Drug Prices Numerous State Laws and Pending Bills Intended to Address Rising Drug… Thomas Sullivan Nov 13, 2019 0 While the federal government continues to debate various policies for lowering prescription drug prices, many states have already…
FDA FDA Issues Four Final Guidances on 510(k) Medical Device Programs Thomas Sullivan Nov 12, 2019 0 The US Food and Drug Administration (“FDA”) recently issued four final guidance documents related to 510(k) medical device…
Clinical Research Step Therapy: Is it Really More Cost Effective? Thomas Sullivan Nov 11, 2019 0 Step therapy, the requirement that more cost effective/inexpensive drugs and therapies must be prescribed for a patient before a…
HHS HHS Secretary Alex Azar Addresses Changes to Kidney Care Reimbursement Thomas Sullivan Nov 8, 2019 0 On Thursday, November 7, 2019, Health and Human Services (HHS) Secretary Alex Azar spoke at the American Society of Nephrology…
CMS Physicians Disagree with Judge Who Struck Down Site-Neutral Payments Thomas Sullivan Nov 7, 2019 0 In September 2019, District of Columbia Federal Judge Rosemary Collyer issued a court ruling that struck down the Trump…
CMS CMS Moves Forward with OPPS, Resulting in 340B Payment Changes Thomas Sullivan Nov 6, 2019 0 Despite a ruling from a federal judge earlier this year, the United States Centers for Medicare and Medicaid Services (CMS) has…
CME 2020 Physician Fee Schedule Includes Changes to Open Payments and CME… Thomas Sullivan Nov 5, 2019 0 As we reported in July, the Centers for Medicare and Medicaid Services (CMS) was proposing changes to the CME industry and Open…
Medical Legal Allergan Subsidiary Forest Settles for $750 Million in Namenda Class Action… Thomas Sullivan Nov 4, 2019 0 On October 28, 2019, Allergan announced that its subsidiaries, several units of Forest Laboratories, have reached an agreement to…
Congress US House HELP Committee Debates Pelosi’s Drug Pricing Bill Thomas Sullivan Nov 1, 2019 0 Recently, the House Health, Employment, Labor and Pensions (“HELP”) Subcommittee held a hearing to consider testimony and discuss…
Anti Kickback Two Charities to Pay $6 Million to Resolve Kickback Claims Thomas Sullivan Oct 31, 2019 0 On October 25, 2019, the United States Attorney’s Office for the District of Massachusetts announced that two foundations, Chronic…