Source: http://www.regulations.gov/?_escaped_fragment_=documentDetail;D=EPA-HQ-OPP-2009-0361-0003;oldLink=true
Timestamp: 2013-05-19 02:38:43
Document Index: 457885909

Matched Legal Cases: ['arts 60', '§ 60', '§ 60', '§ 60', '§ 60', '§ 60', '§ 60', '§ 60', '§ 60', '§ 60', '§ 60', 'art 61']

45 CFR Parts 60 and 61
RIN 0906-AA87
Addresses and Mode of Transmission for Comments
You may submit comments in one of three ways, as listed below. The first is the preferred method. To avoid duplication, please submit your comments in only one
1. Federal eRulemaking Portal.
You may submit comments electronically to http://www.regulations.gov.
Click on the link “Submit a comment” and enter the file code “# HRSA-0906-AA87” in the ID field. Submit your actual comments as an attachment to your message or cover letter. (Attachments should be in Microsoft Word or WordPerfect; however, we prefer Microsoft Word.)
2. By regular, express or overnight mail.
You may mail written comments to the following address only: Health Resources and Services Administration, Department of Health and Human Services, Attention: HRSA Regulations Officer, Parklawn Building Rm. 14-101, 5600 Fishers Lane, Rockville, MD 20857. Please allow sufficient time for mailed comments to be received before the close of the comment period.
3. Delivery by hand (in person or by courier).
If you prefer, you may deliver your written comments before the close of the comment period to the same address: Parklawn Building Room 14-101, 5600 Fishers Lane, Rockville, MD 20857. Please call (301) 443-1785 in advance to schedule your arrival with one of our HRSA Regulations Office staff members.
(1.) The Health Care Quality Improvement Act of 1986 (42 U.S.C. 11101
The National Practitioner Data Bank (NPDB) was established by the Health Care Quality Improvement Act of 1986 (HCQIA), as amended (42 U.S.C. 11101 et seq.
). The HCQIA authorizes the NPDB to collect reports of adverse licensure actions against physicians and dentists (including revocations, suspensions, reprimands, censures, probations, and surrenders); adverse clinical privileges actions against physicians and dentists; adverse professional society membership actions against physicians and dentists; Drug Enforcement Administration (DEA) certification actions; Medicare/Medicaid exclusions; and medical malpractice payments made for the benefit of any health care practitioner. Organizations that have access to this data system include hospitals, other health care entities that have formal peer review processes and provide health care services, State medical or dental boards and other health care practitioner State boards. Individual practitioners may self-query. Information under the HCQIA is reported by medical malpractice payers, State medical and dental boards, professional societies with formal peer review, and hospitals and other health care entities (such as health maintenance organizations).
Groups with access to this information include all organizations eligible to query the NPDB under the HCQIA (hospitals, other health care entities that have formal peer review and provide health care services, Statemedical or dental boards, and other health care practitioner State boards), other State licensing authorities, agencies administering Federal health care programs (including private entities administering such programs under contract), State agencies administering or supervising the administration of State health care programs, State Medicaid fraud control units, certain law enforcement agencies, and utilization and quality control Quality Improvement Organizations (QIOs). Individual health care practitioners and entities may self-query. Information under section 1921 is reported by State licensing and certification authorities, peer review organizations, and private accreditation entities.
Subsection (b) of section 6403 adds to section 1921 the State agency reporting requirements that were eliminated from section 1128E by subsection (a). These State actions, taken against health care practitioners, providers, and suppliers, include State licensing and certification actions, State health care-related criminal convictions and civil judgments, exclusions from State health care programs, and other adjudicated actions or decisions. Subsection (b) also conforms the requirements for reporting State licensing and certification actions to those that apply to Federal agencies under section 1128E and makes amendments to expand the data access provisions of section 1921(b) so that entities that were authorized to access final adverse action information reported to the HIPDB by State agencies under section 1128E will retain access to that information when it is reported to the NPDB under section 1921. Subsection (b) also adds new provisions under section 1921 that are modeled on similar provisions in section 1128E. These new provisions require the Secretary to disclose reported information to a subject of a report and establish other requirements designed to ensure that the information reported pursuant to section 1921 is accurate; authorize the Secretary to establish or approve reasonable fees for the disclosure of information reported pursuant to section 1921; and provide protection against liability in a civil action for entities reporting information as required by section 1921 (so long as such entities have no knowledge of the falsity of the information). Subsection(b) also provides definitions for the following terms: (1) “State licensing or certification agency;” (2) “State law or fraud enforcement agency;” and (3) “final adverse action.” Finally, subsection (b) requires the Secretary, in implementing the amendments to section 1921, to provide for the maximum appropriate coordination with HCQIA and section 1128E.
