The U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) recently published a new resource titled General Compliance Program Guidance (“GCPG”), which is described as a reference guide for the...more
AGG’s Home Health & Hospice team publishes a quarterly newsletter covering legal and regulatory topics specific to the home and community-based healthcare industry. The fields of end-of-life and home healthcare present...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
A new California law – Assembly Bill 1278, which was signed by the Governor on September 29, 2022 – requires physicians to provide patients with notice of the federal Open Payments database. The federal Open Payments program...more
In August 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced an updated and enhanced PhRMA Code on Interactions with Healthcare Professionals (PhRMA Code)....more
We received a number of questions from pharmaceutical and medical device clients over the past several months regarding how to continue “Lunch and Learn” programs for healthcare professionals during the COVID-19 pandemic....more
CMS Announces Hospice Capitation Rates for Medicare Advantage -
The U.S. Centers for Medicare and Medicaid Services (CMS) recently released the capitation rates for hospice care through the value-based insurance design...more
On March 9, 2020, CMS issued a memorandum to State Survey Agency Directors regarding the implications of COVID-19 on providers’ EMTALA obligations. ...more
Novel coronavirus (“2019-nCoV”, also known as “SARS-CoV-2”) and the disease it causes – “coronavirus disease 2019” (abbreviated as “COVID-19”) has garnered significant public attention since being declared a Public Health...more
The “National Physician Payment Transparency Program: Open Payments” requires certain manufacturers of drugs, devices and certain other products to disclose annually to the Centers for Medicare and Medicaid Services (CMS)...more
On April 4, 2019, the Department of Justice (DOJ) announced settlements with three pharmaceutical companies, Jazz Pharmaceuticals plc (Jazz), Lundbeck LLC (Lundbeck), and Alexion Pharmaceuticals (Alexion), related to...more
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
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
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
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
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 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