The U.S. Biden administration announced Thursday that 28 health care providers and payers have signed the White House’s voluntary commitment aimed at ensuring the safe development of artificial intelligence (AI), adding to...more
In November 2023, OIG released its first ever General Compliance Program Guidance (GCPG). The GCPG is a comprehensive document that applies to all individuals and entities involved in the health care sector....more
The state of Connecticut recently enacted HB6669, which requires registration of pharmaceutical manufacturers employing sales representatives who interact with health care professionals (HCPs) in Connecticut. The portions of...more
On April 11, 2022, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published Advisory Opinion No. 22-06, concluding that a pharmaceutical manufacturer’s sponsored genetic testing and...more
As we recently summarized online here, Oregon has approved a temporary rule implementing SB 763, which requires licensure of pharmaceutical sales representatives who visit health care providers in the state of Oregon for 15...more
This morning, the U.S. House passed drug pricing legislation as part of the Build Back Better Act (BBBA) (specifically the Rules Committee version available here and the manager’s amendments available here). In prelude to...more
On August 6, Pharmaceutical Research and Manufacturers of America (PhRMA) released an updated and enhanced version of its voluntary Code on Interactions with Health Care Professionals (HCPs). The updated Code will take effect...more
The United States Court of Appeals for the Fourth Circuit recently affirmed a $114 million judgment in a protracted, and hotly contested, suit filed under the qui tam provisions of the False Claims Act (FCA) against the owner...more
Effective January 1, 2022, the “No Surprises Act” signed into U.S. law as part of H.R. 133, “Consolidated Appropriations Act, 2021,” implicates (1) emergency services provided by non-participating providers at participating...more
2/17/2021
/ Arbitration ,
Billing ,
Consolidated Appropriations Act (CAA) ,
Cost-Sharing ,
Employee Retirement Income Security Act (ERISA) ,
Health Care Providers ,
Healthcare Reform ,
Internal Revenue Code (IRC) ,
New Legislation ,
Out of Network Provider ,
Out-of-Pocket Expenses ,
PHSA ,
Regulatory Requirements ,
Surprise Medical Bills
Following on last October’s publication of two proposed rules, the Department of Health and Human Services (HHS) published on November 20 two final rules intended to “modernize and clarify” the physician self-referral (Stark)...more
Along with proposed Stark Law exceptions designed to accommodate value-based care models, the Centers for Medicare & Medicaid Services (CMS or the agency) adopted additional revisions to the Stark Law regulations (the final...more
12/1/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Healthcare Reform ,
Patient Referrals ,
Physicians ,
Stark Law ,
Value-Based Care
On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019 proposal to exclude certain rebates paid by drug manufacturers from the...more
11/25/2020
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Healthcare Reform ,
MCOs ,
Medicaid Drug Rebate Program ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Safe Harbors ,
Stark Law
On Monday, March 30, the Centers for Medicare & Medicaid Services (CMS) announced an array of temporary regulatory waivers and new rules to equip the American health care system with maximum flexibility to respond to the...more
The Office of Inspector General for the U.S. Department of Health and Human Services (HHS-OIG) announced the launch of a portal that will post announcements and information issued by OIG that are related to COVID-19. ...more
Nearly a decade after the Affordable Care Act signaled a transition of the U.S. health care system to value-based care, the Department of Health and Human Services (HHS) published on October 9 two long-awaited proposed rules...more
10/14/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Healthcare Reform ,
Life Sciences ,
Physicians ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Burden ,
Regulatory Reform ,
Rulemaking Process ,
Safe Harbors ,
Secretary of HHS ,
Stark Law ,
Value-Based Care ,
Value-Based Payments
Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more
8/16/2019
/ Affordable Care Act ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Healthcare Reform ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Open Payments ,
Opioid ,
Pharmaceutical Industry ,
Physician Fee Schedule ,
Proposed Rules ,
Regulatory Agenda ,
Rulemaking Process ,
Sunshine Act
On Tuesday, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published Advisory Opinion No. 19-02, advising that OIG would not pursue enforcement under the Anti-Kickback Statute (AKS) or the...more
On October 3, the U.S. Congress passed H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the SUPPORT Act), a wide-reaching bill that aims to...more
10/9/2018
/ Anti-Kickback Statute ,
Health Care Providers ,
Healthcare Fraud ,
Legislative Agendas ,
Opioid ,
Pain Management ,
Pending Legislation ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Remuneration
On Monday, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) published a wide-ranging request for information (RFI) seeking ideas on how it might add or modify safe harbors to the...more
8/29/2018
/ Anti-Kickback Statute ,
Civil Monetary Penalty ,
CMMI ,
Comment Period ,
Cost-Sharing ,
Department of Health and Human Services (HHS) ,
Fraud and Abuse ,
Health Care Providers ,
Medicare Shared Savings Program ,
OIG ,
Request For Information ,
Safe Harbors ,
Stark Law
The New Jersey Attorney General plans to finalize new limits on payments and other benefits that New Jersey licensed prescribers may accept from pharmaceutical manufacturers, although the expected final rule is less...more
Manufacturers of pharmaceuticals and biologics have been closely watching the industry-wide investigation by the Boston U.S. Attorney's Office into manufacturer support of independent charitable foundations that assist...more
Drug manufacturers are once again facing new state limits on marketing and interactions with healthcare providers. Manufacturers should review the new laws and regulations carefully, consider how they might engage with the...more