The table is only a summary of the statutory reporting and querying requirements before and after passage of section 6403. All elements in the table, including definitions of terms used, are detailed in various sections of this proposed rule.
▪Medical malpractice payers▪Boards of Medical/Dental Examiners▪Hospitals and other healthcare entities▪Professional societies with formal peer review▪Drug Enforcement Administration▪Health and Human Services—Office of Inspector General
▪Medical malpractice payers▪Boards of Medical/Dental Examiners▪Hospitals and other health care entities▪Professional societies with formal peer review▪Drug Enforcement Administration▪Health and Human Services-Office of Inspector General
▪Peer review organizations▪Private accreditation organizations▪State authorities that license practitioners and entities
▪Peer review organizations▪Private accreditation organizations▪State authorities that license or certify practitioners, entities, providers, suppliers▪State law or fraud enforcement agencies
▪Federal and State government agencies (including State law or fraud enforcement agencies)▪Health plans
▪Federal government agencies▪Health plans
▪Medical malpractice payments▪Adverse licensure actions (physicians/dentists):—revocation, suspension, reprimand, probation, surrender, censure▪Adverse clinical privileges actions (primarily physicians/dentists)▪Adverse professional society membership (primarily physicians/dentists)▪DEA certification actions▪Medicare/Medicaid exclusions
▪Licensing actions (practitioners and entities):—revocation, reprimand, censure, suspension, probation—any dismissal or closure of the proceedings by reason ofsurrendering the license or leaving the State or jurisdiction—any other loss of the license—any negative action or finding by a State licensing authority, peer review organization, or private accreditation entity
▪Licensing or certification actions (practitioners, entities, providers, and suppliers):—revocation, reprimand, censure, suspension, probation—any dismissal or closure of the proceedings by reason of surrendering the license or leaving the State or jurisdiction—any other loss of, or loss of the right to apply for, or renew a license—any negative action or finding by a State licensing or certification authority, peer review organization, or private accreditation entity▪Health care-related civil judgments in State court (practitioners, providers, suppliers)▪Health care-related State criminal convictions (practitioners, providers, suppliers)▪Exclusions from State health care programs (practitioners,providers, suppliers)▪Other adjudicated actions or decisions (practitioners, providers, suppliers)
▪Licensing and certification actions(practitioners, providers, and suppliers):—revocation, reprimand, suspension, censure, probation;—any other loss of license, or right to apply for, or renew, a license, whether by voluntary surrender, non-renewability, or otherwise—any other negative action or finding that is publicly available information▪Health care-related civil judgments in Federal or State court(practitioners, providers, suppliers)▪Health care-related Federal or State criminal convictions (practitioners, providers, suppliers)▪Exclusions from Federal or State health care programs(practitioners, providers, suppliers)▪Other adjudicated actions or decisions (practitioners, providers, suppliers)
▪Federal licensing/certification actions (practitioners, providers, and suppliers):—revocation, reprimand, censure, suspension, probation—any dismissal or closure of the proceedings by reason of surrendering the license or leaving the State or jurisdiction—any other loss of, or right to apply for, or renew, a license, whether by voluntary surrender, non-renewability, or otherwise—any negative action or finding that is publicly available information▪Health care-related civil judgments in Federal or State court (practitioners, providers, suppliers)▪Health care-related Federal or State criminal convictions (practitioners, providers, suppliers)▪Exclusions from Federal health care programs (practitioners, providers, suppliers)▪Other adjudicated actions or decisions (practitioners, providers, suppliers)
▪Hospitals▪Other health care entities with formal peer review▪Professional societies with formal peer review▪Boards of Medical/Dental Examiners▪Other health care practitioner State licensing boards▪Plaintiff's attorney/pro se plaintiffs (limited circumstances)▪Health care practitioners (self-query)▪Researchers (statistical data only)
