Kusserow on Compliance: Oncology remains high federal enforcement priority

Oncology continues to be a high enforcement priority for the DOJ, OIG, FBI, and CMS.  The latest fraud investigation by the DOJ involves CCS Oncology, large and prominent providers of cancer care. The reported question being investigated relates to possible billing irregularities involving Medicare and Medicaid. As with most cases related to oncology irregularities, the predication was by a “whistleblower.” The complaint alleges CCS billed for more expensive procedures than were actually performed, billed for procedures that never were performed, and performed medically unnecessary procedures on patients, among other violations, according to the source. The stream of cases is long enough to outline key factors that have led to settlements with the DOJ and OIG. Compliance Officers, whose portfolio of responsibilities include oncology services may wish to review the following to ensure none of these factors are at work in a manner that may trigger investigation.

Common Oncology Enforcement Issues

  1. Employees knowingly submitted false records to Medicare and Medicaid to increase revenue
  2. Claims submitted for services performed without required physician supervision
  3. Offering unnecessary treatments and services to patients
  4. Recruitment and treatment of terminal patients that should have been referred to hospice care
  5. Re-treatment of patients in excess of prescribed dosage limits
  6. Claims for services when physician reviews had not taken place
  7. Claims where treatment occurred without prior required IGRT scan
  8. Physicians allowed registered nurses to fill out prescriptions for medications
  9. Offering inducements (“kickbacks”) to patients by waiving their co-pays
  10. Conducting not necessary fluorescence in situ hybridization (FISH) tests for bladder cancer
  11. Filing payment claims for GAMMA functions by improperly trained physicians and staff
  12. Seeking payments for tests whose results doctors had not reviewed
  13. Billing E&M services on the same day as a related procedure
  14. Double and over-billing Medicare for services that lacked supporting documentation
  15. Improperly billing for radiation treatment without proper physician supervision
  16. Submitting false claims for magnetic resonance imaging (MRI) services
  17. Billing for services that were not documented in the patients’ medical records
  18. Billing twice for the same services
  19. Misrepresentation of the level of a service provided to increase reimbursement
  20. Routinely waived patient copayments as an inducement, then billing Medicare for them.
  21. Claims for services not performed, medically necessary, and/or properly documented
  22. Claims for services rendered to patients referred by physicians benefiting from referral
  23. Purchasing cancer treatments from unlicensed sources for oncology practice
  24. Diluting patients’ chemotherapy treatments and delivering in a manner designed to extend period of treatment time
  25. Claims for medically unnecessary or properly documented intensity-modulated radiation therapy (IMRT)
  26. Unsupported add-on claims for “special treatment procedures” and “specialty physics consults”
  27. Violating the Stark Laws and Anti-Kickback statute by rewarding referring physicians

 

Kusserow on Compliance: OIG reports on the Senior Medicare Patrol (SMP) program

The OIG issued a report on the 2016 performance data for the Senior Medicare Patrol (SMP) program. It is a little known program for many people designed to empower and assist Medicare beneficiaries, their families, and caregivers to prevent, detect, and report health care fraud, errors, and abuse through outreach, counseling, and education. SMPs are grant-funded projects of HHS, U.S. Administration for Community Living (ACL). They play a unique role in the fight against Medicare errors, fraud, and abuse. SMP volunteers and staff are viewed as “eyes and ears” in their communities, educating beneficiaries to be the first line of defense; a sort of ‘neighborhood watch” team. Their work involves conducting presentations to groups, exhibit at events, and work one-on-one with Medicare beneficiaries; engaging volunteers to protect elderly person’s health, finances, and medical identity while saving precious Medicare dollars is a cause that attracts civic-minded Americans; and receiving beneficiary complaints and determining whether it may involve fraud, errors, or abuse. When fraud or abuse is suspected, they make referrals to the appropriate state and federal agencies for further investigation.

The OIG used five performance measures pertaining to recoveries, savings, and cost avoidance; and another five performance measures relating to volunteer and outreach activities.  In 2016, there were 53 SMP projects that had a total of 6,126 total active team members who conducted a total of 26,220 group outreach and education events that reached an estimated 1.5 million people.   The projects also had 195,386 individual interactions with, or on behalf of, a Medicare beneficiary.  The projects reported $163,904 in cost avoidance on behalf of Medicare, Medicaid, beneficiaries, and others. Savings to beneficiaries and others totaled $53,449. Expected Medicare recoveries totaled $2,672. Further, two projects provided information to federal prosecutors that resulted in settlements totaling an additional $9.2 million in expected Medicare recoveries. There were no expected Medicaid recoveries.

