Kusserow on Compliance: Meeting long term care compliance program legal mandates

The Patient Protection and Affordable Care Act (ACA) included a mandate that long term care (LTC) skilled nursing facilities (SNFs) and nursing homes adopt and implement an effective compliance and ethics program as a condition of participation in the Medicare and Medicaid programs. Facilities have until November 28, 2019 to meet the compliance program requirements. At that time, state survey agencies will begin assessing facility compliance with implementation of an effective compliance and ethics program following the CMS State Operation Manual “Guidance to Surveyors for Long Term Care Facilities.”  CMS requires annual review of its compliance and ethics program to ensure that modifications are made to reflect changes in laws, regulations, and to reduce violations.

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 explains that the new mandate parallels the HHS OIG Compliance Program Guidance for Nursing Facilities and those that followed the guidance will have little problem in meeting the new mandate, but those who didn’t have only months to come into compliance. For those organizations with weak programs, he suggests the most cost effective method to begin catching up is to have a compliance expert perform a gap analysis to identify elements needed for the compliance program and how be able to evidence program effectiveness. A gap analysis should provide a “road map” and step-by-step plan for bringing a facility into compliance with the mandates. Those that have already implemented their compliance program should consider having an effectiveness evaluation conducted by experts to verify it will meet mandated standards.

Kash Chopra, J.D., has assisted many smaller LTC organizations in answering the challenge of meeting the mandate challenge by providing Designated Compliance Officers (DCOs) that assume the responsibility of being the Compliance Officer, including the building and managing of the program. The OIG recognizes using DCOs when the wide range of compliance responsibilities become a serious problem for smaller organizations and a full time Compliance Officer is unaffordable. The OIG’s position is that “For those companies that have limited resources, the compliance function could be outsourced to an expert in compliance.”  The OIG further recognize that an outsourced party can provide services on a part time basis.  Using highly experienced experts can lower fixed costs, reduce staff loads, and avoid using someone who is less qualified. Also, most of the work can be done remotely. Using an outside expert part-time, can accomplish more than a lesser experienced full time employee. She advises comparing the cost of hiring a compliance officer against that of a part time expert acting as the DCO.

For more information on this subject, Kash Chopra can be reached at kchopra@strategicm.com or via telephone at (703) 535-1413. Also see https://compliance.com/blog/contracting-compliance-program/

 

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: 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.

Kusserow on Compliance: Understanding and addressing whistleblowers

The vast majority of the cases resolved by the Civil Division of the Department of Justice (DOJ) were cases brought by “whistleblowers” under the qui tam provision of the False Claims Act (FCA). Whistleblowers are responsible for an even higher percentage of cases resulting in OIG Corporate Integrity Agreements (CIAs). Although most compliance officers are well aware of this program, many remain unclear as to how the process works. Tom Herrmann, J.D., who served over 20 years in the Office of Counsel to the OIG and as an Appellate Judge for the Medicare Appeals Board, explained that Congress permitted a whisltleblower called the “Relator” to file a case with the DOJ under the FCA.  Since this provision of law went into effect in 1986, there have been over 10,000 qui tam cases filed with a current average of one such case being filed every day of the year. The intent was to create incentives for private parties to detect and pursue fraud under the FCA. In return for reporting this information, Relators receive a portion (usually about 15 to 25 percent) of any recovered damages.  Once the lawsuit is filed, it is placed “under seal”, meaning that it is kept secret from everyone but the government, in order to give the DOJ enough time to investigate the allegations in deciding whether to join (“intervene”) in the case. Intervention by the DOJ occurs only in about one in five qui tam lawsuits, leaving whistleblowers the option to pursue cases on their own, however the chances of success are much lower than in cases when the government joins. Most successful qui tam cases are resolved through settlement negotiations rather than a court trial, although trials may occur.

Kash Chopra, J.D., noted that the overwhelming number of cases that result in a CIA, arise from whistleblowers and these, in turn, are based upon violations of the federal Anti-Kickback Statute (AKS). It is the government’s position that all claims arising from a corrupt arrangement violating the AKS or in some cases, the Stark Law, are considered fraudulent. This is even when the services rendered were needed and provided appropriately.  She advises here clients that the best ways to manage the whistleblower risk is to ensure that they are channeled through internal communication channels and their complaints are promptly evaluated, investigated, and resolved.  It is worth considering the following:

  1. Using outside experts to independently audit arrangements with physicians and evaluate compliance communication channel effectiveness.
  2. Ensuring a 24/7 hotline operated externally by experts in recognizing health care compliance issues.
  3. Reviewing/updating hotline-related polices/procedures (confidentiality, anonymity, non-retaliation, duty to report, etc.).
  4. Making sure that the duty to report suspected wrongdoing is explained in the Code, policies and training.
  5. Having trained and competent people on hand to conduct prompt and competent investigations of matters raised through the hotline.
  6. Moving quickly to use CMS and OIG self disclosure protocols when there is credible evidence of violations; and not wait until the DOJ gets involved.

For more information on this subject, Kashish Parikh-Chopra can be reached at kchopra@strategicm.com or via telephone at (703) 535-1413.

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: The relationship between an Interim Compliance Officer and the CEO

Getting the right start is the best way to have a good return on investment

Catie Heindel, J.D., a highly experienced compliance consultant who has served as an Interim Compliance Officer, notes it is increasingly common for healthb care organizations to seek a temporary compliance officer to cover a gap. Though the rationale behind hiring an interim compliance officer is different for every organization, the ultimate goal is usually the same—to provide high quality and efficient compliance program leadership that will reduce exposure to unwanted risks and problems. Preparation and communication with staff to introduce the person selected to act in an interim capacity is very important to having a successful result from the engagement.

Ensuring a successful hiring decision really needs the personal involvement of the CEO. The OIG compliance guidance stresses that the compliance officer should report directly to the CEO. This sentiment also applies to Interim Compliance Officers; and the best return on investment for having someone move in and successfully temporarily fill a compliance officer gap is for the CEO to establish a direct reporting relationship. It is also helpful for everyone involved if the CEO personally provides a detailed background briefing on the organization that includes:

  • management structure;
  • mission/vision;
  • why the person was engaged;
  • expectations for the engagement; and
  • their role in the organization.

Upon arrival, the CEO should ensure there is a proper “on-boarding” process that includes personally introducing the interim compliance professional to the executive leadership, key program managers, legal counsel, HRM, and Board members. This interaction, from the outset, sets the right tone and will help to ensure that the interim is in lockstep with the CEO.  Furthermore, this empowerment exercise will permit the interim to move more quickly in gathering the reins of the compliance program and guard against having anything fall “beneath the cracks”.  It will also help the interim compliance professional to “hit the ground” running immediately and begin productive work.

For more information regarding engaging and preparing Interim Compliance Officers, Catie Heindel can be contacted at www.cheindel@strategicm.com, or via phone at (847) 707-9830.

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.