Kusserow on Compliance: OIG adds new work plan items for 2019

The HHS OIG’s six new Active Work Plan (Work Plan) items for 2019, including the following:

  1. Medicare Payments for Clinical Diagnostic Laboratory Tests in 2018: Year 1 of New Payment Rates. Medicare Part B covers most lab tests and allowable charges without beneficiary copayments. The Protecting Access to Medicare Act of 2014 (PAMA) mandates CMS release an annual analysis of the top 25 laboratory tests by expenditures and for them to set payment rates for lab tests using current charges in the private health care market; and the OIG will conduct a study on this data.

 

  1. States’ Compliance with New Requirements to Prevent Medicaid Payments to Terminated Providers. The 21st Century Cures Act requires CMS to provide states with information on Medicaid providers that have been terminated to prevent them from treating enrollees or receiving Medicaid payments. The OIG will examine the extent to which the CMS terminations database have resulted in terminations of all state Medicaid programs and the amount of payments associated with terminated providers; and examine which contracts between states and managed care entities include a provision that excludes terminated providers from all managed care networks.

 

  1. Follow-up Review on Inpatient Claims Subject to the Post-Acute-Care Transfer Policy. Previous OIG reviews found (a) hospitals did not comply with the Medicare post-acute-care transfer policy, resulting in overpayments by the Medicare program; (b) hospitals would use the “to home” patient discharge status codes on their claims even though the patient was transferred to a post-acute-care setting; and (c) CMS’s common working file edits related to beneficiary transfers to home health care, SNFs, and non-IPPS hospitals were not working properly. The review will determine if CMS corrected the CWF edits, ensure that the edits are working properly, and that they recovered the identified overpayments.

 

  1. Utilization and Pricing Trends for Naloxone in Medicaid. Naloxone is a medication designed to rapidly reverse opioid overdose. There is concern its high cost may impede increased access to the drug. The OIG will (a) produce a data showing trends in utilization of and expenditures for naloxone in Medicaid over a 5-year period; (b) compare the cost-per-dose of naloxone under Medicaid compares to other available prices; and (c) determine the proportion of all naloxone paid for under Medicaid between 2014 and 2018.

 

  1. Medicare Outpatient Outlier Payments for Claims with Credits for Replaced Medical Devices. Hospitals are required to submit a zero or token charge when they receive a full credit for a replacement medical device, however CMS does not specify how to reduce charges for partial credits. The OIG will focus on overstated Medicare charges on outpatient claims that contain both an outlier payment and a reported medical device credit.
  1. Duplicate Payments for Home Health Agency (HHA) Services Covered Under Medicare and Medicaid. HHA coverage requirements state that they are responsible for providing all services either directly or under arrangement while a beneficiary is under a physician authorized home health plan of care.  Medicare pays a single HHA overseeing the plan.  For dual eligible beneficiaries with no other coverage who are receiving HHA services, Medicare is the first payer, because Medicaid is generally a payer of last resort.  The OIG will determine whether states made Medicaid payments for HHA services provided to dual eligible beneficiaries who are also covered under Medicare.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

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Copyright © 2019 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: OIG Advisory Opinion 18-14

The OIG’s continued interest and concerns about arrangements that could implicate the Anti-Kickback Statute was reaffirmed recently by another advisory opinion on the subject. A drug company (Requestor) that markets an injectable drug to treat a specific and rare form of epilepsy (the Syndrome) raised the concern with the OIG. The Requestor sought an advisory opinion as to whether the arrangement would be susceptible to sanctions related to the federal Anti-Kickback Statute (AKS). The proposed arrangement would have the Requestor providing a drug to hospitals on a consignment basis, at no cost to the hospitals or any payors, to treat inpatients diagnosed with the Syndrome.  In addition, the company would provide additional free vials to patients that are uninsured after they are discharged. The OIG found that the proposed arrangement implicates the AKS, in that free provision of the drug would constitute remuneration to hospitals that serve as a referral source for the drug. Specifically, hospitals would serve as a direct referral source when their employed physicians prescribe the drug to inpatients or outpatients.  Hospitals could also serve as an indirect referral source for the Drug through inclusion of the Drug in the hospitals’ drug formulary, thereby keeping it stocked and readily available to prescribing physicians. In this manner, the arrangement could induce hospitals to arrange for or recommend additional future purchases of the drug. The OIG highlighted the arrangement’s risks with respect to over-utilization, increased costs to federal health care programs, corruption of medical decision-making, patient steering, and unfair competition.

