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
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
Although most of the recent focus around the implementation of the Inflation Reduction Act (“IRA”) by the press and industry stakeholders has been on the Medicare Drug Price Negotiation Program, the IRA has several other...more
The U.S. Supreme Court recently declined to review a Second Circuit decision that blocked Pfizer from implementing a cost sharing assistance program. Pfizer had sought to cover out-of-pocket expenses for financially eligible...more
Patient assistance programs (PAPs) that seek to subsidize patient co-payments for drugs covered by Medicare may involve compliance challenges. A recent U.S. Department of Health and Human Services (HHS) Office of Inspector...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
Effective January 1, 2022, the “No Surprises Act” signed into U.S. law as part of H.R. 133, “Consolidated Appropriations Act, 2021,” implicates (1) emergency services provided by non-participating providers at participating...more
New rules published last month likely require your employer health plan to phase-in certain disclosures over a three-year period beginning in one year: 1. January 1, 2022 (three files must be disclosed): For plan years...more
Although delayed as a result of the COVID-19 public health emergency, there are persistent and ongoing efforts to reform the Medicare Part D benefit. Since its June 2016 Report to Congress, the Medicare Payment Advisory...more
Providers have faced many challenges since the start of the COVID-19 pandemic and have needed to quickly react to changing laws and regulatory requirements impacting their operations. One such change is the restrictions on...more
Seyfarth Synopsis: Recently, the Trump Administration issued its proposed Notice of Benefit & Payment Parameter for 2021 regulations....more
Employer-sponsored health plans and health insurers may be required to post online - and to provide participants upon request - a range of pricing and cost-sharing information beginning in 2021. Proposed Affordable Care...more
On Jan. 4, 2018, the HHS Office of Inspector General (OIG) issued an open letter containing guidance regarding the provision of certain free drugs to federal healthcare program beneficiaries. Specifically, the OIG stated that...more
In this episode of Triage, Amanda Makki and Corbin Santo of the K&L Gates Public Policy and Law practice group discuss several fundamental issues that are currently at the center of the health care debate in Washington, DC....more
The chart below compares key provisions of the Affordable Care Act (ACA), the American Health Care Act (AHCA) and the Better Care Reconciliation Act (BCRA). This chart is current as of July 13, 2017, and as of that date,...more
To protect patients from receiving an unexpected surprise bill when they seek care at in-network facilities from out-of-network providers, Governor Brown signed AB 72: California’s surprise out-of-network law. The new law...more
This Week: 21st Century Cures Legislation Passes House in Bipartisan Vote... CMS Releases Proposed CY 2016 Home Health Prospective Pay Rule... CMS Releases Final CY 2016 Hospital Outpatient Prospective Payment System (OPPS)...more
As employers and plans prepare for 2016 open enrollment, they must be sure to address in their benefit design and with their third party vendors the new embedded out-of-pocket maximum limitations on individuals that were...more
Most health plan and health insurance policies include strategies that require persons covered under them to share in the costs that are paid. This strategy, often referred to as cost-sharing, serves two purposes. First, it...more