Tag archives: OIG

Healthcare Regulatory Landscape Transformed by Stark, AKS Final Rules

In what may prove to be the most substantial fraud and abuse rulemaking in over a decade, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) and Centers for Medicare & Medicaid Services (“CMS”) published on November 20, 2020 long-awaited final rules changing the regulations addressing the Anti-Kickback Statute (“AKS”) and … Continue reading

COVID-19 Update: HHS Issues Notice of Designation to Prevent Hoarding and OIG launches COVID-19 Portal

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on March 26, 2020 Posted in Coronavirus, General, Regulatory

On March 25, in response to President Trump’s Executive Order, HHS issued a Notice of Designation a list of health and medical resources necessary to respond to COVID-19 that are necessary to combat the spread of the disease. The Defense Production Act “prohibits any person from accumulating designated materials (1) in excess of the reasonable … Continue reading

OIG publishes Medicaid Fraud Control Units Fiscal Year 2018 Annual Report

By Savannah Wiseman (US) on March 27, 2019 Posted in Enforcement

On March 25, 2019, the Office of Inspector General (OIG) published its Medicaid Fraud Control Units Fiscal Year 2018 Annual Report. Forty-nine states and the District of Columbia have a Medicaid Fraud Control Unit (MFCU) which is responsible for investigating and prosecuting Medicaid provider fraud and patient neglect and abuse. The report notes that it … Continue reading

OIG proposes to eliminate safe harbor protection for drug manufacturer rebates to PBMs; proposes two new safe harbors

By Carol Poindexter (US) and Savannah Wiseman (US) on February 5, 2019 Posted in Regulatory

On January 31, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a proposed new rule that, if finalized, would eliminate existing protection under the Anti-Kickback Statute (AKS) “discount” safe harbor (42 C.F.R. 1001.952(h)) for drug manufacturers’ rebates to plan sponsors or pharmacy benefit managers (PBMs) acting under contract with plan … Continue reading

OIG considers new safe harbors and other incentives to promote coordinated care

By Elise LeGros (US) on September 5, 2018 Posted in Regulatory

As part of the Health and Human Services Department’s (“HHS”) “Regulatory Sprint to Coordinated Care” efforts aimed at alleviating unnecessary regulatory barriers to coordinated care while protecting against fraud and abuse, the Office of Inspector General (“OIG”) issued a Request for Information (“RFI”) on August 27, 2018, requesting public input on the following items: Care … Continue reading

OIG launches new compliance resource portal

By on April 30, 2018 Posted in News from DC

The OIG recently launched a new compliance resource portal, compiling some of its resources into one user-friendly webpage. The Compliance Resource Portal provides a list of links to categories of “handy resources for the public that can help ensure that you are in compliance with Federal health care laws,” and may serve as a valuable … Continue reading

Rumors of sea change in DOJ policy potentially confirmed by two recent memos

By Carol Poindexter (US) on January 31, 2018 Posted in Enforcement

Rumors of a significant shift in U.S. Department of Justice (DOJ) policy were confirmed last week when a privileged and confidential internal DOJ memo was leaked to the press. The memo outlines seven factors government attorneys should use for evaluating whether the government should seek dismissal of qui tam actions filed under the federal False Claims … Continue reading

OIG rescinds advisory opinion to charity

By Carol Poindexter (US) on November 30, 2017 Posted in Enforcement

For the first time, the OIG has rescinded an advisory opinion issued to a charity. According to the OIG, the advisory opinion – issued in 2006 and modified in 2015 – was revoked because the charity “failed to comply with certain factual certifications” about independence from donors, potentially steering Medicare beneficiaries toward certain prescription drugs. … Continue reading

Republican Senators continue work on health care reform legislation while another insurer withdraws from a state ACA marketplace; U.S. Senate and House of Representatives committees hold hearings this week on the cost of prescription drugs and funding for safety net health programs

By Thomas Dowdell (US) on June 12, 2017 Posted in News from DC

Last Tuesday, Senior Republican leadership in the Senate held a closed-door briefing for Republican Senate members regarding Senate health care reform legislation. Senior Republican leadership reportedly indicated that they favor the retention of guaranteed protections for individuals with preexisting conditions, a more gradual roll back of the expansion of Medicaid, and may opt to keep … Continue reading

No monetary penalties for manufacturer providing physicians with free vaccine refrigeration storage system

By on September 26, 2016 Posted in Enforcement

In an Advisory Opinion issued on September 23, 2016, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) announced that it would not impose administrative sanctions against the manufacturer of a vaccine refrigeration system (the “Requestor”) for providing the devices to physicians without charge. This development comes at a critical time … Continue reading

Proposed rule strengthens state Medicaid Fraud Control Units

By on September 21, 2016 Posted in Regulatory

On Tuesday, September 20, 2016, CMS published a proposed rule in the Federal Register to bolster the current State Medicaid Fraud Control Units (MFCUs or Units). MFCUs investigate and prosecute Medicaid fraud, including provider fraud, patient abuse, and neglect in health care facilities. MFCUs operate in 49 States and the District of Columbia. The MFCUs, … Continue reading

