Kusserow on Compliance: August update on OIG Work Plan—four new projects added

The OIG Work Plans set forth various audits and evaluations that are underway or planned during the fiscal year and beyond. In June this year, the OIG announced the adjusting of its Work Plan on a monthly basis, rather than semi-annually as has been done previously to ensure that it more closely align with the work planning process. The updates include the addition of newly initiated Work Plan items and the removal of completed items. In conducting its work, the OIG assesses relative risks in HHS programs and operations to identify those areas most in need of attention, including responding mandates set forth in laws, regulations, or other directives; and requests by Congress, HHS management, or the Office of Management and Budget.  The following are four new work plan projects added for this year:

  1. Review of the Patient Safety Organization Program (PSO) [OEI-01-17-00420]. The PSO program established federally to work with health care providers to improve the safety and quality of patient care; and created the first and only comprehensive, nationwide patient safety reporting and learning system in the United States. The OIG plans to determine the reach and value of the PSO program among hospitals and will also oversight and challenges of the PSO program.
  2. Duplicate Drug Claims for Hospice Beneficiaries [W-00-17-35802; A-06-17-xxxxx]. Hospice providers are required to render all services necessary for the palliation and management of a beneficiary’s terminal illness and related conditions, including prescription drugs. Medicare Part A pays providers a daily per diem amount for each individual who elects hospice coverage, and part of the per diem rate is designed to cover the cost of drugs related to the terminal illness. The OIG auditors plan to determine whether Part D continues to pay for prescription drugs that should have been covered under the per diem payments made to hospice organizations, following up on previous work performed in this area related to Part D drug claims for hospice benefits under Part A.
  3. Medicare Part B Payments for Psychotherapy Services [W-00-17-35801; A-09-17-xxxxx]. Medicare Part B covers the treatment of mental illness and behavioral disturbances in which a physician or other qualified health care professional establishes professional contact with a patient.  In calendar year 2016, Part B allowed approximately $1.2 billion for these psychotherapy services. The OIG will review Part B payments for psychotherapy services to determine whether they were allowable in accord with Medicare documentation requirements.
  4. Ventilation Devices: Reasonableness of Medicare Payments Compared to Amounts Paid in the Open Market [W-00-17-35803; A-05-xx-xxxxx]. Medicare reimbursement for ventilation devices has risen from $51 million in 2011 to $72 million in 2015. OIG auditors plan to determine the reasonableness of the fee schedule prices that Medicare and beneficiaries pay for ventilation devices compared to prices on the open market to identify potential wasteful spending in the Medicare 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.

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

Kusserow on Compliance: EHR incentive program attestation is serious business

The American Recovery and Reinvestment Act of 2009 (ARRA) (P.L. 111-5) authorized providing incentive payments to eligible health care professionals, hospitals, and Medicare Advantage Organizations (“MAOs”) to promote the adoption and “meaningful use” of health information technology and electronic health record (“EHR”) systems. CMS established the Medicare and Medicaid Electronic Health Record Incentive Programs (EHR Incentive Programs) to make incentive payments to health care professionals and providers that meet specified requirements for the meaningful use of certified EHR technology (CEHRT). The EHR Incentive Programs are intended to bring about improved clinical outcomes and population outcomes, increase transparency and efficiency in health care, empower individuals to make decisions regarding their care, and generate additional research data on health systems. Program participants must report on their performance pertaining to certain clinical quality measures (CQMs) and objectives to CMS (for Medicare) or the authorized state agency (for Medicaid) through an attestation process. Since 2011, the EHR Incentive Programs have made incentive payments to numerous eligible professionals, eligible hospitals, and critical access hospitals (CAHs) that qualify as “meaningful users” by meeting the objectives and CQMs outlined in the various stages of the applicable programs.

Annual attestations required

Eligible providers must annually attest to meeting the specified objectives and measures in order to receive incentive payments under the EHR Incentive Programs. Once they have attested to meeting the identified objectives and measures, they are deemed to be meaningful users and eligible for incentive payments.  CMS, its contractor, and state Medicaid agencies conduct both random and targeted audits to detect inaccuracies in eligibility, reporting, and receipt of payment with respect to the EHR Incentive Programs.  Eligible hospitals may be selected for pre- or post-payment audits. CMS has required that eligible hospitals retain all supporting documentation used in completing the Attestation Module responses in either paper or electronic format for six years post-attestation. Eligible hospitals are responsible for maintaining documentation that fully supports the meaningful use and CQM data submitted during attestation. Those hospitals undergoing pre-payment audits will be required to provide supporting documentation to validate submitted attestation data before receiving payment.

Unsupported and false attestations

Making false statements, including attestations to the federal government, could implicate federal law (18 U.S.C. § 1001), which generally prohibits knowingly and willfully making false or fraudulent statements or concealing information. Although eligible hospitals receiving incentive payments under the Medicare and Medicaid EHR Incentive Programs are not required to follow any particular parameters when spending the payments, they must annually attest to meeting the relevant measures and objectives in order to be entitled to incentive payments. It is critical that eligible hospitals maintain documentation that supports their attestations.  Supporting documentation needs to make clear that the hospital is meeting the terms and conditions of the EHR Incentive Program. A checklist document by itself would be insufficient as supporting documentation. Failure to maintain such supporting documentation creates potential liability. Although no significant enforcement activity has taken place, compliance officers are advised to verify that proper supporting documentation is maintained.  In fact, the responsible program manager should be maintaining documentation as part of ongoing monitoring. As part of ongoing auditing, the compliance office should ensure that monitoring is conducted and validate that it is adequately meeting regulatory 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.

