News & Analysis as of

Public Comment Healthcare Reform

Fenwick & West LLP

CMS Seeks Public Input to Modernize the Digital Health Ecosystem for Medicare Beneficiaries

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The Centers for Medicare & Medicaid Services (CMS) has issued a new Request for Information (RFI) aimed at transforming how digital health tools serve Medicare beneficiaries....more

Holland & Knight LLP

Holland & Knight Health Dose: May 6, 2025

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Reconciliation markups in the U.S. House of Representatives Committee on Energy and Commerce, as well as the House Committee on Ways and Means, were expected to be held this week but have been postponed until next week at the...more

Maynard Nexsen

HHS Abandons Public Comment Practices Under the Richardson Waiver

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On March 3, 2025, the Department of Health and Human Services (HHS), under Secretary Robert F. Kennedy Jr., officially announced the rescission of the Richardson Waiver, a policy in place since 1971 that required public...more

Pullman & Comley - Connecticut Health Law

OHS Issues 2024 Statewide Health Care Facilities and Services Plan

The Connecticut Office of Health Strategy (OHS) has released the 2024 Statewide Health Care Facilities and Services Plan, along with a biennial inventory of all Connecticut health care facilities and services (the Plan)....more

McDermott+

CMMI Proposes New Mandatory Episode-Based Payment Model

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Last week, the Centers for Medicare & Medicaid Services (CMS) released the Fiscal Year 2025 Inpatient Prospective Payment System (IPPS) proposed regulation. This 1,900+ page annual reg updates Medicare payments and policies...more

Knobbe Martens

Draft Framework for Exercise of March-In Rights under Bayh-Dole Act Targets High Drug Pricing

Knobbe Martens on

The National Institute of Standards and Technology (NIST) released for public comment a “Draft Interagency Guidance Framework for Considering the Exercise of March In-Rights” (“March-In Framework”) on December 8, 2023...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

IP Hot Topic: Biden Administration Proposes Framework for Exercising Bayh-Dole March-in Rights to Control Drug Pricing

The Biden-Harris Administration recently announced various actions to lower healthcare and prescription drug costs. In one action, the National Institute of Standards and Technology (NIST) released in December 2023 a draft...more

Nelson Mullins Riley & Scarborough LLP

The Drive for Equitable Healthcare Access: Departments Seek Public Input on Over-the-Counter Preventive Services

On September 29, the Centers for Medicare & Medicaid Services (CMS) reported that the federal Departments of Health and Human Services, Labor, and the Treasury departments are seeking public input on the possibility of...more

Foley Hoag LLP

FDA and Prescription Drug Use Related Software – FDA’s Draft PDURS Guidance Answers Years-Old Questions and Introduces New Ones

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After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more

McDermott Will & Emery

CMS Pushes to Expand Hospital Price Transparency Requirements, Enforcement Activity

McDermott Will & Emery on

On July 26, 2023, two days after the Centers for Medicare and Medicaid Services (CMS) issued its second largest civil monetary penalty for noncompliance with the hospital price transparency rule, CMS hosted a webinar...more

Polsinelli

“36-Month Rule” Anticipated to Expand to Hospice

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On July 10, the Centers for Medicare & Medicaid Services (“CMS”) issued a Proposed Rule that would extend the “36-Month Rule” to Hospice providers. The 36-Month Rule refers to 42 C.F.R. § 424.550(b), which currently...more

Nossaman LLP

CMS Attempts to Reduce Appointment Times for Medicaid and CHIP Patients - How Will This Impact Your Managed Care Plan?

