A recent U.S. Department of Justice (DOJ) settlement should serve as a reminder that pharmaceutical manufacturers are not the only entity in the drug supply chain that are susceptible to enforcement actions with respect to...more
The Centers for Medicare & Medicaid Services (CMS) on March 30, 2020, issued blanket waivers of sanctions under the physician self-referral law (Stark Law), retroactive to March 1, 2020, in response to the COVID-19 pandemic...more
• The OIG issued an unfavorable advisory opinion on a proposed program by which a marketer would provide free drugs to hospitals to utilize in an inpatient setting to treat infantile epilepsy.
• Contrary to the typical...more
11/28/2018
/ Advisory Opinions ,
Anti-Kickback Statute ,
Drug Pricing ,
Fraud and Abuse ,
Free-Drug Programs ,
Health Care Providers ,
Health Insurance ,
Hospitals ,
OIG ,
Pharmaceutical Industry ,
Prescription Drug Coverage
• The Centers for Medicare & Medicaid Services (CMS) has announced a new proposed reimbursement model for certain Medicare Part B drugs and biologicals.
• The proposed structure, called the International Pricing Index (IPI)...more
11/15/2018
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Hospitals ,
Medicare ,
Medicare Part B ,
Pharmaceutical Industry ,
Pharmacies ,
Physician Medicare Reimbursements ,
Physicians ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Section 340B ,
Vendors
The Joint Committee on Health Care Financing of the Massachusetts legislature took up Bill S. 1048, an "Act to promote transparency and cost control of pharmaceutical drug prices," on Sept. 14, 2015. The bill initially was...more
The Centers for Medicare and Medicaid Services (CMS or the Agency) released a memorandum requesting comments regarding proposed changes to the 2016 star ratings systems for Medicare Advantage Plans (MA Plans) and Medicare...more
- CMS issues final Medicare Advantage and Part D regulatory changes after a controversial proposed rule was announced earlier this year.
- New requirements for the reporting and return of Medicare Advantage and Part D...more
The Medicare Advantage and Part D Final Call Letter announces requirements for the 2015 contract year, including changes to Part C and Part D star ratings and how CMS will evaluate Part D plan structures submitted for the...more
On May 23, 2013, CMS issued its Final Rule on Medical Loss Ratio (MLR) requirements for Medicare Advantage (MA) and Medicare Part D programs. MLR calculates the percentage of revenue used by MA organizations and Part D...more
On November 21, 2012, the Massachusetts Public Health Council (PHC) approved the final regulatory amendments implementing the Pharmaceutical and Medical Device Manufacturer Conduct Law, MGL ch. 111N, which was amended by Gov....more
The Massachusetts Board of Pharmacy (BOP) enacted emergency regulations effective November 1, 2012, in response to the deadly fungal meningitis outbreak caused by drug contamination at a Massachusetts compounding pharmacy....more
Governor Deval Patrick signed into law Massachusetts’ fiscal year 2013 budget on July 8, 2012. The budget includes amendments to the state’s Pharmaceutical and Medical Device Manufacturer Conduct Law, MGL ch. 111N. The...more