FDA Law Blog

SEPTEMBER 29, 2021

Department of Health and Human Services (“HHS”), which reported that discounted purchases totaled $38 billion in 2020, a 27% increase compared to 2019. Manufacturers may choose not to participate in this program, but the federal government will not reimburse for their outpatient drugs under Medicaid or Medicare Part B if they do not.

Manufacturing 52

Manufacturing Government Referral Provider 52

FDA Law Blog

NOVEMBER 6, 2022

In June 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Rather, Pfizer argues, the AKS focuses on “corrupt transactions,” such as the specific examples of “kickback, bribe, or rebate” that Congress provided.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law Blog

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. Lax Controls Provided Employees with Opportunity to Divert. In short, the employees were provided the opportunity to not only commit the crimes but that they went undetected.

Board-Certified 52

Board-Certified Provider Government Management 52

FDA Law Blog

APRIL 19, 2021

The Court decision limiting FDA’s discretion provides regulatory certainty for device manufacturers, as the claimed discretion, if recognized by the Court, would have meant that any medical device potentially could be classified and regulated as a drug. District Court, which sided with Genus in December 2019.

Manufacturing 40

Manufacturing Government Medical IT 40

FDA Law Blog

FEBRUARY 5, 2023

By Faraz Siddiqui — In the Spring of 2021, the Health Resources and Services Administration (HRSA) threatened six drug companies with billions of dollars in penalties for not providing 340B discounts to covered entities that sell drugs through vast networks of contract pharmacies (more background on earlier posts ). A lot is at stake here.

Manufacturing 52

Manufacturing Provider IT Government 52

FDA Law Blog

FEBRUARY 2, 2023

In 2019, FDA formed an agency-wide Alternative Methods Working Group indicating that it viewed the applicable scope of alternative methods to go beyond just toxicology research. FDORA § 3209(b).

Clinic 64

Clinic IT Utilities Government 64

FDA Law Blog

JANUARY 6, 2022

Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.” 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added).

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 52

FDA Law Blog

JANUARY 6, 2022

Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.” 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added).

Lab Testing 40

Lab Testing Referral Individual Patient-Centered 40

GeriPal

MARCH 24, 2023

She happened to focus on some specific for-profit hospice providers. They were all actually publicly traded or private equity owned for-profit hospice providers. And I didn’t read it as damning of all for-profit providers, but I think it needed to happen. It feels somewhat random in some ways. Eric: Lack of a caregiver.

IT 113

IT Provider Patients Families 113

GeriPal

MARCH 2, 2023

AFP 2019 Gabapentin for chronic neuropathic pain in adults. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? We should be able to trust all the data that comes from our governing board. Cochrane Database of Systematic Reviews Review.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

APRIL 13, 2023

Check out some of their recent work, including: Dr. Holt-Lunstad’s and Dr. Perissinotto’s powerful perspective piece in the New England Journal of Medicine which provides a clinical framework for addressing loneliness and social isolation. I think I feel more comfortable as a provider in trying to support people in their isolation.

IT 99

IT Community Patient-Centered Medical 99

FDA Law Blog

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. The preamble provides an example of reporting an incorrect baseline AMP, which reduces the unit rebate amount. Sheldon, v. See 42 U.S.C. 1396r-8(b)(3)(C)(iii).

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

Common Sense Family Doctor

FEBRUARY 21, 2025

Oh, and the CDC's National Immunization Survey has been canceled by the so-called Department of Government Efficiency, even if the Epidemic Intelligence Service seems to have received a temporary reprieve.) to a massive resurgence in 2019, presaged by smaller blips in the prior years?

Vaccination 52

Vaccination DO Family Medicine Hospital 52

Physician's Weekly

JUNE 12, 2025

An “improper” payment refers to payments made erroneously to beneficiaries and their providers or without sufficient documentation. Other experts told PolitiFact that the actual numbers could be higher than what the federal government reports, although not as high as Paragon’s estimate.

Government 52

Government Provider Insurance IT 52

The Clinical Problem Solvers

MAY 2, 2023

[link] CPSolvers: Antiracism in Medicine Series Episode 21 – Psychosocial and Cultural Considerations for Providing Healthcare to Immigrant and Refugee Populations Show Notes by Kiersten T. 2019 Sep;123(9):888-900. Epub 2019 Jul 30. October 18, 2022. Chiesa V, Chiarenza A, Mosca D, Rechel B. Health Policy. 2019.07.018.

Healthcare 52

Healthcare Provider Clinical Practice Clinic 52

Physician's Weekly

JUNE 26, 2025

A Failed Compensation Program Vaccine advocates and skeptics agree that the government program established to compensate people injured by vaccines or other public health measures during emergencies — the Countermeasures Injury Compensation Program — has miserably failed those with covid vaccine-related injuries.

Vaccination 52

Vaccination Patient-Centered Government IT 52

FDA Law Blog

OCTOBER 14, 2022

The President’s comments caused us, who work in the medical product industry, to wonder how the federal government officially declares an end to the Covid-19 public health emergency. FDA provides FAQs about what happens to EUAs when a public health emergency ends (see here ). We all look forward to the end of the COVID-19 pandemic.

Medical 98

Medical Manufacturing Provider Complication 98

GeriPal

APRIL 17, 2025

Farah provides clear examples from the Biden administration, in which having the most diverse cabinet in history was critical to building bridges, empathy, and inspiring others to feel included. Now to the federal government that is going way beyond what I think people truly understand. And the uprooting of DEI is an act of violence.

IT 70

IT Community Government Management 70

FDA Law Blog

SEPTEMBER 13, 2021

A May 2019 CMS final rule that would have required drug TV advertisements to disclose the WAC of the drug was challenged by a group of pharmaceutical companies and vacated on statutory grounds by the D.C. One of the more consequential proposals in the Plan is giving Medicare the authority to directly negotiate prices with drug manufacturers.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98

Physicians News Digest

APRIL 1, 2025

Since returning to the White House, Trump has said he will target fraud in Medicare, Medicaid, and Social Security, and his Republican allies in Congress have made combating fraud a key argument in their plans to slash spending on Medicaid, which provides health care for millions of low-income and disabled Americans.

Government 52

Government Insurance Patients Clinic 52