The following is the latest health policy news from the federal government for June 30 – July 13.  Some of the language used below is taken directly from government documents.

340B

CMS has published a proposed regulation outlining how it plans to reimburse hospitals for reductions in 340B prescription drug payments that it implemented from 2018 to 2022 but that a federal court found to be illegal.  The agency calculates that it owes participating 340B providers $9 billion, which it proposes paying to those providers in single lump-sum payments.  CMS also proposes offsetting these payments through reductions in future non-drug and service outpatient payments that would be in effect for 16 years.  Learn more from this CMS fact sheet; this CMS regulatory announcement about the proposed regulation, which includes a link to a formal Federal Register notice; and this CMS web page that includes downloadable files that list the payments CMS intends to make to eligible providers.  The deadline for submitting comments on the proposed rule is September 11.

No Surprises Act

  • HHS and its Office of the Assistant Secretary for Planning and Evaluation (ASPE) have issued a report to Congress on the impact of the No Surprises Act.  The report establishes a framework for the evaluation of the law’s impact on surprise billing, health care costs, and consolidation that will be used in future reports assessing the impact of the law.  Find the report here.
  • HHS, the Department of Labor, and the Department of the Treasury have published an FAQ clarifying aspects of the No Surprises Act that address out-of-pocket cost protections for consumers under the No Surprises Act and the Affordable Care Act; in-network and out-of-network costs; and costs associated with air ambulance services.  The FAQ also reiterates requirements for plans and insurers to make price information available to consumers, including information on facility fees.  Find that FAQ here.

Centers for Medicare & Medicaid Services

  • CMS has issued its proposed 2024 home health prospective payment system rate update rule, which would reduce Medicare payments for home health agencies 2.2 percent based on a market basket increase of 2.7 percent offset by a statutory reduction of 5.1 percent and other adjustments.  The proposed rule would introduce a permanent, prospective adjustment to the 2024 home health payment rate to account for the impact of the implementation of the Patient-Driven Groupings Model (PDGM); rebase and revise the home health market basket; revise the labor-related share; recalibrate the PDGM case-mix weights; update low utilization payment adjustment thresholds, functional impairment levels, and comorbidity adjustment subgroups for CY 2024; introduce changes in the home health quality reporting program; and more.  Learn more from this CMS fact sheet and this CMS regulatory announcement, which includes a link to a Federal Register notice.  Stakeholder comments are due by August 29.
  • CMS has announced that the hardship exception application period for eligible hospitals that participated in the Medicare Promoting Interoperability Program in 2022 is July 31 and for critical access hospitals is September 30.  Learn more about what a hardship exception is and how to apply for it from this CMS fact sheet.
  • CMS has updated its Electronic Clinical Quality Measure (eCQM) Data Element Repository to provide information on eCQMs used in CMS quality reporting and incentive programs for the calendar year 2024 reporting and performance periods.  The purpose of the repository is to improve clarity for those implementing eCQMs.  The repository provides information on the data elements associated with eCQMs and their definitions.  Find the updated repository here.
  • CMS has posted its “Final 2023 Call Letter for the Quality Rating System (QRS) and the Qualified Health Plan (QHP) Enrollee Experience Survey” to communicate finalized refinements to the QRS and QHP enrollee survey programs for the 2024 ratings year and beyond.  This document also summarizes comments received on the draft 2023 call letter.  Find the final 2023 call letter here.
