In this article, we highlight additional updates issued by state and federal government authorities for the health care community in Massachusetts related to COVID-19....more
3/31/2020
/ 1135 Waivers ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Coronavirus/COVID-19 ,
Determination of Need (DoN) ,
Fee-for-Service ,
Health Care Providers ,
Medicaid ,
Nurses ,
Pharmacies ,
Prior Authorization ,
Relief Measures
On April 2, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule, updating Medicare Advantage (MA) and the prescription drug benefit program (Part D). ...more
4/9/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Enrollment ,
Final Rules ,
Medicare ,
Medicare Advantage ,
Medicare Part D ,
Pharmacies ,
Prescription Drug Coverage ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Standards
This week, the U.S. Food & Drug Administration (FDA) published draft guidance, describing FDA’s policy and process for evaluating bulk drug substances used in compounding by outsourcing facilities that are registered under...more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/ Draft Guidance ,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
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
Connecticut Governor Dannel P. Malloy recently signed into law Public Act 17-241 (PA 17-241), which contains provisions concerning facility fees, the sending and receiving of electronic health records between hospitals and...more