Kusserow on Compliance: OIG adds six new projects in December to its Work Plan

In 2017, the HHS OIG moved to regularly update updating its Work Plan. In December, the OIG added six new projects that set forth various audits and evaluations that are underway or planned in the current fiscal year and beyond. 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 Added

  1. Status Update on States’ Efforts on Medicaid-Provider Enrollment. Provider enrollment is the gateway to billing in the Medicaid program. If this gateway is not guarded, Medicaid is at risk of fraud, waste, and abuse. Prior OIG work found many states had yet to complete fingerprint-based criminal background checks and site visits. CMS agreed with this and moved ahead to assist, however, CMS continues to extend the deadline for completion of fingerprint-based criminal background checks, indicating that states are still working on provider enrollment. The OIG plans to determine the extent to which states have completed fingerprint-based criminal background checks and site visits. For those not completing these steps, the OIG will inquire about challenges preventing them from completing this effort.

 

  1. Review of CMS Systems Used to Pay Medicare Advantage Organizations. CMS has designed its Medicare Part C systems to capture the necessary data in order to make increased hierarchical condition categories (HCC) payments to MA organizations. CMS is transitioning to a new data system to make these payments. The OIG will review the continuity of data maintained on current Medicare Part C systems, specifically instances in which CMS made an increased payment to an MA organization for a HCC and determine whether CMS’s systems properly contained a requisite diagnosis code that mapped to that HCC.

 

  1. State Compliance With Requirements for Reporting and Monitoring Critical Incidents. CMS requires states to implement an incident reporting system to protect the health and welfare of the Medicaid beneficiaries who receive services in community-based settings or nursing facilities. OIG previously found that some states did not always comply with federal and state requirements for reporting and monitoring critical incidents such as abuse and neglect. The OIG will review additional state Medicaid agencies to determine whether the selected states are in compliance with the requirements for reporting and monitoring critical incidents. The work will focus on beneficiaries residing in both community-based settings and nursing facilities.

 

  1. Paper Check Medicaid Payments Made to Mailbox-Rental Store Addresses. The CMS Medicaid Manual sets forth general federal requirements for adequate documentation of Medicaid claims. Potential providers are required to submit an application to bill for Medicaid services, and potential providers can choose to be paid by an electronic funds transfer (EFT) or a paper check. They must also list their practice and correspondence addresses. Because of theft, forgery, or alteration, the issuance of paper checks to providers carries more risk than using an EFT. The GAO reported identifying potential issues with Medicare-provider addresses and revealed that payments made to a provider with a mailbox-rental store, vacant, or invalid practice address increase the potential risk of fraud, waste, or abuse. The OIG will assess whether similar problems exist with the Medicaid program. Specifically, the OIG will determine if Medicaid payments issued by paper checks and sent to providers with mailbox-rental locations were for unallowable services.

 

  1. Prescription Opioid Drug Abuse and Misuse Prevention – Prescription Drug Monitoring Programs. Opioid abuse and related overdoses is a national epidemic and according to the Centers for Disease Control and Prevention (CDC), more than 33,000 people died in 2015 from overdoses involving opioids. HHS, through the CDC and the Substance Abuse and Mental Health Services Administration (SAMHSA), provides funding to States to prevent opioid abuse and misuse. Funding is provided by the CDC’s Prescription Drug Overdose: Prevention for States program and SAMHSA’s Strategic Prevention Framework for Prescription Drugs program. The OIG intends to identify actions state agencies have taken using federal funds for enhancing prescription drug monitoring programs (PDMPs) to achieve program goals—improving safe prescribing practices and preventing prescription drug abuse and misuse—and in doing so determine whether they complied with federal requirements. This series of audits will include states that have had a high number of overdose deaths, have a significant increase in the rate of drug overdose deaths, or received HHS funding to enhance their PDMPs.

