Kusserow on Compliance: Physicians must comply with sharing patient information

Under the electronic health records (EHR) metric, The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (P.L. 114-10) requires attestations from doctors that they are not knowingly and willfully limiting or restricting their EHR’s ability to share information with providers that may have different record systems.  CMS has issued new guidance reminding providers of their responsibilities to promptly share medical information with patients and other clinicians, or else face financial penalties. The targets are providers participating in the Merit-based Incentive Payment System (MIPS) to comply with MACRA. The notice stated physicians will need to attest that they are not engaged in information blocking and that they give patients their data in a timely fashion. Many physicians and medical practices use vendors for their information management systems. They will now have to ensure their vendors enable them to comply with the information sharing mandates.

Under MIPS, providers become eligible for either bonus payments or penalties based on their performance, including evidence of quality improvement, cost reduction or maintaining current levels of spending; efficient use of EHRs; and clinical improvement activities such as later office hours and greater use of care coordination. The Prevention of Information Blocking Attestation has three related statements for MIPS eligible clinicians:

  1. They did not knowingly and willfully take action to limit or restrict the compatibility or interoperability of Certified EHR Technology (CEHRT).
  2. They implemented technologies, standards, policies, practices, and agreements reasonably calculated to ensure the CEHRT was connected and compliance with applicable law and standards for timely access by patients to their data and other health care providers.
  3. They responded in good faith and in a timely manner to request to retrieve or exchange EHR from patients and other health care providers.

CMS also stated that physicians would not be held accountable for things outside of their control, but must get adequate assurances from their vendors that they are able to comply with the information sharing requirements. On the other hand, physicians must take care that they don’t violate the HIPAA Privacy law for patient Protected Health Information (PHI).

 

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: OIG report on research compliance through OHRP

The OIG conducted a study of the Office of Human Research Protection (OHRP) at HHS in response to Congressional requests that raised questions about its independence. The request was for the OIG to review OHRP procedures and make recommendations to strengthen protections for human subjects and ensure OHRP’s independence. OHRP enforces compliance with HHS regulations for protecting human subjects. Its mission is to protect the rights of human subjects-individuals who volunteer to participate in research conducted or supported by the HHS. The OIG conducted a survey of research institutions that were the primary subjects of the compliance evaluations about their experiences with the OHRP. The OIG also reviewed documents from eight compliance evaluations that had been closed; and interviewed OHRP staff, other HHS officials, and individuals with expertise in protections for human subjects.

OIG findings regarding OHRP

The OIG found that OHRP:

  • evidenced carrying out its compliance activities independently from agencies funding the research and the institutions conducting the research;
  • made decisions on how to use resources, resulting in fewer compliance evaluations, while increasing its use of other mechanisms in response to allegations;
  • determined the scope of its evaluations and what methods to employ;
  • was able to access the information it needed to conduct its compliance evaluations;
  • maintained documentation on its determinations;
  • may be limited in its ability to act independently due to its role, placement within HHS, and the way its budget is set may limit; and
  • may have the appearance of limited oversight and independence due to the practice of not reporting publicly on all of its compliance activities.

OIG Recommendations to HHS

The OIG recommended that HHS:

  1. issue guidance that clarifies OHRP’s role;
  2. re-evaluate OHRP’s position within HHS;
  3. evaluate sufficiency of OHRP’s resources;
  4. consider ways to elevate the prominence of OHRP’s budget (e.g. having a separate line item in the President’s budget);
  5. foster a shared understanding for OHRP’s independence by considering seeking statutory authority for OHRP’s independence; and
  6. post on OHRP’s website: (a) a description of its approach to oversight and (b) data (in aggregate) regarding its compliance activities.

 

 

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.

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

Kusserow on Compliance: OIG proposed budget for 2018 cites accomplishments

The HHS OIG submitted their fiscal year (FY) 2018 proposed budget for a total of $359 million that includes $291 million to support oversight of the Medicare and Medicaid programs.  In justifying their request, the OIG reported expected recoveries of more than $5.66 billion for FY 2016 that includes $4.46 billion in investigative receivables and approximately $82 million in CMPs. The OIG’s work also prevents fraud and abuse through industry outreach and guidance and recommendations to HHS to remedy program vulnerabilities. Additionally, OIG reported on its role as a Health Care Fraud and Abuse Control (HCFAC) program participant in returning $5 to the Medicare Trust Funds for every $1 invested in FY 2016. The OIG reported 844 criminal actions against individuals or organizations that engaged in crimes against HHS programs and 708 civil and administrative enforcement actions, including False Claims Act lawsuits filed in Federal district court, and Civil Monetary Penalty (CMP) law settlements. The OIG excluded 3,635 individuals and organizations from participation in Federal health care programs. The OIG is also part of Health Care Fraud Strike Force teams that coordinate operations conducted jointly by Federal, State, and local law enforcement entities that resulted in filing of charges against 255 individuals or entities, 207 criminal actions, and $321 million in investigative receivables.

Over the last five years, the OIG’s expected recoveries have averaged $5.3 billion annually. Changes in the amount of expected recoveries from year to year are due to the particular mix of cases resolved in a given year, as well as continued efforts to work with operating divisions to implement OIG recommendations.

 

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: OIG issues detailed report on state Medicaid Fraud Control Units

1,564 Criminal Convictions

1,000 Civil Settlements

Almost $2 billion in recoveries

The OIG Office of Evaluation and Inspection (OEI) issued a more detailed analysis of statistical results from the State Medicaid Fraud Control Units (MFCUs) for 2016. The OIG is the designated Federal agency that oversees them and has been instrumental in establishing the Units.  As Inspector General, I worked to establish a number of these MFCUs that currently operate in 49 States and the District of Columbia (States). Once established the OIG administers a grant to each of the units that provides 75 percent of their funding and set performance standards, reviews each state’s program, provides technical assistance identify best practices, and collect and analyze statistics. The mission of MFCUs is to investigate and prosecute, under State law, Medicaid provider fraud and patient abuse or neglect. In FY 2016, the OIG reported 1,564 convictions, over one-third of which involved personal care services attendants. The OIG reported nearly 1,000 civil settlements and judgments, with settlements with pharmaceutical manufacturers making up almost half of settlements; along with almost $1.9 billion in criminal and civil recoveries. The OIG works often with the MFCUs and in 2016 the OIG Medicaid cases resulted in 312 indictments, 348 criminal actions, and 222 civil actions. These Medicaid cases—some of which also involved Medicare—resulted in almost $3 billion dollars in expected recoveries. However, in most cases the MFCUs work their own cases without assistance from other agencies.

It is noteworthy that current funding for Medicaid fraud control is at a higher level than for the federally funded and administered Medicare program. Medicaid annual expenditures exceed $500 billion dollars and funding for the MFCUs was also at a high level of $258,698,147 in 2016.  The staffing level of investigators, auditors, and attorneys was 1,965. Those entities investigated 15,505 fraud cases and another 3,221 abuse and neglect cases. The largest category of convictions involved personal care services (PCS) (35 percent). Nursing care came in second (11 percent) and involved of licensed practical nurses (LPN), registered nurses (RN), physician assistants (PA), or nurse practitioners (NP). Convictions of nurse-aides represented the third largest category (10 percent).

In this report, the OIG provided a detailed breakdown of the types of cases and trending data. Statistical results by state are included in the OIG Report.  Comparison of results to the prior year can be made by referring to the OIG issued report for 2015 that noted MFCUs achieving 1,553 convictions, 731 civil settlements and judgments, and $744 million in criminal and civil recoveries.

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.