Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Podcast: IP(DC): Drug Prices, Political Pressures & Patents
As discussed in last week’s Regs & Eggs blog post, the US Department of Health and Human Services (HHS) recently released additional budget documents to support the department’s fiscal year (FY) 2026 discretionary request....more
The Centers for Medicare & Medicaid Services (CMS) recently made meaningful changes to its regulations interpreting the Affordable Care Act’s (ACA’s) so-called “60-day Rule,” which requires Medicare providers to affirmatively...more
In its Final Rule for the 2025 Medicare Physician Fee Schedule, CMS announced changes to the Medicare Shared Savings Program (the Program) targeted at incentivizing providers to both enroll and stay in the Program. The Final...more
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
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
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
"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
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 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 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
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
With the passing of summer and the children back in school, it is time to get to work and check on benefit compliance items that you may have missed over the summer. Below is a short summary of a number of developments....more
When it comes to something as crucial as health care, let’s keep it simple: Americans deserve better than this …...more
Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Highlights this week: PBMs next in Senate committee’s crosshairs; lawmakers continue scrutiny on insulin prices;...more
Coming Week’s Highlights: State of the Union scheduled for Feb. 5; House committees continue discussion on pre-existing conditions....more
Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Highlights this week: Trump will discuss healthcare and drug costs in this week’s State of the Union address;...more
This Week: The government shutdown continues; Congress finishes organizing and finalizing committee members and begins to focus on the issues. Concern has been raised that the Centers for Medicare and Medicaid Innovation...more
Highlights this week: Nearly 7,000 FDA employees are furloughed amid the ongoing government shutdown; lawmakers introduce a slew of anti-pharma bills; 18 new Democrats land plum spots on key healthcare committees; and more....more
Highlights this week: Democrats’ takeover of the House will yield big changes for healthcare policy in 2019; several GOP lawmakers active in healthcare policy are defeated; pharma pushes for Part D changes in the lame duck;...more
Anticipating open enrollment season for coverage in 2019, the Centers for Medicare and Medicaid Services (CMS) released coverage and premium information that will factor into consumer decisions about Medicare and individual...more