Kusserow on Compliance: OIG November 2017 Work Plan update

This year, the OIG is updating its annual Work Plan during the year, rather than annually. The OIG’s Work Plan sets forth various audits and evaluations that are underway or planned during the fiscal year and beyond. The updates will include the addition of newly initiated Work Plan items; removal of completed items. In conducting its work, the OIG assesses relative risks in HHS programs and operations to identify those areas most in need of attention. In evaluating potential projects to undertake, the OIG considers a number of factors, including mandates set forth in laws, regulations, or other directives; requests by Congress, HHS management, or the Office of Management and Budget; top management and performance challenges facing HHS; work performed by other oversight organizations (e.g., GAO); management’s actions to implement OIG recommendations from previous reviews; and potential for positive impact. In addition to working on projects that often result in audits, reviews, and reports, the OIG also engages in a number of legal and investigative activities that are separately reported.

New projects

  1. Use of Funds by Medicaid Managed Care Organizations (MCOs). In 2015, Federal Medicaid managed care payments were approximately $161.8 billion, which was more than 40 percent of the $349.8 billion in total Federal expenditures for Medicaid. States continue to expand their use of managed care. To deliver services to Medicaid managed care enrollees, states contract with MCOs and make monthly capitation payments to those plans to provide enrollees with Medicaid-covered services. Appropriately set capitation rates help to ensure that adequate payments are made to provide services to beneficiaries. OIG auditors plan to examine how Medicaid funds received by MCOs are used to provide services to enrollees with results reported in 2019.

 

  1. Opioids in Medicaid: Concerns about Extreme Use and Questionable Prescribing in Selected States. The OIG Office of Evaluation and Inspection will focus on the problem of opioid abuse and overdose deaths that have reached crisis levels in the United States, with more than 33,000 Americans dying from it annually. These issues are of particular concern for Medicaid beneficiaries because they are more likely to have chronic conditions and comorbidities that require pain relief. Especially affected are beneficiaries who qualify through a disability. The OIG plans to identify beneficiaries who received extreme amounts of opioids through Medicaid and those cases that appear to involve doctor shopping or pharmacy shopping, as well as prescribers associated with these beneficiaries. This review will provide baseline data about beneficiaries receiving extreme amounts of opioids and prescribers with questionable patterns for opioids in Medicaid.

 

  1. Medicaid Services Delivered Using Telecommunication Systems. Medicaid pays for telemedicine, telehealth, and telemonitoring services delivered through a range of interactive video, audio or data transmission (telecommunications). Medicaid programs are seeing a significant increase in claims for these services and expect this trend to continue. OIG auditors will over the next year or two determine whether selected states’ Medicaid payments for services delivered using telecommunication systems were allowable in accord with Medicaid requirements.

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 © 2017 Strategic Management Services, LLC. Published with permission.

Personal service care fraud; a growing problem for Medicaid

Medicaid personal care service (PCS) fraud cases made up a “substantial and growing” portion of cases investigated by the Medicaid Fraud Control Units (MCFUs) and greater oversight is recommended by the HHS Office of the Inspector General (OIG). In a report covering the PCS work of MFCUs over fiscal years 2012-2015, the OIG found that these cases comprised over 12 percent of the total investigations and accounted for 34 percent of the convictions (OIG Report, OEI-12-16-00500, December 6, 2017).

Background

Personal care services are those services that support consist daily living activities, including bathing and dressing, meal preparation, and transportation. PCS providers assist the elderly, people with disabilities, and individuals with chronic or temporary health conditions, allowing these persons to remain living in their homes and communities. PCS are typically delivered through either an agency-directed PCS or a self-directed PCS, through which beneficiaries hire and supervise their own provider. PCS are offered either as an optional benefit through a Medicaid State plan or through demonstration projects and waiver programs. States are required to develop their requirement and qualification standards for PCS providers, resulting in widely varying requirements across the country.

Growing percentage

The OIG found that during the three-year review period, PCS fraud cases made up a substantial and increasing number of MFCU cases and outcomes. In FY 2015, such cases made up 12 percent of total investigations and over the review period, they made up 38 percent of indictments, and 34 percent of convictions. Furthermore, during the review period, indictments increased 56 percent and convictions increased 33 percent. Payments to PCS providers represented $13 billion out of $524 billion total Medicaid expenditures during FY 2015.

Recommendations and challenges

MCFUs have recommended that State Medicaid either enroll PCS attendants as Medicaid providers, or include PCS attendants in a provider registry. This would allow for the assignment of unique provider identification number to PCS attendants to include on claims for reimbursement. Some form of enrollment or registration is needed, as the inability to identify individual PCS attendants restricts the ability to identify fraudulent providers. MCFUs have suggested that enrolling PCS attendants in Medicaid would better inform them about Medicaid procedures and requirements.

MCFUs have also recommended the use of background checks for attendants. They found that the current, minimal, background check requirements could put vulnerable beneficiaries at risk. For example, a PCS attendant in Arizona pleaded guilty to theft and financial exploitation of a vulnerable adult, after having stolen checkbooks, cash, credit cards, and personal items belonging to the beneficiaries. The PCS agency checked for felony arrests and found none; the attendant had, however, numerous misdemeanor convictions and had previously lost her nursing assistant license.