  • CMS has posted a bulletin describing changes in the Medicare ICD-10 and other coding revisions of laboratory national coverage determination (NCD) edit software for October of 2023.  Find that bulletin here.
  • CMS has posted an update on its ambulatory surgical center payment system that includes CY 2023 payment rates for separately payable procedures or services, drugs, and biologicals, including descriptors for new CPT and Level II HCPCS codes.  Find the update here.
  • CMS has posted a bulletin describing changes in the Value-Based Insurance Design Model benefits component for calendar year 2024.  The changes affect hospitals, hospices, and suppliers billing Medicare for services they provide to Medicare Advantage hospice patients participating in the Value-Based Insurance Design Model’s hospice benefit component.  Find that bulletin here.
  • Starting July 1, people with Medicare Part B and Medicare Advantage coverage who get their insulin through a traditional pump will see insulin costs capped at $35 a month for each covered insulin product.  CMS has posted a number of resources, including an FAQ, social media toolkit, and more, to help people understand this change.  Find those resources here.
  • CMS has posted an FAQ for state Medicaid and CHIP agencies explaining the data they must report quantifying certain activities involving Medicaid and CHIP eligibility redeterminations activities conducted through June of 2024.  Failure to report this data in a timely manner would result in a reduction of states’ federal Medicaid matching funds (federal Medical Assistance percentage, or FMAP).  Learn more from this CMS FAQ.
  • CMS’s Office of Minority Health has published a new notice of funding opportunity for its Health Equity Data Access Program.  Through this program, the Office of Minority Health will support up to three “seats” in the CMS Virtual Research Data Center.  Each individual grant will be worth up to $90,000.  The program helps researchers from public, state-controlled, and private institutions of higher education gain access to restricted CMS data for minority health research.  Researchers will conduct health services research focusing on, but not limited to, racial and ethnic minority groups; people with disabilities; members of the lesbian, gay, bisexual, transgender, and queer (LGBTQ+) community; individuals with limited English proficiency; individuals residing in rural areas; and individuals adversely affected by persistent poverty or inequality.  Learn more from this funding notice.  The deadline to submit applications is August 15.
  • CMS has released revised guidance detailing the requirements and parameters of the new Medicare Drug Price Negotiation Program for the first round of negotiations, which will occur during 2023 and 2024 and result in prices that will take effect in 2026.  The latest guidance includes changes from previously released information, including clarification of how CMS will identify drugs selected for negotiation; revisions to and clarification of the process applicable for participating drug companies of selected drugs; and inclusion of additional opportunities for drug companies and members of the public to engage with CMS during the negotiation process.  Learn more from this CMS news release; this CMS fact sheet that further explains the updated guidance; and the complete updated guidance.
  • CMS’s Center for Medicare and Medicaid Innovation has reviewed past evaluations of its various Medicare and Medicaid models for insights into the effect of those models on health equity – even when those models did not have equity among their objectives.  It has published its findings in the new report “Assessing Equity to Drive Health Care Improvements:  Learnings from the CMS Innovation Center.”
  • CMS has posted a chart outlining state Medicaid and CHIP renewal timelines and distribution plans, including for individuals they have preliminarily identified as likely ineligible for Medicaid and CHIP.  Find that chart here.

