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Regulatory Requirements Medicare

Warner Norcross + Judd

Medicare Part D Notices Due Before October 15, 2025: What Employers Need to Know

Employers offering prescription drug coverage must provide an annual notice to Medicare-eligible participants indicating whether their coverage is creditable, meaning it is expected to pay at least as much as the standard...more

Robinson+Cole Health Law Diagnosis

OIG Shines Spotlight on Billing for Remote Patient Monitoring

On August 25, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued a new report (Report) highlighting trends in remote patient monitoring (RPM) Medicare billing, recommending stronger...more

Greenbaum, Rowe, Smith & Davis LLP

One Big Beautiful Bill Act: An Overview of Key Healthcare Provisions & Impacts

The One Big Beautiful Bill Act (OBBBA) was signed into law on July 4, 2025. A sweeping piece of legislation that reshapes healthcare financing and delivery across Medicaid, Medicare, and the insurance marketplaces, the bill...more

Holland & Hart LLP

Correcting Stark Violations: 90-Day Grace Period

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Physicians and entities to which physicians refer may violate the Ethics in Patient Referrals Act (“Stark”) by mistakenly overpaying or underpaying amounts due under a compensation arrangement. For example, a hospital may...more

Arnall Golden Gregory LLP

When Patients Leave Against Medical Advice: What Hospitals Miss and Why It Matters

Delivering high-quality healthcare becomes difficult when patients disregard their doctors’ advice. A patient who chooses to leave the hospital against medical advice (“AMA”) represents a particularly severe case of...more

Gardner Law

NTAP: How to Secure Supplemental Medicare Reimbursement in FY2027

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The New Technology Add-On Payment (NTAP) program remains one of the most powerful and underutilized tools for securing Medicare reimbursement for novel medical technologies. For eligible products, NTAP provides additional...more

Sheppard Mullin Richter & Hampton LLP

So You Want to Start a Concierge Medicine Practice? Here are Five Key Legal Considerations

With increased consolidation of traditional medical practices and declining reimbursement rates, many physicians are turning to alternative models like concierge medicine to preserve their independence. Concierge medicine...more

Gardner Law

TCET—A Medicare Coverage Option for Breakthrough Devices

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For many device makers, the biggest commercial hurdle isn’t FDA authorization—it’s the long wait for Medicare to decide on coverage. Historically, the gap between FDA market authorization and a National Coverage Determination...more

Alston & Bird

Health Care Week in Review | CMS Announces Oversight Initiative to Increase Medicaid and CHIP Citizenship Enforcement; HHS...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Arnall Golden Gregory LLP

OIG Advisory Opinion 25-09: Careful and Intentional Structure Yields Positive Results for Physician-Owned Entity

The Proposed Arrangement - On August 7, 2025, the OIG issued Advisory Opinion 25-09.1 In this instance, the Requestor was a medical device developer, manufacturer, and seller of certain medical devices related to emergency...more

McGuireWoods LLP

CMS Proposes Reimbursement Changes for Remote Patient Monitoring

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On July 14, 2025, the Centers for Medicare & Medicaid Services (CMS) issued the 2026 Medicare Physician Fee Schedule (PFS) Proposed Rule (PFS Proposed Rule). The PFS Proposed Rule proposes to reduce requirements for several...more

King & Spalding

CMS Issues FY 2026 Inpatient Rehabilitation Facility Prospective Payment System and Quality Reporting Program Final Rule

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On August 1, 2025, CMS issued a final rule updating the Medicare rates and policies applicable to inpatient rehabilitation facilities (IRFs) under the IRF Prospective Payment System (PPS) and the IRF Quality Reporting Program...more

Foley & Lardner LLP

CY 2026 Medicare PFS Proposed Rule: Telehealth Takeaways

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In July 2025, the Centers for Medicare & Medicaid Services (CMS) released the CY 2026 Medicare Physician Fee Schedule (PFS) proposed rule (the Proposed Rule), which included several proposed changes that aim to expand...more

