On April 21, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that clinicians participating in the Quality Payment Program (QPP) can earn credit in the Merit-based Incentive payment system (MIPS) by...more
In a Memorandum Opinion, Judge Amit P. Mehta, of the U.S. District Court for the District of Columbia, vacated a U.S. Department of Health and Human Services (HHS) Final Rule, just days before its July 9 effective date. The...more
7/11/2019
/ Advertising ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Drug Pricing ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency ,
Social Security Act ,
Trump Administration ,
Vacated
The Centers for Medicare and Medicaid Services (CMS) announced a final rule, to be published on May 23, 2019, amending the Medicare Advantage program (Part C) and Prescription Drug Benefit program (Part D) regulations. ...more
5/20/2019
/ Amended Regulation ,
Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Electronic Prescribing ,
Final Rules ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
Rulemaking Process
On May 10, 2019, the Centers for Medicare and Medicaid published a Final Rule on drug pricing transparency in consumer advertisements. ...more
5/16/2019
/ Advertising ,
Biologics ,
Biopharmaceutical ,
Centers for Medicare & Medicaid Services (CMS) ,
Direct to Consumer Sales ,
Drug Pricing ,
False Advertising ,
Final Rules ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price Transparency ,
Rulemaking Process
The Centers for Medicare and Medicaid Services (CMS) announced a Proposed Rule to amend Medicare Advantage (MA) regulations and Prescription Drug Benefit program (Part D) regulations. The Proposed Rule will be published on...more
On June 1, 2018, the Health Resources and Services Administration (HRSA) announced it was once again delaying the final rule that had set forth the calculation for the 340B Program ceiling price and drug manufacturer civil...more
On March 21, 2018, the Food and Drug Administration (FDA) published two guidance documents addressing postmarketing safety reporting requirements (PMSR) for combination products. The FDA had previously issued a Final Rule on...more
This week, the U.S. Food & Drug Administration (FDA) published draft guidance, describing FDA’s policy and process for evaluating bulk drug substances used in compounding by outsourcing facilities that are registered under...more
3/28/2018
/ Draft Guidance ,
Drug Compounding ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Pharmaceutical Distribution ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Standards ,
Section 503
In January 2018, the U.S. Food & Drug Administration (FDA) published two guidance documents on Compounded Drug Products That Are Essentially Copies Of Approved Drug Products under Section 503A and Section 503B of the Federal...more
On December 11, 2017, the Health and Human Services Office of Inspector General (OIG) posted a favorable Advisory Opinion, permitting a proposed pilot Program involving a collaboration between a pharmaceutical manufacturer...more
12/20/2017
/ Advisory Opinions ,
Electronic Medical Records ,
Federal Pilot Programs ,
Health Care Providers ,
Hospital Readmission ,
Manufacturers ,
Medicare Advantage ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs
The U.S. Food & Drug Administration (FDA) has issued important guidance on how to prepare for hurricanes when dependent on medical devices. FDA stresses that during hurricanes and other emergency situations, medical devices...more
On September 7, 2017, the HHS Office of Inspector General (OIG) issued an Advisory Opinion to the owner of a retail pharmacy chain (Pharmacy) that would allow Federal health care program beneficiaries to participate in a paid...more
On June 30, 2017, Connecticut Governor Dannel P. Malloy signed into law An Act Preventing Prescription Opioid Diversion and Abuse (Public Act No. 17-131). This legislation addresses opioid drug abuse in Connecticut by...more
On December 28, 2016, the Food and Drug Administration (FDA) issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The guidance clarified aspects of the reporting requirements under Part 806 (21 CFR...more