▪Hospitals and other health care entities (HCQIA)▪Professional societies with formal peer review▪Quality Improvement Organizations▪State licensing agencies that license practitioners and entities▪Agencies administering Federal health care programs, or their contractors▪State agencies administering State health care programs▪State Medicaid fraud control units▪U.S. Comptroller General▪U.S. Attorney General and other law enforcement▪Health care practitioners/entities (self-query)▪Researchers (statistical data only)SECTION 1128E (HIPDB)▪Federal and State government agencies▪Health plans▪Health care practitioners/providers/suppliers (self-query)▪Researchers (statistical data only)
▪Hospitals and other health care entities (HCQIA)**▪Professional societies with formal peer review**▪Quality Improvement Organizations**▪State licensing or certification agencies that license or certify practitioners, entities, providers, or suppliers▪Agencies administering (including those providing payment for services) Federal health care programs and their contractors▪State agencies administering State health care programs▪Federal agencies that license or certify practitioners, providers, suppliers▪Health plans▪State law or fraud enforcement agencies (including State Medicaid fraud control units)▪U.S. Comptroller General▪U.S. Attorney General and other Federal law enforcement▪Health care practitioners, entities, providers, suppliers (self-query)▪Researchers (statistical data only).
Finally, the proposed rule sometimes refers to “practitioner, physician, dentist, provider, and supplier” as one grouping. The manner in which the regulation defines supplier may be read to include physicians and dentists. In the proposed rule, where physiciansand dentists are specified, but other suppliers are not, it is intended that other suppliers are not included in those instances. Where suppliers are mentioned along with physicians and dentists, the intent is not to imply that suppliers do not include physicians and dentists, but that all terms were included for the sake of clarity.
means a court-ordered action rendered in a Federal or State court proceeding, other than a criminal proceeding. This reporting requirement does not include consent judgments that have been agreed upon and entered to provide security for civil settlements in which there was no finding or admission of liability.
means a conviction as described in section 1128(i) of the Social Security Act.
means a temporary or permanent debarment of an individual or entity from participation in any Federal or State health-related program, in accordance with which items or services furnished by such person or entity will not be reimbursed under any Federal or State health-related program.
means, for the purposes of this part, a provider of services as defined in section 1861(u) of the Social Security Act; any health care organization (including a health maintenance organization, preferred provider organization, or group medical practice) that provides health care services and follows a formal peer review process for the purpose of furthering quality health care, and any other health care organization that, directly or through contracts, provides health care services.
The term “health care provider” is currently defined in HIPDB regulations. We slightly modified this definition by replacing the phrase “means a provider” with “means, for purposes of this part, a provider” to avoid any confusion with the manner that Medicare defines such term.
means, for the purposes of this part, a provider of medical and other health care services as described in section 1861(s) of the Social Security Act; or any individual or entity, other than a provider, who furnishes, whether directly or indirectly, or provides access to, health care services, supplies, items, or ancillary services (including, but not limited to, durable medical equipment suppliers, manufacturers of health care items, pharmaceutical suppliers and manufacturers, health record services such as medical, dental, and patient records, health data suppliers, and billing and transportation service suppliers). The term also includes any individual or entity under contract to provide such supplies, items, or ancillary services; health plans as defined in this section (including employers that are self-insured); and health insurance producers (including, but not limited to agents, brokers, solicitors, consultants, and reinsurance intermediaries).
