On May 17, 2021, the Biden Administration took its first major action impacting the 340B Drug Discount Program. In a forceful statement, the Administration made plain its views on a major controversy that has pitted drug...more
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
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
Long time readers of our blog may recall that five years ago, I predicted that 2014 might be a game-changing year for the 340B Drug Discount Program. 2014 saw attempts at regulatory changes, but a successful court challenge...more
3/5/2019
/ Covered Entities ,
Drug Pricing ,
HRSA ,
Medi-Cal ,
Medicare ,
Medicare Part B ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements ,
Section 340B
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
In an attempt to lower drug prices, CMS released a proposed rule last week to reduce payments for new drugs under the Part B program. CMS has proposed that effective January 1, 2019, for new drugs and biologicals that are...more
Timing is everything. In yesterday’s post on 340B, I stated in closing:
There is still one more shoe to drop. On May 4, 2018, the U.S. Court of Appeals heard oral arguments in the expedited appeal of American Hospital...more
7/18/2018
/ Centers for Medicare & Medicaid Services (CMS) ,
Dismissals ,
Drug Pricing ,
Health Care Providers ,
Jurisdiction ,
Medicare ,
Medicare Part B ,
Oral Argument ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Prescription Drugs ,
Section 340B
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
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
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
In January 2018, in the wake of the publication of the House Energy and Commerce Committee’s Review of the 340B Drug Discount Program, I wrote that it was too soon to know whether 2018 will be a game-changing year for the...more
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 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
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
Last week, the California Assembly Committee on Business and Professions voted in favor of Assembly Bill 315. AB 315 seeks to amend the California Business and Professions Code: (a) to require PBMs to obtain licensure from...more
4/26/2017
/ Business & Professions Code ,
Disclosure Requirements ,
Fiduciary Duty ,
Incentives ,
Licensing Rules ,
Pending Legislation ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Rebates ,
State and Local Government ,
Transparency
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
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
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
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
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
With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016. ...more
12/9/2015
/ AstraZeneca ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
FDA Approval ,
HRSA ,
Kickbacks ,
Kmart ,
Novartis ,
Pharmaceutical Industry ,
Pharmacies ,
Section 340B ,
Value-Based Purchasing