Paul Hastings LLP

CMS Proposes Major ASP Reporting Overhaul — Implications for Fair Market Value and Bona Fide Service Fees

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The Centers for Medicare & Medicaid Services (CMS) recently published its Proposed 2026 Physician Fee Schedule Rule (Proposed Rule), with extensive implications for drug pricing, Average Sales Price (ASP) calculations, and...more

Pullman & Comley - Connecticut Health Law

New Billing Codes for At-Home Acute Kidney Injury Renal Dialysis

Earlier this year, the Centers for Medicare and Medicaid Services (CMS) confirmed that, effective January 1, 2025, CMS will pay for acute kidney injury (AKI) renal dialysis treatments at-home at the daily rate based on...more

Jones Day

Coming January 2026: CMS Launches AI Program to Screen Prior Authorization Requests for Treatments

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New CMS program, WISeR, will leverage third parties to screen prior authorization requests using technologically enhanced processes....more

Orrick, Herrington & Sutcliffe LLP

Opportunities and Risks in Remote Patient Monitoring and Remote Therapeutic Monitoring for 2026

The Calendar Year 2026 Medicare Physician Fee Schedule (PFS) proposed rule (see Orrick’s analysis of the proposed rule here) contains important signals for the future of remote patient monitoring (RPM) and remote therapeutic...more

Foley & Lardner LLP

Remote Patient Monitoring (RPM) and Remote Therapeutic Monitoring (RTM): What You Need to Know About CMS’ Proposed Changes

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On July 14, 2025, the Centers for Medicare and Medicaid Services (CMS) proposed key changes to remote patient monitoring (RPM) and remote therapeutic monitoring (RTM) services reimbursed under the Medicare program. The...more

Mintz - Health Care Viewpoints

CMS Proposes New Standards for Bona Fide Service Fees in Average Sales Price Calculations: What Plans, PBMs, and Other Recipients...

The CY 2026 Physician Fee Schedule Proposed Rule (PFS Proposed Rule) introduces significant changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs) when calculating Average Sales Price (ASP) for Medicare...more

Tucker Arensberg, P.C.

CMS Unveils 2026 Physician Fee Schedule Proposal: Key Changes Ahead

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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

Ropes & Gray LLP

Proposed Changes to Medicare Payment Rules: What Life Sciences Companies Need to Know

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The Centers for Medicare & Medicaid Services (“CMS”) recently released two proposed updates to Medicare payment rules that, if implemented, could have a significant impact on life sciences companies. The Medicare proposed...more

King & Spalding

The One Big Beautiful Bill Act Explained: A Detailed Review of Key Changes for the Healthcare Industry

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To offset the cost of other provisions in the bill, the One Big Beautiful Bill Act (OBBBA) includes significant reforms to Medicaid, Medicare, and Affordable Care Act (ACA) premium tax credits that are expected to result in...more

Mintz - Health Care Viewpoints

WISeR Model Will Test the Use of Artificial Intelligence for Prior Authorization in Medicare: Key Considerations for Health Care...

The Center for Medicare and Medicaid Innovation (CMMI) recently announced a six-year payment model for 2026-2031 called the Wasteful and Inappropriate Service Reduction (WISeR) Model. WISeR will test the use of artificial...more

Blank Rome LLP

Impact of Recent CMS Rule on Site Neutrality and 340B Programs—Implications for Oncology Services

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Overview - The Centers for Medicare & Medicaid Services (“CMS”) has finalized and proposed several significant changes affecting both site neutrality in Medicare payments and the 340B Drug Pricing Program. These changes...more

Foley & Lardner LLP

Update: CMS Extends Skilled Nursing Facilities’ Medicare Revalidation Deadline

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On July 17, 2025, the Centers for Medicare and Medicaid Services (CMS) announced an additional extension of the deadline by which skilled nursing facilities (SNFs) must revalidate their Medicare enrollments. Enrolled SNFs...more

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