Compared to 2015, the projects reported much higher amounts for cost avoidance ($163,904, up from $21,533) and somewhat higher amounts of savings to beneficiaries and others ($53,449, up from $35,059). However, the projects reported significantly lower expected Medicare recoveries ($2,672, down from $2.5 million). The projects reported no Medicaid recoveries in either year. Some common examples of suspected Medicare fraud or abuse identified by the SMP include:

  • Billing for services or supplies that were not provided
  • Providing unsolicited supplies to beneficiaries
  • Misrepresenting a diagnosis, beneficiary’s identity, service provided, or other facts
  • Prescribing or providing excessive or unnecessary tests and services
  • Violating the participating provider agreement with Medicare by refusing to bill Medicare for covered services or items and billing the beneficiary instead
  • Offering or receiving a kickback (bribe) in exchange for a beneficiary’s Medicare number
  • Requesting Medicare numbers at an educational presentation or in an unsolicited phone call
  • Routinely waiving co-insurance or deductibles

The OIG noted that the projects may not be receiving full credit for recoveries, savings, and cost avoidance attributable to their work. It is not always possible to track referrals to Medicare contractors or law enforcement from beneficiaries who have learned to detect fraud, waste, and abuse from the projects. In addition, the projects are unable to track the potentially substantial savings derived from a sentinel effect, whereby Medicare beneficiaries’ scrutiny of their bills reduces fraud and errors.

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

Kusserow on Compliance: Compliance officers’ checklist—25 suggestions

Health care organizations are facing increasing risk of exposure to actions by government regulators or enforcement authorities. Government authorities are conducting aggressive investigations and taking actions to hold entities and responsible corporate executives more accountable. It is well understood that having an effective compliance program is a necessity to prevent and detect misconduct that could give rise to liabilities. Despite the abundance of guidance pertaining to corporate compliance, achieving a program that is effective in reducing the likelihood of unwanted events or actions that could give rise to liabilities remains a continuing challenge. The following are suggestions that Compliance Officers may wish to consider during the course of the year.

Ensure That…

  1. A charter for the Compliance Officer function provides proper empowerment and authority.
  2. Minutes of Board and executive oversight committee evidence proper support and oversight.
  3. A clear and consistent message is communicated to everyone that compliance applies to all, regardless of position.
  4. Program managers are engaged in ongoing monitoring over their areas, including risk identification, policies addressing those risks, training of their staff on them, and verifying they are adhering to them.
  5. The code of conduct (code) is written as the “Constitution” for the compliance program, setting forth commitments to the patients being served, staff performing the services, safety of the work environment, and adherence to applicable laws, regulations, and standards.
  6. The code is understandable by all employees; written at no higher than 10th grade level.
  7. Policies and procedures reflect in detail what must be followed to adhere to the code.
  8. Compliance program-related policies/procedures are up to date.
  9. A document management system that tracks changes, revisions, and recessions in policies.
  10. Adequate written guidance are in place for all risk-related aspects of the organization’s
  11. There is evidence that managers/executives are held responsible for supporting compliance.
  12. Adequate resources and support for the compliance program is evidenced in the record.
  13. Periodic independent assessments are made to evidence compliance program effectiveness.
  14. All deficiencies found in reviews are remediated quickly and documented.
  15. A test of the hotline to ensure calls are answered and reported promptly, accurately.
  16. Available metrics are used to confirm the hotline and other channels of communication are
  17. Compliance training and education effectively convey the commitment to compliance.
  18. There is evidence of employee understanding of compliance education programs.
  19. Employee participation in training is documented and filed.
  20. Policies address timely self-disclosures of overpayments and potential violations of law or regulation.
  21. Meaningful and consistent discipline occurs for conduct that violates the code.
  22. A process is in place to capture lessons learned from costly errors resulting from compliance weaknesses.
  23. Assessments are being conducted for all high-risk areas and corrective actions for identified weaknesses.
  24. Periodic surveys of employees to measure and evidence employee understanding of the compliance program; and in measuring the compliance culture of the organization.
  25. Compliance is included in management performance reviews and compensation.