The MCFUs have also recommended using additional documentation requirements, such as requiring require PCS attendants to provide detailed or standardized timesheets and to show the start and stop times for the services. The currently minimal PCS documentation means that PCS claims data may not contain the identity of the PCS attendant, the number of hours worked, or the time of day during which the services were provided.

Lastly, the MCFUs recommended that State Medicaid agencies implement a variety of controls regarding oversight of PCS providers and their services. These controls include more frequent in-home supervisory visits, training for PCS attendants and cross-reference attendant and beneficiary location. For a variety of reasons, beneficiaries may be reluctant to report abuses and more frequent in-home visits could curtail fraud.

Funding issues

The units reported that their efforts to protect beneficiaries are hamstrung by their ineligibility to receive Federal funding to investigate and prosecute complaints in nonfacility settings. Such complaints are often referred to other agencies. Those agencies often do not receive the same level of training on patient abuse and neglect that MCFU staff receives and may have severely strained resources.

Conclusions

The report found that the volume and increase of MFCU investigations and prosecutions indicates that PCS remain vulnerable to fraud. The report noted that the recommendations are similar to those made in previous reports and states that it is crucial that federal funding authority be expanded to allow MFCUs to investigate and prosecute cases of patient abuse and neglect in nonfacility settings.

Breakthrough cancer detection device gets parallel FDA, CMS review

A breakthrough cancer in vitro diagnostic (IVD) device that uses next generation sequencing (NGS) to detect genetic mutations in solid tumors took only six months from product application to FDA approval and a preliminary national coverage determination (NCD) from CMS, thanks to the Parallel Review program. Foundation Medicine’s FoundationOne® CDx™ (F1CDx) received simultaneous overlapping review by the FDA and CMS, which reduces the time necessary to marketing and coverage of innovative medical devices.

The Parallel Review program for medical devices was fully implemented in October 2016 following a pilot program (see Parallel Review program will be fully implemented and extended indefinitely, Health Law Daily, October 24, 2016). Ordinarily, CMS does not begin the NCD decision-making process until after a device has been approved or cleared for marketing by the FDA, which results in a longer wait before Medicare beneficiaries can access the device. Through Parallel Review, manufacturers receive feedback from both agencies through the clinical trial design stage, which helps them to design trials that fulfill evidentiary requirements for both steps of the process, potentially eliminating the need for additional trials.

Although the F1CDx device is a laboratory-developed test and therefore generally would not require premarket review from the FDA, Foundation Medicine requested Breakthrough Device designation for the test. The 21st Century Cures Act (P.L. 114-255) expanded the Expedited Access Pathways (EAP) program to breakthrough technologies that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions (see Will the Cures Act address what ails the FDA approval process?, Health Law Daily, March 9, 2017). The FDA granted that designation because the F1CDx test has “potential to consolidate multiple companion diagnostic claims for patients and health care providers into a single test.”

Kusserow on Compliance: OIG report on research compliance through OHRP

The OIG conducted a study of the Office of Human Research Protection (OHRP) at HHS in response to Congressional requests that raised questions about its independence. The request was for the OIG to review OHRP procedures and make recommendations to strengthen protections for human subjects and ensure OHRP’s independence. OHRP enforces compliance with HHS regulations for protecting human subjects. Its mission is to protect the rights of human subjects-individuals who volunteer to participate in research conducted or supported by the HHS. The OIG conducted a survey of research institutions that were the primary subjects of the compliance evaluations about their experiences with the OHRP. The OIG also reviewed documents from eight compliance evaluations that had been closed; and interviewed OHRP staff, other HHS officials, and individuals with expertise in protections for human subjects.

OIG findings regarding OHRP

The OIG found that OHRP:

  • evidenced carrying out its compliance activities independently from agencies funding the research and the institutions conducting the research;
  • made decisions on how to use resources, resulting in fewer compliance evaluations, while increasing its use of other mechanisms in response to allegations;
  • determined the scope of its evaluations and what methods to employ;
  • was able to access the information it needed to conduct its compliance evaluations;
  • maintained documentation on its determinations;
  • may be limited in its ability to act independently due to its role, placement within HHS, and the way its budget is set may limit; and
  • may have the appearance of limited oversight and independence due to the practice of not reporting publicly on all of its compliance activities.

OIG Recommendations to HHS

The OIG recommended that HHS:

  1. issue guidance that clarifies OHRP’s role;
  2. re-evaluate OHRP’s position within HHS;
  3. evaluate sufficiency of OHRP’s resources;
  4. consider ways to elevate the prominence of OHRP’s budget (e.g. having a separate line item in the President’s budget);
  5. foster a shared understanding for OHRP’s independence by considering seeking statutory authority for OHRP’s independence; and
  6. post on OHRP’s website: (a) a description of its approach to oversight and (b) data (in aggregate) regarding its compliance activities.

 

 

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 © 2017 Strategic Management Services, LLC. Published with permission.