Kusserow on Compliance: OIG plans 2021 evaluation of nursing home discharge requirements

The HHS Office of Inspector General (OIG) announced it is planning in 2021 to examine the extent to which nursing homes meet CMS requirements for facility-initiated discharges. In its announcement, the OIG noted that a facility-initiated transfer or discharge of a resident from a nursing home can be an unsafe and traumatic experience for the resident and his or her family. In response to this concern, Congress passed the Nursing Home Reform Act of 1987 to protect residents against inappropriate facility-initiated transfer and discharge.

However, data from the National Ombudsman Reporting System show, from 2011 through 2016, cited complaints related to “discharge/eviction” more frequently than any other concern. The OIG also took note of the media reports that highlighted the rise in nursing home evictions and complaints about the discharge process. Past reviews found varying reasons for non-compliant discharges. Some discharges are driven by changes to payment source, but the most frequently reported discharge reason relates to residents that are discharged due to “behavioral, mental, and/or emotional expressions or indications of resident distress.” This includes facilities discharging residents while they are hospitalized related to these behaviors as the basis for discharge. The most common discharge violations included: (1) placement in a questionable/unsafe setting; (2) where a resident remains hospitalized; and (e) where there is a pattern of discharge violations in the facility, among other issues.

The OIG has long monitored the extent to which state long-term care ombudsmen, state survey agencies, and CMS address facility-initiated discharges from nursing homes.  As part of its ongoing work in this area, it will, in 2021, be further examining the extent to which nursing homes meet CMS requirements for facility-initiated discharges. Nursing Home Compliance Officers should take note of this and build a review of this compliance issue in their 2021 workplan.

 

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 LinkedIn.

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Copyright © 2020 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: The OIG announces plan to begin auditing the Two-Midnight Rule

The HHS Office of Inspector General (OIG) announced that it will begin auditing short stay claims again, and when appropriate, recommend overpayment collections. The agency’s previous audits identified millions of dollars in overpayments for inpatient claims with short lengths of stay. The OIG found that many have billed stays as inpatient claims when they should have been billed as outpatient claims, which usually results in a lower payment.

To reduce inpatient admission errors, CMS implemented the Two-Midnight Rule in 2014. CMS generally considered it inappropriate to receive payment under the inpatient prospective payment system (IPPS) for stays not expected to span at least two midnights. The only procedures excluded from the rule were newly initiated mechanical ventilation and any procedures appearing on the Inpatient Only List. Revisions were made to the Two-Midnight Rule after its implementation.

The OIG plans to once again audit hospital inpatient claims after the implementation of and revisions to the Two-Midnight Rule. The objective is to determine whether inpatient claims with short lengths of stay were incorrectly billed as inpatient and should have been billed as outpatient or outpatient with observation. The OIG also plans to review policies and procedures for enforcing the Two-Midnight Rule at the administrative level and contractor level. With this new initiative, hospital Compliance Officers should consider focusing on this issue as part of their 2021 work plan.

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 LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2020 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: OIG cautions pharmaceutical and medical device companies over speaker programs

The HHS OIG published a Special Fraud Alert cautioning pharmaceutical and medical device companies against conducting speaker programs given the “inherent risks” of implicating the Anti-Kickback Statute and False Claims Act. The OIG cited numerous enforcement actions related to speaker program arrangements, as well as Sunshine Act payment records reflecting significant payments for such programs in recent years. The OIG called for companies to assess the need for re-starting in-person speaker programs that have been paused during the COVID-19 pandemic. The Fraud Alert outlines “suspect” characteristics of a speaker program that may provoke an enforcement action, including the following:

  • Selected high-prescribing persons to be speakers and rewarded them with lucrative fees.
  • There is little or no substantive information presented at the program.
  • Alcohol is available or a meal exceeding “modest value” is provided to program attendees.
  • Held speaker programs at entertainment venues not conducive to educational presentation.
  • Company sponsors many programs on the same or substantially the same topic or product, especially if there has been no recent substantive change in relevant information.
  • Programs conducted where there has been a “significant period of time” with no new medical or scientific information nor new-FDA approval of a product or indication.
  • Programs where the attendees have attended other programs on the same or substantially the same topics more than once.
  • Attendees include individuals who do not have a legitimate business reason to attend the program, such as friends, significant others, family members, practice employees, and others with no use for the information.
  • Sales representatives or marketing personnel involved in the selection of speakers or the company selects HCP speakers or attendees based on past or potential revenue generated by prescriptions (e.g., a return on investment analysis).
  • Payment to HCP speakers exceeds fair market value for the speaking service or compensation takes into account the volume of business generated by the HCPs.
  • Conditioned speaker remuneration on sales targets (e.g., required speaker HCPs to write a minimum number of prescriptions in order to receive the speaker honoraria).