 

  1. Impact of the Indian Health Service (IHS) Delivery of Information Technology/Information Security Services and Opioid Prescribing Practices. IHS has a decentralized management structure that is separated into two major categories: Headquarters and 12 Area Offices. The Area Offices are responsible for overseeing 26 hospitals, 59 health centers, and 32 health stations, some of which are located in remote locations. The OIG found that hospitals with limited cybersecurity resources struggle to implement information technology improvements and update the IHS electronic heath record system. The OIG will analyze and compare information technology/information security (IT/IS) operations and opioid prescribing practices at five IHS hospitals to determine whether (1) IHS’s decentralized management structure has affected its ability to deliver adequate IT/IS services in accordance with federal requirements and (2) hospitals prescribed and dispensed opioids in accordance with IHS policies and procedures.

 

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

Kusserow on Compliance: OIG Work Plan now being updated monthly

The OIG announced that its work planning process is being modified to be more dynamic and to reflect the adjustments being made throughout the year in response to changing priorities and responding to new emerging issues. The OIG, as of June 15, 2017, will now adjust its Work Plan on a monthly basis, rather than semi-annually as has been done previously to ensure that it more closely aligns with the work planning process. The monthly updates will include the addition of newly initiated Work Plan items and the removal of completed items.

The Work Plan sets forth various audits and evaluations that are underway or planned during the fiscal year and beyond. Projects listed in the Work Plan span the Department and include CMS, public health agencies such as the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH), and human resources agencies such as Administration for Children and Families (ACF) and the Administration on Aging. The OIG also plans work related to issues that cut across departmental programs, including State and local governments’ use of Federal funds, as well as the functional areas of the Office of the HHS Secretary. 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.

New Projects Added

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.

 

 

Billions in ‘transfers of value’ to physicians, hospitals by industry get DOJ attention

In calendar year (CY) 2015, over $7.5 billion in “transfers of value” were made by pharmaceutical companies to physicians and hospitals through the federal Open Payments program, which in turn has caused the Department of Justice (DOJ) to focus on this area while investigating fraud in the health care system. In an HCCA sponsored seminar titled “Sunshine, Open Payments, and Potential Conflicts of Interest,” Senior Compliance Executive C.J. Wolf, M.D., of Healthicity, noted that under the Open Payments program, CMS has now accumulated over 28 million records of transfer of value. Within this vast repository of data, CMS uses it to uncover outliers in payments, and as a result, industry and providers, alike, are very interested in how the open payment system affects their operations.

Open Payments

Under Section 6002 of the Affordable Care Act (ACA), manufacturers must disclose to CMS payments made to physicians and teaching hospitals. Manufacturers and group purchasing organizations must also report ownership and investment interests held by physicians. The HHS Office of Inspector General (OIG) included these aspects into its list of priorities in its 2017 Work Plan, with Medicare and Medicaid payments high on the list (see Focus remains on Medicare, Medicaid payments in 2017 OIG Work Plan, Health Law Daily, November 10, 2016).

The 2017 Work Plan also stressed that the OIG will also determine how much Medicare paid for drugs and durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) ordered by physicians who had financial relationships with manufacturers and group purchasing organizations.

Wolf noted the DOJ has taken a keen interest in this area of open payments, as evidenced by actions such as Teva Pharmaceuticals USA, Inc., and its subsidiary IVAX, LLC, agreeing to pay a total of $27.6 million to the federal government and the State of Illinois in a settlement regarding allegations of false billing practices under the False Claims Act (see Teva Pharmaceutical to pay federal and state government $27.6 million to resolve false billing allegations, Health Law Daily, March 11, 2014).

Conflicts of interest

There are 11 payment “categories” that must be reported under the Open Payments program: (1) consulting fees, (2) honoraria, (3) gift, (4) entertainment, (5) food and beverage, (6) travel and lodging, (7) education, (8) charitable contribution, (9) royalty or license, (10) grant, and (11) research.

As part of the transparency initiatives under the ACA, the dollars that physicians receive from industry is reported and documented. Physicians and providers should be aware that these categories touch upon even compensation for serving as faculty or as a speaker for a non-accredited and noncertified continuing education program.

Because the Open Payments program also includes ownership interests that physicians or their immediate family members have in various companies and the data is then made available to the public each year, reporting often is paramount.

