Regulatory Update – Week of May 27, 2024

Introduction
DC-types thinking big thoughts on healthcare just in time for the Trump hush money verdict. Cue the clowns!

Weekly Spotlight

A few weeks ago, we reported that the publication of the Inpatient Prospective Payment System (IPPS) proposed rule, and specifically CMS’s big reveal of its mandatory Transforming Episode Accountability Model (TEAM) payment proposal, would awaken some of the physician payment policy wonks from a briefer than usual slumber. These past few weeks have shown signs of life, even in some unexpected places.

It all started with Senators Cassidy (R-LA) and Whitehouse (D-RI) unveiling their plan for primary care provider payment reform, complete with a request for information and legislation, the Pay PCPs Act. Just two days later, Senator Wyden (D-OR) and Crapo (R-ID), Chair and Ranking Member of the Senate Finance Committee, respectively, unveiled a whitepaper focused on physician payment reform titled, “Bolstering Chronic Care through Physician Payment: Current Challenges and Policy Options in Medicare Part B.” While the Cassidy/Whitehouse effort focuses on primary care, the Wyden/Crapo paper delves into one of Senator Wyden’s top priorities, treatment for patients suffering from chronic illnesses. As a former lobbyist for a surgical subspecialty, I have to confess that both of these developments tell me that the Senate is ready to reform physician payment to make sure primary care physicians get paid more. Add to that the notion that the TEAM payment proposal is, by definition, aimed at reducing the costs of specific episodes of specialty care and you start to see why I’m happy to have a few from the spectator’s gallery on this one.

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Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

When ‘Prior Authorization’ Becomes a Medical Roadblock

Medicare Advantage plans say it reduces waste and inappropriate care. Critics say it often restricts coverage unnecessarily.

#Patient

Alliance for Aging Research Leads Non-Diabetes Orgs in Commenting on Diabetes MEDCAC

In a letter to CMS, 28 non-diabetes advocacy organizations voiced opposition to any efforts by CMS to restrict beneficiary access to FDA-approved devices for self-management of Type 1 and insulin-dependent Type 2 diabetes.

#Patient, #Drug, #Device, #Provider, #Payer

Drug Pricing

Don’t Import British Methods For Rationing Access To Drugs
The Inflation Reduction Act, signed into law by President Biden in 2022, gives the federal government the power to set drug prices—and encourages the use of comparative effectiveness measures in doing so.

#Drug

Medicare Plan to Verify Negotiated Drug Prices Spurs Unease
The Medicare system proposed by the Biden administration to verify negotiated drug prices reach eligible individuals is generating concerns about compliance and operational challenges for manufacturers and dispensing entities.

#Drug, #Patient

Recent Medicare attempts to lower drug prices (beyond IRA)
Healthcare Economist eplores some of the other ways CMS has tried to curb prescription drug prices outside of the Inflation Reduction Act (IRA).

#Drug, #Patient

Healthcare Delivery Reform

Value-based payment is getting renewed attention. What it means isn’t getting any clearer
Nearly 20 years ago, policymakers had an epiphany: The health care system should pay for value instead of volume. Unfortunately, it’s now less clear than ever what value-based payment means, and whatever it is, it hasn’t lived up to the hype.

#PATIENT, #PROVIDER, #PAYER

Hospitals push back on bundled care coordination proposal
Hospital groups say the proposed TEAM payment bundling program may prove overly burdensome to an industry already working to implement other Centers for Medicare and Medicaid Services reimbursement experiments.

#Hospital

Health insurers retreat from ACO REACH
Health insurers are pulling back from an accountable care organization pilot program intended to reduce costs for fee-for-service Medicare enrollees amid a surprise spike in medical costs and unfavorable regulatory changes.

#Payer

Medicare Advantage health equity factor to shake up ratings
A federal effort to promote health equity will redistribute billions of dollars in Medicare Advantage Star Ratings bonus payments among health insurance companies: Beginning in 2027, CMS will reward Medicare Advantage plans that demonstrate progress addressing health disparities. At the same time, the agency scrapped a bonus policy that benefited insurers that sustained high overall quality ratings over time.

