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Biden Administration Throws Down Its First Gauntlet on 340B
May 18, 2021 | Blog
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 manufacturers against 340B covered entities for the past year - proclaiming that drug manufacturers are violating the 340B statute by restricting covered entity access to 340B discounts for drugs dispensed through 340B contract pharmacies.
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340B Administrative Dispute Resolution Goes Live Amid a Flurry of 340B Litigation
January 18, 2021 | Blog | By Daryl Berke
The U.S. Department of Health and Human’s 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 ADR regulations, which have lingered in HHS since 2010, arrive amid increasing tensions and a flood of 340B-related litigation between covered entities, manufacturers, and HHS.
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CMS Proposes Additional Cuts to Part B Reimbursement of 340B Drugs
August 7, 2020 | Blog | By Daryl Berke
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 cut Medicare Part B reimbursement for 340B drugs by an additional 6% in 2021 and comes days after the D.C. Court of Appeals upheld a 340B rate reduction of nearly 30% in the 2018, 2019, and 2020 OPPS rules. The agency is relying on data collected through a recent 340B acquisition cost survey to justify the additional rate reduction.
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340B Rate Cuts Are Legal, D.C. Circuit Court Holds
August 4, 2020 | Blog | By Daryl Berke
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 Part B reimbursement to hospitals for 340B drugs by nearly 30%. The reduction in Part B reimbursement was originally proposed in the 2018 Outpatient Prospective Payment Services (OPPS) rule. HHS estimated it would reduce total Part B spending by $1.6 billion annually, and save Medicare beneficiaries millions in copayments. Covered entities sued to overturn the rate cut, and litigation has been ongoing since the rate cut was implemented in early 2018.
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Bipartisan Group of Senators Introduces Legislation to Waive 340B Eligibility Requirements Due to COVID-19
July 21, 2020 | Blog | By Daryl Berke
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 340B-eligible based on their disproportionate share (“DSH”) adjustment percentage to maintain eligibility even if their DSH adjustment percentage falls below the requisite threshold.
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Five Suggested Updates for 340B Covered Entities Facing COVID-19 Challenges
April 2, 2020 | Blog | By Daryl Berke
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 Services’ broader effort to maximize regulatory flexibility for health care providers scrambling to meet patient needs during the COVID-19 crisis. While HRSA’s new guidance begins by acknowledging “it is appropriate to take into account the realities of the COVID-19,” HRSA offers little in the way of substantive relief when it comes to 340B. Long on generalities and short on specifics, HRSA merely advises entities to ensure they “have policies and procedures in place to address the proper dispensing of 340B drugs.”
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340B Ceiling Price Transparency – HRSA Now Requiring Pharmaceutical Manufacturers to Issue Refunds to Covered Entities for Overcharges
February 24, 2020 | Blog | By Daryl Berke
As regular readers of our blog know, the Centers for Medicare & Medicaid Services (CMS) intensified its push for drug pricing transparency in 2019. In 2020, we see a continuation of those efforts, and their impacts on the 340B program are now starting to reveal themselves. On January 1, 2019, the Health Resources & Services Administration (HRSA) finally implemented the ceiling price and manufacturer civil monetary penalties (CMPs) regulations that the agency proposed in 2017. The regulations implement certain provisions of the Affordable Care Act and were initially scheduled to go into effect on February 28, 2017, but were repeatedly delayed.
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340B Reimbursement Cut Update: 135 Hospitals File Suit to Block Rate Cuts Previously Ruled Unlawful
January 2, 2020 | Blog | By Daryl Berke
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 prior blog post, the 2020 OPPS Final Rule reduces by nearly 30% the Medicare Part B reimbursement for certain drugs provided by hospitals to outpatient beneficiaries that are acquired through the 340B Program. The final rule purports to continue the reimbursement cuts for 340B drugs first implemented in 2018, despite the fact that those cuts (and the 2019 OPPS rule continuing those cuts) are the subject of ongoing litigation in which the cuts were determined to be unlawful. For a detailed walk-through of the 2020 OPPS Final Rule and litigation up to this point, please see our prior three blog posts here, here, and here.