means, for the purposes of this part, a plan, program, or organization that provides health benefits, whether directly, through insurance, reimbursement, or otherwise, and includes but is not limited to:
means formal or official final actions taken against a health care practitioner, physician, dentist, provider, or supplier by a Federal governmental agency, a State law or fraud enforcement agency, or a health plan; which include the availability of a due process mechanism, and are based on acts or omissions that affect or could affect the payment, provision or delivery of a health care item or service. For example, a formal or official final action taken by a Federal governmental agency, a State law or fraud enforcement agency, or a health plan may include, but is not limited to, personnel-related actions such as suspensions without pay, reductions in pay, reductions in grade for cause, terminations, or other comparable actions. A hallmark of any valid adjudicated action or decision is the availability of a due process mechanism. The fact that the subject elects not to use the due process mechanism provided by the authority bringing the action is immaterial, as long as such a process is available to the subject before the adjudicated action or decision is made final. In general, if an adjudicated action or decision follows an agency's established administrative procedures (which ensure that due process is available to the subject of the final adverse action), it would qualify as a reportable action under this definition. This definition specifically excludes clinical privileging actions taken by Federal government agencies or State law and fraud enforcement agencies and similar paneling decisions made by health plans. This definition does not include overpayment determinations made by Federal or State government programs, their contractors or health plans; and it does not include denial of claims determinations made by Federal government agencies, State law or fraud enforcement agencies, or health plans. For health plans that are not government entities, an action taken following adequate notice and the opportunity for a hearing that meets the standards of due process set out in section 412(b) of the HCQIA (42 U.S.C. 11112(b)) also would qualify as a reportable action under this definition.
State law or fraud enforcement agency
State licensing or certification agency
includes, but is not limited to, any authority of a State (or of a political subdivision thereof) responsible for the licensing or certification of health care practitioners, physicians, dentists, (or any peer review organization, or private accreditation entity reviewing the services provided by health care practitioners, physicians, or dentists), health care entities, providers, orsuppliers. Examples of such State agencies include Departments of Professional Regulation, Health, Social Services (including State Survey and Certification and Medicaid Single State agencies), Commerce, and Insurance.
Board of Medical Examiners, or Board
means a body or subdivision of such body which is designated by a State for the purpose of licensing, monitoring, and disciplining physicians or dentists. This term includes a Board of Osteopathic Examiners or its subdivision, a Board of Dentistry or its subdivision, or an equivalent body as determined by the State. Where the Secretary, pursuant to section 423(c)(2), of the HCQIA (42 U.S.C. 11112(c)) has designated an alternate entity to carry out the reporting activities of § 60.12 due to a Board's failure to comply with § 60.8, the term Board of Medical Examiners or “Board” refers to this alternate entity.
means, for purposes of this part:
Health care practitioner, licensed health care practitioner, licensed practitioner, or practitioner
means an individual other than a physician or dentist, who is licensed or otherwise authorized by a State to provide health care services (or any individual who, without authority, holds himself or herself out to be so licensed or authorized).
means, for purposes of this part, an entity described in paragraphs (1) and (7) of section 1861(e) of the Social Security Act.
Negative action or finding
by a Federal or State licensing or certification authority, peer review organization, or private accreditation entity means:
(c) Any negative action or finding that under the State's law is publicly available information and is rendered by a Federal or State licensing or certification authority, including but not limited to, limitations on the scope of practice, liquidations, injunctions, and forfeitures. This definition also includes final adverse actions rendered by a Federal or State licensing or certification authority, such as exclusions, revocations, or suspension of license or certification, that occur in conjunction with settlements in which no finding of liability has been made (although such a settlement itself is not reportable under the statute). This definition excludes administrative fines or citations and corrective action plans and other personnel actions, unless they are:
means, for purposes of this part, an organization with the primary purpose of evaluating the quality of patient care practices or services ordered or performed by health care practitioners, physicians, or dentists measured against objective criteria which define acceptable and adequate practice through an evaluation by a sufficient number of health practitioners in such an area to ensure adequate peer review. The organization has due process mechanisms available to health care practitioners, physicians, and dentists. This definition excludes utilization and quality control peer review organizations described in Part B of Title XI of the Social Security Act (referred to as QIOs) and other organizations funded by the Centers for Medicare and Medicaid Services (CMS) to support the QIO program. We slightly modified this definition by changing “means an organization” to “means, for the purposes of this part, an organization” to avoid confusion with the definition of this term in Section 1152 of the Social Security Act.
