Administrative Agency Health

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What a PA Should Know When Searching for a Supervising Physician

Although supervising physicians are required to follow regulatory guidelines, it is also important that physician assistants (“PAs”) understand their role in the authority delegated to them and the specifics of regulatory...more

FDA Addresses Compounding of Animal Drugs From Bulk Drug Substances

The U.S. Food and Drug Administration (FDA) has released a Notice of Draft Guidance and Withdrawal of Compliance Policy Guidance (Guidance Notice), along with a Draft Guidance for Industry (Draft Guidance) addressing...more

Congress Could Be Coming For Dietary Supplements Soon

The next chapter in the saga of New York State Attorney General Eric T. Schneiderman's investigation of the dietary supplements industry may take place on Capitol Hill. On April 2, Schneiderman and the state attorneys general...more

State Regulatory Scheme Offering Antitrust Immunity to Healthcare Collaborations Creates Tension Between Federal and State...

On April 22, 2015, the Federal Trade Commission submitted a public letter to the New York State Department of Health (DOH) expressing “strong concerns” over state regulations offering to provide antitrust immunity to certain...more

ONC Releases Updated Guide to Privacy and Security of Electronic Health Information

The Office of the National Coordinator for Health Information Technology (“ONC”) of the U.S. Department of Health and Human Services (“HHS”) recently released Version 2.0 of the Guide to Privacy and Security of Electronic...more

Comingling of employee and patient data compromises employer’s HIPAA defense to employee’s claim of discharge for union activity

An administrative law judge (ALJ) of the National Labor Relations Board has concluded that a health care employer’s use of its medical records software to store employee contact information allowed an employee to access that...more

Justice to Target Corporations and C-Suite Executives in the Healthcare Industry

On Thursday, May 14, 2015, at a meeting of the American Bar Association’s Healthcare Fraud Section, Leslie Caldwell, the Assistant Attorney General for the Department of Justice (DOJ) Criminal Division, declared stamping out...more

Healthcare Fraud Initiatives in 2015

In order to predict what 2015 will look like in the war against health care fraud, it is necessary to quickly review what happened in 2014. In 2014, the government’s health care fraud prevention and enforcement efforts...more

FDA Issues Biosimilars Q&A Guidance Document

On May 13, the FDA released a draft question-and-answer guidance document, titled “Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.” The...more

OIG Issues Compliance Guidance for Healthcare Governing Boards

Members of healthcare governing boards now have direction from the OIG as to what is expected of them as they oversee the regulatory compliance of their organizations. And the good news is that the board members don’t have to...more

Animal Compounding Guidance (Draft) for Use of Bulk Drug Substances Released by FDA Today

On May 18, 2015, FDA released new draft guidance on animal drug compounding from bulk drug substances. While FDA’s current statutory framework and regulations do not permit compounding of animal drugs from bulk drug...more

DOJ Pursuing Therapy Providers Under the FCA

As most recently spotlighted by the Department of Justice’s intervention in whistleblower claims against ManorCare, DOJ is increasing its enforcement of the False Claims Act (FCA) against therapy providers. In particular, DOJ...more

OCR Launches Phase 2 HIPAA Audit Program with Pre-Audit Screening Surveys

Health Insurance Portability and Accountability Act of 1996 (HIPAA) covered entities have reported that the U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently sent pre-audit screening surveys...more

More Biosimilar Q&A’s Released by FDA

After finalizing three key guidance documents on biosimilars at the end of April (reported on our blog here), yesterday FDA released another “Question and Answer” guidance in draft form. The draft guidance is called...more

FDA Issues Guidance for Mobile Medical Apps

Just so you know, that iPhone or iPad you have with you may be an FDA-regulated medical device. More precisely, the apps on the device may meet the definition of a medical device under the Federal Food, Drug, and Cosmetic Act...more

Amarin Pharma Sues FDA Over Constitutional Right to Discuss Off-Label Uses

Drug makers and the Food and Drug Administration (FDA) have often disagreed over whether drug makers can discuss unapproved uses for their products with physicians. While courts have sided with drug makers in certain...more

FDA Finalizes Guidance Documents on Biosimilars

Six years after legislation was adopted creating a new pathway for the approval of biological products that are biosimilar to existing FDA-approved biologics, the Food and Drug Administration (FDA) continues to issue guidance...more

Compliance Guidelines for Governing Boards: Some Further Thoughts and Comments

On April 20, 2015, four organizations (including OIG, American Health Lawyers Association, the Association of Healthcare Internal Auditors and the Health Care Compliance Association) issued “Practical Guidance for Health Care...more

OIG Guidance for Healthcare Boards

In April, the Office of the Inspector General for the U.S. Department of Health and Human Services (“OIG”), in conjunction with the American Health Lawyers Association, the Association of Healthcare Internal Auditors, and the...more

FDA Issues Three Biosimilar Final Guidances

On April 28, 2015, the federal Food and Drug Administration (FDA) finalized three guidances for industry on developing biosimilar drugs. The guidances, which follow the FDA’s first approval of a biosimilar drug in March, are...more

FDA Initiates Expedited Access Pathway Program for Medical Devices via Final Guidance Document

The U.S. Food and Drug Administration (FDA) initiated an Expedited Access Pathway (EAP) Program, effective April 15, 2015, for certain medical devices that are subject to premarket approval applications (PMAs) or de novo...more

Summary of HUD's LEAN 232 Program E-mail Blast: Office of Residential Care Facilities (ORCF), April 30, 2015

In an effort to summarize the highlights of the LEAN Email Blasts that we receive, and rarely have time to review in a timely fashion, we at Pepper Hamilton are providing this quick synopsis of the latest LEAN update. Our aim...more

FDA Releases "Final" Guidances for Industry regarding the Biosimilar Approval Pathway

About three years ago, and less than two years after Congress passed and President Obama signed the Biologics Price Competition and Innovation Act (BPCIA) into law, the U.S. Food and Drug Administration issued a series of...more

New state law allows access to investigational drugs

In line with a nationwide movement, on April 21, 2015, Governor Fallin signed into law House Bill 1074, the Oklahoma Right to Try Act. The Act allows physicians to prescribe to terminally ill patients investigational drugs,...more

Two Laboratories Settle Claims Regarding Specimen Processing Fees

Continuing the scrutiny of laboratory arrangements with referring physician practices, the United States Department of Justice (DOJ) recently announced the settlement of False Claims Act allegations against two cardiovascular...more

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