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CMS Ignores the Courts: 2020 Hospital Outpatient Prospective Payment System Final Rule Includes 340B Rate Cuts Already Ruled Unlawful
November 14, 2019 | Blog | By Daryl Berke
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 drugs provided by hospitals to outpatient beneficiaries that are acquired through the 340B drug discount program. Through the final rule, CMS purports to continue Medicare reimbursement cuts for 340B drugs first implemented in 2018, despite the fact that those cuts (and the 2019 OPPS rule continuing those cuts) are the subject of ongoing litigation in which the cuts were determined to be unlawful. That ruling, and a Court-imposed stay of the cuts, are the subject of a just-argued appeal. For a detailed walk-through of the litigation up to this point, please see our prior blog post.
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CMS Takes Another Swing at 340B Reimbursement Cuts. Will It Be Strike Three?
August 13, 2019 | Blog
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 rates for 340B drugs. CMS opened its discussion of 340B provisions in the 2020 OPPS proposed rule by first stating it was keeping in effect the 340B reimbursement cut first implemented though the 2018 OPPS rule. The 2018 OPPS rule slashed most hospitals’ Part B reimbursement for 340B drugs from Average Sales Price (ASP) plus 6% down to ASP less 22.5%, a reduction of almost 30%.
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March 2019: Where Are We Now With 340B?
March 1, 2019 | Blog
What might 2019 mean for the 340B program? This post addresses the on-going litigation over the OPPS Medicare payment reduction for 340B drugs, ceiling price validation, and state initiatives related to the 340B program.
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340B, When a Price Adjustment is Not Really an Adjustment, and the Implications for CMS Efforts to Attack Drug Prices
January 2, 2019 | Blog
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 prices.
On December 27, 2018, Judge Rudolph Contreras granted the American Hospital Association’s Motion for a Permanent Injunction over CMS’ Medicare Part B reimbursement cut for 340B hospitals. As I have previously written, the vehicle for that reimbursement cut was the 2018 Outpatient Prospective Payment System (OPPS) rule, and CMS’ existing authority to adjust OPPS drug reimbursement.
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On December 27, 2018, Judge Rudolph Contreras granted the American Hospital Association’s Motion for a Permanent Injunction over CMS’ Medicare Part B reimbursement cut for 340B hospitals. As I have previously written, the vehicle for that reimbursement cut was the 2018 Outpatient Prospective Payment System (OPPS) rule, and CMS’ existing authority to adjust OPPS drug reimbursement.
Six Initiatives States May Pursue to Curb Drug Prices and the 340B Factor
October 23, 2018 | Blog
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 revealed in the form of CMS’ Proposed Rule requiring manufactures to include the “list price” for prescription drugs reimbursable by Medicaid or Medicare in television advertisements. While I do think that there will be new initiatives to address drug pricing, I believe most will come through the state and not the federal level. This post addresses six potential initiatives from a recently released report of the National Governors' Association.
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ML Strategies Weekly Health Care Preview – July 23, 2018
July 23, 2018 | Blog
This week, the House is looking at advancing several health care tax proposals, including permanent repeal of the medical device tax. They will also consider a proposal to delay the health insurance tax by two years.
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Court of Appeals Weighs in on 340B
July 18, 2018 | Blog
Timing is everything. In yesterday’s post on 340B, I stated in closing: There is still one more shoe to drop.
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July 2018: Where Are We Now With 340B?
July 17, 2018 | Blog
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 House hearing, and introduction of more than a dozen new bills in Congress.
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Last Week in 340B: the Revival [not] of the 340B Mega-Guidance, Another Senate Hearing, and the Trump Blueprint to Lower Drug Prices
May 21, 2018 | Blog
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 Guidance. Readers of our blog know that, as we predicted, this so-called Mega-Guidance was withdrawn in January 2017 without ever seeing the light of day.
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ML Strategies Health Care Preview - May 14, 2018
May 15, 2018 | Blog
This week, the House Energy & Commerce Committee will hold its second round markup of opioid-related legislation. While they remain on pace for passage by Memorial Day, the timing will be determined by how smooth the markup this week goes.
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President Trump Delivers Much Anticipated Drug Pricing Speech
May 14, 2018 | Blog | By Theresa Carnegie, Tara E. Dwyer
On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration's plan to lower drug prices and reduce out-of-pocket costs.
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Will CMS Drive Further Changes to 340B?
May 1, 2018 | Blog
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 signaling that additional changes to 340B may be coming?
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Viewpoint Editors
Karen S. Lovitch
Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice
Joanne S. Hawana
Member
Rachel E. Yount
Of Counsel
Pat G. Ouellette
Associate
Stephnie A. John
Associate
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