means, for purposes of this part, a doctor of medicine or osteopathy legally authorized to practice medicine or surgery by a State (or who, without authority, holds himself or herself out to be so authorized). We slightly modified this definition by changing “means a doctor” to “means, for the purposes of this part, a doctor” to avoid confusion with the definition of this term used in Section 1861(r) of the Social Security Act.
means an entity or organization that:
means a surrender made after a notification of investigation or a formal official request by a Federal or State licensing or certification authority for a health care practitioner, physician, dentist, health care entity, provider, or supplier, to surrender the license or certification (including certification agreements or contracts for participation in Federal or State health care programs). The definition also includes those instances where a health care practitioner, physician, dentist, health care entity, provider, or supplier voluntarily surrenders a license or certification (including program participation agreements or contracts) in exchange for a decision by the licensing or certification authority to cease an investigation or similar proceeding, or in return for not conducting an investigation or proceeding, or in lieu of a disciplinary action.
The NPDB and HIPDB regulatory definitions for voluntary surrender were nearly identical with respect to voluntary surrenders of State licensure. However, the HIPDB definition also contained language with respect to surrender of Federal licensure, as well as Federal and State certification (including certification agreements or contracts for participation in Federal or State health care programs). This additional HIPDB language was included in the NPDB definition to ensure that original HIPDB reporting requirements remained unchanged.
In addition to the definitions we have added or clarified, we also propose to eliminate the term “Act” from section 60.3. We chose this approach to avoid confusion when referencing the different statutes governing NPDB operations. NPDB regulations currently define “Act” as the Health Care Quality Improvement Act of 1986, title IV of Public Law 99-660, as amended. HIPDB regulations define “Act” as the Social Security Act. We instead reference each of these statutes (as well as other governing statutes) by name where they appear in the regulations.
We also propose to modify paragraphs (a) and (b) to reflect the range of subjects reported under this section to include health care practitioners, physicians, dentists, health care entities, providers, and suppliers. In addition, we propose to amend paragraphs (a)(1) through (a)(4) to reflect changes to those reporting requirements made by section 6403(b)(1)(A), which intended to harmonize State licensure and certification action reporting requirements with Federal licensure and certification action reportingrequirements under section 1128E. To reflect the fact that section 6403 transfers State licensure and certification action reporting requirements from section 1128E to section 1921, we propose the following changes to ensure that the original reporting requirements from the HIPDB regulations remain unchanged. First, we amended language in paragraphs (a)(1) through (4) to clarify the range of reportable licensure and certification actions with respect to a license, certification agreement, or contract for participation in State health care programs. Second, in paragraph (c)(4)(ii), which was previously a reserved field, we added a data element for the date of any appeal. Third, we added paragraph (e) to incorporate the sanctions for failure to report that were included in the HIPDB regulations for State licensure and certification actions. Finally, we are also adding “Individual Tax Identification Number (ITIN)” to § 60.9(b)(1)(ii) after the word Social Security Number.
As previously noted, we propose redesignating § 60.12 as § 60.17.
As a result of Section 6403 of the Patient Protection and Affordable Care Act of 2010, the HIPDB will cease to function. Data contained in the HIPDB will be transferred to the NPDB, along with the reporting and querying functions. Therefore, we will announce through the issuance of notice(s) in theFederal Registerwhen the merged system will be open for reporting and querying. Further, the announcement will identify when and how information will be available from the NPDB. A revised reporting form will be used to accommodate system integration functions when this form is approved by the Office of Management and Budget in accordance with the Paperwork Reduction Act of 1995.
