Subchapter K. CREs

§ 9.741. Applicability.

 (a)  Sections 9.742—9.748 of this subchapter set standards for the certification of CREs and the maintenance of that certification.

 (a)  To conduct UR activities, including review of health care services delivered or proposed to be delivered in this Commonwealth for or on behalf of a plan, an entity shall be certified as a CRE by the Department.

 (b)  Certification shall be renewed every 3 years unless otherwise subjected to additional review, suspended or revoked by the Department. The Department may subject a CRE to additional review, suspend or revoke certification if it determines that the CRE is failing to comply with Act 68 and this chapter.

 (a)  A CRE seeking certification shall submit two copies of the Department’s application to the Department’s Bureau of Managed Care.

 (b)  The application shall contain the following:

   (1)  The name, address and telephone number of the applicant as it should appear on the Department’s official list of certified CREs.

   (2)  Information relating to its organization, structure and function, including the following:

     (i)   The location of the principal office handling UR.

     (ii)   The articles of incorporation and bylaws, or similar documents regulating the internal affairs of the applicant.

     (iii)   The name of each owner of more than 5% of the shares of the corporation, if the applicant is a public corporation.

     (iv)   A chart showing the internal organization of the applicant’s management and administrative staff.

   (3)  The names and resumes of each officer, director and senior management.

   (4)  A listing of each plan in this Commonwealth for which the applicant currently conducts UR.

   (5)  A description of the applicant’s:

     (i)   Ability to respond to each telephone call received as required by section 2152 of the act (40 P. S. §  991.2152), including toll-free telephone numbers and the applicant’s system to provide access during nonbusiness hours.

     (ii)   Acceptable selection and credentialing procedures and criteria for physician and psychologist clinical peer reviewers.

     (iii)   Ability to arrange for a wide range of health care providers to conduct reviews. The applicant shall have access to a pool of clinical peer reviewers sufficient to reasonably assure that appropriately qualified reviewers will be available on a timely basis.

     (iv)   Procedures for protecting the confidentiality of medical records and certification that the applicant will comply with the confidentiality provisions in section 2131 of the act (40 P. S. §  991.2131) and other applicable State and Federal laws and regulations imposing confidentiality requirements.

     (v)   Procedures to ensure that a health care provider is able to verify that an individual requesting information on behalf of the plan is a representative of the plan.

     (vi)   Capacity to maintain a written record of UR decisions adverse to enrollees for at least 3 years, including a detailed justification and all required notifications to the health care provider and enrollee.

     (vii)   Evidence of approval, certification or accreditation received by a Nationally recognized accrediting body in the area of UR, if it has secured the approval, certification or accreditation.

     (viii)   The length of time the applicant has been operating in this Commonwealth, if applicable.

     (ix)   A list of three clients, if any, for which the applicant has conducted UR including the name, address, position and telephone number of a contact person for each client. The Department may contact these references for an assessment of the applicant’s past performance and its ability to meet the time frames for prospective, concurrent and retrospective UR in section 2152 of the act (40 P. S. §  991.2152).

 (c)  The applicant shall certify that decisions resulting in a denial shall be made by:

   (1)  A licensed physician.

   (2)  An approved licensed psychologist in a same or similar specialty to the health care provider of the service in question, if the review is of behavioral health care services within the psychologist’s scope of practice, and the psychologist’s clinical experience provides sufficient experience to review that specific behavioral health care service. A licensed psychologist may not review the denial of payment for a health care service involving inpatient care or a prescription drug.

 (d)  Compensation from a plan to a CRE, employee, consultant or other person performing UR on its behalf does not contain incentives, direct or indirect, to approve or deny payment for the delivery of any health care service. See section 2152(b) of the act (40 P. S. §  991.2152(b)).

 (e)  The Department may request additional information from the applicant necessary to review the application for compliance with Act 68 and this chapter.

 (a)  To be certified to review internal and external grievances, the applicant shall supply the following additional information to the Department for review, along with the application:

   (1)  The name and type of business of each corporation, affiliate or other organization that the applicant controls; the nature and extent of the affiliation or control; and a chart or list clearly identifying the relationship between the applicant and affiliates.

   (2)  The name, title, address and telephone number of a primary and at least one backup designee with whom the Department may communicate regarding assignment of external grievances and other issues.

   (3)  A disclosure of any known potential conflict of interest which would preclude its review of an external grievance—for example, ownership of or affiliation with a competing plan or other health insurance company.

   (4)  A description of the applicant’s:

     (i)   Capacity and procedures for notifying the health care provider of additional facts or documents required to complete the UR within 48 hours of receipt of the request for an expedited review.

