In a significant development with far-reaching implications for health plans and pharmacy benefit managers (PBMs), Judge John D. Bates of the U.S. District Court for the District of Columbia has recently struck down a federal...more
On September 27, 2023, the Chief Judge of the District of Massachusetts decided that the standard in False Claims Act (“FCA”) cases premised on alleged violations of the Anti-Kickback Statute (“AKS”) is but-for causation....more
Although most of the recent focus around the implementation of the Inflation Reduction Act (“IRA”) by the press and industry stakeholders has been on the Medicare Drug Price Negotiation Program, the IRA has several other...more
On May 17, the U.S. District Court for the District of Columbia issued a decision vacating the Accumulator Adjustment Rule, regulations issued by the Centers for Medicare and Medicaid Services (CMS) in December 2020 as part...more
Drug Pricing Initiatives: Discussion continues in Congress and among stakeholders of drug pricing reform measures, including those that were originally part of H.R. 5376 (the Build Back Better Act, or BBBA). ...more
Medicare premiums are rising sharply next year, cutting into the large Social Security cost-of-living increase. The basic monthly premium will jump 15.5 percent, or $21.60, from $148.50 to $170.10 a month. The Centers for...more
With the spread of COVID-19, barriers to testing, treating, and getting paid for coronavirus-related care and containment efforts are being identified and addressed by federal and state regulators on a daily basis. ...more
CMS just released the 2020 final rule with changes to remote patient monitoring (RPM), officially titled “Chronic Care Remote Physiologic Monitoring,” reimbursed under the Medicare program, as part of the Physician Fee...more
Study finds that Marketplace premiums are lower than employer-based premiums, even without federal subsidies; New York regulators move to shield insurers from outsized federal risk adjustment payments; and Missouri will seek...more
Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more
Arizona seeks Medicaid Waiver to implement new coverage restrictions for Medicaid expansion enrollees and delivery system reform; Tennessee’s uninsured rate continues to drop; and Louisiana gubernatorial candidates line up...more
The trend toward placing more Medicare beneficiaries into observation status in the hospital has come under increasing attack by patient advocates. Such patients are considered outpatients reimbursed by Medicare Part B rather...more
In This Issue: - Connecticut Supreme Court Rules State Does Not Recognize Mature Minor Doctrine - OIG Issues Advisory Opinion Permitting Copayment Assistance - CMS Announces Recovery Audit Program...more
In This Issue: - CMS Updates Guidance on Hospital Governing Body and Medical Staff Conditions of Participation (CoPs) - DOL Announces Delay of Home Care Minimum Wage Enforcement - OIG Releases Special...more