – Medicaid and CHIP Renewals –December 6
HHS and CMS have been holding a series of monthly webinars on Medicaid and CHIP renewals to educate partners. Topic covered vary each month. The final webinar will be held on Wednesday, December 6 at noon (eastern) Go here to register to participate and go here for recordings, transcripts, and slides from past webinars.
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.