Category: Regulatory

HRSA Takes Step Forward on 340B Dispute Resolution Petitions

In Federal, Judicial, RegulatoryMarch 25, 20219 Views

The federal government on Tuesday declared 340B administrative dispute resolution (ADR) petitions by covered entities against drug manufacturers AstraZeneca, Eli Lilly, and Sanofi to be “complete,” a sign that claims against two of the three companies—AstraZeneca and Sanofi—are ready for …

Health Centers Get Reprieve as 340B Insulin Pricing Rule Delayed Again

In Federal, RegulatoryMarch 19, 20212 Views

Tom Mirga

The U.S. Health and Human Services Department (HHS) announced late this morning that it will delay, from this coming Monday, March 22 until July 20, the effective date of a Trump administration rule to require health centers to provide insulin …

Opposition to Express Scripts’ 340B Claims ID Requirement Grows

In Federal, Other Industry, RegulatoryMarch 16, 202112 Views

Tom Mirga

Legislation addressing pharmacy benefit manager Express Scripts’ (ESI) new claims identification requirement for 340B drugs could be introduced in Congress soon, advisers to 340B covered entities said yesterday.

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FQHCs Fiercely Oppose Trump’s 340B Insulin Pricing Rule in New Round of Comments

In Federal, RegulatoryMarch 16, 20210 Views

Ron Shinkman

Federally qualified health centers and their trade groups are adamantly opposed to implementing a Trump administration rule to require health centers to provide insulin and injectable epinephrine to low-income patients at the price the centers pay for those drugs under …

Medicare’s 340B Drug Reimbursement Cuts in 2019 Were Exacerbated by Change in Drugs’ Payment Status

In Federal, Regulatory, Research/ReportsMarch 16, 20212 Views

Tom Mirga

Medicare Part B drug payments to 340B hospitals “declined substantially” in 2019 because the payment status of “an unusually high number of drugs” changed that year, congressional Medicare advisers said in a report yesterday.

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Biden Nominates Veteran Capitol Hill Aide to be HHS Assistant Secretary

In Federal, RegulatoryMarch 16, 20212 Views

Tom Mirga

President Biden has nominated Melanie Egorin, a veteran Democratic congressional health care adviser, to serve as U.S. Health and Human Services (HHS) Assistant Secretary for Legislation. If confirmed, Egorin would be a top deputy to Xavier Becerra, whose nomination to …

Utah Might Soon Outflank Express Scripts’ New 340B Requirement

In Regulatory, StateMarch 11, 202111 Views

Tom Mirga

Pharmacy benefits manager Express Scripts’ (ESI) new pharmacy reporting requirement for reclassifying a previously submitted prescription drug claim as 340B-eligible “applies to the extent not prohibited by law,” the PBM says in an FAQ on its website. Utah is on …

State Activity to Rein in PBM Discrimination Against 340B Entities Heats Up

In Regulatory, StateMarch 11, 20214 Views

Ron Shinkman

At least six states have introduced or passed bills in recent weeks that would forbid pharmacy benefit managers from discriminating against 340B covered entities regarding reimbursements and other practices.

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Biden Wants to Delay 340B Health Center Insulin Rule Again, to July 20

In Federal, RegulatoryMarch 11, 20211 Views

Tom Mirga

The Biden administration proposes once again to push back, this time from March 22 to July 20, the effective date of the Trump administration’s controversial final rule to require health centers to provide insulin and injectable epinephrine to low-income patients …

Biden Names Health Care Advisers with Strong Ties to Hill Democrats

In Federal, RegulatoryMarch 11, 20211 Views

Tom Mirga

Two health care policy experts with ties to congressional Democratic chairs influential on 340B matters have gone to work for the Biden White House.

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