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.

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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.

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

Kusserow on Compliance: Time running out for nursing and long term care providers’ development of mandated compliance programs

Tips to meet the challenge in a timely and cost effectively manner

The OIG issued voluntary Compliance Program Guidance for Nursing Facilities in March 2000, followed by Supplemental Compliance Program guidance in September 2008. However, the Patient Protection and Affordable Care Act (ACA) made compliance a mandate and it is a game changer for this sector. The new mandates note as a condition of enrollment in Medicare and Medicaid “a facility shall . . . have in operation a compliance and ethics program. . . .”   HHS was directed to issue regulations “for an effective compliance and ethics program for operating organizations” and CMS has issued those regulations with a deadline for organizations and facilities to meet these requirements by November 28, 2019. At that time, state survey agencies will begin assessing facility compliance for compliance.

Tom Herrmann, J.D., served over 20 years in the OIG Office of Counsel and for the past ten years has been a compliance consultant, specializing in nursing home compliance programs. He noted that many nursing facilities lagged behind in developing effective compliance programs because it was viewed as cost prohibitive. Those that implemented programs following the OIG guidance will have little difficulty in meeting the standards. For those who delayed program development, time is running out. State survey agencies will conduct compliance audits following the CMS State Operation Manual “Guidance to Surveyors for Long Term Care Facilities”.  Survey protocols and guides for State Survey Agencies have also been posted by CMS and can be reviewed by nursing homes in preparation for the reviews.  When building or improving the compliance program, CMS requires an annual review of its compliance and ethics program to assess the resources needed for an effective compliance program that includes mandatory training for all covered persons. For more information regarding advisory services in building effective compliance programs, Tom Herrmann can be reached at therrmann@strategicm.com or via phone at (703) 535-1410.

Kash Chopra, JD, provides compliance staffing for clients. She explained that many nursing homes may not require hiring a fulltime compliance office, however, designating someone on the staff to act as a compliance officer as a secondary duty is not a good idea and seldom works satisfactorily. Invariably, the primary duties drive out time for the compliance responsibilities.  One solution that should be considered is using an expert as a Designated Compliance Officer (DCO) to quickly, efficiently, and inexpensively build and manage the program. The OIG in its compliance program documents specifically advises: “For those companies that have limited resources, the compliance function could be outsourced to an expert in compliance.”  For more on staffing compliance officers, Kash Chopra can be reached at 703-236-1291 or at kchopra@strategicm.com

Daniel Peake of the Compliance Resource Center said that many nursing home clients have found an economical solution to the costs of building and managing their compliance program by outsourcing key elements, such as hotline services, sanction screening, compliance training, code and policy development. These services can take a big bite out of the work of building an effective compliance program at a very small price for most organizations providing nursing or long term care. For more information about the cost and benefits of outsourcing key compliance elements, Daniel Peake can be reached at (dpeake@compliancereource.com (703)-236-9854).

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.