As the single largest payor for health care in the United States, the Centers for Medicare & Medicaid Services (CMS) has recognized and acted on the need to move quickly in the fight against COVID-19....more
A critical question faced by state agencies as well as owners, operators, and managers of assisted living facilities is whether to permit new admissions. ...more
The President’s national emergency declaration on March 13, 2020, issued in response to COVID-19, enabled the Centers for Medicare and Medicaid Services (CMS) to grant state Medicaid agencies added flexibility through a...more
Parties to a health care transaction must be prepared for and informed on a number of aspects unique to the health care industry. This is certainly true for proposed changes of ownership or control, where a buyer plans to...more
Intellectual and developmental disabilities (IDD) providers fill a critical need in our communities and around the country. ...more
In November 2019, the Centers for Medicare & Medicaid Services proposed the Medicaid Fiscal Accountability Regulation (MFAR), a set of regulations targeted at promoting financial integrity in state Medicaid programs. ...more
The Centers for Medicare & Medicaid Services’ (CMS) final rule addressing program integrity and vulnerability issues, which was issued on September 5, 2019, went into effect on November 4, 2019. ...more
Certificates of need (CONs) are a creature of state law, which means no two states take exactly the same approach to the review, issuance, or maintenance of certificates of need (that is, if the state has a CON program at...more
In a recently released report titled “Help Wanted: Who will Care for Mom & Dad?”, the Pennsylvania Auditor General, Eugene DePasquale, lists a number of observations of and recommendations for varying facets of the...more
Changes may be coming to Georgia’s new (and not yet implemented) long-term care background check law. If passed, the new Georgia House Bill 91 would authorize the Georgia Bureau of Investigation and Federal Bureau of...more
In a 119-page report titled “Reforming America’s Healthcare System through Choice and Competition,” issued on December 3, 2018, Secretaries Alex Azar (Health and Human Services), Steve Mnuchin (Treasury), and Alexander Acosta...more
The Centers for Medicare & Medicaid Services (CMS) issued a fact sheet related to proposed regulations addressing conditions of participation (CoPs) and conditions for coverage (CfCs). ...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
On June 21, 2018, FDA issued new guidance related to the Prescription Drug User Fee Act. The document, titled Guidance for Industry: Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological...more
The American Hospital Association has announced a new pilot program that would implement an “age-friendly health system” involving partnerships with hospitals, ambulatory care providers, long-term care providers, and...more
The Centers for Medicare & Medicaid Services (CMS) announced that it is seeking input on direct provider contracting (DPC) between “payers and primary care or multi-specialty groups to inform potential testing of a DPC model”...more
The U.S. Senate is continuing to ramp up efforts to address the opioid abuse crisis. As a part of that effort, on April 16, 2018, the Senate introduced S. 2680, the Opioid Crisis Response Act of 2018. The Bill is currently in...more
An increasing number of Medicare providers have found themselves in financial distress and are contemplating bankruptcy filings. While provider bankruptcies include a host of issues outside the government reimbursement...more
A Centers for Medicare & Medicaid Services (CMS) call letter (the “Call Letter”) released on April 2, 2018, could mean a dramatic and positive shift in CMS policy related to Medicare Advantage (MA) plans and senior living and...more
Nursing facilities undergoing changes of ownership (CHOW) in Vermont could see new requirements starting in 2019 if a recent bill is passed. The state, which currently can take as long as one year (or more in some cases) to...more
Proposed legislation in Minnesota would dramatically reshape the state’s licensing requirements for assisted living (“AL”) and memory care (“MC”) communities. Minnesota’s current AL licensing requirements are unique in the...more
The Centers for Medicare & Medicaid Services (CMS) recently released a new Medicare Learning Network “MLN Matters” education document to remind applicable providers and suppliers about the need to timely report provider...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
8/18/2017
/ Cosmetics ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Pilot Programs ,
Food and Drug Administration (FDA) ,
GAO ,
Health Care Providers ,
Healthcare Fraud ,
Medical Devices ,
Opioid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 340B
Scott Gottlieb, M.D., FDA's commissioner, recently announced new digital health initiatives that will aid in the agency's push to regulate and support digital healthcare in the medical device space. In a statement posted to...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