Regulatory Update – Week of April 1, 2024

Introduction
The regulatory update for this week features finalized payment policies for Medicare Advantage and Part D programs, alongside ongoing negotiations with pharmaceutical companies. Additionally, the FDA approves Abbott's TriClip™ device for repairing leaky tricuspid heart valves amidst a Senate hearing addressing concerns about private equity's impact on healthcare.

Weekly Spotlight

With the first payment rules out this week and last, it appears that regulatory season is again upon us. Before the Inpatient Rule comes out and really shakes things up, and while Congress is away, we want to hear from you. What are you reading about that interests you? What trends are you keeping an eye on? How are you positioning your priorities in an election year to ensure success? Let us know at info@shpconsulting.llc!

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

CMS Publishes MA and Part D Notices

This week, CMS finalized the Calendar Year (CY) 2025 Rate Announcement for the Medicare Advantage (MA) and Medicare Part D Prescription Drug (Part D) Programs that updates payment policies for these programs and ensures payment accuracy. (Fact Sheet & FAQ / Press Release)

CMS concurrently released the Final CY 2025 Part D Redesign Program Instructions. The final program instructions contain a detailed description of, and guidance related to, changes newly in place for CY 2025 made by the IRA, as well as guidance for CY 2023 Medical Loss Ratio reporting related to the Inflation Reduction Act Subsidy Amount. (Fact Sheet)

CMS also issued the Contract Year (CY) 2025 Policy and Technical Changes to the Medicare Advantage Plan Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly, and Health Information Technology Standards and Implementation Specifications Final Rule. In addition to finalizing policies from the CY 2025 Medicare Advantage and Part D proposed rule, published in November 2023, this rule finalizes several key provisions that remain from the CY 2024 Medicare Advantage and Part D proposed rule, published in December 2022. (Fact Sheet / Press Release)

More information will be shared soon.

#All

CMS Rejects Pharma Counter Proposals

HHS Reports that CMS received and “responded to counteroffers from all manufacturers participating in Medicare drug price negotiations – which the Inflation Reduction Act [IRA] made possible – and invited them to participate in further discussions.” Additional discussions are the next step in the drug price negotiation process prescribed by the IRA if CMS does not accept the manufacturers’ counter offers.

#Drug, #Patient

The CMS Innovation Center’s Strategy To Support Person-Centered, Value-Based Specialty Care: 2024 Update

The Innovation Center reports on its strategic refresh and progress on one of its aims to have 100 percent of Traditional Medicare beneficiaries and the vast majority of Medicaid beneficiaries in accountable care relationships by 2030. This article is the latest in the Health Affairs Forefront series, Accountable Care for Population Health, featuring analysis and discussion of how to understand, design, support, and measure patient-centered, cost-efficient care under the umbrella of accountable care. The series is supported by Arnold Ventures.

#Provider, #Patient

More from CMS

Medicare Billing Forms are Running Out of Space for Growing Health Care Prices
According to Stat reporting, health care costs are getting so high that prices are literally running off of the page. Medicare, on a couple of occasions recently has had to deal with billing forms that don’t provide adequate space for prices.

#All

Medicare Bayesian Improved Surname Geocoding (MBISG) algorithm to predict the race and ethnicity of people with Medicare now available in the Chronic Conditions Warehouse
CMS is announcing the availability of a new Research Identifiable File (RIF) that utilizes the Medicare Bayesian Improved Surname Geocoding (MBISG) algorithm to predict the race and ethnicity of Medicare beneficiaries. This data file is available for public use through the Chronic Conditions Warehouse (CCW). CMS developed the MBISG algorithm to enhance existing race and ethnicity data to better understand the Medicare population.

#All

MIPS MVP Registration Open
The Merit-based Incentive Payment System (MIPS) Value Pathways (MVPs) registration window is open for the 2024 performance year. Individuals, groups, subgroups, and Alternative Payment Model (APM) Entities that wish to report an MVP can register until December 2, 2024, at 8 p.m. ET.

