Category: Regulatory

Biden Administration Moves a Step Closer to Trashing Trump’s 340B Health Center Insulin/EpiPen Rule

In Federal, RegulatorySeptember 14, 2021204 Views

Former President Trump signed an executive order in July 2020 directing HHS to limit what 340B health centers can charge patients for insulin and EpiPen-type devices.

The dumping of a controversial Trump administration rule limiting what 340B health centers can charge patients for insulin and EpiPen-type devices took a big step closer to being finalized last week.

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Arkansas Insurance Dept. to Rule Next Month on PhRMA’s Petition to Block Novel 340B Contract Pharmacy Law

In Regulatory, StateSeptember 14, 2021150 Views

Tom Mirga

An Arkansas Insurance Department hearing officer said last week she would decide by Oct. 13 whether to stay enforcement of a state law requiring drug manufacturers to honor 340B contract pharmacy arrangements.

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Napo Pharmaceuticals Tells Entities How They Can Keep Getting 340B Price on Limited-Distribution Drug

In Federal, Pharma Industry, RegulatorySeptember 14, 2021156 Views

Tom Mirga

Napo Pharmaceuticals has told covered entities how they can continue to buy Mytesi, an antidiarrheal for patients living with HIV/AIDS who take antiretroviral drugs, at its 340B price.

Napo Pharmaceuticals yesterday posted a public notice to 340B covered entities about how to obtain 340B pricing on Mytesi, an antidiarrheal for patients living with HIV/AIDS who take antiretroviral drugs.

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In Largely Symbolic Move, Becerra Expresses “Strong Support” for 340B in Drug Pricing Plan

In Federal, RegulatorySeptember 10, 2021399 Views

Tom Mirga

HHS Secretary Xavier Becerra yesterday expressed "strong support" for the 340B program in a drug pricing report to the White House, but recommended no changes to the program.

U.S. Health and Human Services Secretary Xavier Becerra yesterday reiterated HHS’ “strong support for the 340B Drug Pricing Program” in a 29-page plan to lower drug prices.

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As Hospital Recertification Deadline Nears, 340B Eligibility Challenges Appear Not to Be Widespread for Now

In Federal, RegulatorySeptember 10, 2021193 Views

Ron Shinkman

The COVID-19 pandemic’s impact on hospitals’ eligibility for 340B could become an issue beginning later this year, industry observers say.

With the deadline for hospitals to recertify their eligibility for 340B drug discounts arriving on Monday, it appears most facilities will remain qualified—at least for now.

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HRSA Grants 340B Flexibilities to N.J. and N.Y. Due to Hurricane

In Federal, RegulatorySeptember 10, 202169 Views

Tom Mirga

Federal health officials yesterday added New Jersey and New York to the list of states granted 340B enrollment flexibility due to Hurricane Ida.

Federal health officials have added New Jersey and New York to the list of states granted 340B enrollment flexibility due to Hurricane Ida.

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Hearing Friday on PhRMA’s Push to Quash First State Law to Protect 340B Contract Pharmacy Program

In Regulatory, StateSeptember 8, 2021249 Views

Tom Mirga

Arkansas Insurance Commissioner Alan McClain temporarily suspended his state's new 340B contract pharmacy law pending a review of its constitutionality.

The Arkansas Insurance Department is holding a public hearing this Friday morning on whether it should strike down as unconstitutional the nation’s first state law to address pharmaceutical manufacturer denials of 340B pricing on drugs when they are dispensed by

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After HRSA Notification, NACHC Refiles 340B Dispute Complaints Against Drug Manufacturers

In Federal, RegulatorySeptember 2, 2021289 Views

Tom Mirga

Community health centers split their 340B dispute resolution petition against drug manufacturers Eli Lilly, Sanofi, and AstraZeneca into two—one against Lilly alone, the other against Sanofi and AstraZeneca together.

Community health centers on Tuesday split their 340B dispute resolution petition against drug manufacturers Eli Lilly, Sanofi, and AstraZeneca into two—one against Lilly alone, the other against Sanofi and AstraZeneca together—to let federal officials commence proceedings against Sanofi and AstraZeneca.

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Medicare Trustees Say Part B Drug Payments Will More than Double by 2030

In Federal, RegulatorySeptember 2, 202170 Views

Tom Mirga

The Medicare Board of Trustees expects Part B reimbursement for physician-administered drugs will more than double to $46.2 billion by 2030.

Medicare Part B reimbursement for physician-administered drugs is projected to rise from $18.7 billion in 2020 to $21.7 billion this year, and then to more than double to $46.2 billion by 2030, the Medicare Board of Trustees reported to Congress

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In Hurricane Ida’s Wake, HRSA Announces 340B Registration Flexibility in Louisiana and Mississippi

In Federal, RegulatorySeptember 2, 202164 Views

Tom Mirga

In light of Hurricane Ida, Louisiana and Mississippi health care providers eligible to participate in the 340B program may enroll immediately rather than having to wait until the next quarterly registration period Oct. 1 through 15.

Louisiana and Mississippi health care providers eligible to participate in the 340B program may enroll immediately rather than having to wait until the next quarterly registration period Oct. 1 through 15, the U.S. Health Resources and Services Administration (HRSA) announced

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