According to its latest Semiannual Report to Congress, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) expects fiscal year (FY) 2019 investigative recoveries from criminal and civil actions to top $5 billion – up from $2.9 billion in FY 2018. Additionally, the OIG expects to recover $819
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Proposed Rules to Modernize Stark Law and Anti-Kickback Statute Released Today
Today, the Department of Health and Human Services (HHS) announced proposed changes to modernize the regulations that interpret the Physician Self-Referral Law (the Stark Law) and the Federal Anti-Kickback Statute. In a press release, HHS states these proposed rules are intended to “provide greater certainty for healthcare providers participating in value-based arrangements and providing coordinated care for patients . . . while maintaining strong safeguards to protect patients and programs from fraud and abuse.”
Over the last 30 years, HHS has issued a series of final regulations establishing exceptions and safe harbors that limit the reach of the Stark Law’s strict liability civil penalties and the Anti-Kickback Statute’s criminal penalties to protect from enforcement certain non-abusive and beneficial arrangements. These final regulations have not, however, reflected the significant shift in recent years in health care delivery and payment systems from a fee-for-service model to models based on improving value and quality of care provided to patients. As a result, many in the health care industry identify these laws, as well as the Civil Monetary Penalty (CMP) Law, as barriers to more effective care coordination and management that can deliver value-based care to improve quality of care, health outcomes, and efficiency. In response, on June 25, 2018, the Centers for Medicare & Medicaid Services (CMS) published a Request for Information seeking input on how it could address existing Stark Law barriers to these emerging value-based payment and delivery systems. Similarly, on August 27, 2018, the Office of Inspector General (OIG) published a Request for Information seeking feedback on how OIG could modify or add new safe harbors addressing these barriers. CMS and OIG received more than 350 comments each, which HHS has considered in publishing these proposed rules.
CMS and OIG Coordinated Proposals
The proposed rules, which span hundreds of pages, reflect close coordination between CMS and OIG, which tried to align the regulations, where appropriate, and the proposals are significant. More specifically, the coordinated proposals include:
- Three new exceptions and safe harbors for value-based payment arrangements
- Modifications to the existing electronic health record (EHR) exception and safe harbor
- The addition of a new exception and safe harbor related to the provision of cybersecurity technology and services
Continue Reading Proposed Rules to Modernize Stark Law and Anti-Kickback Statute Released Today
HHS OIG Pulls CMP, Safe Harbor Proposed Regs Pending for More Than a Decade
Seeking to “eliminate any confusion,” the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has formally withdrawn proposed civil money penalty (CMP) and anti-kickback (AKS) safe harbor regulations that it no longer intends to finalize. Specifically, the OIG is withdrawing:
- A 1994 proposed rule that would have codified the
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Health Fraud Recoveries Continue to Dip in FY 2018, According to Latest OIG/DOJ Fraud Report
Federal health care fraud judgments and settlements totaled $2.3 billion in fiscal year (FY) 2018 – down from $2.6 billion in recoveries in FY 2017 and $3.3 billion in FY 2016 — according to latest Health Care Fraud and Abuse Control (HCFAC) Program Annual Report. During FY 2018, the Department of Justice (DOJ) opened…
HHS Finalizes Updates to State Medicaid Fraud Control Unit Rules
The Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) have finalized changes to State Medicaid Fraud Control Unit (MFCU) regulations to reflect statutory changes and policies adopted since the MFCU rules were first issued in 1978. Among other things, the regulations incorporate statutory policies that: authorize a federal matching…
HHS OIG Recaps FY 2018 Enforcement Highlights
The Office of Inspector General (OIG) of the Department of Health and Human Services has issued its Semiannual Report to Congress, which summarizes key program integrity efforts in fiscal year (FY) 2018. Notably, during FY 2018, OIG achieved:
- Expected investigative recoveries of $2.91 billion (compared to $4.13 billion in FY 2017)
- Criminal actions against
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OIG Invites Comments on Potential Changes to Federal Anti-kickback and Beneficiary Inducement Policies to Promote Value-Based Care
The Office of Inspector General (OIG) of the Department of Health Human Services (HHS) has issued a request for information (RFI) on ways to amend or add new safe harbors to the Anti-Kickback Statute and exceptions to the beneficiary inducement provisions of the Civil Monetary Penalty statute, in order to foster arrangements that promote care…
OIG Moving Ahead on Changes to Anti-Kickback Safe Harbor Protection for Drug Rebates to Plans, PBMs
On July 18, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) submitted to the Office of Management and Budget (OMB) for regulatory review a proposed rule entitled “Removal Of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor…
OIG, DOJ Announce FY 2017 Health Care Fraud and Abuse Control (HCFAC) Program Recoveries
