Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Podcast: IP(DC): Drug Prices, Political Pressures & Patents
The 60-day Refund Rule, created by the 2010 Affordable Care Act, requires providers to report and return Medicare and Medicaid overpayments within 60 days of identifying them. See Section 1128J(d) of the Social Security Act,...more
In a recent On the Subject (available here), we reported on the impact of the final rule (final rule) interpreting Section 1557 of the Affordable Care Act (ACA) on self-funded group health plans that contract with licensed...more
Over the last two months, there has been a steady influx of regulatory and legislative efforts regarding drug pricing and the pharmacy industry. To streamline your review, we summarize below a few noteworthy developments that...more
On April 15, the Centers for Medicare & Medicaid Services (CMS) released a fact sheet on the potential national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV. CMS...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
Before the Thanksgiving holiday, the Centers for Medicare & Medicaid Services (CMS) issued two proposed regs that would make changes to certain health insurance plan policies starting in 2025: one impacting Medicare Advantage...more
Medicare Advantage Organizations and Part D sponsors have a responsibility to ensure they offer and provide their members and potential enrollees with content and materials in alternate languages or accessible formats for...more
Here we are in fourth quarter of 2023 already! As companies start wrapping up 2023 and preparing and modeling for 2024, we thought it was a good time to highlight five regulatory developments, changes, or challenges on the...more
Transgender protections and rights in the workplace are currently the subject of much confusion. This issue extends to employer-sponsored health plans. Whether an employer-sponsored health plan must cover gender-affirming...more
"Rather than reacting, you must be proactive and preventive. By doing this, you will not only be prepared for the potential obstacles that face your company, but you will most likely eliminate obstacles before they appear." ...more
The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims...more
On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule which, in part, seeks to amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for when an...more
After almost a year of negotiations among congressional Democrats and the White House, the Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022. It passed in the US Senate by a vote...more
On August 16, President Biden signed into law the Inflation Reduction Act of 2022 (P.L. 117-169; the “Act”). Although the Act differs considerably from the wide-ranging domestic economic package Democrats had initially...more
Congress ended a busy work period after passing the Inflation Reduction Act (IRA) last week. This Holland & Knight alert summarizes the healthcare provisions in the IRA and provides an outlook on health policy issues that may...more
The U.S. Senate on Aug. 7, 2022, passed the Inflation Reduction Act of 2022 (IRA). This comprehensive legislation is the result of many months of negotiations among Democrats to advance some of President Joe Biden's highest...more
On March 17, the same day we wrote about proposed legislation in Connecticut to cap drug price increases, Governor Charlie Baker of Massachusetts included a similar proposal in his proposed budget. Similar to the Connecticut...more
Medicare and Medicaid programs themselves are not old enough to qualify for Medicare coverage (quick history lesson: President Lyndon Johnson signed the Social Security Amendments into law on July 30, 1965, and the Medicaid...more
On January 6, 2022, the Centers for Medicare and Medicaid Services (“CMS”) issued the proposed rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs...more
On November 19, 2021, the U.S. House of Representatives voted to approve the Build Back Better Act (H.R. 5376, the “BBB Act”), the budget reconciliation bill that includes much of President Biden’s economic and social policy...more
The Big Picture - Before leaving for its August recess, the Senate made progress on two major Biden Administration priorities by passing bipartisan infrastructure legislation and a fiscal year (FY) 2022 budget resolution....more
On April 28, 2021, President Biden gave his first address to Congress and announced the American Families Plan (AFP or the Act). The AFP follows the 1.9 trillion-dollar stimulus, the American Rescue Plan Act, signed into law...more
The Biden Administration wasted no time in implementing some of the new President’s campaign promises relating to health insurance and the Affordable Care Act (“ACA”). First, on February 10 the Department of Justice filed a...more
Health care policy has been a key issue leading up to the 2020 elections, and the final outcome of the presidential and congressional elections will likely impact the health care policy priorities of the future. While the...more
On November 20, 2020, 60 days before the end of his Administration, President Trump announced a series of major drug pricing regulations. This Alert summarizes the Most Favored Nation Model (“MFN Model”) for Medicare Part B...more