The Regulatory Flexibility Act (RFA) and the Small Business Regulatory Enforcement and Fairness Act of 1996, which amended the RFA, require HRSA to analyze options for regulatory relief of small businesses. For purposes of theRFA, small entities include small businesses, nonprofit organizations, and government agencies. Further, in accordance with the RFA, if a rule has a significant economic effect on a substantial number of small entities, the Secretary must specifically consider the economic effect of the rule on small entities and analyze regulatory options that could lessen the impact of the rule. The purpose of the proposed rule is to eliminate duplication between the HIPDB and the NPDB. The NPDB will serve as the sole repository for all information previously captured in the HIPDB. This will not substantially alter reporting requirements. Therefore the Secretary certifies that these regulations will not have a significant impact on a substantial number of small entities.
Claims, Fraud, Health, Health maintenance organizations (HMOs), Health professions, Hospitals, Insurance companies, Malpractice, Reporting and recordkeeping requirements.
Billing and transportation services, Durable medical equipment suppliers and manufacturers, Health care insurers, Health maintenance organizations (HMOs), Health professions, Home health care agencies, Hospitals, Pharmaceutical suppliers and manufacturers, Reporting and recordkeeping requirements, Skilled nursing facilities.
Applicability of these regulations.
Subpart B Reporting of Information
Reporting licensure and certification actions taken by Federal agencies.
Subpart C Disclosure of Information by the National Practitioner Data Bank
The Health Care Quality Improvement Act of 1986 (HCQIA), as amended, title IV of Public Law 99-660 (42 U.S.C. 11101 et seq.
) (hereinafter referred to as “title IV”), authorizes the Secretary to establish (either directly or by contract) a National Practitioner Data Bank (NPDB) to collect and release certain information relating to the professional competence and conduct of physicians, dentists and other health care practitioners. Section 1921 of the Social Security Act (hereinafter referred to as “section 1921”), as amended, (42 U.S.C. 1396r-2) expanded the requirements under the NPDB and requires each State to adopt a system of reporting to the Secretary adverse licensure or certification actions taken against health care practitioners, physicians, dentists, health care entities, providers, and suppliers, as well as certain final adverse actions taken by State law andfraud enforcement agencies against health care practitioners, physicians, dentists, providers, and suppliers. Section 1128E of the Social Security Act (hereinafter referred to as “section 1128E”), as amended, (42 U.S.C. 1320a-7e) authorizes the Secretary to implement a national healthcare fraud and abuse data collection program for the reporting and disclosing of certain final adverse actions taken by Federal government agencies and health plans against health care practitioners, physicians, dentists, providers, and suppliers. Information from section 1921 and section 1128E is to be reported and distributed through the NPDB. The regulations in this part set forth the reporting and disclosure requirements for the NPDB, as well as procedures to dispute the accuracy of information contained in the NPDB.
means reducing, restricting, suspending, revoking, or denying clinical privileges or membership in a health care entity.
Affiliated or associated
refers to health care entities with which a subject of a final adverse action has a business or professional relationship. This includes, but is not limited to, organizations, associations, corporations, or partnerships. This also includes a professional corporation or other business entity composed of a single individual.
Board of Medical Examiners, or Board,
means a body or subdivision of such body which is designated by a State for the purpose of licensing, monitoring, and disciplining physicians or dentists. This term includes a Board of Osteopathic Examiners or its subdivision, a Board of Dentistry or its subdivision, or an equivalent body as determined by the State. Where the Secretary, pursuant to section 423(c)(2) of the HCQIA (42 U.S.C. 11112(c)), has designated an alternate entity to carry out the reporting activities of § 60.12 due to a Board's failure to comply with § 60.8, the term Board of Medical Examiners or Board refers to this alternate entity.
means the authorization by a health care entity to a physician, dentist or other health care practitioner for the provision of health care services, including privileges and membership on the medical staff.
means a doctor of dental surgery, doctor of dental medicine, or the equivalent who is legally authorized to practice dentistry by a State (or who, without authority, holds himself or herself out to be so authorized).
means the conduct of professional review activities through formally adopted written procedures which provide for adequate notice and an opportunity for a hearing.
means a proceeding held before a State licensing or certification authority, peer review organization, or private accreditation entity that maintains defined rules, policies, or procedures for such a proceeding.
