Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more
On September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver of the long-standing HRSA...more
As the COVID-19 pandemic continues across the United States, states, payers, and providers are looking for ways to expand access to telehealth services. Telehealth is an essential tool in ensuring patients are able to access...more
As COVID-19 testing continues to increase throughout the nation, providers and patients alike are faced with the issue of who is responsible for covering the cost of testing. Whether a payor will reimburse for a COVID-19 test...more
The Centers for Medicare & Medicaid Services (CMS) on Nov. 18, 2019, published a proposed Medicaid Fiscal Accountability rule that would amend existing regulations related to 1) base and supplemental payments, 2)...more
The Trump Administration on Feb. 12 released its Fiscal Year (FY) 2019 budget request, titled "An American Budget." Unlike last year's budget, which was released in late May, the release of this budget conforms to the typical...more
Eric Zimmerman, along with McDermott+Consulting Vice Presidents Adaeze Enekwechi and Piper Su, wrote this +Insights publication detailing the possible effects of the Trump Administration's 2018 budget on health programs and...more
I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...more
I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more