Common Sense Family Doctor

JUNE 8, 2025

A 2024 editorial in Science , noting rising tensions between the United States and Russia, China, and North Korea, observed that “the risk of nuclear war has not been so high since the Cuban Missile Crisis.” Both countries are spending enormous amounts to modernize their existing arsenals.

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Permanente Medicine

MAY 22, 2025

In the 2024 National Committee for Quality Assurance’s annual report , Kaiser Permanente’s commercial and Medicare plans rated highest or tied for highest for overall treatment, prevention, equity, and patient experience among competitors in every geographic region served. To learn more about Permanente Medicine, visit permanente.org.

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ABIM

APRIL 24, 2025

Dave, MD, MPH , inquired how stressors may contribute to candidates failing the certification examination and Dr. McDonald stated that knowledge gaps were the primary cause, though ABIM provides safeguards to reduce stress like grace periods and consideration of compassionate exemptions for extraordinary life circumstances.

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ABIM

JUNE 24, 2025

In 2024, 78% of hematologists who were due for an assessment and chose to enroll in one chose the LKA over the traditional, 10-year MOC exam, which is on par with the average across specialties. Community Practice in ABIM Governance* Erica N. Advanced Practice Providers in the Hematology-Oncology Workforce* Guinevere Z.

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ABIM

MAY 30, 2025

Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. In 2024, 77% of ABIM Board Certified nephrologists due for an assessment opted for the LKA over the traditional, 10-year MOC exam. Community Practice in ABIM Governance* Erica N. Siddharta G.

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Maine Academy of Family Physicians

JUNE 21, 2024

Pat Connolly reported on the 2024 Maine Legislative Session: It was a short but busy session in Augusta this year. Providers of abortion and gender affirming care in Maine are effectively shielded from laws in other states by the passage of protection by the legislature. Here in Maine the "shorter" Legislative Session was quite full!

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ABIM

JUNE 4, 2025

In 2024, 77% of eligible ABIM Board Certified endocrinologists who chose an assessment opted for the LKA over the traditional, 10-year MOC exam. Community Practice in ABIM Governance* Erica N. Some data, such as exam pass rates and resident and fellow workforce trends , are publicly available on ABIM’s website.)

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Physician's Weekly

JULY 10, 2025

Its overarching conclusion — that patients shouldn’t be stuck in the crossfire between providers and payers — was not controversial or partisan. This new measure was aimed at providing similar protections against bills from public ambulance services and for transfers between hospitals. That leaves out a lot of workers.

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Physician's Weekly

JULY 15, 2025

Kennedy and those four advisers — three of whom have been tapped for official government roles — earned at least $3.2 Office of Government Ethics and the Department of Health and Human Services; published media reports; and tax forms filed with the IRS. “Any attempt to suggest impropriety is reckless and politically motivated.”

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ABIM

JUNE 11, 2025

In 2024, 75% of infectious disease physicians who chose an assessment opted for the LKA over the traditional, 10-year MOC exam. Community Practice in ABIM Governance* Erica N. IDSA has also been hosting member forums to maintain public access to evidence-based guidelines no longer available through government institutions.

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Physician's Weekly

JULY 2, 2025

The Trump administration has launched investigations into health care organizations in an effort to allow providers to refuse care for transgender patients on religious or moral grounds. The health system denied all allegations, and in April 2024, U.S. Kloosterman’s lawyers filed an appeal with the U.S.

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Physician's Weekly

JUNE 27, 2025

Quality issues that preceded the pandemic have expanded: The percentage of nursing homes that federal health inspectors cited for putting residents in jeopardy of immediate harm or death has risen alarmingly from 17% in 2015 to 28% in 2024. “The people that work in my building become so important to us,” Goodness said.

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Physician's Weekly

JUNE 12, 2025

An “improper” payment refers to payments made erroneously to beneficiaries and their providers or without sufficient documentation. In a 2024 report covering the years 2022, 2023, and 2024, Medicaid’s parent agency — the Centers for Medicare & Medicaid Services — said the rate was about 5.1%.

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Physician's Weekly

JULY 2, 2025

Maria is among what the federal government estimates are 2.6 without legal permission — along with the providers and community workers that help them — are anxiously weighing the benefits of pushing forward with Medi-Cal applications against the risks of discovery and deportation by the federal government. Currently, about 1.6

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Community Government Provider Insurance 52

Doctors for America

MAY 5, 2025

FOR IMMEDIATE RELEASE Doctors for America PO Box: 21161 2300 18th St NW Lbby Washington, DC 20009-9996 May 5, 2025 Doctors, Local Governments File Brief to Defend Reproductive Health Care Privacy Rights Brief Argues that Upending HIPAA Privacy Rights Would Contradict Decades of Established Precedent WASHINGTON, D.C.

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Physician's Weekly

JUNE 12, 2025

More than 10 million people were automatically reenrolled in their coverage for the 2025 plan year, with their eligibility for tax credits confirmed via a system that allows ACA marketplaces to check government or other data sources. The House bill would end that, requiring documentation before receiving tax credits. .

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Insurance Family Families Government 52

Physician's Weekly

JULY 16, 2025

And Medicare doesn’t provide easy-to-understand five-star ratings as it does for general hospitals. Such facilities are required to provide three hours of therapy a day, five days a week. At the same time, the number of small, specialized units within acute care hospitals — where most rehab used to be provided — has dwindled.