Connect with Richard Kusserow on
Google+ or LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

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

 

 

CPC+ Round 2 taking applications from Louisiana, Nebraska, North Dakota, and Buffalo NY practices

The second round of regions for participation in the Comprehensive Primary Care Plus (CPC+) model, an Advanced Alternative Payment Model (Advanced APM) has been announced by CMS, which is seeking eligible practices in three statewide regions—Louisiana, Nebraska, and North Dakota—and in the Greater Buffalo Region (Erie and Niagara Counties), New York. CPC+ Round 2 will accept applications beginning May 18 through July 13, 2017; accepted practices will be part of an innovative payment structure that rewards value and quality for primary care practices that improve quality, access, and efficiency. The four regions were chosen based on payer alignment and market density.

CPC+ Round 2 is smaller than Round 1, which included 14 regions (see More clinicians able to join Next Generation ACOs, CPC+ for 2018, December 16, 2016), and chosen practices will participate from 2018 through 2022. Practices located in Round 1 regions are not eligible to participate in Round 2, even if they applied for Round 1 and were not accepted or did not apply for Round 1. As part of the announcement for Round 2, CMS also provisionally selected five payer partners to provide additional support in certain Round 1 regions.

CPC+ was developed by the CMS Innovation Center, which was established by section 3021 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148). As an Advanced APM, the program is part of the Quality Payment Program (QPP), which is designed to reform Medicare payments to physicians as part of CMS’ implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (P.L. 114-10).

Kusserow on Compliance: Factors OIG considers in deciding exclusions

The HHS Office of Inspector General (OIG) has authority exclude any individual or entity engaging in prohibited activities from participation in the federal health care programs, and add him or her to their List of Excluded Individuals and Entities (LEIE). The effect of this is that no payment may be made for any items or services furnished by an excluded individual or entity, or directed or prescribed by an excluded physician. This authority is anchored in legislation going back to 1977; the OIG was delegated authority to impose civil monetary penalties (CMPs), assessments, and program exclusion on health care providers and others determined to have submitted, or caused the submission of, false or fraudulent claims to the Medicare or Medicaid programs. During my 11-year tenure as Inspector General (IG), the administrative remedies were broadened to address additional types of misconduct. This has continued over the years.  Passage of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) amended and expanded the existing authority for the OIG to impose CMPs and exclusions.

 Factors in exclusion decisions

The LEIE database is very large, with 3,000 new exclusions being added annually. About half of the exclusions included in the database are for criminal convictions related to health care programs and for patient abuse or neglect. These are mandatory exclusion.  In addition, the OIG has discretionary authority to exclude for other types of misconduct, such as license revocation or suspension, exclusion or suspension from another federal or state health care program, provision of unnecessary or substandard services, fraud or kickbacks, and default on a health education loan.

Tom Herrmann, J.D. served over 20 years in the Office of Counsel to the Inspector General. He explained that when exercising its discretionary authority to exclude, the OIG takes into consideration a number of factors, including the following:

  • Nature and circumstances of conduct. This includes determining adverse physical, mental, financial, or other impact to program beneficiaries, recipients, or other patients.
  •  Financial loss. Conduct  that (1) was part of a pattern of wrongdoing; (2) occurred over a substantial period of time; (3) was continual or repeated; and (4) continued until or after the person learned of the Government’s investigation indicates higher risk.
  • Leadership role. If the individual organized, led, or planned the unlawful conduct.
  • History of prior fraudulent conduct. History of judgments, convictions, decisions, or settlements in prior enforcement actions, as well as (1) refusal to have entered into a corporate integrity agreement (CIA), (2) breach of a prior CIA, or (3) lies or failure to cooperate with the OIG while under a CIA.
  • Conduct during investigation. Any (1) obstruction in the investigation or audit; (2) taking any steps to conceal the conduct from the government; or (3) failure to comply with a subpoena.
  • Resolution. The inability to pay an appropriate monetary amount (including damages, assessments, and penalties) to resolve a fraud case.
  • Absence of compliance program. Absence of a compliance program that incorporates the seven elements of an effective compliance program.

Avoiding exclusion

There are a number of steps that can be taken to reduce the likelihood of the OIG exercising its discretion to exclude parties and put them on the LEIE. These include being able to evidence:

  1. Initiating internal investigation and sharing results before the government gets involved;
  2. Self-disclosing an internal investigation;
  3. Cooperating with the government, if it initiate an investigation;
  4. Taking appropriate disciplinary action against individuals responsible for bad conduct;
  5. Implementing an effective compliance program, prior to government investigation;
  6. Devoting increased/improved support for the compliance program; and
  7. Having in the past self-disclosed overpayments in good faith to the OIG and CMS.

LEIE sanction screening

Screening individuals and entities prior to engagement and periodically thereafter is not optional–it is a necessity.   The best practice is to screen monthly against the LEIE and any state exclusion database where business is conducted, in that CMS has set this as a standard for Medicaid Directors.   In addition to screening against the LEIE, most states require screening against their database of sanction parties. Often there are delays in resolution of cases, so that a party may not be included in a sanction database at time of engagement, but is added later. Furthermore, inasmuch as most state Medicaid Fraud Control Units report their criminal actions to the OIG, that in turn includes them in the LEIE, resulting in frequent cases of multiple hits for the same underlying action. This is further complicated by the fact that there are delays when actions by state agencies are reported to the OIG for their determination to add them to the LEIE.

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.