NATIONAL PRACTITIONER DATA BANK CHANGES AFFECT PODIATRISTS. Kern Augustine Conroy & Schoppmann, P.C.

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1 NATIONAL PRACTITIONER DATA BANK CHANGES AFFECT PODIATRISTS Kern Augustine Conroy & Schoppmann, P.C. Effective March 1, 2010, new regulations governing the National Practitioner Data Bank (NPDB) became effective. These regulations implement a statutory expansion of the NPDB to include adverse licensure information on all licensed healthcare practitioners, including podiatrists, and healthcare entities and to include certain sanctions taken by Private Accreditation Entities and Peer Review Organizations. This expansion was enacted in an attempt to provide further protection to the beneficiaries of federal healthcare programs from unfit healthcare practitioners and to improve the anti-fraud provisions of those programs. BACKGROUND The NPDB is a creation of the Health Care Quality Improvement Act (HCQIA), 42 U.S.C et seq. Pursuant to that statute, the NPDB contains reports relative to certain actions taken against physicians and dentists only, including adverse licensure actions, clinical privilege actions, professional society membership actions, malpractice payments, DEA actions, and Medicare and Medicaid exclusions. This information may only be accessed by hospitals, healthcare entities which perform peer review and provide health care services, and medical and dental licensing boards. The changes to the regulations that became effective March 1, 2010, do not change any of these existing requirements related to physicians and dentists. However, Section 1921 of the Social Security Act (Section 1921) expands the scope of the NPDB and the new regulations implement that expansion. Now, each state must report adverse licensure actions against all licensed healthcare practitioners, including podiatrists, as well as against healthcare entities, by any state authority responsible for the licensure of such practitioners or entities. In addition, each State must adopt a system to report to the NPDB negative actions and findings that a Peer Review Organization or Private Accreditation Organization has concluded against a healthcare practitioner or entity. The same organizations noted above that have NPDB access may also access Section 1921 information by querying the NPDB. However, for the new Section 1921 information only, the NPDB may also be queried by other licensing authorities, state health care programs, agencies or contractors of Federal health care programs, state Medicaid Fraud Control Units, the U.S. Comptroller General, the U.S. Attorney General and other law enforcement officials, and Medicare Quality Improvement Organizations (QIOs). A separate national data bank the Healthcare Integrity and Protection Data Bank (HIPDB)--has overlapping reporting requirements. The HIPDB collects information reported by federal and state government agencies and health plans similar to that included previously in the NPDB, related to healthcare practitioners, providers (e.g., hospitals, SNFs), and suppliers (e.g., DME suppliers). However, the HIPDB also collects reports of healthcare-related civil judgments, healthcare-related criminal convictions, exclusions from federal or state health care programs,

2 and other adjudicated actions or decisions. This data can only be queried by federal and state government agencies, health plans, researchers (for statistical data only), and self-querying practitioners, providers and suppliers. Private hospitals, for example, cannot obtain information contained in the HIPDB. The impact of Section 1921 on most reporters will be minimal as most of the Section 1921 information is already reported to the HIPDB (although duplicate reporting will not be required). DETAILS OF THE NEW SECTION 1921 Who must report? Under the NPDB as expanded by Section 1921, the following entities report to the NPDB: Medical malpractice payers All State healthcare practitioner licensing and certification authorities State healthcare entity licensing and certification authorities Hospitals Other healthcare entities with formal peer review (such as managed care organizations) Professional societies with formal peer review OIG DEA Peer review organizations Private accreditation organizations Peer review organizations are defined as organizations with the primary purpose of evaluating the quality of patient care practices or services ordered or performed by healthcare practitioners, physicians, or dentists measured against objective criteria which define acceptable and adequate practice. To qualify as a peer review organization for purposes of the NPDB, such organizations must have due process mechanisms available to healthcare practitioners, physicians, and dentists. This definition excludes utilization and quality control peer review organizations referred to as Quality Improvement Organizations (QIOs) and other organizations funded by the Centers for Medicare and Medicaid Services to support the QIO program. As above, the due process requirements are not specified in these regulations. The comments to the adopted rules specifically exclude hospital internal peer review processes from this definition, and further comment that peer review organizations must be separate from hospitals and other healthcare entities. Peer review organizations are required to report any recommendation to sanction a healthcare practitioner. Private accreditation entities are defined as organizations that (a) evaluate and seek to improve the quality of health care provided by a healthcare entity; (b) measure a healthcare entity's performance based on a set of standards and assigns a level of accreditation; (c) conducts ongoing assessments and periodic reviews of the quality of health care provided by a healthcare entity; and (d) has due process mechanisms available to healthcare entities. Private accreditations entities, as peer review organizations, must have due process protections afforded to affected practitioners to render its actions reportable events. Private accreditation agencies are

