The Office for Civil Rights (“OCR”) under the U.S. Department of Health and Human Services (“HHS”) recently issued a Notice of Proposed Rulemaking (the “Proposed Rule”) to modify the Health Insurance Portability and...more
The California Legislature recently passed Assembly Bill 3129 (“AB 3129” or the “Bill”), which, if signed by California Governor Gavin Newsom, would increase oversight of healthcare entity transactions involving private...more
As the North Carolina General Assembly prepares for its short session beginning April 24, 2024, one of the focal points will be Senate Bill 145 (House Bill 170), the Continuing Care Retirement Communities Act (the “Act”),...more
On December 7, 2023, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced its first-ever settlement involving a phishing attack under the Health Insurance Portability and...more
The Centers for Medicare & Medicaid Services (“CMS”) announced it is expanding access to behavioral health services for Medicare beneficiaries through intensive outpatient services coverage. In general, Medicare will cover...more
The U.S. Department of Health and Human Services (“HHS”) on October 30, 2023, issued a Notice of Proposed Rulemaking (“NPRM”) to establish penalties for healthcare providers found to have committed information blocking. This...more
11/9/2023
/ 21st Century Cures Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Information Technologies ,
Information Blocking Rules ,
Medicare ,
NPRM ,
ONC
Earlier this month, the United States Drug Enforcement Administration (“DEA”) and Department of Health and Human Services (“HHS”) issued a temporary rule extending certain flexibilities for the prescription of controlled...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
8/18/2023
/ Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
NAD ,
OPDP ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Labels ,
Warning Letters
The Illinois Legislature recently passed HB2222, new antitrust legislation that will require advance notice to the attorney general for “covered transactions” between healthcare facilities and healthcare provider entities. If...more
Effective July 13, 2023, the Centers for Medicare & Medicaid Services (“CMS”) announced a period of enhanced oversight for new hospices in Arizona, California, Nevada, and Texas. According to the Medicare Learning Network...more
Summer is in full swing, but the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) is doing anything but taking a vacation from HIPAA. In May and June, OCR issued five resolution agreements...more
Before Comedy Central, TikTok videos, and other social media inventions, Monty Python entertained us (admittedly, an acquired taste). Many of us remember the classic scene from the 1975 movie Monty Python and the Holy Grail,...more
In 1994, the rock band Bush sang, “breathe in, breathe out,” in one of its biggest hits, “Machinehead.” In 2023, a medical device company tried to promote its 510(k)-cleared treatment hood/hyperbaric chamber device for...more
Channeling Men Without Hats’ 1982 catchy (not classic) hit, “Safety Dance,” FDA told industry in a recently issued guidance that medical device companies could submit marketing applications for cyber devices if they want to...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
The Georgia Department of Community Health (“DCH”) recently announced its intent to revise the Georgia regulations governing the hospital permit requirement, specifically Ga. Comp. R. & Regs 111-8-40-.03. The proposed rule...more
On September 28, 2022, the U.S. Food and Drug Administration issued a Proposed Rule to revise the criteria for when foods can be labeled with the nutrient content claim “healthy.” Since 1994, FDA has recognized that when a...more
In a previous article, we discussed Georgia’s announcement to award over $217 million to eligible healthcare facilities as a result of the American Rescue Plan Act (“ARPA”), which was signed into law by Congress on March 11,...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update 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
In 1982, Chris de Burgh (of “Lady in Red” fame) sang, “Don’t pay the ferryman, don’t even fix a price until he gets you to the other side,” where the narrator warns the passenger not to pay the ferryman (because a storm...more
In a colorful nod to one of Georgia’s most famous and respected musical bands, R.E.M., and its 1988 hit, “Orange Crush” (from the album Green — coincidence?), in July 2022, the Food and Drug Administration issued a guidance...more
On July 21, 2022, the Centers for Medicare & Medicaid Services (“CMS”) released its first-ever nationally standardized Home- and Community-Based Services (“HCBS”) quality measure set to encourage consistent quality...more
In September 2014, AGG prepared a Bulletin on the Food and Drug Administration’s Breakthrough Therapy Designation (BTD) program, referencing The Doors’ “Break On Through to the Other Side.” Time for Part 2. FDA issued a draft...more
States now have through March 31, 2025 to use the federal medical assistance percentage (FMAP) funding made available by the American Rescue Plan Act (ARPA). The announcement was made by the U.S. Department of Health and...more