The Centers for Medicare & Medicaid Services (CMS) has extended the eligible hospital and critical access hospital (CAH) attestation deadline from February 28, 2018 to March 16, 2018....more
On February 21, 2018, the Food and Drug Administration (FDA) published a Final Rule, amending its regulations on acceptance of data from investigations for medical devices that are performed outside of the United States as...more
In January 2018, the U.S. Food & Drug Administration (FDA) published two guidance documents on Compounded Drug Products That Are Essentially Copies Of Approved Drug Products under Section 503A and Section 503B of the Federal...more
On January 25, 2018, Associate Attorney General Rachel Brand issued a memo on behalf of the U.S. Department of Justice (DOJ) prohibiting certain DOJ uses of federal agency guidance documents in affirmative civil enforcement...more
On January 29, 2017, the Centers for Medicare and Medicaid Services (CMS) announced a temporary moratorium on enrolling Part B non-emergency ambulance providers/suppliers and home health agencies, subunits and branch...more
On January 9, 2018, the Centers for Medicare & Medicaid (CMS) Center for Medicare and Medicaid Innovation announced a new voluntary bundled payment model called Bundled Payments for Care Improvement Advanced (BPCI Advanced). ...more
On January 5, 2018, the Health and Human Services Office of Inspector General (OIG) posted a favorable Advisory Opinion, permitting an arrangement involving payment by a Medical Center to a multi-specialty physician Group for...more
On December 11, 2017, the Health and Human Services Office of Inspector General (OIG) posted a favorable Advisory Opinion, permitting a proposed pilot Program involving a collaboration between a pharmaceutical manufacturer...more
12/20/2017
/ Advisory Opinions ,
Electronic Medical Records ,
Federal Pilot Programs ,
Health Care Providers ,
Hospital Readmission ,
Manufacturers ,
Medicare Advantage ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs
The Centers for Medicare and Medicaid Services (CMS) issued the 2018 Medicare: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs Final Rule with comment...more
11/8/2017
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Critical Access Hospitals ,
Drug Pricing ,
Final Rules ,
Hospitals ,
Inpatient Billing ,
Inpatient Quality Reporting ,
Outpatient Prospective Payment System (OPPS) ,
Outpatient Quality Reporting ,
Section 340B
On September 11, 2017, the Ninth Circuit in US and State of Nevada ex rel. Welch v. My Left Foot Children’s Therapy, LLC, upheld the denial of the defendant’s motion to compel arbitration in a False Claims Act (FCA) relator...more
9/27/2017
/ Arbitration ,
Arbitration Agreements ,
Employment Contract ,
Employment Litigation ,
False Claims Act (FCA) ,
Federal Arbitration Act ,
Healthcare Fraud ,
Medicaid ,
Motion to Compel ,
Relators ,
Whistleblowers
The U.S. Food & Drug Administration (FDA) has issued important guidance on how to prepare for hurricanes when dependent on medical devices. FDA stresses that during hurricanes and other emergency situations, medical devices...more
On September 7, 2017, the HHS Office of Inspector General (OIG) issued an Advisory Opinion to the owner of a retail pharmacy chain (Pharmacy) that would allow Federal health care program beneficiaries to participate in a paid...more
On July 25, 2017, the U.S. House of Representatives passed by voice vote a bipartisan bill which is now in the Senate’s hands for consideration, the Medicare Part B Improvement Act of 2017. The bill would amend the Stark Law...more
Connecticut Governor Dannel P. Malloy recently signed into law Public Act 17-241 (PA 17-241), which contains provisions concerning facility fees, the sending and receiving of electronic health records between hospitals and...more
Connecticut Governor Dannel P. Malloy recently signed into law Public Act 17-241 (PA 17-241), which contains provisions concerning facility fees, the sending and receiving of electronic health records between hospitals and...more
On June 30, 2017, Connecticut Governor Dannel P. Malloy signed into law An Act Preventing Prescription Opioid Diversion and Abuse (Public Act No. 17-131). This legislation addresses opioid drug abuse in Connecticut by...more
The Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a university health system (Requestor) regarding two arrangements: (1) a proposal to waive cost-sharing obligations of...more
On December 28, 2016, the Food and Drug Administration (FDA) issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The guidance clarified aspects of the reporting requirements under Part 806 (21 CFR...more
On December 7, 2016, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited final rule (Final Rule) that expands the safe harbor regulations under the Anti-Kickback Statute (AKS)...more
12/20/2016
/ Ambulance Providers ,
Anti-Kickback Statute ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Medicaid ,
Medicare ,
OIG ,
Remuneration ,
Rural Areas ,
Safe Harbors
On October 14, 2016, the Centers for Medicare and Medicaid Services (CMS) released a final rule with comment period (Final Rule) implementing the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The Final Rule...more
10/28/2016
/ Alternative Payment Models (APM) ,
CEHRT ,
Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Healthcare ,
Medicare ,
Medicare Access and CHIP Reauthorization (MACRA) ,
MIPS ,
Physician Medicare Reimbursements ,
Physicians ,
PQRS ,
Quality Payment Program (QPP) ,
Rural Health Care Providers ,
Value-Based Payments
On September 27, 2016, the U.S. Court of Appeals for the Third Circuit handed the Federal Trade Commission (FTC) a significant antitrust victory by granting its request for a preliminary injunction to stay the pending merger...more
DOJ, NY AG REACH SETTLEMENT WITH HOSPITALS IN LANDMARK 60 - DAY RULE CASE -
On August 24, 2016, the U.S. attorney for the Southern District of New York and the New York State attorney general announced a $2.95 million...more
9/7/2016
/ 60-Day Rule ,
Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Medicare Part A ,
Medicare Part B ,
Overpayment ,
Overpayment Recovery Time Limits ,
Physician Assistants ,
Settlement ,
Vaccinations
On June 14, 2016, a federal district court in the Northern District of Illinois denied a request from the Federal Trade Commission (FTC) for a preliminary injunction to enjoin the pending merger of Advocate Health Care...more
7/19/2016
/ Antitrust Investigations ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
FTC Act ,
Health Care Providers ,
Hospital Mergers ,
Hospitals ,
Mergers ,
Penalties ,
Preliminary Injunctions ,
Stark Law
This legislation (P.A. 16-77) makes substantive and technical changes related to Public Act 15-146, a major public health and health care bill passed by the Connecticut Legislature during its 2015 Legislative Session....more
The Centers for Medicare and Medicaid Services (CMS) recently announced it will implement a pre-claim review demonstration for home health services. The three-year demonstration will apply to home health services performed in...more