Other OIG Developments

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In a March 11 advisory opinion the Department of Health and Human Services’ Office of Inspector General (“OIG”) permitted a medical device manufacturer to pay Medicare-reimbursable costs for subjects enrolled in a clinical trial sponsored by the manufacturer and involving the manufacturer’s therapy.

The OIG indicated it would not impose administrative sanctions, despite the fact…

With another presidential transition in the history books, you may find it unsurprising to hear that many of us at Reed Smith are continuing to closely monitor and track which of the outgoing Trump administration’s “midnight regulations” will survive past the early months of the Biden administration. But for those less familiar with the topic…

Even amidst the chaos of a global pandemic, this year multiple U.S. Department of Health and Human Services (HHS) agencies have dialed in on promoting and enforcing patients’ rights to access their health information.

In just the past month, HHS’ Office for Civil Rights (OCR), the agency that enforces the Health Insurance Portability and Accountability Act of 1996 (HIPAA), settled five costly investigations with HIPAA-regulated parties for potential violations of the HIPAA right of access provision.  Under HIPAA, individuals have a legal, enforceable right to view and obtain copies, upon request, of the information in their medical and other health records maintained by a HIPAA covered entity, typically a health care provider or health plan, with limited exception.  Individuals generally have a right to access this information for as long as the information is maintained by a covered entity, or by a business associate on behalf of a covered entity, regardless of the date the information was created, whether the information is maintained in paper or electronic systems onsite, remotely, or is archived, or where the information originated (e.g., whether the covered entity, another provider, or the patient).
Continue Reading Patient access to health information at the forefront of government initiatives and scrutiny

Earlier this week, the Department of Health and Human Services (HHS) Office of General Counsel issued Advisory Opinion 20-02, which declared that the Public Readiness and Emergency Preparedness Act (PREP Act), combined with the HHS Secretary’s March 10, 2020 declaration, preempts state or local requirements that would prevent pharmacists from ordering or administering COVID-19 tests…

The HHS Office of Inspector General (OIG) has issued its annual solicitation of recommendations for new or revised Anti-kickback Statute (AKS) safe harbors and new Special Fraud Alerts.  In reviewing proposed safe harbor changes, the OIG will consider the extent to which the proposals would increase or decrease:

  • Access to health care services
  • Quality of

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The Trump Administration has decided against finalizing a controversial proposed Office of Inspector General (OIG) regulation that would have modified Federal Anti-Kickback Statute safe harbor protection for certain prescription drug rebates to health plans and pharmacy benefit managers (PBMs).  As we previously reported, the proposed rule would have (i) removed safe harbor protection for …

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.…

The Trump Administration has released its fiscal year (FY) 2019 budget proposal, which includes extensive health policy provisions. While most of the President’s policy proposals for Department of Health and Human Services (HHS) programs would require Congressional approval, others are characterized as administrative proposals that presumably would not involve Congress.
Continue Reading Trump Administration’s Proposed FY 2019 Budget Targets Medicare, Medicaid for Savings, Seeks (Again) to Repeal/Replace ACA

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…

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)…

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:

  1. Ensuring Program Integrity in Medicare (addressing improper payments, fraud, payment policies, health care reforms, and health information technology).
  2. Ensuring Program Integrity in Medicaid (including compliance with fiscal controls, fraud prevention,

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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:…
Continue Reading OIG Wants CMS to Track Medicare Costs from Device Failures

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…

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…

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…