Kusserow on Compliance: OIG reports on new items added to its 2016 work plan

The HHS Office of Inspector General (OIG) released a mid-year update on its 2016 Work Plan that summarizes new and ongoing reviews and activities it plan to pursue with respect to HHS programs and operations during the current fiscal year and beyond. This report includes those items that have been completed, postponed, or canceled, as well as including new items begun since the original plan had been published for this fiscal year, with links to the full summaries for new work. The following is a summary of some of the new items added to the Work Plan for the current year. Compliance Officers might find it useful to review to determine if any of this new work impacts on their organization.

  • Outpatient Outlier Payments for Short-Stay Claims. To determine the extent of potential Medicare savings if hospital outpatient stays were ineligible for an outlier payment. The purpose of the outlier payment is to ensure beneficiary access to services by having the Medicare program share in the financial loss incurred by a provider associated with individual, extraordinarily expensive cases.
  • Skilled Nursing Facility Prospective Payment System. Review of the compliance with the skilled nursing facility (SNF) prospective payment system requirement related to a three-day qualifying inpatient hospital stay. If the beneficiary is subsequently admitted to a SNF, the beneficiary is required to be admitted either within 30 days after discharge from the hospital or within such time as it would be medically appropriate to begin an active course of treatment.
  • National Background Checks for Long-Term Care. Review the procedures implemented by participating states for long-term-care facilities or providers to conduct background checks on prospective employees and providers who would have direct access to patients and determine the costs of conducting background checks to determine the outcomes of the states’ programs and whether the checks led to any unintended consequences.
  • Potentially Avoidable Hospitalizations of Medicare and Medicaid Eligible Nursing Home Residents for Urinary Tract Infections. Review of nursing home records for residents hospitalized for urinary tract infections (UTI) to determine if the nursing homes provided services to prevent or detect UTIs in accordance with their care plans before they were hospitalized.
  • Accountable Care Organizations: Beneficiary Assignment and Shared Savings.  Determine whether CMS properly performed the process of assigning beneficiaries to ACOs in the Medicare Shared Savings Program (MSSP). Examine CMS’ shared savings payments for beneficiaries who were assigned to ACOs under the MSSP to ensure that there is no duplication of payments for the same beneficiaries by other savings programs or initiatives.
  • Medicare Home Health Fraud.  Analyze Medicare claims data to identify the prevalence of potential indicators of home health fraud.
  • Physician-Administered Drugs for Dual Eligibles.  Determine whether Medicare requirements for processing physician-administered drug claims impact state Medicaid agencies’ ability to correctly invoice Medicaid drug rebates for dual eligible enrollees.
  • Oversight and Effectiveness of Medicaid. Determine the extent to which selected States made use of Medicaid waivers and if costs associated with the waivers are efficient, economic, and do not inflate federal costs.
  • State Medicaid Agency Breach Protections. Examine breach notification procedures of State Medicaid agencies and their contractors, as well as their responses to past breaches of unsecured patient health information.
  • CMS Oversight of Risk Adjustment Data. Timelines, Validity, and Review of summary reports produced by the ACA risk adjustment data collection system, as well as to determine the extent of any data discrepancies and what actions were taken by issuers to review and resubmit data as well as the extent to which issuers appealed risk adjustment changes.
  • Risk Corridors: Insights from 2014 and 2015. Assess the difference in reported risk corridors data from benefit years 2014 and 2015; and the guidance and tools that CMS used to ensure the accuracy of reported risk corridors data for the two benefit years.
  • CMS’ Implementation of New Medicare Payment System for Clinical Diagnostic Laboratory Tests-Mandatory Review. Assess CMS’ ongoing activities and progress toward implementing CMS’s new Medicare payment system for clinical diagnostic laboratory tests.
  • Other Providers and Suppliers. Assess CMS’ ongoing activities and progress toward implementing CMS’ new Medicare payment system for clinical diagnostic laboratory tests.

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 © 2016 Strategic Management Services, LLC. Published with permission.