 

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 LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2020 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: Time for Compliance Program evaluation

  1. Have a 2021 workplan focusing on improving the Compliance Program
  2. Not having independent evaluations is evidence of lack of program effectiveness
  3. DOJ & OIG: Identifying & addressing weaknesses evidences program effectiveness

With 2020 coming to an end, it is time to look forward to the New Year and plan ways to identify areas for improvement of the Compliance Program, building off of results of independent evaluations. Both the OIG and DOJ stress the importance of evidencing Compliance Program (“CP”) effectiveness and that all programs are in progress, never completed. They see compliance officers identifying weakness and gaps that lead to improvements as positive evidence of an effective program. The DOJ “Evaluation of Corporate Compliance Programs” notes that there will always be ways the program can be improved and enhanced. The DOJ, in its 2020 Compliance Program Evaluation Guidelines noted: “One hallmark of an effective compliance program is its capacity to improve and evolve. The actual implementation of controls in practice will necessarily reveal areas of risk and potential adjustment.”  The DOJ highlights the importance of effective implementation and evaluation measures” to determine whether the compliance program a “paper program” or one that is fully “implemented, reviewed, and revised, as appropriate, in an effective manner.” DOJ prosecutors are directed to ask: Does the company evaluate periodically the effectiveness of the organization’s compliance program?” Regular, rigorous, and consistent review of compliance programs is now the expectation.  The OIG calls for ongoing monitoring and independent ongoing auditing of Compliance Programs to evidence continuous improvement.

There are three general ways for independent evaluations: (1) a complete compliance program evaluation; (2) a compliance program gap analysis; or (3) an independently developed and administered employee survey of compliance knowledge, attitude and perceptions.

  1. Compliance Program effectiveness evaluations is recognized by experts as by far the best method to evidence how well the program is functioning. It measures outcome by conducting a 360-degree evaluation that includes: (a) full document examination and review; (b) on site review and testing of operations in action; and (c) interviews of Board members, executives, selective key staff, and focus group meetings. If done properly, the resulting reports with be 60 to 100 pages that include findings, observations, along with recommendations and suggestions for program improvement.
  2. Compliance program gap analysis is about half of the cost or less than a full compliance program evaluation, but the reduction of costs is matched by the diminished value of results. It is primarily a document “checklist” review, focusing on output metrics, rather than outcome metrics related to program effectiveness. It is best used with organizations with new or incomplete programs, desiring assistance in identifying elements needed to complete development of their program.  It can identify gaps for inexperienced compliance officers but lacks details by which this can be accomplished.
  3. Independently developed, validated, and administered compliance surveys of employees is the least expensive means, at a fraction of the cost for either of the two other methods, for evidencing and benchmarking compliance program effectiveness. The use of surveys has long been advocated by regulatory bodies, including in the Federal Sentencing Guidelines, OIG Compliance Program Guidance and DOJ guidelines. These organizations advise using surveys of employees to gauge how well the program is functioning. Surveys that are anchored in a large database of organization, permit benchmarking an organization to the universe. Compliance knowledge surveys test knowledge of the compliance program structure and operations and can provide very credible empirical evidence of the advancement of program knowledge, understanding and effectiveness. Compliance culture surveys focuses on employee beliefs, attitudes, and perception concerning compliance, useful in measuring the extent to which individuals, coworkers, supervisors, and leaders demonstrate commitment to compliance. Both types of surveys should be considered as they are useful in benchmarking and measuring change in the compliance environment over a period and provide different dimensions and perspectives on a compliance program.

For more information on the difference in scope of work between a full compliance program evaluation and a gap analysis, send your queries to Richard Kusserow at rkussserow@strategicm.com.

 

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 LinkedIn.

Subscribe to the Kusserow on Compliance Newsletter

Copyright © 2020 Strategic Management Services, LLC. Published with permission.