On March 13, 2020, the President of the United States issued a proclamation that the 2019 Novel Coronavirus (previously referred to as 2019-nCoV, now as COVID-19) outbreak in the United States constitutes a national emergency...more
5/19/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Medicaid ,
Medicare ,
Public Health Emergency ,
Social Security Act ,
Stafford Act ,
Telehealth ,
Telemedicine
On May 4, 2020, the Food and Drug Administration (FDA) updated its “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) | Immediately in Effect Guidance for Clinical Laboratories, Commercial...more
On April 23, 2020, the Centers for Medicare & Medicaid Services (CMS) released the “State Medicaid & CHIP Telehealth Toolkit: Policy Considerations for States Expanding Use of Telehealth” (the Toolkit). Telehealth allows...more
In light of the COVID-19 public health emergency (Pandemic), on April 2, 2020, Governor Brad Little of Idaho issued a proclamation (Proclamation) that suspended 18 regulations (in addition to the 125 previously suspended...more
On March 23, 2020, the New York State (NYS) Department of Health issued updated guidance regarding use of telehealth by Medicaid providers, Comprehensive Guidance Regarding Use of Telehealth including Telephonic Services...more
4/1/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Response ,
Health Care Providers ,
HIPAA Privacy Rule ,
Medicaid ,
Medicare ,
State of Emergency ,
Telehealth ,
Telemedicine ,
Waivers
On March 15, 2020, in response to the a state of emergency due to the outbreak of the 2019 novel Coronavirus (COVID-19), Massachusetts Governor Charlie Baker executed an Order Expanding Access To Telehealth Services And To...more
Massachusetts Governor Charlie Baker has restarted the discussion on health care cost containment in the Commonwealth with a proposed bill that contains a raft of initiatives. Foley & Lardner LLP will be addressing each of...more
Massachusetts Governor Charlie Baker has restarted the discussion on health care cost containment in the Commonwealth with a proposed bill that contains a raft of initiatives. Foley & Lardner will be addressing each of the...more
Blockchain technology originated in 1991, and was conceived as a secure way to timestamp digital documents akin to how a notary timestamps physical documents. The true value lies in the fact that once stamped, the document...more
7/18/2019
/ Blockchain ,
Credentialing ,
Distributed Ledger Technology (DLT) ,
DSCSA ,
EHR ,
Electronic Medical Records ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Smart Contracts ,
Supply Chain ,
Technology
In February, the Department of Justice (DOJ) successfully leveraged a new weapon to target pharmacies as it battles the nation’s opioid crisis. The new approach utilizes court-ordered temporary restraining orders (TROs) that...more
4/3/2019
/ Controlled Substances ,
DEA ,
Department of Justice (DOJ) ,
License Suspensions ,
Opioid ,
Order to Show Cause ,
Pharmacies ,
Preliminary Injunctions ,
Prescription Drugs ,
Substance Abuse ,
TRO
The Massachusetts Medicaid Program (known locally as MassHealth) issued a new All Provider Bulletin in January, setting forth new policies for certain behavioral health services delivered to MassHealth covered patients. The...more
On January 31, 2019, the United States Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) announced a proposed rule, which would eliminate certain drug rebates and encourage direct discounts for...more
2/5/2019
/ Anti-Kickback Statute ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Regulatory Agenda ,
Safe Harbors
Justice Reed O’Connor’s recent decision, Texas et al. v. U.S. et al., No. 4:18-cv-00167-O (E.D. Tex. Dec. 14, 2018), to strike down the entire Patient Protection and Affordable Care Act, 42 U.S.C. § 18001 et seq. (2010) (the...more
In a final rule published on January 19, 2017, HHS and several federal departments and agencies made revisions to the Common Rule, the federal policy for the protection of human subjects applicable to human subject research...more
On February 28, 2018, Ethan P. Davis, the Deputy Assistant Attorney General for the Consumer Protection Branch, addressed the life sciences community regarding off-label promotion. In his remarks, Deputy Assistant Attorney...more
3/6/2018
/ Anti-Kickback Statute ,
Attorney General ,
CGMP ,
Department of Justice (DOJ) ,
Enforcement Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Misleading Statements ,
Off-Label Promotion ,
Opioid ,
Pharmaceutical Industry ,
REMS