The Centers for Medicare & Medicaid Services (CMS) has taken another step to further the adoption of value-based purchasing within the health care industry. (Readers may recall the Department of Health & Human Services’ two...more
6/26/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Medicaid ,
OIG ,
Proposed Regulation ,
Proposed Rules ,
Safe Harbors ,
Trump Administration ,
Value-Based Purchasing
For much of the past 18 months, the Trump Administration, and in particular CMS, have talked a good game regarding reducing pharmaceutical prices. On October 16, 2018, a key component of the Administration’s strategy was...more
10/24/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Drug Wholesaling ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements ,
Section 340B ,
Transparency ,
Trump Administration
It seems like every week, there are multiple new developments in the 340B program. While it has just been a few weeks since my last 340B blog post, since that time we have had another Senate hearing, a new GAO Report, a new...more
7/17/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Drug Pricing ,
GAO ,
HRSA ,
Medicaid ,
Medicare Part B ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B ,
Trump Administration
State Medicaid Agencies have historically engaged in an epic balancing act. Federal law requires State Medicaid Agencies to ensure beneficiaries have access to medically necessary services. Federal law also requires State...more
It has been a few weeks since the publication of the Trump Administration’s Blueprint to Lower Drug Prices, and Secretary Azar’s Request for Information (RFI) on the Blueprint. We previously posted about the Blueprint’s focus...more
6/19/2018
/ 1115 Waivers ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Generic Drugs ,
Medicaid ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements ,
Section 340B ,
Trump Administration
There are now multiple proposals in the House and Senate for substantive changes to the 340B Drug Discount Program. The odds of a legislative “fix” to 340B are increasing. But independent of congressional action, is CMS...more
5/2/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
HRSA ,
Legislative Agendas ,
Medicaid ,
Medicare ,
OPPS ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Physicians ,
Prescription Drugs ,
Section 340B
I previously said that the year 2014 may be a game-changer for the 340B Drug Discount Program. Increasing HRSA audits, a lawsuit over the 340B Orphan Drug Rule, and HRSA’s promise to issue a 340B mega-regulation, all pointed...more
1/18/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
GAO ,
HRSA ,
Medicaid ,
Medicare Part B ,
OIG ,
Omnibus Guidance ,
Orphan Drugs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
On August 17, 2017, the U.S. Department of Justice (DOJ) announced that it had reached a $465 million false claims settlement with Mylan, the manufacturer of EpiPen, over the company’s alleged underpayment of Medicaid Drug...more
8/23/2017
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Generic Drugs ,
Medicaid ,
Medical Devices ,
Mylan Pharmaceuticals ,
OIG ,
Prescription Drug Coverage ,
Prescription Drugs ,
Qui Tam ,
Rebates ,
Section 340B ,
Settlement
On July 18, 2017, just days after CMS went public with its proposal to reduce Medicare Part B reimbursement to certain 340B covered entities, Congress held its first hearing on 340B Program Oversight since March 2015. A...more
7/26/2017
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
GAO ,
HRSA ,
Medicaid ,
Medicare Part B ,
OIG ,
Omnibus Guidance ,
Orphan Drugs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
The latest installment in the ongoing saga over EpiPen Medicaid Drug Rebates came on May 31, 2017, when Senator Charles Grassley issued a press release stating that between 2006-2016 taxpayers may have overpaid for EpiPen by...more
6/7/2017
/ Brand Name Prescription Drugs ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Generic Drugs ,
Medicaid ,
Medical Devices ,
Mylan Pharmaceuticals ,
OIG ,
Prescription Drug Coverage ,
Rebates
Here we are in March 2017 and no one is sure where things stand with the 340B Drug Discount Program. HRSA and its oversight of the 340B program are subject to the recent Executive Orders restricting issuance of federal...more
3/16/2017
/ Affordable Care Act ,
Drug Pricing ,
Executive Orders ,
HRSA ,
Medicaid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Repeal ,
Section 340B ,
Trump Administration
Earlier this week, the Office of Inspector General for the Department of Health and Human Services (“OIG”) posted its fiscal year (“FY”) 2016 data about Medicaid Fraud Control Units (“MFCUs”) across the country....more
For several years now, the public outcry over the issue of drug pricing and reimbursement has increased in frequency and fervor. At least one government agency wants you to know that it has been listening and wants to help...more
Back in early October, we were all transfixed by the announced Mylan settlement with the U.S. Department of Justice (DOJ) over Mylan’s alleged underpayments of Medicaid Drug Rebates for the EpiPen. Although Mylan indicated...more
Before we all turn our full attention to the nominations of Representative Tom Price as Secretary of Health and Human Services, and policy consultant Seema Verma to lead CMS, we need to remember that there are still...more
Our eyebrows were raised by Mylan’s October 7, 2016 announcement that it had reached a $465 million “settlement” with the United States Department of Justice (DOJ) and “other government agencies” over its Medicaid Drug Rebate...more
Last week, Mintz Levin and ML Strategies released a joint Alert analyzing key provisions of the Covered Outpatient Drug final rule (“Final AMP Rule”) and their impact on manufacturers, pharmacy benefit managers (“PBMs”), and...more
In late January, the Centers for Medicare & Medicaid Services (“CMS”) released the much anticipated Covered Outpatient Drugs Final Rule with Comment (the “AMP Final Rule”). The rule creates the regulatory definition for...more
We have now had more than 30 days to digest HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance (“Proposed Guidance”), intended to clarify expectations and provide guidance on key issues in the 340B Program. There are...more
10/8/2015
/ Comment Period ,
Covered Entities ,
Drug Pricing ,
Health Care Providers ,
Healthcare ,
Hospitals ,
HRSA ,
Interpretive Rule ,
MCOs ,
Medicaid ,
Medicare ,
Omnibus Guidance ,
Patients ,
Pharmaceutical Industry ,
Pharmacies ,
Proposed Regulation ,
Section 340B ,
State Medicaid Programs
As a veteran of the AWP litigation era, I am struck by the recent state efforts to legislate transparency into pharmaceutical pricing. Multiple states have introduced bills that would require pharmaceutical manufacturers to...more
8/26/2015
/ Attorney General ,
Disclosure Requirements ,
Drug Pricing ,
Fraud ,
Medicaid ,
Pending Legislation ,
Pharmaceutical Industry ,
Pharmacies ,
Transparency ,
Whistleblowers ,
Wholesale
New York State Attorney General Eric Schneiderman recently announced that his office had reached a $2.5 million settlement in a federal False Claims Act (FCA) case with Trinity HomeCare and its related entities. The case,...more
The 340B Drug Discount Program has operated for more than 20 years with just a few governing regulations codified in 42 CFR Part 10. Through the Affordable Care Act (“ACA”), Congress adopted several amendments to the 340B...more
On May 27, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published a 653-page proposed rule affecting the thirty-nine states (plus the District of Columbia) that use managed care organizations (“MCOs”) to...more
In early April, Colorado joined multiple other states in passing a biosimilar substitution law that addresses the circumstances under which an FDA-approved interchangeable biosimilar product may be substituted for the...more
As states attempt to control increasing healthcare costs, many Medicaid programs are seeking approval from the Centers for Medicare & Medicaid Services (CMS) to implement Medicaid managed care programs. In 2013, nearly 68...more