In a letter dated March 19, 2019, U.S. Senate Finance Committee Chairman Chuck Grassley of Iowa and Ranking Member Ron Wyden of Oregon wrote to the Department of Health and Human Services (HHS) Office of Inspector General...more
On March 6, 2019, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) posted Advisory Opinion No. 19-03, which permits a non-profit medical center (Requestor), and its affiliated...more
After a relatively slow first six months, 2018 turned into an active year for HIPAA enforcement, with the Department of Health and Human Services’ (HHS) Office of Civil Rights (OCR) announcing the largest-ever HIPAA...more
On January 31, 2019, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) proposed a new rule that would amend the safe harbor regulations under the Federal anti-kickback statute (42 U.S.C....more
2/14/2019
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
MCOs ,
Medicare Part D ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Rebates ,
Safe Harbors
On January 9, 2019, the Advanced Medical Technology Association (AdvaMed) issued a press release announcing approval of an updated Code of Ethics on Interactions with Health Care Professionals (HCPs) in the U.S.. The Code...more
On October 24, 2018, the President signed the sweeping, opioid-focused SUPPORT for Patients and Communities Act (Pub. L. 115-271, the “Act”) into law. Title III, Chapter 4 of the Act, titled the Special Registration for...more
11/7/2018
/ Controlled Substances ,
DEA ,
Electronic Prescribing ,
Health Care Providers ,
In-Person Exam ,
New Legislation ,
Prescription Drugs ,
Registration ,
Ryan Haight Act ,
Telehealth ,
Telemedicine
Summary and Practical Tips -
- The federal government can waive certain EMTALA requirements during a flu pandemic.
- Federal and state governments and the hospital must take specific formal actions before these...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
In June 2018, Senator Claire McCaskill (D-Mo.) introduced the Patient Advocacy Transparency Act of 2018 (the “Act”), which, if adopted, would amend the Physician Payment Sunshine Act (the “Sunshine Law”). ...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
1/26/2018
/ Abbreviated New Drug Application (ANDA) ,
Anti-Kickback Statute ,
CGMP ,
Department of Justice (DOJ) ,
Dietary Supplements ,
Drug Pricing ,
False Claims Act (FCA) ,
FDA Reauthorization Act ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Human Resources Professionals ,
OCR ,
PHRMA
On December 20, 2017, United Therapeutics Corporation, a Silver Spring, Maryland-based pharmaceutical company that manufactures and sells a number of drugs to treat pulmonary arterial hypertension (PAH), agreed to pay $210...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
As prescription drug pricing continues to dominate political headlines, state legislatures are taking action intended to lower drug prices for health plans and patients. Despite industry opposition, California has enacted a...more
On January 12, 2017, the Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule expanding its authority to exclude providers from participation in federal healthcare programs. This...more
On October 4, 2016, the Centers for Medicare & Medicaid Services (CMS) published its final “Reform of Requirements for Long-Term Care Facilities” rule in the Federal Register, marking the first time since 1991 that the...more
On August 22, 2016, the Office of Inspector General of the Department of Health and Human Services (OIG) released updated guidance on Independent Review Organization (IRO) independence and objectivity (the “Guidance”). The...more
Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more
5/20/2016
/ Abbreviated New Drug Application (ANDA) ,
App Developers ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Medical Devices ,
Medical Foods ,
OIG ,
Pharmaceutical Industry ,
SCOTUS ,
Securities and Exchange Commission (SEC) ,
Universal Health Services Inc v United States ex rel Escobar
On April 18, 2016, the Office of Inspector General of the Department of Health and Human Services (OIG) released a revised policy statement on its exclusion authority, entitled Criteria for Implementing Section 1128(b)(7)...more
On October 30, 2015, the Centers for Medicare & Medicaid Services (“CMS”) issued the 2016 final Medicare payment rules for physicians, hospitals and other providers. The rules include a provision that empowers patients,...more
The Office of Inspector General (“OIG”) posted its most recent advisory opinion addressing a transportation program on October 21. This opinion analyzed a plan for a free van shuttle service provided by an integrated health...more
On July 8, 2015, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that updates payment rates and related reimbursement and quality policies for physician services furnished under the Medicare...more
7/17/2015
/ American Medical Association ,
Beneficiaries ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
End-of-Life-Care ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Physician Fee Schedule ,
Physician Medicare Reimbursements ,
Physicians ,
Proposed Regulation ,
Public Comment