Kusserow on Compliance: New OIG Work Plan items

The HHS Office of Inspector General (OIG) recently issued updates to its Active Work Plan (Work Plan). The Work Plan outlines ongoing and planned audits and evaluations for the fiscal year and beyond. Recent additions related to Medicare/Medicaid include the following:

  1. Medicare Part D Rebates Related to Drugs Dispensed by 340B Pharmacies. Drug manufacturers often do not pay for Medicare Part D prescription rebates filled at 340B-covered entities and contract pharmacies because the manufacturer already provides a discount on the drug. The OIG will conduct a study to determine the potential rebate savings if Part B program sponsors and manufacturers could agree on eligible prescriptions filled at 340B pharmacies that receive rebates.

 

  1. Characteristics of Part D Beneficiaries at Serious Risk of Opioid Misuse or Overdose. An OIG data brief found that about 71,000 Medicare Part D beneficiaries were at serious risk of opioid misuse or overdose in 2017. The OIG will study: (1) the characteristics of these beneficiaries, including their demographics and diagnoses; (2) the opioid utilization of these beneficiaries; and (3) the extent to which these beneficiaries have had adverse health effects related to opioids and any overdose incidents.

 

  1. Ensuring Dual-Eligible Beneficiaries’ Access to Drugs Under Part D: Mandatory Review.

Part D plans that meet certain limitations have the discretion to include different Part D drugs and drug utilization tools in their formularies. Under the Affordable Care Act, the OIG conducts an annual study to review the extent to which Part D sponsors’ formularies include drugs commonly used by Medicaid and Medicare Part D beneficiaries.

 

  1. Nursing Facility Staffing: Reported Levels and CMS Oversight. CMS uses the Payroll Based Journal auditable daily staffing data to analyze staffing patterns and populate the staffing component of the Nursing Home Compare website. It aids the public determine the results of health and safety inspections, quality of care at nursing facilities, and staffing. The OIG will issue two reports to: (1) describe nursing staffing levels that facilities report to the Payroll-Based Journal; and (2) examine CMS efforts to ensure data accuracy and improve resident quality of care.

 

  1. Medicare Part B Payments for Podiatry and Ancillary Services. Medicare Part B covers podiatry services for medically necessary treatment of foot injuries, diseases, or other medical conditions affecting the foot, ankle, or lower leg. It does not cover routine foot-care services unless they are: (1) necessary and integral part of otherwise covered services; (2) for the treatment of warts on the foot; (3) in the presence of a systemic condition or conditions; or (4) for the treatment of infected toenails. The OIG will review Part B payments to determine whether podiatry and ancillary services were medically necessary and supported in accordance with Medicare 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 © 2019 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: OIG Work Plan update

The OIG Work Plan sets forth various projects including OIG audits and evaluations that are underway or planned to be addressed during the fiscal year and beyond. Projects included in the Work Plan span the Department and include CMS. The OIG also plans work related to issues that cut across departmental programs, including state and local governments’ use of federal funds. At the end of December, the OIG announced two new projects led by the Office of Evaluation and Inspection beginning in 2019. They are:

  1. T-MSIS Data Assessment: Usefulness of National Data to Monitor Opioid Prescribing in Medicaid. Although all States have been submitting T-MSIS data, it does not mean the data are complete and without complete data, it cannot be used as a national dataset to help Medicaid manage critical issues such as the opioid crisis. The will OIG determine whether T-MSIS contains the data necessary to identify recipients of opioid prescriptions through Medicaid who may be at risk of opioid abuse nationally.  The OIG intends to interview states to determine the challenges they face, if any, in submitting the data necessary to identify and prevent beneficiary harm from opioid misuse.

 

  1. States’ Compliance with FFS and MCO Provider Enrollment Requirements. The OIG noted that provider enrollment is a key program integrity tool to protect Medicaid from fraudulent and abusive providers. The 21st Century Cures Act requires states to enroll all Medicaid providers, both those in Medicaid fee-for-service (FFS) and managed care organizations (MCOs). This study, by the OIG, is mandated by the Cures Act and will survey state Medicaid agencies about their enrollment of FFS and managed care providers and implementation of required provider enrollment screening 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 © 2018 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.