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Hospital Patient-Centered Patients IT 52

California Academy of Family Physicians (CAFP)

MAY 14, 2025

Key Health Care Budget Proposals: Proposed Medi-Cal Cuts and Enrollment Changes Medi-Cal, California’s Medicaid program, is typically funded through a partnership between the state and the federal government. To fill that gap, California has chosen to use state-only funds to provide certain Medi-Cal benefits to undocumented Californians.

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FDA Law

OCTOBER 8, 2023

That First Temporary Rule also provided a one-year grace period, through November 11, 2024, for any practitioner-patient telemedicine relationships established on or before November 11, 2023. DEA also announced that it is working to promulgate these new telemedicine standards or safeguards by the fall of 2024.

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FDA Law

OCTOBER 13, 2024

A very important aspect of the program is that it costs FDA, and the government, no additional dollars, though we do not wish to minimize the additional resources a priority review demands over the standard review that such an application might otherwise receive. Notably, it was reauthorized in 2016 (until 2020) and in 2020 (until 2024).

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Government IT Education Individual 64

FDA Law

MARCH 4, 2024

This essential event for regulatory professionals in the biopharmaceutical and medical device industries will take place March 12-13, 2024, in Arlington, VA. Before joining HP&M, Ms.

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FDA Law

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.

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FDA Law

DECEMBER 11, 2024

The Webinar will explore the CMS rule and provide actionable recommendations for manufacturers on how to navigate the new requirements. (HPM) and Riparian LLC will co-host a webinar on an important CMS rule imposing penalties for misclassification of drugs and other reporting errors under the Medicaid Drug Rebate Program.

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Manufacturing Management Provider Government 59

FDA Law

DECEMBER 9, 2024

The Webinar will explore the CMS rule and provide actionable recommendations for manufacturers on how to navigate the new requirements. (HPM) and Riparian LLC will co-host a webinar on an important CMS rule imposing penalties for misclassification of drugs and other reporting errors under the Medicaid Drug Rebate Program.

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Manufacturing Management Provider Government 59

FDA Law

MAY 7, 2025

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Mallory , 988 F.3d 3d 730 (4th Cir. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th Polin , 194 F.3d

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FDA Law

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. By Steven J. Gonzalez & Allyson B.

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FDA Law

MARCH 24, 2024

The 340B contract pharmacy dispute involves several manufacturers who are refusing to provide 340B discounts to covered entities if they requested 340B drugs to be delivered to, and dispensed from, a network of contract pharmacies. On March 12, 2024, a three-judge panel of the Eighth Circuit affirmed. 22-3675, 2024 U.S.

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Manufacturing Government IT Provider 59

FDA Law

JANUARY 18, 2023

Recall that CMS is required to negotiate and publish the 2016 maximum fair price for 10 high expenditure, single source Part D drugs by September 1, 2024. Upcoming CMS Guidance CMS provides a list of topics on which it plans to issue guidance. The Agency has promised it will provide comment periods for each guidance.

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Manufacturing IT Provider Government 59

FDA Law

OCTOBER 7, 2024

2117 (2024). 27, 2024), the plaintiff H&P challenged an FDA administrative complaint assessing a civil money penalty of $20,678 for H&P sale of an electronic cigarette without FDA authorization. Constitution’s Seventh Amendment right to a jury trial. See SEC v Jarkesy , 144 S. In Huff and Puffers v. 8:24-cfv-02110 (C.D.

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Electronics IT Government Provider 59

FDA Law

JULY 17, 2022

Currently, a health care provider identifies any discarded quantity from such a vial in the claim using a JW modifier, and Medicare Part B pays for both the utilized and the discarded amount. The following example is provided in the preamble: If Part B paid a total of $1.5

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FDA Law

DECEMBER 7, 2023

In his conference keynote address , Arun Rao—the Deputy Assistant Attorney General for DOJ’s Consumer Protection Branch—provided an overview of DOJ’s year in FDA enforcement. DOJ has provided few bright lines about when conversations and disclosures to FDA may also satisfy its own VSD requirements.

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Consulting Manufacturing Provider Specialization 52

FDA Law

APRIL 21, 2024

Government—was that, despite having missed the statutory 60-day filing deadline, the patent was granted a PTE due to a change in the law created by Section 37 of the Leahy-Smith America Invents Act (“AIA”) ( Pub. . § The statute does not provide any applicable exception for such a falsity. Patent Nos.

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Provider IT Government 59

FDA Law

JANUARY 11, 2024

Notably, the purpose of the statute seemed to govern much of FDA’s interpretation. The first commercial marketing of each, according to the biosimilar patent settlement agreement, was July 1, 2023, which would render the FIE expiration date July 1, 2024. This all sounds complicated, I know.

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FDA Law

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs). By Steven J. Gonzalez & Gail H.

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Clinic Management Medical IT 59

FDA Law

JULY 10, 2025

These particular CRLs were issued in response to original and supplemental drug and biological product applications submitted to the Agency between 2020 and 2024 that ultimately gained approval. The letter provides detailed descriptions of the deficiency(ies) and often includes FDA’s suggestions or requirements for resolving them.

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Manufacturing IT Government Provider 52

FDA Law

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs December 5, 2024 draft guidance on accelerated approvals appears intended to cover each of these topics even if not by dividing them precisely along those lines.

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Clinic Relationship Provider IT 64

FDA Law

JUNE 16, 2023

The statement must itemize the cost components related to production of the drug, identify increases in materials or manufacturing costs, and provide other information that the manufacturer believes relevant to determining whether a violation has occurred. SF 2744 also provides a private right of action to enforce the prohibition.

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