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This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more
Does your company's health plan provide prescription drug coverage? If so, you have until October 15, 2024 to send a notice to individuals who are enrolled in Medicare Part A or Part B and are eligible for the company's...more
On August 7, 2024, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) issued a final procedural notice (“Notice”) outlining a new Medicare coverage pathway, aimed at achieving timelier and predictable access...more
Obtaining Medicare coverage and reimbursement for medical devices is notoriously more difficult than for drugs or biologics, and any progress on expanding coverage pathways has been agonizingly slow for industry stakeholders....more
On December 14, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that contemplates several changes to, and clarifications of, guidance for the Medicare Advantage (MA) program in coverage year 2024....more
Does your company's health plan provide prescription drug coverage? If so, you have until October 15, 2022 to send a notice to individuals who are enrolled in Medicare Part A or Part B and are eligible for the company's...more
On Aug. 4, the Department of Health and Human Services (HHS) published its proposed rule, Nondiscrimination in Health Care and Activities (Proposed Rule), to revise its regulations pertaining to Section 1557 of the...more
Group health plan sponsors are required to send annual notices (as well as at other particular times) to individuals who are eligible for Medicare Part D that explain whether the health plan’s prescription drug coverage is...more
Employers that provide prescription drug coverage (Rx Coverage) to their employees must notify all Medicare-eligible employees regarding the Rx Coverage’s creditable or non-creditable status under the Medicare Prescription...more
On November 27, 2019, the Centers for Medicare and Medicaid Services (CMS) published its final rule outlining new price transparency requirements as part of the 2020 update to the Outpatient Prospective Payment System....more
If prescription drug coverage is offered under your group health plan, you must provide an annual notice by October 15th to plan participants (and their dependents) who are Medicare eligible, whether they are active...more
Hospitals now have additional time before they must meet federal requirements to provide written notice to Medicare patients who are receiving observation services. Congress passed the Notice of Observation Treatment and...more
While CMS’s demonstration model will allow for reduced cost sharing and other benefit design elements to encourage targeted use of high-value clinical services, Medicare Advantage Organizations should be aware of certain...more
In Int’l Rehab. Sci. v. Burwell, No. 08-cv-05442 (W.D. Wash. Feb. 13, 2015), the court found inadequate an advance beneficiary notice (ABN) which stated that “Medicare has not established coverage criteria... or does not...more
CMS has modified the Medicare Claims Processing Manual to require home health agencies (HHAs) to begin using the standard advance notice of noncoverage (ABN) used by other providers, rather than the previous HHA ABN (Form...more
In the past week, the Congressional Budget Office (CBO) released an updated federal budget to account for new regulations from the Department of Health and Human Services (HHS) and the Internal Revenue Service (IRS),...more