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
On August 4th, the Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) published the 2021 Hospital Outpatient Prospective Payment System (OPPS) proposed rule. The rule proposes to...more
8/10/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Drug Pricing ,
Health Care Providers ,
Hospitals ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Section 340B
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
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
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 November 1, 2017, CMS announced that it is in fact cutting Medicare Part B reimbursement for 340B drugs to the tune of $1.6 billion. To be accurate, what CMS announced is its intent to finalize proposed rule changes to the...more
11/3/2017
/ Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Drug Pricing ,
Final Rules ,
HCPCS ,
Medicare ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Physician Medicare Reimbursements ,
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
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
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
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
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
Last week, under the cover of the impending Thanksgiving Holiday, OIG lobbed another grenade at the 340B Drug Discount Program. The means of delivery was an OIG Report on Medicare Part B payments for 340B drugs which...more
Our recent post on HRSA’s Omnibus Proposed Guidance for the 340B Drug Discount Program (Proposed Guidance) noted that since the DC District Court had yet to rule on the validity of HRSA’s “interpretive” 340B orphan drug rule,...more
10/21/2015
/ Affordable Care Act ,
Comment Period ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Covered Entities ,
Drug Pricing ,
HRSA ,
Interpretive Rule ,
Omnibus Guidance ,
Orphan Drugs ,
Pharmaceutical Industry ,
Pharmacies ,
PHRMA ,
Section 340B
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