Podcast — UK FinReg Focus Areas in 2025: Wholesale Markets
On January 23, 2025, in Pharmaceutical Coalition for Patient Access v. United States, the Fourth Circuit held that a proposed patient assistance program, which would help cancer patients afford certain oncology drugs, would...more
On January 19, 2022, the Department of Health and Human Services, Office of Inspector General (“OIG”) released a favorable advisory opinion, OIG Advisory Opinion No. 22-01 (the “Opinion”), analyzing a proposed expansion of...more
Today, January 16, 2018 is the deadline for interested parties to submit comments to CMS regarding the proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule focuses on many issues. In...more
CMS has completed the 2016 Final Part D Payment Reconciliation. Each Medicare Part D plan sponsor’s reconciliation reports will be available on October 12, 2017....more
The OIG approved a retail pharmacy chain's proposal to expand its benefit program, which allows participating federal health care program beneficiaries to receive discounts and other benefits when purchasing certain products...more
The U.S. Senate Republicans on July 13, 2017, released an updated discussion draft of the Better Care Reconciliation Act of 2017 (BCRA), its bill to repeal and replace the Affordable Care Act (ACA). As we have outlined in a...more
U.S. Senate Republicans on June 22, 2017, released a discussion draft of the Better Care Reconciliation Act of 2017 (BCRA), its bill to repeal and replace the Affordable Care Act (ACA). The BCRA follows on the heels of the...more
On Friday, June 23, 2017, CMS released the Final Medicare Part D DIR Reporting Requirements for 2016. Part D sponsors may begin submitting their DIR information on June 30, 2017 and must finish their submissions by the end of...more
Yesterday, CMS released the Proposed Part D DIR (Direct and Indirect Remuneration) Reporting Requirements for 2016 and postponed the 2016 DIR Reporting deadline....more
The House Committee on Ways and Means and the House Energy and Commerce Committee released proposed legislation on March 6, 2017, to partially repeal and replace parts of the Affordable Care Act (ACA), which was signed into...more
On December 7, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a final rule creating additional “safe harbors” for the Federal Anti-Kickback Statute (42 USC § 1320a-7b(b) et...more
In an uncertain health care environment following the presidential election, the Department of Health & Human Services Office of Inspector General (“OIG”) finalized a new rule expanding existing safe harbors to the federal...more
Just last month the “Improving Transparency and Accuracy in Medicare Part D Spending Act” was introduced in the Senate to amend the Social Security Act. The bill seeks to prohibit Part D plans (and their contracted pharmacy...more