Kusserow on Compliance: OIG issues annual report on top management challenges facing HHS

Annually, the OIG prepares a summary of the most significant management and performance challenges facing the Department of Health and Human Services. This summary is referred to as the Top Management Challenges (TMC). The OIG forecasts new and emerging issues HHS will face HHS in the years to come. The current TMCs are identified as follows:

  1. Preventing and Treating Opioid Misuse. The challenges includes (a) reducing inappropriate prescribing and misuse of opioids; (b) combating fraud and diversion of prescription opioids and potentiator drugs; (c) ensuring access to appropriate treatment for opioid use disorder; and (d) ensuring that funding for prevention and treatment is used appropriately

 

  1. Ensuring Program Integrity in Medicare Fee-for-Service and Effective Administration of Medicare. Medicare spending represents over 15 percent of all federal spending and it is estimated that the Trust Fund for Medicare Part A will be depleted by 2026. Challenges include (a) reducing improper payments; (b) combating fraud; (c) fostering prudent payment policies; and (d) maximizing the promise of health information technology.

 

  1. Ensuring Program Integrity and Effective Administration of Medicaid. Medicaid is the largest federal health care program, with 67 million individuals enrolled, and expenditures of $592 billion. Challenges include (a) improving the reliability of national Medicaid data; (b) reducing improper payments; (c) combating fraud; and (d) ensuring appropriate Medicaid eligibility determinations.

 

  1. Ensuring Value and Integrity in Managed Care and Other Innovative Healthcare Payment and Service Delivery Models. Managed care and other innovative models promote innovation and effectiveness. Challenges include (a) ensuring effectiveness and integrity in new models; (b) combating provider fraud and abuse; (c) fostering compliance by managed care organizations.

 

  1. Protecting the Health and Safety of Vulnerable Populations. HHS programs provide critical health and human services to many vulnerable populations in many different settings. Challenges include (a) ensuring the safety and security of unaccompanied children in HHS care; (b) addressing substandard nursing home care; (c) reducing problems in hospice care; (d) mitigating risks to individuals receiving home- and community-based services; (e) ensuring access to safe and appropriate services for children; and (f) addressing serious mental illness.

 

  1. Improving Financial and Administrative Management and Reducing Improper Payments. With annual outlays of over $1.1 trillion, HHS must also ensure the completeness, accuracy, and timeliness of any financial and program information provided to other entities. Challenges include (a) addressing weaknesses in financial management systems; (b) addressing Medicare trust fund issues/social insurance; (c) reducing improper payments; (d) improving contract management; and (d) implementing the DATA Act.

 

  1. Protecting the Integrity of HHS Grants. In FY 2017, HHS awarded $101 billion in grants (excluding CMS) that requires additional verification of existing controls and reporting requirements. Challenges include (a) ensuring appropriate and effective use of grant funds; (b) ensuring effective grant management at the department level; (c) ensuring program integrity and financial capability at the grantee level; and (d) combating fraud, waste, and abuse.

 

  1. Ensuring the Safety of Food, Drugs, and Medical Devices. FDA has the challenge of ensuring the safety and security of the nation’s food and medical products (including drugs, biological products, and medical devices), which directly affect the health of every American. Challenges include (a) ensuring food safety; (b) ensuring the safety, effectiveness, and quality of drugs and medical devices; and (c) ensuring the security of drug supply chains.

 

  1. Ensuring Quality and Integrity in Programs Serving American Indian/Alaska Native Populations. Many HHS programs provide health and human services to AI/ANs throughout the U.S. Challenges include (a) addressing deficiencies in IHS management, infrastructure, and quality of care; and (b) preventing fraud and misuse of HHS funds serving AI/AN populations.

 

  1. Protecting HHS Data, Systems, and Beneficiaries from Cybersecurity Threats. Challenges include (a) protecting data on internal systems; (b) overseeing the cybersecurity of data in cloud environments; (c) ensuring that providers, grantees, and contractors are adhering to sound cybersecurity principles; (d) securing HHS’s data and systems; and (e) advancing cybersecurity within the healthcare ecosystem.

 

  1. Ensuring that HHS Prescription Drug Programs Work as Intended. HHS oversees coverage of prescription drugs under various programs operated by the Department. Challenges include (a) protecting the integrity of prescription drug programs; (b) fostering prudent payments for prescription drugs; and (b) ensuring appropriate access to prescription drugs.

 

  1. Ensuring Effective Preparation and Response to Public Health Emergencies. HHS is responsible for ensuring both it and its State and local partners are prepared to respond to, and recover from, public health emergencies efficiently and effectively. Challenges include ensuring (a) access to health and human services during and after emergencies: (b) effective use and oversight of funding; and (c) effective and timely responses to infectious disease threats.

 

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 © 2018 Strategic Management Services, LLC. Published with permission.