The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
340B Drug Pricing Program Compliance
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Podcast: Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act - Diagnosing Health Care
Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act
Edible Bites Episode 3: Cannabis and Life Sciences Video Webinar Series
Health Care Continues to Drive False Claims Act Recoveries: Thought Leaders in Health Law Video Series
Drug Pricing Initiatives During the Trump Presidency
Bill on Bankruptcy: AMR Make-Whole Opinion Vulnerable on Appeal
On August 20, 2024, OIG issued Advisory Opinion No. 24-07 in which it responded to a request for an advisory opinion regarding a nonprofit grant-making organization’s (Requestor) proposal to fund a patient assistance program...more
A bipartisan group of attorneys general from 31 states and the District of Columbia filed an amicus brief in support of a petition for certiorari by Oklahoma’s insurance commissioner to review a decision by the U.S....more
The price of prescription drugs has brought scrutiny to the entire drug supply chain. Congress and other policymakers continue to seek opportunities to lower costs for patients and the federal government. Pharmacy benefit...more
The U.S. Court of Appeals for the 10th Circuit issued a sweeping decision that (1) maintains long-standing federal protections for employer and union-sponsored health plans to design their health benefit plans, including...more
The US Court of Appeals for the Tenth Circuit recently held in Pharmaceutical Care Management Association (PCMA) v. Mulready that the Employee Retirement Income Security Act (ERISA) and Medicare Part D preempted several...more
A recent decision by the Supreme Court clarified the required intent for a defendant to be held liable under the False Claims Act. According to the Court, the FCA’s scienter requirement refers to a defendant’s knowledge and...more
This legislative session, Florida has joined Arkansas and Oklahoma among the most regulatory-minded states with respect to pharmacy benefit plans and programs as well as pharmacy benefit managers (PBMs). Florida's...more
The Centers for Medicare & Medicaid Services (CMS) recently issued initial guidance on how the agency expects the Medicare Drug Price Negotiation Program (the “Negotiation Program”) to operate. The Negotiation Program was...more
Despite a busy 2022, drug pricing remains a hot topic at the federal and state levels, with a number of recent developments and trends worth monitoring heading into 2023. In the past year, the FTC increasingly focused on the...more
2022 Medicaid Drug Rebate Program Summit Concludes: The annual Medicaid Drug Rebate Program Summit took place Oct. 12-14 in Chicago. Latham partner Christopher H. Schott spoke at two sessions: the panel “Ask the Attorneys:...more
States remain at the forefront of legislative efforts on a range of issues relating to drug pricing, such as increasing price transparency, capping out-of-pocket costs for insulin, and limiting certain PBM practices. These...more
The U.S. House of Representatives is expected today to pass legislation passed by the U.S. Senate that will significantly alter the landscape for pharmaceutical pricing and reimbursement under the Medicare program for certain...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
The next post in our series analyzing the recently proposed Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs rule (Proposed Rule) focuses on a...more
This morning, the U.S. House passed drug pricing legislation as part of the Build Back Better Act (BBBA) (specifically the Rules Committee version available here and the manager’s amendments available here). In prelude to...more
Connecticut has recently notified pharmacies and prescribing providers that various quantity limits and refill criteria will revert back to pre-COVID 19 requirements come May 21, 2021. The reinstatement of pre-COVID 19...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
On November 20, 2020, the U.S. Department of Health & Human Services (HHS) finalized a rule to take effect in 2022, which eliminates the safe harbor under the federal anti-kickback statute for manufacturer rebates to Medicare...more
The first ever VIRTUAL Managed Care Compliance Conference will have the great speakers and content you have come to expect from the in-person event. Each year, we look forward to hosting compliance professionals at our...more
Manufacturers and providers participating in the 340B Drug Pricing Program have entered into a new phase of tensions this summer, as manufacturers push back on the use of contract pharmacies by providers. At least one major...more
The recent Centers for Medicare & Medicaid Services (CMS) memorandum to all Medicare Advantage Organizations, Part D Sponsors, and Medicare-Medicaid Plans (CMS Memo) does not provide any express relief for specialty...more
On Monday, March 9, 2020, the Centers for Medicare and Medicaid (CMS) released information on permissible flexibilities and obligations that are in effect during a disaster and emergency resulting from COVID-19....more
The Centers for Medicare & Medicaid Services (CMS) published the Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program,...more
The Centers for Medicare & Medicaid Services (CMS) recently released three items relating to the Medicare Advantage and Part D programs: a proposed rule, Part II of the Advance Notice and Rate Announcement for Calendar Year...more
On February 5, 2020, CMS issued a proposed rule advancing multiple updates and changes to Medicare Advantage (MA) and Medicare prescription drug benefit (Part D) programs (Proposed Rule). Unlike in past years, CMS will not...more