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
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
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
On July 2, a bipartisan group of six senators introduced legislation to waive 340B eligibility requirements for hospitals participating in the program during the COVID-19 pandemic. S. 4160 permits hospitals that are...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
On December 16, 2019, a nationwide coalition of hospitals sued HHS to block implementation of the 340B rate cuts contained in the 2020 Hospital Outpatient Prospective Payment System (“OPPS”) Final Rule. As detailed in our...more
The Centers for Medicare and Medicaid Services (CMS) recently published the 2020 Hospital Outpatient Prospective Payment System (OPPS) rule, which finalizes a proposed reduction in Medicare Part B reimbursement for certain...more
11/15/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Hospitals ,
Medical Reimbursement ,
Medicare Part B ,
Outpatient Prospective Payment System (OPPS) ,
Outpatient Services ,
Prescription Drugs ,
Public Comment ,
Regulatory Authority ,
Section 340B
The proposed 2020 Outpatient Prospective Payment (OPPS) rule was published on August 9, 2019. Buried in the 819 pages of proposed changes and justifications, CMS took another swing at cutting Medicare Part B reimbursement...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
The Federal Courts gave the America Hospital Association and 340B covered entities a late Christmas present and in doing so may have dealt a blow to the Trump Administration’s initiatives aimed at controlling or reducing drug...more
In this issue, we provide an overview of 62 recently unsealed qui tam cases and take an in-depth look at four of those cases. Two of the featured cases concern alleged schemes to provide unnecessary therapy to residents of...more
11/9/2018
/ Anti-Kickback Statute ,
False Claims Act (FCA) ,
Former Employee ,
Health Care Providers ,
Healthcare ,
Medicare ,
Medicare Part D ,
Physicians ,
Qui Tam ,
Relators ,
Settlement Agreements ,
TRICARE
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
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
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