 

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2019 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: OIG second half 2018 semiannual report to Congress

The OIG recently released its second 2018 Semiannual Report for 2018 that highlighted its key accomplishments, areas of top concern, and a summary from reports, congressional hearings, legal and investigative activities. The OIG reported for FY Fiscal Year 2018: (a) audit recoveries of $521 million; (b) investigative recoveries of $2.91 billion; (c) 764 criminal actions against individuals or entities; (d) exclusion of 2,712 individuals and entities; and (e) civil actions against 813 individuals or entities. The OIG highlights reported included the following:

  1. In response to the Opioid Crisis, the OIG (a) released a data analysis toolkit to assist both the private and public sector in combating the crisis; (b) engaged in the largest fraud takedown of providers participating in opioid related fraud; (c) reported on the effect of the opioid epidemic and opioid prescribing practices on Medicare Part D and its beneficiaries; and (d) conducted its first state specific Medicaid review targeted toward the opioid epidemic.
  2. Took several actions during this reporting period to combat health and safety issues affecting this population and made recommendations for specific grantees that failed to meet health and safety requirements.
  3. Focused on improving the quality of care in hospice settings and protecting hospice benefits from fraud, waste, and abuse that included enforcement actions against a large hospice chain; and released a portfolio of highlights and 15 recommendations for improving hospice care for Medicare beneficiaries.
  4. Identified waste by inpatient rehabilitation facilities (IRFs) that did not meet Medicare’s necessary and reasonable coverage requirements; and identified $631 million in overpayments related to replacement positive airway pressure device supplies that did not comply with Medicare requirements.
  5. Found that MCOs were identifying few cases of fraud and abuse and failed to refer the incidents to the state when they were identified.
  1. Findings that many adult day care facilities fail to meet certain requirements to ensure the health and safety of individuals in the facilities’ care; and recommended that states correct instances of patient harm and improve oversight of staffing, training, and administration in adult day care facilities.

 

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

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Copyright © 2019 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: CMS Preclusion list

Those on Preclusion List are prohibited from MA Plan or Part D sponsor payment

Effective April 2019, under a final rule published by CMS, Part D sponsors, or their pharmacy benefit manager must screen against the Preclusion List and reject any pharmacy claim prescribed by an individual or entity on the Preclusion List. Additionally, effective April 2019, MA plans must deny payment for a health care item or service furnished by an individual or entity on the list. Plans and sponsors must also notify impacted beneficiaries who received care or a prescription from a provider on the Preclusion List in the last twelve months. The list includes those who are currently revoked from Medicare; are under an active reenrollment bar, where CMS has determined that the underlying conduct is detrimental to the Medicare program; or have engaged in behavior for which CMS could have revoked the prescriber and determined the underlying conduct would have led to the revocation. Such conduct includes, but is not limited to, felony convictions and OIG exclusions. Only health care plans approved by CMS will have access to the Preclusion List. MA plans and Part D sponsors will be required to access the list through an Enterprise Identity Data Management (EIDM) account with CMS.  The List will be updated around the first business day of each month. CMS indicated that individuals or entities appearing on the List of Excluded Individuals/Entities (LEIE) and/or the System for Award Management (SAM) list would also be placed on the Preclusion List.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2019 Strategic Management Services, LLC. Published with permission.