Federal health fraud recoveries for FY 2017 totaled $2.6 billion, according to the latest HCFAC program annual report, compared to $3.3 billion in FY 2016. The Department of Justice (DOJ) opened 967 new criminal health care fraud investigations in FY 2017, filed criminal charges in 439 cases involving 720 defendants, obtained convictions of 639…
OIG Evaluates Risks of Relying on Unverified Patient Lists in Home Health Surveys
The Department of Health and Human Services, Office of Inspector General, has issued a new Risk Alert focusing on the home health agency (HHA) survey process. The alert specifically examined whether HHA-supplied patient lists during surveys may omit certain patients from review and thereby present opportunities to conceal fraudulent activity or health and safety violations.…
OIG Invites Anti-kickback Safe Harbor, Fraud Alert Recommendations
The HHS Office of Inspector General (OIG) has published its annual solicitation of recommendations for new or revised anti-kickback statute safe harbors and new Special Fraud Alerts. The OIG states that in considering any recommendations, it will seek to determine potential financial benefits to health care providers in ordering or referring health care services. The…
OIG Report Assesses Accuracy of Manufacturer-Reported Medicaid Rebate Program Data
The OIG recently issued a report evaluating the accuracy of pharmaceutical manufacturer-reported Medicaid drug rebate program data, including pricing information and FDA classification (e.g., innovator/brand or noninnovator/generic). The OIG determined that the “vast majority” of the drugs in the Medicaid rebate program were classified appropriately in 2016, but about 3% of these drugs (885 drugs)…
OIG Highlights Recent Audit, Investigation, and Enforcement Accomplishments
The Office of Inspector General (OIG) of the Department of Health and Human Services has released its semiannual report for the period of April 1, 2017, through September 30, 2017. The report also includes aggregated data for all of fiscal year (FY) 2017. For instance, during FY 2017, the OIG achieved:
- $4.13 billion in expected
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OIG: Medicare Program Integrity at the Top of HHS Management Challenges
The OIG’s latest compilation of top HHS management and performance challenges flags vulnerabilities in key HHS health and social services programs, including includes the following:
- Ensuring Program Integrity in Medicare (addressing improper payments, fraud, payment policies, health care reforms, and health information technology).
- Ensuring Program Integrity in Medicaid (including compliance with fiscal controls, fraud prevention,
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OIG Wants CMS to Track Medicare Costs from Device Failures
A recent Office of Inspector General (OIG) report suggests that the lack of medical device-specific information on Medicare claim forms complicates CMS efforts to identify and track Medicare costs related to the replacement of recalled or prematurely failed medical devices. The OIG also believes the lack of device information on claims data “impedes the ability of FDA and CMS to identify poorly performing devices as early as possible” and interferes with the provision of timely follow-up care. The OIG recommends that CMS:
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OIG: “High-Performing” ACOs Point the Way for Medicare Shared Savings Program Savings
The OIG has examined the results of the first three years of the Medicare Shared Savings Program, under which accountable care organizations (ACOs) coordinate care to reduce Medicare costs and improve quality of care. The OIG reports that 428 participating ACOs serving 9.7 million beneficiaries saved almost $1 billion in net Medicare spending while generally…
OIG Issues “Early Alert” on Potential Cases of SNF Abuse/Neglect
The Office of Inspector General has issued an “early alert” warning that “CMS procedures are not adequate to ensure that incidents of potential abuse or neglect of Medicare beneficiaries residing in [skilled nursing facilities] are identified and reported.” In the course an ongoing review, the OIG identified 134 Medicare beneficiaries with injuries resulting…
OIG Targets Additional Medicare/Medicaid Policy Areas for Review
The OIG has added 18 reviews to its FY 2017 Work Plan – most of which target CMS programs, with a particular emphasis on prescription drug policies. For instance, the OIG now intends to examine the following Medicare and Medicaid topics (among others):
- Excessive Use of Opioids in Medicare Part D
- Including Non-Covered Versions When
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First Look at OIG’s FY 2017 Fraud Recoveries/Enforcement Activities
The HHS Office of Inspector General (OIG) expects its investigative recoveries during the first half of fiscal year (FY) 2017 to top $2.04 billion – which is down from $2.77 billion for the first half of FY 2016. During this period, the OIG reports 468 criminal actions against individuals or entities that engaged in crimes…
OIG Estimates CMS Made $730 Million in Improper EHR Incentive Payments, Based on Small Sample of Claims
The HHS Office of Inspector General (OIG) estimates that CMS made $729.4 million in Electronic Health Incentive (EHR) payments to providers who did not meet meaningful use requirements from May 2011 to June 2014 – representing about 12% of the $6 billion in total EHR payments made during this period. This dramatic finding is based…