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Ellen Pighini

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On October 21, 2024, the U.S. Department of Health and Human Services, Labor Department, and the Treasury Department (collectively “the Departments”) jointly released a proposed rule that would require insurers to expand coverage of and eliminate cost sharing on certain preventative services, including over-the-counter (“OTC”) contraceptive items and certain Food and Drug Administration (“FDA”) approved prescription birth control medications. The rule would require private health plans to provide new disclosures to beneficiaries regarding coverage of these services with no cost-sharing obligations.

According to the fact sheet issued by the White House, the rule if finalized would expand free birth control coverage for 52 million American women of reproductive age who are covered by private health insurance and would reduce barriers to coverage of contraceptive services, including OTC contraceptives.

However, there is some complexity to the finalization of this rule. The incoming Trump administration could follow the recommendations of Project 2025 and rescind this rule in whole or in part. Additionally, if the rule is finalized, it currently falls within the Congressional Review Act look-back period and that could result in a Republican-controlled Congress disapproving the rule in its entirety next year.Continue Reading Proposed Rule Could Enhance Contraceptive Coverage If It Survives New Administration

On March 27, 2023, two United States Senators, Bill Cassidy, MD (R-LA) and Jeff Merkley (D-OR) introduced the bipartisan No Unreasonable Payments, Coding, or Diagnoses for the Elderly (“No UPCODE”) Act to address perceived financial incentives inherent in the Medicare Advantage patient risk scoring reimbursement methodology. Senator Merkley alleges that the current reimbursement…

On February 28, 2023, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a favorable advisory opinion regarding an arrangement through which a pharmaceutical company provides free enzyme replacement therapy (“ERT”) medication to patients who satisfy certain eligibility requirements where the patients’ insurer is delayed in making a coverage determination.

The OIG noted that, although the arrangement would generate prohibited remuneration under the federal Anti-Kickback Statute (“AKS”) if conducted with the requisite intent, it would not impose administrative sanctions. Further, the OIG opined that the arrangement would not generate prohibited remuneration under the beneficiary inducement prohibition (“Beneficiary Inducement CMP”).Continue Reading OIG allows drug company to provide free medication during coverage determination delay

On August 26, 2022, the Departments of Health and Human Services, Labor, and Treasury (the “Departments”) issued the highly anticipated Requirements Related to Surprise Billing (“August 2022 Final Rule”) and associated guidance materials concerning the independent dispute resolution (“IDR”) process established by the No Surprises Act. The August 2022 Final Rule is narrow in scope and responds to two recent decisions by the Eastern District of Texas vacating portions of the October 2021 Interim Final Rule, Requirements Related to Surprise Billing: Part II (“IFR II”), and incorporates stakeholder comments solicited by the Departments.

Importantly, as discussed more below, the August 2022 Final Rule removes the qualifying payment amount (“QPA”) as the presumptive factor in IDR payment decisions and requires health plans to submit additional information in the IDR process for cases where a claim at issue was “downcoded” by the plan.   

The August 2022 Final Rule will take effect October 25, 2022, 60 days after its publication in the Federal RegisterContinue Reading Departments issue new Final Rule and guidance materials for No Surprises Act IDR process

The Centers for Medicare & Medicaid Services (“CMS”) issued the first round of civil monetary penalties to two hospitals in Georgia for failure to comply with the requirements of the Hospital Price Transparency Final Rule (the “Rule”) on June 7, 2022.

According to the Notices of Imposition of a Civil Monetary Penalty published on the CMS Price Transparency Website, Northside Hospital Atlanta (“Northside Atlanta”) and Northside Hospital Cherokee (“Northside Cherokee”) failed to publish their standard charges and provide access to a machine-readable searchable tool, which would include standard prices for the hospitals’ items and services. CMS took this action after both hospitals failed to respond to the Warning Notices and Requests for Corrective Action Plans issued by CMS.

Effective January 1, 2021, hospitals must publish a machine-readable file that discloses the hospital’s negotiated rates with health plans, gross charges, discounted cash prices, and de-identified minimum and maximum negotiated charges for all items and services. Additionally, hospitals must publish a consumer-friendly, searchable tool that displays in plain language the prices of 300 shoppable medical services that a consumer can schedule in advance.Continue Reading CMS levies penalties for non-compliance with Hospital Price Transparency Rule

The Department of Health and Human Services’ Office of Inspector General (“OIG”) recently issued a favorable advisory opinion to a digital health company that offers direct monetary incentives to patients as part of a technology-enabled contingency management program for patients with substance use disorders.

Contingency management, also known as motivational incentives, is a treatment approach that utilizes tangible rewards to reinforce positive behaviors (e.g., abstinence from opioids) and to motivate and sustain behavioral health efforts (e.g., treatment adherence) in patients who suffer from substance use disorders. Because these monetary incentives are an integral part of the protocol-driven and evidenced-based program, the OIG concluded that it would not impose sanctions under the federal Anti-Kickback Statute (“AKS”) or the Beneficiary Inducements Civil Monetary Penalty (“CMP”) provision, notwithstanding the involvement of federal health care program beneficiaries, providers/suppliers, and reimbursable services.

Nevertheless, the mitigating facts that motivated the OIG’s favorable treatment of the program here—namely, the clinical nature and independence of the program—could likely trigger compliance with other federal and state regulatory frameworks.
Continue Reading OIG blesses digital health substance use disorder treatment program paid for by providers and suppliers

In an increasingly digital and interconnected world, the privacy and security of personal information is a significant concern. Applications and connected devices collect a bevy of personal information from consumers, including sensitive information about consumers’ health. Because of the sensitivity of health information, the United States has developed a variety of legal protections and enforcement…