means, for purposes of this part, a provider of services as defined in section 1861(u) of the Social Security Act; any organization (including a health maintenance organization, preferred provider organization or group medical practice) that provides health care services and follows a formal peer review process for the purpose of furthering quality health care, and any other organization that, directly or through contracts, provides health care services.
means, for purposes of this part, a provider of medical and other health care services as described in section 1861(s) of the Social Security Act; or any individual or entity, other than a provider, whofurnishes, whether directly or indirectly, or provides access to, health care services, supplies, items, or ancillary services (including, but not limited to, durable medical equipment suppliers, manufacturers of health care items, pharmaceutical suppliers and manufacturers, health record services [such as medical, dental, and patient records], health data suppliers, and billing and transportation service suppliers). The term also includes any individual or entity under contract to provide such supplies, items, or ancillary services; health plans as defined in this section (including employers that are self-insured); and health insurance producers (including but not limited to agents, brokers, solicitors, consultants, and reinsurance intermediaries).
means, for purposes of this part, a plan, program or organization that provides health benefits, whether directly, through insurance, reimbursement or otherwise, and includes but is not limited to:
Medical malpractice action or claim
means a written complaint or claim demanding payment based on a physician's, dentist's, or other health care practitioner's provision of or failure to provide health care services, and includes the filing of a cause of action based on the law of tort, brought in any State or Federal Court or other adjudicative body.
means the subject's business or employer at the time the underlying acts occurred. If more than one business or employer is applicable, the one most closely related to the underlying acts should be reported as the “organization name,” with the others being reported as “affiliated or associated health care entities.”
means a description of the nature of that business or employer.
means formal or official final actions taken against a health care practitioner, physician, dentist, provider, or supplier by a Federal governmental agency, a State law or fraud enforcement agency, or a health plan; which include the availability of a due process mechanism, and are based on acts or omissions that affect or could affect the payment, provision, or delivery of a health care item or service. For example, a formal or official final action taken by a Federal governmental agency, a State law or fraud enforcement agency, or a health plan may include, but is not limited to, a personnel-related action such as suspensions without pay, reductions in pay, reductions in grade for cause, terminations, or other comparable actions. A hallmark of any valid adjudicated action or decision is the availability of a due process mechanism. The fact that the subject elects not to use the due process mechanism provided by the authority bringing the action is immaterial, as long as such a process is available to the subject before the adjudicated action or decision is made final. In general, if an “adjudicated action or decision” follows an agency's established administrative procedures (which ensure that due process is available to the subject of the final adverse action), it would qualify as a reportable action under this definition. This definition specifically excludes clinical privileging actions taken by Federal government agencies or State law and fraud enforcement agencies and similar paneling decisions made by health plans. This definition does not include overpayment determinations made by Federal or State government programs, their contractors or health plans; and it does not include denial of claims determinations made by Federal government agencies, State law or fraud enforcement agencies, or health plans. For health plans that are not Government entities, an action taken following adequate notice and the opportunity for a hearing that meets the standards of due process set out in section 412(b) of the HCQIA (42 U.S.C. 11112(b)) also would qualify as a reportable action under this definition.
means, for purposes of this part, an organization with the primary purpose of evaluating the quality of patient care practices or services ordered or performed by health care practitioners, physicians, or dentists measured against objective criteria which define acceptable and adequate practice through an evaluation by a sufficient number of health practitioners in such an area to ensure adequate peer review. The organization has due process mechanisms available to health care practitioners, physicians, and dentists. This definition excludes utilization and quality control peer review organizations described in Part B of Title XI of the Social Security Act (referred to as QIOs) and other organizations funded by the Centers for Medicare and Medicaid Services (CMS) to support the QIO program.
means, for purposes of this part, a doctor of medicine or osteopathy legally authorized to practice medicine or surgery by a State (or who, without authority, holds himself or herself out to be so authorized).
means an action or recommendation of a health care entity:
means an activity of a health care entity with respect to an individual physician, dentist, or other health care practitioner:
means a utilization and quality control peer review organization (as defined in part B of title XI of the Social Security Act) that:
means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom the authority involved has been delegated.
means the fifty States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands.