#Provider

2024 CAHPS for MIPS Survey Registration is Now Open
Registration is open for the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for the Merit-based Incentive Payment System (MIPS) Survey for the 2024 performance year.

#Provider

Open Payments Review and Dispute of Pre-publication Data Open
Pre-publication review and dispute for the Program Year 2023 Open Payments data is available  April 1, 2024 through May 15, 2024.

#Provider, #Drug, #Device

Food and Drug Administration (FDA)

Request for Nominations on Device Good Manufacturing Practice Advisory Committee

The Food and Drug Administration (FDA or Agency) is requesting that any industry organization interested in participating in the selection of a nonvoting industry representative to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to fill an upcoming vacancy on DGMPAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for an upcoming vacancy effective with this notice.

#Device

Abbott Receives FDA Approval for TriClip™, First-of-Its-Kind Device to Repair Leaky Tricuspid Heart Valve

Abbott announced that FDA approved the company’s TriClip™ transcatheter edge-to-edge repair (TEER) system that’s specifically designed for the treatment of tricuspid regurgitation (TR), or a leaky tricuspid valve.

#Device, #Hospital, #Patient, #Payer, #Provider

Strategies to Increase Clinical Trial Participation for Diverse Communities, A Panel Discussion with the OMHHE REACH Consortium

This National Minority Health Month, is hosting an event at 11 a.m. ET, on April 17, 2024, on  Strategies to Increase Clinical Trial Participation for Diverse Communities.

#All

Amylyx Pulls ALS Drug from Market and Cuts 70% of staff

Amylyx Pharmaceuticals is removing its ALS treatment, called Relyvrio, from the U.S. and Canadian markets, where the medicine is currently approved. The company’s decision comes weeks after the drug failed to show any benefits for patients in a large clinical trial.

#Drug, #Patient

Hill Happenings

Senate Hearing Tackles Private Equity’s Impact on Healthcare Amid Steward Saga

In the wake of a deal for financially strapped Steward Health Care to sell its nationwide physician practice to UnitedHealth Group subsidiary Optum, a Senate subcommittee meeting was held in Boston on Wednesday to address ongoing concerns that the corporatization of healthcare is putting patients and providers at risk. During the hearing, Sen. Markey announced plans to introduce legislation to reform the role of private equity in health care. The bill, which is more of a conversation-starter than a proposed legislative solution, would impose registration and reporting requirements on private equity and for-profit providers looking to acquire businesses and make the Department of Health and Human Services responsible for regulating those arrangements.

#Provider

Notable Notes

ACC Meeting to Make Noise on Beta-Blockers, SGLT2i, Chelation Therapy for Acute MI

MEDPAGE Today offers a preview of the ACC Annual Conference this weekend.

#Device, #Drug, #Hospital, #Patient, #Provider

Forget ‘Pack-Years’ for Lung Cancer Screening Eligibility, Study Suggests

Dropping pack-years for lung cancer screening eligibility in favor of a simpler 20-year history of smoking could substantially increase the number of cancers detected and eliminate racial disparities as well, according to an analysis of smokers from two large cohort studies.

#Patient, #Provider

Conservative groups object to ‘naming names’ rule from Pfizer diversity decision

Reuters writes: Do No Harm, a conservative group opposed to diversity initiatives in the health care industry, wants the full court to reverse the dismissal of its lawsuit to block a Pfizer fellowship program for minority college students.

#All

The Organ Is Still Working. But It’s Not in a Body Anymore.

Perfusion keeps a donated organ alive outside the body, giving surgeons extra time and increasing the number of transplants possible. However, increasing costs may put this medical innovation out of reach.

#All

US scientists are leaving academia. That’s bad news for drug companies

According to CNN reporting, scientists in the United States, especially those in the biomedical fields, are increasingly leaving the world of academia for better-paying industry jobs amid stagnant federal funding and low wages.

#Drug

More Patients Are Losing Their Doctors — And Trust in the Primary Care System

KFF reports on the status of the doc shortage.

#Patient, #Provider

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