In recently issued draft guidance related to the implementation of product identifiers under the Drug Supply Chain Security Act ("DSCSA"), FDA has stated that it intends to exercise enforcement discretion for a period of one...more
On The American Health Lawyers Association (AHLA) held its Annual Meeting on June 24 - 28, 2017 in San Francisco, California. The meeting “[o]ffer[s] the most current information and analysis of myriad legal issues the health...more
A recent House bill, titled the "Closing Loopholes for Orphan Drugs Act," would narrow the exception for orphan drugs in the federal 340B Drug Pricing program. Representative Peter Welch (D-VT) introduced the bill on June 13,...more
A recent Senate bill would lift the ban on expansion of physician-owned hospitals imposed by the Patient Protection and Affordable Care Act (PPACA). Senator James Lankford (R-OK) introduced this bill on May 16, 2017. The...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
5/22/2017
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Lately, we have received a number of client inquiries about prescription user fee waivers. The Prescription Drug User Fee Act (PDUFA), enacted in 1992, authorizes FDA to collect fees from companies that produce certain human...more
The Georgia Rural Hospital Tax Credit, created in 2016 to throw a lifeline to Georgia's struggling rural hospitals, received an update after Governor Nathan Deal signed S.B. 180 into law on May 8, 2017. The new law is...more
During its most recent session, the Georgia legislature passed SB16, expanding Georgia’s Medical Cannabis Bill, “Haleigh’s Hope Act” (the “Act”), which legalized the possession of low THC oil for individuals with certain...more
President Donald Trump’s action to repeal 2010’s Patient Protection and Affordable Care Act (ACA) should not be a surprise. After all, President Trump, along with many other candidates for office, made repeal of the ACA a...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
1/25/2017
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The 21st Century Cures Act (Cures Act) makes a number of changes affecting the pharmaceutical and biologics industries, and AGG previously has written on some of these changes. This update will focus on how the Cures Act...more
On April 24, 2016, Georgia Governor Nathan Deal signed into law S.B. 258, a bill permitting individuals and companies to receive state tax credits for contributions to certain rural Georgia hospitals. As AGG previously...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
The Centers for Medicare & Medicaid Services (CMS) made changes to important written guidance to Medicare providers by issuing a Change Request on June 24, 2016, to Chapter 15 of its Program Integrity Manual (titled “Medicare...more
Some of us remember the television commercial and poster, created by the then-audio cassette company, Memorex, asking “is it live, or is it Memorex?” Forty years later, the Food and Drug Administration could paraphrase the...more
After reviewing Medicare and Medicaid enrollment and revalidation applications, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued a report titled Enhanced Enrollment Screening of...more
Tennessee’s governor, Bill Haslam, has signed legislation that will significantly change the state’s certificate of need (CON) laws. The changes include revised requirements for multiple services regulated by CON, including...more
On On March 24, 2016, the Georgia General Assembly passed S.B. 258, a bill aimed at throwing a lifeline to Georgia’s struggling rural hospitals through rural hospital tax credit provisions. ...more
A bill introduced last week in the Georgia General Assembly sought to eliminate the state’s Certificate of Need (“CON”) program, which has been in place since 1979. The CON program’s goals are: “(1) to measure and define...more
South Carolina's proposed hospice licensure rule changes are expected to be approved in the next month, as the expiration date for the 120-day review period for automatic approval by the South Carolina General Assembly is...more
The Centers for Medicare & Medicaid Services (CMS) has just released the final 60-day overpayment rule (the Rule) on February 11, 2016, in what the agency describes as a continuing move targeted at rooting out fraudulent...more
On February 1, 2016, the Utah Legislature's House Health and Human Services Committee debated proposed legislation permitting an assisted living facility resident, or their representative, to install a video or audio...more
In yet another move emphasizing the Centers for Medicare & Medicaid Services’ (CMS) focus on quality health care, the agency has released the first patient experience of care star ratings on Home Health Compare. ...more
U.S. Senators Elizabeth Warren (D-MA), Susan Collins (R-ME), Claire McCaskill (D-MO), and Orrin Hatch (R-UT) requested in a letter dated July 8, 2015 that the U.S. Government Accountability Office (GAO) undertake a review of...more
The Department of Health and Human Services’ Office of Inspector General has recently recommended that the Food and Drug Administration continue to increase its pre-approval inspections of generic drug companies. The OIG...more