 

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.

Kusserow on Compliance: Reminder to compliance officers—EMTALA is a high risk area

EMTALA enforcement is on the rise, and a good example of this was AnMed Health, a hospital located in South Carolina. The hospital recently agreed to pay $1.3 million for violating EMTALA; the largest such settlement to date and it included a CIA. This was as result of failing to provide appropriate screening examinations and stabilizing treatment to patients presented to the emergency department (ED) with psychiatric conditions. As large as the penalty was, the OIG indicated it would have likely been much larger, but AnMed was credited with being cooperative with the OIG during the investigation and having engaged in significant corrective action. It is worth recalling that the OIG issued new regulations that (1) increased the civil monetary penalty amounts for EMTALA violations and (2) encourage providers to self-report EMTALA violations to CMS in order to potentially receive more lenient penalties where there is a violation of the law. Compliance officers should ensure the EMTALA high-risk area is being addressed by ongoing monitoring and auditing. The following offers a suggestions and tips for Compliance officers provided by the Policy Resource Center that have detailed audit guides for high-risk areas, including EMTALA, as well as many related policies and procedures. For more information, contact them directly.

EMTALA Policies

Comprehensive EMTALA policies should address:

  • Who conducts screening with detailed screening protocols
  • Processes for reassessing patients after initial screenings
  • Screenings to be conducted by a physician or qualified medical personnel
  • Documentation and uniformity of screenings regardless of ability to pay
  • Conduct and timeframes for stabilization of patients as obligated under EMTALA
  • Process and patients’ rights for transfers
  • Requirements for physician certifications and medical record documentation for transfers
  • Processes for transfers into the hospital
  • Transfers to medical records and patient consent
  • Refusal for emergencies transfers and state-specific transfer requirements
  • Prohibition of retaliation against whistleblowers that make reports
  • Creating a method to internally report and address potential violations and timely conduct investigations
  • Any changes in the law or accreditation standards.

Training on Policies

The key to a successful EMTALA program is education so that the policies can be followed appropriately by frontline staff. All new staff assigned to the ED should first undergo intensive training on EMTALA policies and annual refresher training is advisable. The training should address scenarios of real life situations that prepare for making quick decisions on the job.

Determine EMTALA Investigating and Reporting Responsibility

EMTALA complaints can come from many sources, including other hospitals, patients, family members and ambulance companies. They frequently also are reported to CMS and the OIG.  It is critical that reported EMTALA issues are addressed promptly and appropriately and how this is handled is viewed seriously by regulatory and enforcement agencies. Clinical leadership should play a key role in this process, but they should understand when and how they would work with the compliance officer and legal counsel who will need to be involved in guiding investigations and interactions with government agencies. Investigations at the direction of legal counsel, especially outside counsel, will preserve privilege, especially since EMTALA provides for the potential for a private cause of action in malpractice cases.

22 Ongoing Auditing EMTALA Tips

  1. Verify that policies/procedures specifically address EMTALA compliance.
  2. Check to see that transfer policies and arrangements are being followed
  3. Determine if there are long delays in the ED
  4. Review triage and screening protocols and training
  5. Review on-call polices and contracts to ensure the ED has adequate coverage
  6. Review bylaws related to who can conduct screenings
  7. Ensure that staff members are not requesting payment prior to screening patients
  8. Review transfer forms and logs
  9. Conduct a medical record audit for screening and transfers
  10. Confirm whistleblower protections
  11. Review internal reporting chain
  12. Review training materials and documentation
  13. Verify specialists are on staff to meet the screening and stabilization requirements, as well as inpatient capabilities for stabilizing emergency patients
  14. Ensure there are no payments requested prior to screening patients
  15. Verify policies prohibit retaliation against whistleblowers that make reports
  16. Verify a method for internally reporting (e.g. hotline) and addressing potential violations
  17. Check to see there is a central log that is properly maintained for disposition and compliance with legal requirement
  18. Confirm that the physician on-call list reflects coverage of services available to inpatients
  19. Verify triaging of patients is being performed properly
  20. Verify all physicians come to the facility when called and are in compliance with the timeframes set forth in policies
  21. Confirm all transfers of individuals with un-stabilized EMCs are initiated either by (a) a written request for transfer or (b) a physician certification regarding the medical necessity for the transfer
  22. Verify there is an established a transfer request log to capture necessary information.

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.