Medical Device Legal News with Sam Bernstein: Episode 19
Midyear Premium Increases and Cafeteria Plan Rules
K&L Gates Triage: An Insider’s Perspective on the Health Care Debate in Washington, DC
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
Collaborating Before The PTAB
Once again, the U.S. Departments of Labor, Health and Human Services, and the Treasury have issued guidance on the Affordable Care Act’s (ACA) required coverage of contraception without cost sharing, clarifying the permitted...more
On January 16, 2023, the Department of Health and Human Services (“HHS”) dropped its appeal of the U.S. District Court for the District of Columbia’s September 29, 2023 decision that vacated a portion of the 2021 Notice of...more
The Centers for Medicare & Medicaid Services (CMS) has announced new measures to enhance access to behavioral health services for Medicare beneficiaries and improve hospital price transparency as part of the final rule for...more
Summary - Employers taking advantage of copay accumulator programs now face unexpected administrative complications following a recent federal court decision....more
On September 29, 2023, the U.S. District Court for the District of Columbia vacated a Trump-era rule from 2021 that allowed insurers to exclude drug manufacturer co-pay support coupons and assistance from a patient’s annual...more
5 Questions is a periodic feature produced by Cornerstone Research, which asks our professionals, senior advisors, or affiliated experts to answer five questions. We interview Professor Erin Trish, of the Schaeffer Center...more
Summary - The Departments of Labor, Health and Human Services, and the Treasury have issued guidance that coordinates application of the No Surprise Billing rules under the Consolidated Appropriations Act, 2021, with the...more
On March 30, Judge Reed O’Connor of the U.S. District Court for the Northern District of Texas issued a decision in Braidwood Management Inc. v. Becerra (“Braidwood”), invalidating the Affordable Care Act’s (“ACA’s”) mandate...more
In a March 2023 ruling, a Texas federal district court vacated all actions taken by the Departments of Labor (“DOL”), Health and Human Services (“HHS”), and Treasury (collectively, the “Departments”) to implement or enforce...more
In light of the March 30 Braidwood Mgmt. Inc. v. Becerra decision, the Department of Labor, Department of Health and Human Services, and Department of the Treasury (the “departments”) have issued FAQ guidance on how the...more
Employers, at least for now, may have some relief from some of the Affordable Care Act (ACA) requirements to cover preventive care services without cost sharing under a nationwide injunction issued March 30, 2023, by a...more
Where did the time go? Just a brief 1,199 days after it began, the COVID-19 Public Health Emergency (PHE) is coming to an end. The PHE formally ends on May 11, 2023, short of any unexpected developments. And that means the...more
In response to Braidwood Mgmt. Inc. v. Becerra, a recent case striking down part of the Affordable Care Act (ACA) preventive services mandate, the US Departments of Labor, Health and Human Services, and the Treasury...more
On March 30, 2023, the District Court for the Northern District of Texas issued an opinion and order in Braidwood Mgmt. Inc. v. Becerra that vacates the implementation and enforcement of certain preventive service provisions...more
The Consolidated Appropriations Act of 2022 (“2022 CAA”), which was recently signed into law, reinstates the exception that allows high deductible health plans (“HDHPs”) to waive all or a portion of participant cost-sharing...more
The federal No Surprises Act (NSA), which went into effect January 1, 2022, protects patients from surprise medical bills for emergency services and for when they are treated by out-of-network providers in an in-network...more
On December 2, 2021, President Biden announced new actions to combat COVID-19, given the emergence of the new Omicron variant. As part of his nine-point plan, the President included a directive that “the more than 150...more
A few short weeks ago we told you in a blog post that, with only four days’ notice, the Departments of Labor, Treasury, and HHS (the Departments) required that, starting January 15, 2022, group health plans cover FDA-approved...more
On January 1, 2022, the Biden Administration’s Federal No Surprises Act (NSA) took effect. The NSA provides new protections against unsuspected medical bills. It is intended to combat the negative impact of the rising cost of...more
Revisions to preventive care and screening guidelines will require health plans and health insurance policies to provide 100 percent coverage for additional services for women, adolescents, children, and infants, following an...more
On Monday, the government issued frequently asked questions (FAQs) requiring employer group health plans (Plans) and health insurance issuers to cover certain over-the-counter (OTC) COVID-19 tests at no cost to the...more
Effective January 15, 2022, health plans are required to cover the cost of over-the-counter (“OTC”) COVID-19 test kits obtained without a health care provider’s prescription or clinical assessment. This new requirement was...more
Beginning January 15, 2022, and through the duration of the public health emergency, insurers and group health plans must cover at-home COVID-19 diagnostic tests available over-the-counter (OTC) without imposing cost-sharing,...more
Looking forward to the weekend? Many employers and plan administrators may also have been . . . up until yesterday, when the government issued new requirements that take effect on Saturday. ...more
On July 1, 2021, the Biden-Harris Administration issued “Requirements Related to Surprise Billing; Part 1,” an interim final rule (IRM) that will restrict health care providers and facilities from sticking patients with...more