Department of Health and Human Services

  • HHS, the Department of Labor, and the Department of the Treasury have proposed modifying the definition of short-term, limited-duration insurance (STLDI) to limit the length of the initial contract period to no more than three months and the maximum coverage period to no more than four months, thereby reducing the maximum length of STLDI from the current initial contract term length of less than 12 months and maximum total duration of up to a total of 36 months.  The proposal also would prohibit the same issuer from issuing multiple STLDI policies to the same policyholder within a 12-month period.  STLDI plans also would be required to communicate more directly with their customers about the very limited nature of the benefits they offer.  Learn more from this CMS fact sheet, which summarizes this and other new HHS regulatory proposals, and from this notice from the three agencies involved, which includes a link to a Federal Register notice.  Stakeholder comments are due by September 11.
  • HHS, the Consumer Financial Protection Bureau, and the Treasury Department have issued a request for information about high-cost specialty financial products, such as medical credit cards and installment loans, that are marketed to patients as a way to pay for routine medical care.  The agencies seek information about the specialty medical payment product market; patient experiences and downstream consequences; billing and financial assistance issues; and health care provider incentives.  Learn more from this HHS regulatory announcement, which includes a link to a Federal Register notice.  Stakeholder comments are due September 11.
  • HHS’s Health Resources and Services Administration (HRSA) has announced that it is extending the transition time communicated in its July 7, 2022 notice for jurisdictions and facilities to prepare for potential loss of designation as a federal Health Professional Shortage Area (HPSA) for primary medical care, dental health, and mental health providers.  HPSA designations that are currently proposed for withdrawal will remain in this status until they are re-evaluated in preparation for the publication of a Federal Register notice planned for January 2, 2024 in which HPSAs will be listed.  If HPSAs that are currently proposed for withdrawal do not meet the requirements for designation based on a review of data scheduled for November 15, 2023 they will be withdrawn with the publication of that January 2, 2024 notice.  Learn more from this HRSA notice.
  • HHS’s Office of the Inspector General has posted adverse events toolkits to serve as technical resources to help the health care community, government agencies, and researchers identify and measure adverse events – patient harm events that occur due to medical care or lack of care and are not caused by underlying disease – in hospitals or other inpatient settings.  Go here to learn more about the toolkits and their use and to find links to two such toolkits.
  • HHS has proposed a regulation to affirm civil rights and equal opportunity for participants in HHS-funded programs and services.  The proposed rule would protect LGBTQI+ people from discrimination in federal health and human services programs by clarifying and reaffirming the prohibition on discrimination on the basis of sexual orientation and gender identity in certain statutes.  The proposed rule also includes a provision that ensures that those with religious objections may seek an exemption from or modification of program requirements.  Learn more from this HHS news release and this HHS regulatory announcement, which includes a link to a Federal Register notice.  Stakeholder comments will be due by 60 days of the rule’s official publication, which is scheduled for July 13.
  • HHS’s Agency for Healthcare Research and Quality (AHRQ) has published a document describing how it plans to invest $100 million a year over the next ten years in initiatives to move local health systems closer to providing more equitable, whole-person care across the lifespan and to disseminate and implement evidence-based innovations to improve patient and provider experience.  Learn more from the new AHRQ document “Strategic Framework for the Patient-Centered Outcomes Research Trust Fund.”
  • HHS has submitted to Congress a report titled “Non-Emergency Medical Transportation in Medicaid, 2018-2021.”  The report was required by the Consolidated Appropriations Act of 2021.  Find it here.
  • HHS has issued a request for information seeking public input on its “Draft HHS 2023 Framework to Support and Accelerate Smoking Cessation” to guide its efforts to foster smoking cessation, with an emphasis on serving populations and communities disproportionately affected by smoking-related morbidity and mortality.  Find the draft framework and learn how to respond to this request for information from this HHS notice.

HHS Newsletters

Centers for Disease Control and Prevention

The CDC is seeking nominations for membership on the Board of Scientific Counselors of its National Center for Injury Prevention and Control.  The board consists of up to 18 experts in relevant disciplines involved in injury and violence prevention.  Learn more about the committee and its work and how to submit nominations from this CDC notice.  Nominations are   by September 15.

Medicaid and CHIP Payment and Access Commission (MACPAC)

The statutes governing Medicaid and CHIP – Titles XIX and XXI of the Social Security Act – have evolved in the years since their enactment and can be challenging to navigate.  MACPAC has annotated the Medicaid and CHIP statutes to provide an informal resource to help users identify and understand selected provisions.  MACPAC’s annotations are overlaid on the March 30, 2023 versions of Titles XIX and XXI of the Social Security Act published by the Office of the House Legislative Counsel.  Go here to learn more about this MACPAC project and find links to the annotations.

Stakeholder Events

CMS – National Stakeholder Call – July 18

CMS will hold a national stakeholder call on Tuesday, July 18 at 1:00 (eastern).  During the call, CMS Administrator Chiquita Brooks-LaSure and her leadership team will provide an update on CMS’s recent accomplishments and their efforts to advance their agency’s strategic plan.  Go here to register to participate.

CMS – Medicare Promoting Interoperability Program Webinar – July 20

CMS will host a Medicare Promoting Interoperability Program 101 webinar on Thursday, July 20 at 1:00 (eastern).  The webinar will offer a review of Medicare Promoting Interoperability Program basics and important updates for 2023.  Go here to register to participate.

CMS – Hospital Price Transparency Machine Readable File Sample Format Webinar – July 26

CMS will hold a webinar on Wednesday, July 26 at 2:30 (eastern) to review voluntary sample formats hospitals may use to make their standard charges public in a machine-readable file so they can comply with the federal hospital price transparency requirement.  During the webinar CMS will present sample formats that use a standardized set of data elements and a new validator tool hospitals can use to test the accuracy of their files.  Go here to register to participate.