#Payer, #Patient

Food and Drug Administration (FDA)

Public Workshop: Using Patient-Generated Health Data in Medical Device Development

FDA announced a co-sponsored public workshop with the Digital Medicine Society (DiMe), Using Patient-Generated Health Data in Medical Device Development: Case Examples of Implementation Throughout the Total Product Life Cycle. June 26-27, 2024, from 11:00 a.m. – 3:00 p.m. (ET)

#Device

Health and Human Services (HHS)

The Agency for Healthcare Research and Quality (AHRQ) Budget: Fact Sheet

CRS Breakdown of the AHRQ Budget

#All

Plans and Enrollment Often Fell Short for Underrepresented Groups in a Sample of NIH-Funded Clinical Trials

The HHS Office of the Inspector General reports,clinical trials that are funded by the U.S. National Institutes of Health often enroll fewer Black patients and other underrepresented racial groups than planned.

#Device, #Drug, #Patient

Hill Happenings

Dr. Bucshon, Rep. Carter, and Rep. Harshbarger Introduce 340B Legislation

U.S. Representatives Larry Bucshon, MD (R-IN-08), Buddy Carter (R-GA-01), and Diana Harshbarger (R-TN-01) introduced the 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B ACCESS Act).

#Drug, #Patient

Pallone Releases GAO Report on Medicaid Managed Care Plans’ Prior Authorization Requirements for Children

Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ) released a new report, which he requested from the Government Accountability Office (GAO) on Medicaid managed care plans’ use of prior authorization for children’s health care benefits.

#Patient, #Provider, #Drug, #Device

Cassidy, Wyden, Bipartisan Finance Members Outline Proposal to Improve Medicare Physician Training to Reduce Workforce Shortages

A bipartisan group of six Senate Finance Committee members are asking for stakeholder feedback on a policy outline that calls for increasing by an unspecified amount Medicare graduate medical education slots, encouraging hospitals to train physicians in rural areas, creating a temporary council to improve the distribution of GME slots and improving data collection and transparency, among other things.

#Provider

Notable Notes

Imagine What EHR Interoperability Could Do for Healthcare

Opinion: Connected systems would benefit patients and clinicians alike

#All

Biden’s got a plan to protect science from Trump

The White House has told the National Institutes of Health to safeguard its work from political interference. In an effort to Trump-proof, NIH has designated an official to identify political meddling in the agency’s work and is tasking a soon-to-be-established scientific integrity council with reviewing those cases.

#All

Increase in Colorectal Cancer Cases in Younger Age Groups Extends to Preteens

While cases remain rare in younger people, they’re much more common than 25 years ago

Medpage today

#Patient

New compact allows social workers to practice across state lines

Amid what many Americans are calling a mental health crisis, an increasing number of states are trying to address the problem by empowering social workers to practice across state lines.

#Patient, #Provider

Doc Pay

You Can Thank Private Equity for That Enormous Doctor’s Bill
Private-equity investors have poured billions into healthcare but often game the system, hurting both doctors and patients

#Provider

AHA, FAH,  and other national associations send letter to FTC requesting delayed implementation of non-compete rule
A coalition of 230 national associations,  submitted a letter the week of May 20 to the Federal Trade Commission requesting a stay on the Sept. 4 effective date of the Non-Compete Clause Final Rule to allow for judicial review.

#Hospital

Provider, payer contract disputes are heating up
Contract negotiations are growing more contentious between providers and payers as both sides battle rising costs.

#Payer, #Provider

Physicians continue to see pay growth, ties to quality: MGMA
Physician and advanced practice provider compensation continued to rise in 2023 despite increasing overhead costs and reimbursement challenges, according to a recent survey by the Medical Group Management Association (MGMA). MGMA says they earned it by working harder. While some reporting focused on gains for specialists, others noted that primary care physician compensation surpassed $300,000 last year as doctor practices and the healthcare industry grapple with staffing issues in a tight labor market.

#Provider

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