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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

Most Medicare Advantage (“MA”) beneficiaries rely on agents and brokers to help them navigate the complex process of selecting a health plan that will meet their needs. In exchange, brokers and agents received certain fixed payments set by Medicare, as well as, in some cases, significant additional payments from health plans. Concerned over the potential for abuse, these arrangements have been the subject of Congressional scrutiny and an enforcement priority for both the Department of Justice (“DOJ”) and the Department of Health and Human Services Office of the Inspector General (“HHS OIG”). The Biden Administration and the Centers for Medicare & Medicaid Services (“CMS”) are tackling this issue head-on in a recently published final rule that addresses both marketing tactics and compensation methodologies used by Medicare Advantage organizations (“MAOs”) to pay MA agents or brokers.[1]Continue Reading Increased Scrutiny into Agents & Brokers in the Medicare Advantage Space

On April 4, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued the contract year 2025 (CY2025) Medicare Advantage and Part D final rule (the “Final Rule”). In addition to finalizing its CY2025 proposed rule, CMS also addressed several key provisions that remained from the CY2024 proposed rule. According to CMS’ Fact Sheet, the Final Rule builds on existing Biden-Harris Administration policies to strengthen protections and guardrails, promote healthy competition, and ensure Medicare Advantage and Part D plans best meet the needs of enrollees. The Final Rule also promotes access to behavioral health care providers, promote equity in coverage, and improve supplemental benefits.Continue Reading CMS Issues CY2025 Medicare Advantage and Part D Final Rule

On April 1st, the Centers for Medicare & Medicaid Services (“CMS”) announced its Medicare Advantage (“MA”) Capitation Rates and Part C and Part D Payment Policies for Calendar Year (“CY”) 2025. This announcement builds on the Advanced Notice of Methodological Changes for CY 2025 for MA Capitation Rates and Part C and Part D Payment Policies (“Advanced Notice”) that CMS released on January 31, 2024. Continue Reading CMS Announces Medicare Advantage and Part D Rates for CY 2025

“The American people deserve to know that the insurance companies receiving more than $700B annually in taxpayer funds are working to ensure you receive effective, high-quality care. Remember, you have rights and options to ensure you receive the care you deserve.”Continue Reading OIG Sparks Public Excitement about Managed Care and Alludes to Incoming Enforcement Guidance

The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department of Health and Human Services, Office of the Inspector General (“OIG”) concerning pharmaceutical manufacturers’ offers of cost-sharing subsidies to Medicare Part D (“Part D”) beneficiaries. The opinion under review was Advisory Opinion No. 22-19,[1] which we previously wrote about[2] and in which the OIG advised that if pharmaceutical manufacturers offered the proposed cost-sharing subsidies to Part D beneficiaries via PCPA, they could be subject to liability under the Federal health care program Anti-Kickback Statute (the “AKS”), even though the proposed subsidies would not violate the Civil Monetary Penalty Law’s Beneficiary Inducement Prohibition (“BIP”).Continue Reading District Court Elucidates the Meaning of “to Induce” Under the Federal Health Care Program Anti-Kickback Statute

On December 28, 2023, the Office of Inspector General (the “OIG”) issued a favorable Advisory Opinion (No. 23-15) (the “Opinion”) to a consulting vendor (the “Requestor”) that wanted to provide up to $75 in gift cards to physician practices in exchange for referring the Requestor’s practice optimization services (e.g., workflow and performance assessment, data analytics, and certain Medicare eligibility and performance assistance). Among other things, the Requestor: (i) did not itself provide any services that were eligible for reimbursement under any Federal healthcare program to any of its clients, (ii) did not have an ownership or investment interest in any entity that provided items or services paid for by any Federal healthcare program, and (iii) received compensation from the physician practices that did not vary based on whether the physician practices received a greater or lesser reimbursement from Medicare based on the Requestor’s services. The Opinion concluded that this proposed arrangement would not generate prohibited remuneration under Section 1128B(b) of the Social Security Act (the “Act”), also known as the Federal Anti-Kickback Statute (“Anti-Kickback Statute”), and thus OIG would not impose administrative sanctions under Section 1128A(a)(7) (exclusion) or Section 1128(b)(7) (civil monetary penalty) of the Act on the Requestor. As always, the Opinion stipulated that it may only be relied on by the Requestor on the specific facts presented to OIG, and that certain state and federal laws may continue to limit similar arrangements. However, the Opinion indicates that the tight scope of potential marketing options for physician practice vendors could expand a bit for those who are similarly situated to the Requestor.Continue Reading New Marketing Possibilities for Vendors Contracted with Medicare Providers and Suppliers Following OIG’s Favorable Advisory Opinion on Limited Referral Bonuses

On November 6, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released the contract year 2025 proposed rule for Medicare Advantage (“MA”) organizations and Part D sponsors (the “Proposed Rule”). The Proposed Rule covers an array of regulatory topics including the Star Ratings program, marketing and communications, agent and broker compensation, health equity, dual eligible special needs plans (“D-SNPs”), utilization management, network adequacy, and access to biosimilars.Continue Reading CMS Promotes Competition, Transparency, Health Equity and More in the CY2025 Medicare Advantage and Part D Proposed Rule

The Centers for Medicare & Medicaid Services (“CMS”) released the final rule on risk adjustment data validation (“RADV”) audits of Medicare Advantage (“MA”) organizations (the “Final Rule”) on January 30, 2023. Among other changes, this Final Rule will allow CMS to audit a sample of an MA organization’s (“MAO”) diagnoses reported for risk adjustment purposes (from 2018 and later) and then use the audit findings to calculate an extrapolated improper payment amount for the MAO’s contract. This extrapolation technique is controversial for a number of reasons, including whether CMS has the authority to use it in the manner proposed in the Final Rule, and whether it is an actuarially sound method of auditing. As we predicted in February, this Final Rule is now being challenged in court.Continue Reading Medicare Advantage RADV Audit Final Rule Challenged in Court

On July 13, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued its proposed rule (the “Proposed Rule”) for the 2024 Medicare Physician Fee Schedule (“PFS”). The Proposed Rule, which was issued in the Federal Register on August 7, 2023,  includes updated payment rates, changes to reimbursement for services related to health equity and social determinants of health, increases to payment for cancer care support, and changes to enrollment for mental health providers. CMS projects that the Proposed Rule will lead to growth in the Medicare Shared Savings Program (“MSSP”).Continue Reading CMS Announces Proposed Rule for 2024 Medicare Physician Fee Schedule