     (ii)   Systems and procedures, including staffing and resources, to meet the time frames for decisions as specified in section 2152 of the act (40 P. S. §  991.2152). The applicant shall have access to a pool of clinical peer reviewers sufficient to reasonably assure that appropriately qualified reviewers will be available on a timely basis for internal and external grievance reviews. To be certified, an applicant shall demonstrate it has a contracted and credentialed network of providers, which shall include, at a minimum, all general specialities represented by the American Board Of Medical Specialities (ABMS), the subspecialties of oncology and physician reviewers specializing in transplanation. An applicant shall also provide a description of its ability to obtain within 24 hours the services of a qualified peer reviewer from any speciality or subspecialty required for an external grievance review.

     (iii)   Capability and agreement to receive and decide all external grievances, or just behavioral health grievances if so desired, and the process for ensuring that clinical peer reviewers, when making an external appeal determination concerning medical necessity, consider the clinical standards of the plan, the information provided concerning the enrollee, the attending physician’s recommendation and applicable generally accepted practice guidelines developed by the Federal government, National or professional medical societies, boards and associations.

     (iv)   The capacity, procedures and agreement to maintain the information obtained in the review of the grievances, including outcomes, for at least 3 years in a manner that is confidential and unavailable to any affiliated entity or person who may be a direct or indirect competitor to the plan being reviewed.

     (v)   Fee schedule for the conduct of grievance reviews. An applicant will not be certified as a CRE unless the proposed fees for external reviews are determined to be reasonable by the Department.

   (5)  A certification that the following conditions apply:

     (i)   The CRE is willing and able to participate on a rotational basis in grievance reviews.

     (ii)   Internal and external grievances and expedited grievances will be reviewed and processed in accordance with Act 68 and Subchapter I (relating to complaints and grievances).

 (b)  The Department will add the name of each CRE to its rotational list of CREs certified to conduct external grievances.

 (a)  To be certified by the Department, an applicant for certification to perform UR shall be a responsible person.

   (1)  To make this determination, the Department may review and verify the credentials of any officer, director or member of the management staff of the applicant.

   (2)  The Department may consider whether any of the officers, directors or management personnel have ever:

     (i)   Been involved in a bankruptcy proceeding as an officer, director or senior manager of a corporation.

     (ii)   Been convicted of a state or Federal offense related to health care.

     (iii)   Been listed by a state or Federal agency as debarred, excluded or otherwise ineligible for state or Federal program participation.

     (iv)   Been convicted of a criminal offense which would call in to question the individual’s ability to operate a CRE.

     (v)   Had a history of malpractice or civil suits, penalties or judgments against them.

 (b)  To be determined a responsible person, an applicant shall demonstrate to the Department that it has the ability to perform URs and grievance reviews based on medical necessity and appropriateness, without bias.

 (a)  An entity applying for certification shall include a fee of $1,000 payable to the Commonwealth of Pennsylvania with its application. Applicants seeking certification to perform external grievance reviews shall include an additional $1,000.

 (b)  The fee for recertification is $500.

 (a)  The Department will review the application for certification as a CRE. If the Department finds deficiencies, it will notify the applicant, identifying the changes required to bring the applicant into compliance.

 (b)  The Department will have access to the applicant’s books, records, staff, facilities and any other information it finds necessary to determine an applicant’s compliance with Act 68 and this subchapter. In lieu of a site visit and inspection, the Department may accept accreditation of the applicant by a Nationally recognized accrediting body whose standards meet or exceed the standards of Act 68 and this subchapter.

 (c)  If the applicant is not accredited by a Nationally recognized accrediting body whose standards are acceptable to the Department, the Department may provide the applicant with the option to undergo an onsite inspection by a Nationally recognized accrediting body whose standards meet or exceed the standards of Act 68 and this subchapter. The cost of the inspection shall be borne by the applicant.

 (a)  Maintenance. A CRE shall continue to comply with the requirements of Act 68 and this subchapter to maintain its certification. To determine whether a CRE is complying with Act 68 and this subchapter, and is qualified to maintain its certification during the 3-year certification period, the Department may do one or more of the following:

   (1)  Perform periodic onsite inspections.

   (2)  Require proof of the CRE’s continuing accreditation by a Nationally recognized accrediting body whose standards meet or exceed the standards of Act 68 and this subchapter.

   (3)  Require an onsite inspection as set forth in §  9.747 (relating to Department review and approval of a certification request).

 (b)  Renewal.

   (1)  A CRE shall submit an application for renewal of certification to the Department along with the appropriate renewal fee at least 60 days prior to the expiration of the 3-year certification period.

   (2)  The renewal application shall include the following:

     (i)   Evidence of the CRE’s continued accreditation by a Nationally recognized accrediting body whose standards meet or exceed the standards of Act 68 and this subchapter.

     (ii)   A certification that the CRE has complied with and will continue to comply with Act 68 and this subchapter.

