The U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) long-awaited administrative dispute resolution (ADR) final rule went into effect last week, on January 13, 2021. The...more
While health care entities often want to provide free or discounted items or services to patients (e.g., free transportation, co-payment waivers, free supplies), these free or discounted items or services pose risk under both...more
This week, the Friday surprise came courtesy of the D.C. Court of Appeals. In a long-awaited split decision, the court ruled that the U.S. Department of Health and Human Services (HHS) acted lawfully when it reduced Medicare...more
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
The Health Resources and Services Administration (HRSA) recently published guidance regarding the evolving impact of COVID-19 on 340B stakeholders. This new guidance is one part of the U.S. Department of Health and Human...more
Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR), Chairman and Ranking Member (respectively) of the Senate Finance Committee, have fired the latest shot in Congress’s ongoing battle against high drug prices. Last week, the...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
On Wednesday May 9th, I was floored when the Administration released the Spring 2018 Unified Agenda of Regulatory and Deregulatory Actions, which contained this nugget: by December 2018, HRSA will publish its 340B Omnibus...more
5/22/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
GAO ,
Health Care Providers ,
Manufacturers ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B ,
Trump Administration
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
Earlier this month the House Energy and Commerce Committee’s subcommittee on Government Oversight and Investigations held its second hearing on the 340B Drug Discount Program. The hearing followed on the heels of a July 18th...more
11/2/2017
/ CEOs ,
Charitable PAPs ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
FQHC ,
GAO ,
GPOs ,
HRSA ,
Medicare ,
OIG ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Prescription Drugs ,
Reporting Requirements ,
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
In March, I posted about the Uncertain Future of the 340B Drug Discount Program. When opining about What Could Happen Next I speculated about possible changes to government reimbursement for 340B drugs “so that government...more
7/17/2017
/ Budget Cuts ,
Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Medicare ,
Medicare Part B ,
MedPAC ,
OIG ,
Outpatient Prospective Payment System (OPPS) ,
Physician Medicare Reimbursements ,
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
On May 17, 2017 the American Bar Association convened its 27th National Institute on Health Care Fraud. I have attended many of the past annual meetings, and always enjoy the presentations and the opportunity to network with...more
5/29/2017
/ American Bar Association (ABA) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement ,
Exemptions ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Kickbacks ,
Materiality ,
Medicare Part D ,
OIG ,
Opioid ,
Universal Health Services Inc v United States ex rel Escobar ,
Yates Memorandum
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
More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback...more
12/12/2016
/ Affordable Care Act ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Co-payments ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Final Rules ,
Generic Drugs ,
Hospitals ,
Inducements ,
OIG ,
Pharmaceutical Industry ,
Safe Harbors
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
Thus far, 2016 has been a relatively quiet year for the 340B program at the federal level. Neither Congress nor the Health Resource and Service Administration (HRSA) has shown an appetite to take on the issues plaguing the...more
Recently, HHS-OIG announced a first-of-its-kind settlement over pharmaceutical manufacturer reporting of Average Sales Price (ASP). Sandoz, Inc. agreed to pay a civil monetary penalty of $12.64 million for alleged failure to...more
With all due credit to the Coroner from the Wizard of Oz, like the Wicked Witch of the East crushed by Dorothy’s house, the 340B Drug Discount Program mega-reg is “not only merely dead, it’s really most sincerely dead.” And...more
The U.S. Department of Health and Human Services (HHS) announced on April 9th a “historic” release of Medicare payment data to provide consumers with “unprecedented transparency on the medical services physicians provide and...more
I recently posted that 2014 is expected to be a year of major developments in the 340B Drug Discount Program, with HRSA receiving enhanced funding, stepping up audit activity, and drafting regulations in response to criticism...more
Outlining its high-level priorities and goals for the next five years, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) published its Strategic Plan for 2014-2018. In the Strategic...more