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.

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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.

Kusserow on Compliance: Using culture surveys to measure compliance program effectiveness

Organizations are increasingly making use of employee perception and attitudes in measuring the compliance culture through using surveys. Increasingly, board directors, given their oversight duties and personal exposure, see the value of an independently administered survey to better understand the status of the compliance program. Using surveys to measure compliance culture has long been advocated by regulatory bodies.  The U.S. Sentencing Commission explicitly recognizes the significance of culture in its 2004 Amendments to the Federal Sentencing Guidelines, stating that businesses must “promote an organizational culture that encourages ethical conduct and a commitment to compliance with the law.”  The HHS Office of Inspector General (OIG) from its earliest compliance guidance documents has recommended the use of “[q]uestionnaires developed to solicit impressions of a broad cross section” of the workforce to evaluate program effectiveness that can measure the compliance culture of the organization. In the Compliance Program Guidance for Hospitals and Supplemental Compliance Program Guidance for Hospitals, it states that “fundamentally, compliance efforts are designed to establish a culture within a hospital that promotes prevention, detection and resolution of instances of conduct that do not conform to Federal and State law, and Federal, State and private payor health care program requirements, as well as the hospital’s ethical and business policies . . . As part of the review process, the compliance officer or reviewers should consider techniques such as using questionnaires developed to solicit impressions of a broad cross-section of the hospital’s employees and staff . . . Organizations should evaluate all elements of a compliance program through employee surveys.” In its Compliance Guidance for Nursing Facilities, it recommended evaluations of the compliance program through “employee surveys, management assessments, and periodic review of benchmarks established for audits, investigations, disciplinary action, overpayments, and employee feedback.”

Jillian Bower, a health care compliance consultant, has been overseeing, on behalf of the Compliance Resource Center, the administration of the Compliance Benchmark Survey© for six years to assess the compliance culture.  It has been administered to hundreds of health care organizations and more than a half million surveyed population since 1993. It measures perceptions and attitudes of employees on a number of issues, as they relate to them personally, their immediate work group, their supervisor, and the management of the organization. The results provide important insights as to organization’s strengths on which to advance the compliance culture and areas warranting special attention.  Results from the survey can measure the outcome of the compliance program and examine the extent to which individuals, coworkers, supervisors, and leaders demonstrate commitment to compliance. These can be extremely useful tools for assessing the current state of the compliance climate or culture of an organization.  Reports from the survey run 30-50 pages and include tips for addressing weaknesses. They also benchmark results against the huge universe of those who have used the same survey in three ways: (1) overall results, (2) by category, and (3) individual questions. Use of the same survey has an advantage to benchmark or measure survey results from the current year against past years. Most importantly for those using the survey, results can be benchmarked against peer organizations that utilized the same survey. This provides invaluable metrics of program effectiveness.

Steve Forman, CPA, has 35 years’ experience as a full-time compliance officer at major health care organizations, as well as in assisting organizations in developing and evaluating their compliance programs.   In all his evaluations of compliance programs, he urges clients to consider including a survey of employees because the combination of the consultant’s findings and recommendations are reinforced in the survey report. He also cautions that to have a valid and tested survey instrument that produces reliable results is a serious business.  The survey needs to be developed by experts who validate and test the instruments over many organizations.  Any survey developed in-house is not likely to meet these standards.  They also can be viewed by employees as suspect and designed to bias the results in favor of management and will lack credibility to any outside authorities. As such, they will have little value in providing credible evidence of an effective compliance program.  Furthermore, the administration of the survey process is critical to useful results.  It must be independently administered that ensures the confidentiality and anonymity of participants.

Al Bassett, J.D., is another nationally recognized compliance expert with over 30 years’ experience in the OIG and as a consultant. He has found the use of surveys to evidence compliance program effectiveness is quite inexpensive, costing a small fraction of a full consultant-led compliance program effectiveness evaluation. As such, many of his clients opt for conducting the survey as a standalone engagement.  Another feature of using standardized surveys is that they can be supplemented with organization-specific questions and/or open-ended questions designed to provide more dimension to the information gathered.  He frequently links survey results in conducting focus group meetings and interviews when evaluating program effectiveness to shed additional light on the reason why there may be a problem, as might be suggested in survey response to certain questions. This can assist if certain issues require deeper probing and more nuanced evaluation.

Carrie Kusserow is another expert with 15 years’ experience as a compliance officer and consultant who has used compliance culture surveys extensively. She believes surveys can provide great insight into the compliance program’s effectiveness and very importantly can benchmark the progress of the program.  Reports can identify both strengths in the compliance program and potential gaps needing attention. Results can also be used as a benchmark for measuring progress and track improvements in the operation of the compliance program over time.  This is very important. She cites the OIG Compliance Program Guidance for Hospitals that states that “[t]he existence of benchmarks that demonstrate implementation and achievements are essential to any effective compliance program.” Another benefit of using an employee survey is that it can communicate a strong message to employees that their opinions are valued, the organization is committed to them as individuals, and their input is being used to make positive changes.  These messages can have a powerful influence on increased compliance, reduced violations, and heightened integrity.

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.

MedPAC votes to recommend recalculation of MA benchmarks

The Medicare Payment Advisory Commission (MedPAC) unanimously voted to recommend that the HHS Secretary modify the calculation of Medicare Advantage (MA) benchmarks. The recommended change, discussed at the January 12, 2017, MedPAC meeting, would increase spending between $750 million and $2 billion over one year and between $5 billion to $10 billion over five years. Mark Miller, executive director of MedPAC, suggested, however, that previous coding recommendations from the June 2016 report could offset the increased cost.

CMS sets the MA county benchmark based on the average risk-adjusted per capita Part A and Part B fee-for-service (FFS) spending in the county. While this calculation includes all beneficiaries in Part A or Part B, MA enrollees must be in both Part A and Part B. MedPAC policy analyst Scott Harrison noted that 12 percent of FFS beneficiaries are enrolled in Part A only, and Part A-only beneficiaries spend less than half than what those with Part A and Part B spend on Part A. This, he said results in an underestimate of FFS spending compared to MA spending, which leads, in turn, to an understatement of MA benchmarks.

To make calculations more reflective of MA enrollment, the members voted on a draft recommendation, which they also discussed at the December 2016 meeting, that the HHS Secretary should calculate MA benchmarks using FFS spending data only for beneficiaries enrolled in both Part A and Part B.

CMS already adjusts the rate calculation in Puerto Rico so that it is based on beneficiaries who are enrolled in both Part A and Part B. In the April 2016 Announcement of Calendar Year 2017 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter, CMS stated in response to a comment that it would consider expanding this Part A and Part B adjustment to all counties in the future.

At the same meeting, MedPAC also voted to recommend that the Secretary should require hospitals to add a modifier on claims for all surgical services provided at off-campus, stand-alone emergency department facilities. The modifier would allow Congress and CMS to track the growth of off-campus emergency departments, which are reimbursed at higher rates than urgent care centers.