News & Analysis as of

Department of Health and Human Services (HHS) Cancer

Alston & Bird

Health Care Week in Review: CMS Finalizes the TCET Pathway for Breakthrough Technologies; HRSA Awards Health Centers Funding for...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 2, March 2024

HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: February 2024

The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more

Baker Donelson

HHS Announces $5 Million for Cancer Screenings at Health Centers with June 15 Application Deadline

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In a recent press release, the U.S. Department of Health and Human Services (HHS) announced the availability of $5 million for community health centers to increase equitable access to life-saving cancer screenings. Grant...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 4. In This Month's E-News: April 2022

Report on Research Compliance 19, no. 4 (April, 2022) - A six-year review of the institutional review board (IRB) at National Jewish Health (NJH) of Denver has been resolved, with the organization outsourcing the...more

The Volkov Law Group

Department of Justice Brings Criminal Charges Against 35 Individuals for Involvement in $2.1 Billion in Fraudulent Genetic Testing...

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The Justice Department, in coordination with HHS-OIG and the FBI recently announced the arrest and prosecution of 35 individuals for a massive genetic testing fraud scheme involving dozens of telemedicine companies and cancer...more

Foley & Lardner LLP

Radiation Oncology: What You Need to Know About the Long Awaited Bundled Payment Proposal

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On July 10, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Center for Medicare & Medicaid Innovation (Innovation Center) released a much awaited proposal for a new bundled payment model for radiation...more

King & Spalding

CMS Proposes New Radiation Oncology Model

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On July 10, 2019, CMS announced a new proposal for episode-based payment for radiation oncology services. The aim of this new proposal is to determine whether episode-based payment to hospitals, physician groups, and...more

Skadden, Arps, Slate, Meagher & Flom LLP

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

BCLP

New ACA, et. al. FAQs Cover Items From “Top” to “Bottom”

BCLP on

On April 20, the “Big Three” agencies (DOL, Treasury/IRS, and HHS) released another set of FAQs (the 31st, for those of you counting at home). Consistent with earlier FAQs, the new FAQs cover a broad range of items under the...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

Alston & Bird

A&B Healthcare Week in Review

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I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On February 24, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a guidance entitled, “Special Enrollment Confirmation Process” that will enhance program integrity...more

Foley & Lardner LLP

Precision Medicine - Even Medicare Will Pay for It!

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President Barack Obama announced in his 2015 State of the Union address that he was introducing a new Precision Medicine Initiative, supported with over $200 million in the proposed 2016 federal budget. "Precision Medicine"...more

Baker Donelson

OIG Approves Limited, Free Drug Program

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On August 12, 2015, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-11, approving two pharmaceutical manufacturers’ free starter drug program. Citing the limited scope...more

Sheppard Mullin Richter & Hampton LLP

HHS Launches New Payment and Delivery Model to Improve Oncology Care

Cancer care is notoriously complex, intensive and costly. With more than 1.6 million people diagnosed with cancer each year, there is a strong impetus towards reforming service delivery. Accordingly, the U.S. Department of...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: President’s FY2016 Budget Request... FDA Commissioner Hamburg to step down... Tennessee Medicaid expansion plan rejected by legislature. 1. Congress House House Ways and Means Committee Hosts Hearing...more

Foley Hoag LLP - Environmental Law

A Nice, Straightforward Administrative Law Decision: HHS’s Decision to List Styrene as Reasonably Anticipated to Cause Cancer is...

Last week, in Styrene Information and Research Center v. Sebelius, Judge Reggie Walton of the District Court for the District of Columbia rejected challenges to the decision by HHS Secretary Kathleen Sebelius to list styrene...more

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