The rising cost of prescription drugs under Medicare continues to pose significant challenges for seniors, a population that relies heavily on consistent and affordable access to medications. This issue underscores broader gaps in the healthcare system and highlights the critical need for legal, regulatory, and economic strategies that prioritize aging populations.Continue Reading The Legal and Economic Realities of Medicare Drug Pricing: Navigating Opportunities and Challenges

With only two weeks remaining in the year, Congress is considering a government funding deal (the “Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, 2025” or the “Bill”) that includes a welcome holiday gift for health care providers and patients – an expansive health care package that would extend certain telehealth flexibilities promulgated during the COVID-19 public health emergency (“PHE”) for an additional two years. The extended telehealth flexibilities are currently set to expire on December 31, 2024. This extension would generally allow providers to continue to serve Medicare patients via telehealth consistent with the current practices.Continue Reading Congress Extends Telehealth Flexibilities for Two More Years

On November 26, 2024, the Centers for Medicare & Medicaid Services (“CMS”) released the contract year 2026 proposed rule for the Medicare Advantage (“MA”) program, Medicare Prescription Drug Benefit Program (“Part D”), Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (the “Proposed Rule”). Likely one of the last significant Medicare reform initiatives of the Biden administration, the Proposed Rule incorporates many of the Administration’s broader policy priorities, focusing on equity, transparency, and modernization in healthcare delivery and oversight.Continue Reading Key Proposals from the CY 2026 Medicare Advantage and Part D Proposed Rule

Yesterday, the OIG released a Special Fraud Alert related to: (1) marketing arrangements between Medicare Advantage Organizations (“MAOs”) and health care professionals (“HCPs”), and (2) arrangements between HCPs and MA plan agents and brokers. In the Alert, OIG states that these types of arrangements may implicate the Federal anti-kickback statute (the “AKS”) and could result in unfair competition and improper steering of Medicare beneficiaries. Despite flagging these concerns, the Alert fails to offer specific, practical guidance on the types of arrangements that would or would not violate the law, and therefore does little to alleviate industry-wide confusion as to how to compliantly engage in beneficiary outreach and support.Continue Reading Special Fraud Alert: Suspect Payments in Marketing Arrangements Related to Medicare Advantage and Providers

The Centers for Medicare & Medicaid Services (“CMS”) and its contractor, Wisconsin Physicians Service Insurance Corporation (“WPS”), recently notified over 940,000 Medicare beneficiaries of a data breach that has potentially exposed their protected health information (“PHI”) and personally identifiable information (“PII”). CMS reported on the breach portal of the U.S. Department of Health and Human Services (“HHS”) that the total number of impacted people was 3,112,815 individuals.Continue Reading Over 940,000 Medicare Beneficiaries Impacted by Data Breach

A federal district court in the Middle District of Florida issued a decision on Sept. 30th that threatens the federal government’s continued reliance on the False Claims Act (“FCA”) as the most powerful weapon in the Department of Justice’s enforcement arsenal. U.S. District Judge Kathryn Kimball Mizelle threw out a case against a group of Medicare Advantage organizations and providers on the grounds that an individual whistleblower suing on behalf of the federal government under the FCA, often called a “relator” in a “qui tam” lawsuit, violates the U.S. Constitution’s “appointments clause.” The Court concluded that relators, who are acting on behalf of the federal government, must be considered officers of the government and appointed in a manner consistent with Constitutional requirements. See U.S. ex rel Zafirov v. Florida Medical Associates, LLC, No. 8:19-cv-1236, 2024 U.S. Dist. LEXIS 176626, ECF No. 346 (M.D. Fl. Sept. 30, 2024).Continue Reading FCA Whistleblowers – No More?

CMS recently published the First Annual Evaluation Report (the “Report”) highlighting its most significant observations in the first year following implementation of the Kidney Care Choices Model (the “KCC Model”). By way of background, the KCC Model is a payment model which creates certain incentives for providers that are intended to improve care management for Medicare patients with chronic kidney disease (“CKD”) (Stage 4 or 5) or end-stage renal disease (“ESRD”). The KCC Model is intended to, among other things, delay the dialysis progression and increase use of home dialysis, while also aiming to reduce the cost of care and improve quality of outcomes.Continue Reading CMS Releases First Annual Evaluation Report for Kidney Care Choices Model

On July 31, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued its proposed rule (“Proposed Rule”) for the 2025 Medicare Physician Fee Schedule, which includes implications for telehealth services reimbursable by Medicare. Although the majority of telehealth waivers enacted during the COVID-19 public health emergency (the “PHE”) are set to expire at the end of 2024 in the absence of legislative action, CMS has proposed to leave certain key flexibilities in place, including the allowance for physicians and other practitioners to furnish remote “direct supervision” through their immediate availability via audio-video technology.Continue Reading Key Telehealth Updates in the CY 2025 Physician Fee Schedule Proposed Rule

An April 2024 independent[1] report (“Report”) analyzed the results of the first four years following implementation of the Maryland Total Cost of Care Model (the “TCOC Model”), finding that between 2019 and 2022 (the “TCOC Measuring Period”), the TCOC Model reduced Medicare spending, hospital admissions, and health disparities. CMS also distributed a summary of the Report’s findings.Continue Reading Attention Maryland Providers: Are You Availing Yourselves of Regulatory Flexibilities under the TCOC Model?

On June 10, 2024, the U.S. Supreme Court granted certiorari in Advocate Christ Medical Center v. Becerra[1] for the October 2024 – 2025 term to review a D.C. Circuit Court of Appeals ruling potentially affecting up to $4 billion in federal funding for hospitals.[2] The Supreme Court will determine whether the federal Department of Health and Human Services (“HHS”) properly reimbursed hospitals for providing care to patients receiving financial aid from the Supplemental Security Income Program (the “SSI Program”).[3] Hospitals benefiting from Medicare reimbursement adjustments for treating low-income patients should closely monitor this case, as a favorable ruling for the plaintiffs may impact how hospitals are reimbursed for similar claims in the future.Continue Reading SCOTUS to Review Case Impacting Medicare Reimbursement for Hospitals Treating Low-Income Patients

On May 16, 2024, the Subcommittee on Health of the House Committee on Energy and Commerce (the “Subcommittee”) announced that it advanced the Telehealth Modernization Act of 2024 (H.R. 7623) as amended (the “Bill”) during a markup session. The Bill is meant to extend a number of telehealth flexibilities under Medicare through 2026. This corresponded with 22 other bills advanced by the Subcommittee to strengthen access to healthcare.Continue Reading Congress Seeks to Extend COVID-19 Telehealth Flexibilities Through 2026 and Expand Reimbursement