Mintz’s PBMs & Pharmacies practice is pleased to present the second edition of our Mintz IRA Update, a regular publication that delves into developments under the Inflation Reduction Act of 2022 (“IRA”) impacting the health...more
Today, the Centers for Medicare & Medicaid Services (CMS) released the first 10 drugs (“Listed Drugs”) that will be included in the Inflation Reduction Act’s Medicare Drug Price Negotiation Program (“Negotiation Program”)....more
On April 22, 2021, Reps. G.K. Butterfield (D-NC) and David McKinley (R-WV), along with 22 co-sponsors from both major parties, introduced H.R. 2759, “A Bill to amend title XVIII of the Social Security Act to provide for...more
On June 26, the Department of Health and Human Services Office of the Inspector General (OIG) issued Advisory Opinion No. 20-03 approving the payment by a discount medical plan organization (DMPO) of a five dollar ($5.00) fee...more
On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued blanket waivers to the Stark Law that permit certain arrangements between physicians and health care providers implemented in response to COVID-19...more
4/1/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Deadlines ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Medicare ,
OIG ,
Relief Measures ,
Stark Law ,
Telehealth ,
Telemedicine ,
Time Extensions ,
Waivers
In an unexpected turn of events, the Trump administration has apparently reversed course and has withdrawn the proposed rule that would have amended the discount safe harbor under the Anti-Kickback Statute to eliminate...more
7/12/2019
/ Anti-Kickback Statute ,
Drug Pricing ,
Executive Orders ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Price Transparency ,
Proposed Rules ,
Safe Harbors ,
Secretary of HHS ,
Trump Administration
On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration’s plan to lower drug prices and reduce out-of-pocket costs....more
5/14/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Manufacturers ,
Medicaid ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Comment ,
REMS ,
Section 340B ,
Trump Administration
A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post...more
5/23/2017
/ Biologics ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
HCPCS ,
Healthcare Reform ,
Innovation ,
Legislative Agendas ,
Medicare ,
Medicare Part B ,
Obama Administration ,
Pharmaceutical Industry ,
Reimbursements ,
Rollbacks ,
Trump Administration
On March 30, 2015, CMS released guidance addressing Medicare and Medicaid coverage for biosimilar drug products. The Medicare/Medicaid coverage guidance comes on the heels of the FDA’s landmark approval of a biosimilar...more
Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its final rules on policy and technical changes to the Medicare Advantage (MA) and Prescription Drug Benefit programs (Part D) for contract year...more
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Fiscal Year 2015 Work Plan on October 31. The Work Plan provides the OIG’s planned reviews and activities with respect to...more
Following an onslaught of criticism, CMS told Congress today that it will not move forward with certain controversial provisions of its proposed rule on the Medicare Advantage and Medicare Part D prescription drug program. ...more
On Jan. 10, the Centers for Medicare & Medicaid Services (CMS) published proposed rules labeled as ‘‘policy and technical’’ changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs....more
On Jan. 10, the Centers for Medicare & Medicaid Services published proposed rules labeled as ‘‘policy and technical’’ changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs....more
On January 27, 2014, the U.S. Department of Justice issued a press release announcing that its Medicare Fraud Task Force had “set record numbers for health care prosecutions in Fiscal Year 2013.” ...more
On January 10, the Centers for Medicare & Medicaid Services published proposed rules labeled as “policy and technical” changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs. If...more
On January 10, the Centers for Medicare & Medicaid Services (CMS) published proposed rules labeled as “policy and technical” changes to the Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) Programs....more
On October 11, 2013, CMS posted the 2014 Medicare Health Plan Quality and Performance Ratings, which are commonly referred to as “Star Ratings.” CMS released the 2014 Star Ratings several days later than originally...more
Representative Jackie Speier (D-Calif) has introduced a bill (HR 2914) that would eliminate advanced diagnostic imaging, anatomic pathology, radiation therapy, and physical therapy services from the Stark Law’s in-office...more
Starting June 17, state Medicaid Fraud Control Units (MFCUs) can use federal funding to pay for data mining, according to a final rule published by the Department of Health and Human Services Office of Inspector General in...more
In a newly issued Report, the OIG has expressed concern regarding CMS’s lack of oversight of P&T Committee conflicts of interest. As the entities responsible for making Medicare Part D formulary decisions, P&T Committees...more
In Advisory Opinion 12-21, the OIG concluded that a Federally qualified health center’s offer of grocery store gift cards to capitated managed care patients would not constitute grounds for the imposition of sanctions under...more
Originally published in BNA’s Medicare Report, 11/30/2012.
On Oct. 12, the Centers for Medicare & Medicaid Services published its 2013 Medicare Health Plan Quality and Performance Ratings, also called ‘‘Star Ratings’’...more