3 required to report final denials or terminations of accreditation status that indicate a risk to patient safety or quality of health care services. Who is affected? With the changes to the NPDB under Section 1921, state licensing boards for both healthcare practitioners and healthcare entities must report any adverse licensure actions to the NPDB. This reporting has several critical components. The definition of healthcare practitioner is not limited to medical doctors, osteopaths and dentists. Rather, it now includes any healthcare practitioner licensed or otherwise authorized to provide health care services. Podiatrists are specifically mentioned in this category in the comments to the adopted regulation, but it also presumably includes alcohol and drug counselors, acupuncturists, athletic trainers, chiropractors, dental hygienists and assistants, licensed practical nurses, registered nurses, advanced practice nurses, midwives, occupational therapists and assistants, optometrists, paramedics and emergency medical technicians (currently certified not licensed in New Jersey, although currently proposed for licensure), perfusionists, physical therapists and assistants, physician assistants, psychologists, respiratory therapists, social workers, and speech pathologists. What is reported? Under the NPDB, not including Section 1921 information, the following information is reported: Medical malpractice payments (all healthcare practitioners) Adverse physician/dentist licensure actions (competence and conduct related) Adverse clinical privileging actions Adverse professional society membership actions DEA actions Medicare/Medicaid exclusions Under the new Section 1921, the following additional information is reported (Section 1921 data): Any adverse licensure actions (all healthcare practitioners and entities) - Revocation, reprimand, censure, suspension, probation - Voluntary surrender, if such a surrender is made publicly available - Any dismissal or closure of formal proceedings by reason of the practitioner or entity surrendering the license or leaving the State or jurisdiction - Any other loss of license Any negative action or finding by a State licensing or certification authority Peer review organization negative actions or findings against a healthcare practitioner or entity Private accreditation organization negative actions or findings against a healthcare practitioner or entity Notably, actions that are reported must be the product of formal proceedings, which are poorly-defined as a proceeding before an authority that maintains defined rules, policies or

4 procedures for such a proceeding. This is a somewhat circular definition, and is not explicit on the impact of a settlement prior to the institution of a formal disciplinary proceeding, for example. It is noteworthy that the comments to these rules state that actually following the rules, policies or procedures is not a condition of reporting by the authority. Rather, the existence of the rules themselves is the determining factor. Excluded from reporting obligations are licensure surrenders for non-payment of fees, retirement, or change to inactive status, unless tied to a reportable event. The fact that non-publicly available actions remain non-reportable is beneficial to practitioners, as it continues to provide a non-reportable alternative. There is also a provision in the Section 1921 comments for non-reportable corrective action plans which may provide an additional carve-out from the reporting obligations that can be utilized in lieu of discipline in the future. The comments to the adopted rule note that a provider s participation in a diversionary or impairment monitoring program is not considered an adverse action, and would remain a nonreportable event to the NPDB for all healthcare practitioners, as is presently the case for physicians and dentists. Who can access the data? Entities that were allowed to query the NPDB before the implementation of Section 1921 now have access to the new Section 1921 information, as well. These entities (and individuals) are as follows: Hospitals Other healthcare entities, with formal peer review Professional societies with formal peer review All State healthcare practitioner licensing and certification authorities Researchers (non-identifiable statistical data only) Healthcare practitioners (self-query) The following entities have only been given access to the NPDB through Section 1921and are allowed to query only Section 1921 data: State entity licensing and certification authorities Agencies or contractors administering Federal health care programs State agencies administering State health care programs State Medicaid Fraud Units U.S. Comptroller General U.S. Attorney General and other law enforcement Medicare Quality Improvement Organizations (Utilization and Quality Control Peer Review Organizations) Healthcare entities (self-query) Plaintiff s attorneys and pro se plaintiffs, under limited circumstances, are eligible to receive only non-section 1921 reports. No individual NPDB data is available to the general public.

5 CONCLUSION Where previously only physicians and dentists were concerned about reports made to the National Practitioner Data Bank, the recent implementation of Section 1921 expands those concerns to all healthcare practitioners including podiatrists. In addition, the reports related to physicians and dentists are expanded beyond those actions previously reportable. For this reason, we suggest that all licensed healthcare practitioners closely examine the impact of any events which could be reportable to the Data Bank from now on. As described above, such events can have far-reaching implications with hospitals and other health care entities with formal peer review (whether the practitioner seeks credentialing or employment), licensing boards, and other governmental authorities. For assistance or more information, contact Bob Conroy, Kern Augustine Conroy & Schoppmann, at