includes, but is not limited to, any authority of a State (or of a political subdivision thereof) responsible for the licensing or certification of health care practitioners, physicians, dentists (or any peer review organization or private accreditation entity reviewing the services provided by health care practitioners, physicians, or dentists), health care entities, providers, or suppliers. Examples of such State agencies include Departments of Professional Regulation, Health, Social Services (including State Survey and Certification and Medicaid Single State agencies), Commerce, and Insurance.
means a surrender made after a notification of investigation or a formal official request by a Federal or State licensing or certification authority for a health care practitioner, physician, dentist, health care entity, provider, or supplier to surrender the license or certification (including certification agreements or contracts for participation in Federal or State health care programs). The definition also includes those instances where a health care practitioner, physician, dentist, health care entity, provider, or supplier voluntarily surrenders a license or certification (including program participation agreements or contracts) in exchange for a decision by the licensing or certification authority to cease an investigation or similar proceeding, or in return for not conducting an investigation or proceeding, or in lieu of a disciplinary action.
Information required under §§ 60.7, 60.8, and 60.12 must be submitted to the NPDB within 30 days following the action to be reported, beginning with actions occurring on or after September 1, 1990; information required under § 60.11 must be submitted to the NPDB within 30 days following the action to be reported, beginning with actions occurring on or after January 1, 1992; and information required under §§ 60.9, 60.10, 60.13, 60.14, 60.15, and 60.16 must be submitted to the NPDB within 30 days following the action to be reported, beginning with actions occurring on or after August 21, 1996.Following is the list of reportable actions:
(viii) Other information as required by the Secretary from time to time after publication in theFederal Registerand after an opportunity for public comment.
(12) Other information as required by the Secretary from time to time after publication in theFederal Registerand after an opportunity for public comment.
(vi) Other numbers assigned by Federal or State agencies, including, but not limited to Drug Enforcement Administration (DEA) registrationnumber(s), Clinical Laboratory Improvement Act (CLIA) number(s), Food and Drug Administration (FDA) number(s), and Medicaid and Medicare provider number(s);
(d) Sanctions for failure to report. The Secretary will provide for a publicationof a public report that identifies those agencies that have failed to report information on adverse actions as required to be reported under this section.
(xi) Other information as required by the Secretary from time to time after publication in theFederal Registerand after an opportunity for public comment.
(iii) The statement of factual issues in dispute is frivolous or inconsequential. In the event that the Secretary denies a hearing, the Secretary will send a written denial to the health care entity setting forth the reasons for denial. If a hearing is denied, or if as a result of the hearing the entity is found to be in noncompliance, the Secretary will publish the name of the health care entity in theFederal Register. In such case, the immunity protections provided under section 411(a) of the Act will not apply to the health care entity for professional review activities that occur during the three-year period beginning 30 days after the date of publication of the entity's name in theFederal Register.
(a) Who must report. Federal and State prosecutors must report criminal convictions against health care practitioners, physicians, dentists, providers, and suppliers related to the delivery of a health care item or service (regardless of whether the conviction is the subject of a pending appeal).
(a) Policy on Fees. The fees described in this section apply to all requests for information from the NPDB. The amount of such fees will be sufficient to recover the full costs of operating the NPDB. The actual fees will be announced by the Secretary in periodic notices in theFederal Register.However, for purposes of verificationand dispute resolution at the time the report is accepted, the NPDB will provide a copy—at the time a report has been submitted, automatically, without a request and free of charge—of the record to the health care practitioner, physician, dentist, entity, provider, or supplier who is the subject of the report and to the reporter.
(c) Assessing and collecting fees. The Secretary will announce through notice in theFederal Registerfrom time to time the methods of payment of NPDB fees. In determining these methods, the Secretary will consider efficiency, effectiveness, and convenience for the NPDB users and the Department. Methods may include: credit card electronic fund transfer, and other methods of electronic payment.
4. Chapter I Department of Health and Human Services
Part 61 Removed
HHS_FRDOC_0001-0444
You are viewing a non-interactive page that is intended for the crawler. You probably want to see this page: http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2009-0361-0003;oldLink=true