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A recent survey found that the average wait time for a new patient to see a physician in 15 of the largest cities in the U.S. was 26 days, up from 24.1 days in 2017.  Timely access to health care providers has long been an...more

Polsinelli

Telehealth: CMS Proposes to Discontinue Audio-Only E/M Services and Virtual Direct Supervision in 2023 Proposed Rule

Polsinelli on

On July 07, 2022 the Centers for Medicare and Medicaid Services (“CMS”) released the 2023 Physician Fee Schedule (“PFS”) Proposed Rule, which proposes several significant changes to Medicare telehealth services....more

Morgan Lewis

Biden-Harris Administration Issues Part I of Surprise Billing Rule

Morgan Lewis on

The US Departments of Treasury, Labor, and Health and Human Services (the Departments) along with the Office of Personnel Management (OPM) issued Requirements Related to Surprise Billing; Part I on July 1. ...more

Mintz - Health Care Viewpoints

HHS Proposes Sweeping Changes to AKS and Stark Law, Part 6: Proposed Changes to the AKS Related to Beneficiary Inducement

As reported previously, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published two proposed rules that seek to implement wholesale changes to the Anti-Kickback Statute (AKS) and...more

Bricker Graydon LLP

CMS proposes new Stark Law exception for limited remuneration to a physician

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On October 9, 2019, the Centers for Medicare and Medicare Services (CMS) released proposed changes to the regulations interpreting the Physician Self-Referral Law (Stark Law), including a new proposed exception for limited...more

Jones Day

OIG Proposes New Exception for Dialysis-Related Telehealth Technologies

Jones Day on

The Situation: Telehealth services continue to evolve and show promise for improving quality care, care coordination, and access to services while also reducing the costs of care. The Action: The Office of Inspector...more

McDermott Will & Emery

Stark Law and Anti-Kickback Statute Proposed Rules Would Facilitate Donations of EHR and Cybersecurity Technology and Services

McDermott Will & Emery on

On October 17, 2019, the Department of Health & Human Services (HHS) published proposed rules in the Federal Register that would amend existing and create new exceptions to the physician self-referral law (Stark Law) and safe...more

Bricker Graydon LLP

OIG proposes changes to existing Anti-Kickback Statute safe harbors

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On October 9, 2019, the Office of Inspector General (OIG) released proposed changes interpreting the federal Anti-Kickback Statute (AKS) and its regulatory safe harbors, including changes to several existing safe harbors. ...more

Bricker Graydon LLP

CMS and OIG propose changes to existing rules for donations of electronic health records and new rules for donations of...

Bricker Graydon LLP on

On October 9, 2019, the Office of Inspector General (OIG) released proposed changes to the regulations interpreting the federal Anti-Kickback Statute (AKS). On the same day, the Centers for Medicare and Medicaid Services...more

Sheppard Mullin Richter & Hampton LLP

Critical Analysis of CMS’ Proposed Stark Law Changes

As part of HHS’ Regulatory Sprint to Coordinated Care, CMS recently published a proposed rule that, if finalized, would fundamentally change and alleviate the manner in which the Stark Law regulatory framework has...more

Epstein Becker & Green

HHS’s Regulatory Sprint to Coordinated Care – Part 3: CMS Proposes Expansive Set of Changes to Stark Regulations

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This Client Alert serves as the third in a three-part series in which we describe and analyze the rules proposed by the Department of Health and Human Services (“HHS”) Centers for Medicare & Medicaid Services (“CMS”) as part...more

Mintz - Health Care Viewpoints

The Other Shoe Drops: FDA Withdraws 30-Year-Old Homeopathic Drug Enforcement Policy and Puts Industry on Notice of Further...

To anyone who has been following government enforcement and private litigation trends related to the over-the-counter (OTC) homeopathic drug industry over the past several years, the Food and Drug Administration’s (FDA)...more

Bricker Graydon LLP

CMS proposes to change the way group practices can pay profit shares to physicians under Stark Law

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Part of the Centers for Medicare and Medicaid Services’ (CMS) proposed changes to the regulations interpreting the Physician Self-Referral Law (the “Stark Law”), released on October 9, 2019, include changes to the special...more

Bricker Graydon LLP

CMS proposes to recalibrate the scope and application of the Stark regulations

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As part of the long-awaited proposed changes “to modernize and clarify” the regulations that interpret the Physician Self-Referral Law (the “Stark Law”) released on October 9, 2019, the Centers for Medicare and Medicaid...more

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