     (iii)   An updating of the CRE’s originally filed list of conflicts of interest and CRE contracts with plans.

     (iv)   A reaffirmation of certifications included in the CRE’s original application.

   (3)  The Department may perform an onsite inspection at the CRE before approving renewal of certification, or may require an onsite inspection set forth in §  9.747.

 (c)  The Department will have access to the books, records, staff, facilities and other information, including UR decisions, it finds necessary to determine whether a CRE is qualified to maintain its certification in accordance with Act 68 and this chapter.

   This section cited in 28 Pa. Code §  9.741 (relating to applicability).

OPERATIONAL STANDARDS

§ 9.751. UR system description.

 (a)  An entity performing UR shall have a written UR system description which shall include the following:

   (1)  The scope of the program.

   (2)  The process used in making decisions.

   (3)  The resources used in making decisions.

   (4)  The requirements of this section and of § §  9.752 and 9.753 (relating to UR system standards; and time frames for UR).

 (b)  The entity shall evaluate its UR system annually. The evaluation shall include a report to the board of directors or the quality assurance or quality improvement committee, and shall address the following:

   (1)  The appropriateness of clinical criteria.

   (2)  The consistency of decisionmaking through the conduct of reliability studies of staff application of utilization criteria.

   (3)  Staff resources and training.

   (4)  The timeliness of decisions.

 (c)  The UR system shall include a policy and procedure to enable a health care provider to verify that an individual requesting information for UR purposes is a legitimate representative of the entity.

 (d)  The entity shall ensure that it has sufficient staff, resources and program oversight to ensure adherence to this subchapter, and to section 2152 of the act (40 P. S. §  991.2152).

 (e)  The entity shall make this description available to the Department for review every 3 years or upon request for the conduct of any investigation necessary to determine compliance of the entity with Act 68 and applicable sections of this chapter.

 (a)  An entity performing UR shall include a physician in any UR program.

 (b)  An entity performing UR shall develop clinical criteria to be used in making review decisions as follows:

   (1)  The clinical criteria shall be developed with input from health care providers in active clinical practice.

   (2)  The clinical criteria shall be reviewed regularly by the entity performing UR and shall be modified to reflect current medical standards.

   (3)  The entity shall make its UR criteria available upon the written request of any health care provider.

 (c)  A UR decision denying or approving payment of a service shall be based on the medical necessity and appropriateness of the requested service, the enrollee’s individual circumstances, and the applicable contract language concerning benefits and exclusions. UR criteria may not be the sole basis for the decision.

 (d)  A UR decision denying payment based on medical necessity and appropriateness shall be made by a licensed physician. An approved licensed psychologist may perform UR for a behavioral health care service within the psychologist’s scope of practice if the psychologist’s clinical experience provides sufficient expertise to review that specific behavioral health care service, and the following standards are satisfied:

   (1)  An approved licensed psychologist may not review the denial of payment for a health care service involving inpatient care or a prescription drug.

   (2)  The use of a licensed psychologist to perform UR must be approved by the Department as part of the certification process for CREs.

 (e)  An entity performing UR shall notify the health care provider within 48 hours of the request for service of additional facts, documents or information required to complete the UR.

 (f)  If a UR decision includes a denial, it shall include the contractual basis and clinical reasons for the denial. If a UR decision is a denial, or approves anything less than what was requested, it shall include language informing the enrollee of how to appeal the decision, including location to which the appeal must be sent and time frames.

 (g)  Copies of written decisions of internal grievance reviews conducted by CREs shall be sent to the plan at the same time the letter is sent to the enrollee, the enrollee’s representative, and to the health care provider if the provider filed the grievance with the consent of the enrollee.

 (a)  A concurrent UR decision shall be communicated to the plan, the enrollee and the health care provider within 1-business day of the receipt of all supporting information reasonably necessary to complete the review. The plan shall give the enrollee and the health care provider written or electronic confirmation of the decision within 1-business day of communicating the decision.

 (b)  A prospective UR decision shall be communicated to the plan, enrollee and health care provider within 2-business days of the receipt of all supporting information reasonably necessary to complete the review. The plan shall give the enrollee and the health care provider written or electronic confirmation of the decision within 2-business days of communicating the decision.

 (c)  A retrospective UR decision shall be communicated to the plan, the enrollee and the health care provider within 30 days of the receipt of all supporting information reasonably necessary to complete the review. The plan shall give the enrollee and the health care provider written or electronic confirmation of its decision within 15-business days of communicating the decision.

 (d)  A grievance review decision shall comply with the requirements and time frames set out in § §  9.705 and 9.707 (relating to internal grievance process; and external grievance process).

   This section cited in 28 Pa. Code §  9.631 (relating to content of an application for an HMO certificate of authority); and 28 Pa. Code §  9.741 (relating to applicability).