News & Analysis as of

Comment Period Public Comment Centers for Medicare & Medicaid Services (CMS)

Goodwin

340B Rebate Pilot Program Proposed by HRSA

Goodwin on

On July 31, 2025, the Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA) issued a 340B Drug Pricing Program notice (the “Notice”) announcing the launch of a voluntary 340B rebate model pilot...more

Tucker Arensberg, P.C.

CMS Unveils 2026 Physician Fee Schedule Proposal: Key Changes Ahead

Tucker Arensberg, P.C. on

On July 14, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for the 2026 Physician Fee Schedule. As expected, there are several meaningful updates that providers, practices, and health systems...more

McDermott Will & Schulte

CMS Revives, Expands Proposed Changes to Medicare Overpayment Rule

In response to comments on the 2022 proposed changes to the overpayments regulation, the Centers for Medicare & Medicaid Services (CMS) proposed additional changes to the overpayment rule to clarify that the obligation to...more

McDermott+

Top 10 Comments on Proposed Mandatory Episode-Based Payment Model, TEAM

McDermott+ on

Time’s up and pencils down! Public comments on the Centers for Medicare & Medicaid Services (CMS) Fiscal Year 2025 Inpatient Prospective Payment System (IPPS) proposed regulation were due this past Monday, June 10, 2024. CMS...more

McDermott+

CMMI Proposes New Mandatory Episode-Based Payment Model

McDermott+ on

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

Nelson Mullins Riley & Scarborough LLP

CMS Issues Interim Rule in Response to State Medicaid Disenrollment Trend

When the COVID-19 Public Health Emergency (PHE) ended in April 2023, the Families First Coronavirus Response Act’s Medicaid continuous enrollment condition also came to an end. The condition had allowed states to claim a...more

Troutman Pepper Locke

New Proposed Rules to Combat Health Information Blocking

Troutman Pepper Locke on

The U.S. Department of Health and Human Services (HHS) has just unveiled a proposed rule designed to penalize health care providers engaging in information blocking. Information blocking is a practice where health care...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

Nelson Mullins Riley & Scarborough LLP

FDA Proposes Drastic Overhaul of Laboratory Developed Test Regulation

Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more

Holland & Knight LLP

CMS Proposes Minimum Staffing Standards for Long-Term Care Facilities

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) published a proposed rule on Sept. 1, 2023, that, if finalized, would impose minimum staffing standards for long-term care facilities participating in Medicare or Medicaid....more

Polsinelli

“36-Month Rule” Anticipated to Expand to Hospice

Polsinelli on

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?

Nossaman LLP on

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

Goodwin

CMS Issues First Request for Public Comments on the Medicare Drug Price Negotiation Program “Small Biotech” Exception - Due March...

Goodwin on

The Inflation Reduction Act’s (“IRA”) drug price negotiation provisions have captured the pharmaceutical and biotech industry’s attention. In part, the IRA allows the Centers for Medicare & Medicaid Services (“CMS”) to...more

McDermott Will & Schulte

CMS Seeks Provider and Stakeholder Feedback on First National Directory of Healthcare Providers and Services

McDermott Will & Schulte on

The US Centers for Medicare & Medicaid Services (CMS) released a Request for Information (RFI) seeking comments on the creation of a national directory of healthcare providers and services that would become a “centralized...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

Faegre Drinker Biddle & Reath LLP

FCC Seeks Comment on HHS/CMS Request for Certainty About Communications Critical to Federal and State Health Insurance Programs...

Reacting quickly to a joint request by the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) (collectively, the Health Agencies) last Thursday, the FCC released a Public...more

Bowditch & Dewey

New CMS Regulations Mandating Vaccination of Health Care Facility Staff

Bowditch & Dewey on

On November 5, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued an interim final rule requiring that a wide variety of providers and suppliers participating in the Medicare program ensure their staff are...more

Goodwin

Exactly One Year Later, CMS Reverses Course on Covering Innovative MedTech

Goodwin on

In September 2020, the Centers for Medicare & Medicaid Services (CMS) proposed a new rule that would expedite Medicare coverage for medical technology approved through the Food & Drug Administration’s (FDA’s) “Breakthrough...more

Goodwin

CMS Proposes Important New Updates to the Sunshine Act’s Open Payments Program

Goodwin on

The Centers for Medicare & Medicaid Services (CMS) released its proposed 2022 Physician Fee Schedule rule (Proposed Rule) on July 13, 2021. Included in the rule are several proposed updates to the CMS Open Payments Program,...more

Holland & Knight LLP

HHS Releases Four Major Rules to Lower Drug Prices, Amend Anti-Kickback and Stark Laws

Holland & Knight LLP on

The U.S. Department of Health and Human Services (HHS) issued four major rules on Nov. 20, 2020, which was the final day for the Trump Administration to issue a rule with a 60-day implementation period for it to take effect...more

Mintz - Health Care Viewpoints

CMS Proposes Changes to Medicare’s Coverage Determination Criteria and Expedites Approval of Breakthrough Devices

The Centers for Medicare and Medicaid Services recently issued a proposed rule that would grant Medicare coverage to breakthrough medical devices immediately upon FDA approval. The rule also proposes to codify a new...more

Jackson Walker

CMS Implements Stricter COVID-19 Testing Regulations on Nursing Homes

Jackson Walker on

As part of a broader Trump administration announcement made on August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) issued sweeping oversight changes in the form of an Interim Final Rule with Comment Period...more

Akin Gump Strauss Hauer & Feld LLP

CMS Proposes to Streamline Medicare Coverage Process for Innovative Technology and Consider Commercial Coverage in “Reasonable and...

- The proposed rule seeks to “demolish the existing bureaucratic barriers that have created a ‘valley of death’ for innovative products.” - A new Medicare Coverage of Innovative Technology (MCIT) pathway would allow...more

Akin Gump Strauss Hauer & Feld LLP

CMS Proposes New Hospital Reporting Requirements and Signals Major Shift in Hospital Rate-Setting Methods

- Tucked into a massive Medicare payment rule is a proposal to fundamentally change how CMS sets hospital payment rates. - Recognizing that a hospital’s chargemaster rarely reflects true market costs, CMS seeks to use...more

ArentFox Schiff

CMS Releases Proposed Changes for Medicare Advantage and Medicare Part D

ArentFox Schiff on

The Centers for Medicare & Medicaid Services (CMS) published the Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program,...more

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