HHS announces near-doubling of civil penalties for numerous infractions

By on September 12, 2016 Posted in Enforcement

Last week, HHS, OIG, CMS, the Office of the Assistant Secretary for Financial Resources, and the Administration for Children and Families issued an interim final rule (the Rule) that adjusts maximum civil monetary penalties for inflation.… Continue reading

OIG finds ED drug-discount program would not trigger kickback sanctions

By on July 1, 2016 Posted in Regulatory

On June 27, 2016, the OIG posted Advisory Opinion No. 16-07 stating that an erectile dysfunction (ED) drug manufacturer would not face sanctions for a planned discount-card promotion for the drug.… Continue reading

OIG finds CMS deficient in monitoring compliance by hospitals with provider-based status requirements

By Thomas Dowdell (US) on June 17, 2016 Posted in Regulatory

On June 17, 2016, the Department of Health and Human Services’ Office of Inspector General (OIG) released a report entitled “CMS Is Taking Steps to Improve Oversight of Provider-Based Facilities, But Vulnerabilities Remain” (OEI-04-12-00380). The OIG reviewed oversight by the Centers for Medicare & Medicaid Services (CMS) of compliance by hospitals with the Medicare provider-based … Continue reading

OIG reports gain in expected recoveries for fraud and abuse matters

By on June 2, 2016 Posted in Enforcement

On Tuesday, the OIG released its Semiannual Report to Congress, which stated that expected recoveries for fraud and abuse activities total $2.77 billion in the first half of fiscal year 2016. This represents a gain of almost $1 billion when compared to the first half of fiscal year 2015. The report, which covers the time … Continue reading

CMS seeks feedback on standard form for SRDP submissions

By on May 11, 2016 Posted in Regulatory

CMS has asked for comments on a form for healthcare providers to disclose actual or potential violations of the federal self-referral (Stark) law. The proposed format includes a disclosure form, a physician-information form, and a financial-analysis worksheet. As many providers know, CMS is significantly backlogged with self-disclosures, and so the standard form may help the agency more … Continue reading

New OIG exclusion guidance places value on self-disclosure

By on April 18, 2016 Posted in Enforcement

The OIG has issued updated guidance on the agency’s exclusion authority, as announced by Inspector General Daniel Levinson at the HCCA’s 2016 Compliance Institute. According to the new guidance, good-faith self-disclosures will place providers at the lower-risk end of the spectrum for an exclusion release without integrity obligations. As a result, providers have additional support … Continue reading

Government healthcare fraud-and-abuse recovery drops to $2.4 billion in FY 2015

By on March 2, 2016 Posted in Enforcement

In a report released on February 26, 2016, the federal government announced that it recovered $2.4 billion through its Health Care Fraud and Abuse Control Program (HCFAC) during FY 2015. The $2.4 billion is almost $1 billion lower than the recovery of $3.3 billion in FY 2014. Over the last three years, the return on … Continue reading

CMS issues anticipated Medicare overpayments final rule; relaxes initial proposals

By Thomas Dowdell (US), Carol Poindexter (US) and Mark Faccenda (US) on February 12, 2016 Posted in Regulatory

On February 11, 2016, CMS issued a final rule clarifying the requirement of § 1128J(d) of the Social Security Act (created by § 6402(d) of the Affordable Care Act) that health care providers must report and return overpayments within 60 days of the date when they have identified the overpayment or the date any applicable … Continue reading

Increased focus on data analysis by government agencies

By on January 20, 2016 Posted in Enforcement

At a recent DC Bar program called “The Use of Data by the OIG-DHHS and CMS/CPI in Medicare Program Integrity, Investigations and Compliance,” representatives from CMS and the OIG provided their perspectives on the evolving capabilities of government agencies to review and analyze large datasets related to the provision and reimbursement of healthcare services.… Continue reading

OIG changes requirements for Patient Assistance Programs, modifies favorable Advisory Opinions

By Carol Poindexter (US) on November 9, 2015 Posted in Regulatory

The Office of Inspector General has revised two Advisory Opinions in light of changes made by two charities in response to new fraud protection guidance from the OIG. As we previously discussed, in 2014 the OIG issued a Supplemental Bulletin (“the Bulletin”) providing guidance to independent charities that operate patient assistance programs (“PAPs”) to ensure … Continue reading

OIG releases FY 2016 work plan

By Carol Poindexter (US) on November 3, 2015 Posted in Regulatory

On November 2, 2015, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published its Work Plan for fiscal year (FY) 2016. The OIG announced that in the upcoming year, it will continue to investigate various Medicare and Medicaid claims made by nearly every type of provider group. Below is a … Continue reading

CMS and OIG finalize rules on MSSP ACO waivers

By Jim Wiehl (US) on October 28, 2015 Posted in Regulatory

On October 28, 2015, CMS and OIG jointly issued a final rule for the Medicare Shared Savings Program ACO waivers, which is slated for publication in the Federal Register on October 29. The ACO waivers have been in place since an interim final rule with comment period (IFC) was published on November 2, 2011, and … Continue reading

OIG approves complimentary hospital shuttle services

By on October 23, 2015 Posted in Regulatory

On October 21, 2015, the HHS Office of Inspector General (OIG) released Advisory Opinion No. 15-13, stating that it would not impose administrative sanctions against members of a health system for offering free van shuttle services to certain medical facilities within the health system. The Proposed Arrangement Under the proposed arrangement, the health system would … Continue reading