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
Audrey Crowell is an associate in the Corporate Practice Group in the firm's Dallas office and a member of the Healthcare, FDA and Life Sciences teams.
This month, pharmaceutical manufacturer, Merck & Co., Inc. (“Merck”), as well as four chambers of commerce, have filed suits against the federal government, arguing that the Medicare Drug Price Negotiation Program introduced by the Inflation Reduction Act of 2022 stands in violation of multiple constitutional provisions.Continue Reading The Drug Price Negotiation Program Faces Pushback from Private and Public Industry Participants
In light of the increasing demand for mental health treatment and simultaneous provider shortages, the private insurance industry is rolling out targeted initiatives to increase mental health support for members by mitigating many of the barriers to entry facing the mental health industry today.Continue Reading Payor-Led Initiatives to Strengthen Mental Health Resources
On February 9, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released two highly-anticipated guidance documents (the “Guidance”) detailing the agency’s proposed implementation of the Medicare Part B (“Part B”) and Medicare Part D (“Part D”) Prescription Drug Inflation Rebate Programs (each, a “Rebate Program” and, collectively, the “Rebate Programs”). The Rebate Programs are administered as part of the prescription drug affordability provisions of the Inflation Reduction Act (the “IRA”), which is aimed at “lower[ing] out-of-pocket drug costs for people with Medicare and improv[ing] the sustainability of the Medicare program for current and future generations.” The IRA represents the most sweeping healthcare legislation passed by Congress since the Affordable Care Act. Please refer to our previous blog post on the IRA.Continue Reading CMS Releases Guidance on Implementation of Rebate Programs for Certain Medicare Part B and Part D Drugs
On October 5, 2022, the Office of Inspector General (“OIG”) posted Advisory Opinion No. 22-19 (the “Opinion”), which limits the ability of pharmaceutical manufacturers to offer cost-sharing subsidies to Medicare Part D (“Part D”) beneficiaries via 501(c)(3) charities without running afoul of the Federal Anti-Kickback Statute (the “AKS”).Continue Reading OIG Limits Pharmaceutical Manufacturers’ Ability to Offer Drug Cost-Sharing Subsidies
On July 25, 2022, the U.S. Department of Health and Human Services (“HHS”) issued a proposed new rule that significantly expands the scope of protection available to vulnerable populations under Section 1557 of the Affordable Care Act (the “ACA”).Continue Reading Proposed Rule Leverages Section 1557 for Healthcare Equity
Last month, in Cummings v. Premier Rehab Keller, P.L.L.C., the Supreme Court denied a petitioner’s right to emotional distress damages in a private action brought under federal anti-discrimination laws. The Petitioner, a woman who is both deaf and legally blind, alleged that when she requested an American Sign Language interpreter at Premier Rehab Keller (“Premier”), the clinic denied her request, resulting in her inability to receive treatment. She filed suit under Section 504 of the Rehabilitation Act (“Rehab Act”) and Section 1557 of the Affordable Care Act (“ACA”), two federal statutes that prohibit recipients of federal funding from discriminating in the delivery of services based on disability. The Fifth Circuit dismissed her claim, reasoning that emotional distress damages are categorically unavailable in private actions and cannot be used to enforce either the Rehab Act or the ACA. As explained below, the Supreme Court affirmed the Fifth Circuit ruling.Continue Reading Supreme Court Discrimination Case Narrows Scope of Restitution for Individuals
Texas HB 1445, which went into effect on January 1, 2022, exempts medical billing services performed before the submission of the relevant insurance claim from state sales tax. The new legislation legally exempts medical billing services from the statutory definition of taxable “insurance services.” Practically speaking, this relieves management services companies, and ultimately physicians and patients, from bearing the burden of tax payments of up to 8.25% for the provision of certain medical billing services. The legislation is hailed by many as a meaningful step in lowering needlessly high healthcare costs, which are felt by patients and providers alike.
Continue Reading Tax Break for Certain Medical Billing Services in Texas
Scope of practice expansion has been a hot-button issue within medical communities and state legislatures for more than thirty years. The debate is centered on what services advanced practice providers (“APPs”) who hold Master’s Degrees (e.g., Physician Assistants, Nurse Practitioners, Pharmacists, Dental Hygienists, etc.) should or should not be able to furnish in their professional practices. Scope of practice is defined by state regulatory boards, often based on limitations established by state legislatures.
Continue Reading Debate Continues Around Scope of Practice Expansion for APPs