[29 Pa.B. 6409]
[Continued from previous Web Page] § 9.673. Plan provision of prescription drug benefits to enrollees.
(a) A plan providing prescription drug benefit coverage to enrollees, either as a basic benefit or through the purchase of a rider or additional benefit package, and using a drug formulary which lists the plan's preferred therapeutic drugs, shall clearly disclose in its marketing material and enrollee literature that restrictions in drug availability may result from use of a formulary.
(b) An enrollee or a prospective enrollee may make a written inquiry to a plan asking whether a specific drug is on the plan's formulary. The plan shall respond in writing to the request within 30 days from the date of its receipt of the request.
(c) A plan utilizing a drug formulary shall have a written policy that includes an exception process by which a health care provider may prescribe and obtain coverage for the enrollee for specific drugs, drugs used for an off-label purpose, biologicals and medications not included in the formulary for prescription drugs or biologicals when the formulary's equivalent has been ineffective in the treatment of the enrollee's disease or if the drug causes or is reasonably expected to cause adverse or harmful reactions to the enrollee.
(d) The plan shall distribute its policy and process to each participating health care provider who prescribes.
(e) If the plan does not approve a health care provider's request for an exception, the enrollee or the health care provider with the written consent of the enrollee may file a grievance under Subchapter I (relating to complaints and grievances).
§ 9.674. Quality assurance standards.
(a) A plan shall have an ongoing quality assurance program that includes review, analysis and assessment of the access, availability and provision of health care services. The quality assurance program shall provide for a mechanism allowing feedback to be reviewed and used for continuous quality improvement programs and initiatives by the plan.
(b) The quality assurance program shall meet the following standards:
(1) The plan shall maintain a written description of its quality assurance program, documenting studies undertaken, evaluation of results, subsequent actions recommended and implemented, and aggregate data, and shall make this information available to the Department upon request.
(2) The plan shall document all quality assurance activities and quality improvement accomplishments.
(3) The activities of the plan's quality assurance program shall be overseen by a quality assurance committee that includes plan participating physicians in active clinical practice.
(4) The plan's quality assurance structures and processes shall be clearly defined, with responsibility assigned to appropriate individuals.
(5) The plan shall demonstrate dedication of adequate resources, in terms of appropriately trained and experienced personnel, analytic capabilities and data resources for the operation of the quality assurance program.
(6) The plan shall ensure that all participating health care providers maintain current and comprehensive medical records which conform to standard medical practice.
(7) The plan's review of quality shall include consideration of clinical aspects of care, access, availability and continuity of care.
(8) The plan's quality assurance program shall have mechanisms that provide for the sharing of results with health care providers in an educational format to solicit input and promote continuous improvement.
(9) The plan shall provide to the Department a description of the annual quality assurance work plan, or schedule of activities, which includes the objectives, scope and planned projects or activities for the year.
(10) The plan shall present a report of the plan's quality assurance activities annually to the plan's board of directors, and shall provide a copy of the report to the Department.
§ 9.675. Delegation of medical management.
(a) A plan may contract with an entity for the performance of medical management relating to the delivery of health care services to enrollees. The plan shall submit the medical management contract to the Department for review and approval prior to implementation.
(b) If the contractor is to perform UR, the contractor shall be certified in accordance with Subchapter K (relating to utilization review entities).
(c) To secure Department approval, a medical management contract shall include the following:
(1) Reimbursement methods being used to reimburse the contractor which complies with section 2152(b) of the act (40 P. S. § 991.2152(b)) which relates to operational standards for CREs compensation.
(2) The standards for the plan's oversight of the contractor.
(d) Acceptable plan oversight shall include:
(1) Written review and approval by the plan of the explicit standards to be utilized by the contractor in conducting quality assurance, UR or related medical management activities.
(2) Reporting by the contractor to the plan regarding the delegated activities on at least a quarterly basis and the impact of the delegated activities on the quality and delivery of health care to the plan's enrollees.
(3) Random sample re-review and validation of the results of delegated responsibilities to ensure that the decisions made and activities undertaken by the contractor meet the agreed-upon standards in the contract.
(4) A written description of the relationship between the plan's medical management staff and the contractor's medical management staff.
(5) A requirement that the contractor submit written reports of activities and accomplishments to the plan's quality assurance committee on at least a quarterly basis.
(e) With respect to medical management arrangements involving an HMO, the medical management contract shall include a statement by the contractor agreeing to submit itself to review as a part of the HMO's external quality assurance assessment. See § 9.655 (relating to HMO external quality assurance assessment). A contractor may receive a separate review of its operations by an external quality review organization approved by the Department. The Department will consider the results of the review in its overall assessment provided the review satisfies the requirements of § 9.674 (relating to quality assurance standards).
§ 9.676. Standards for enrollee rights and responsibilities.
The plan shall adopt policies and procedures to assure implementation of enrollee rights and responsibilities which shall include:
(1) Access to the information required by Act 68 and the Insurance Department regulations pertaining to enrollee disclosures.
(2) Instructions as to how non-English speaking and visually-impaired enrollees may obtain the information in an alternative format.
(3) An affirmation that enrollees have the right to be treated with dignity and respect, that medical records will be maintained in a confidential manner, and that enrollees have the right to information and participation with decisionmakers concerning their health care services regardless of whether or not the services are benefits covered by the plan.
(4) Other rights and responsibilities mandated by State and Federal law.
§ 9.677. Requirements of definitions of ''medical necessity.''
The definition of ''medical necessity'' shall be the same in the plan's provider contracts, enrollee contracts and other materials used to evaluate appropriateness and to determine coverage of health care services.
§ 9.678. Primary care providers.
(a) A plan shall make available to each enrollee a primary care provider to supervise and coordinate the health care of the enrollee.
(b) A primary care provider shall meet the following minimum standards, unless a specialty health care provider is approved by the plan to serve as a designated primary care provider as provided for in § 9.683 (relating to standing referrals or specialists as primary care providers):
(1) Provide office hours of a minimum of 20 hours-per-week.
(2) Be available directly or through on-call arrangements with other qualified plan participating health care providers, 24 hours-per-day, 7 days-per-week for urgent and emergency care and to provide triage and appropriate treatment or referrals for treatment.
(3) Maintain medical records in accordance with plan standards and accepted medical practice.
(4) Maintain hospital admitting privileges or an alternate arrangement for admitting an enrollee, approved by the plan, that provides for timeliness of information and communication to facilitate the admission, treatment, discharge and follow-up care necessary to ensure continuity of services and care to the enrollee.
(5) Possess an unrestricted license to practice in this Commonwealth.
(c) A plan may consider a physician in a nonprimary care specialty as a primary care provider if the physician meets the plan's credentialing criteria and has been found by the plan's quality assurance committee to demonstrate, through training, education and experience, equivalent expertise in primary care.
(d) A plan may consider a certified registered nurse practitioner (CRNP), practicing in an advanced practice category generally accepted as a primary care area, as a primary care provider, if the CRNP meets the plan's credentialing criteria and practices in accordance with State law.
(e) A plan shall include in its provider directory a clear and adequate disclosure of the applicable referral limitations caused by the choice of a given provider as a primary care provider.
(f) A plan shall establish and maintain a policy and procedure to permit an enrollee to change a designated primary care provider with appropriate advance notice to the plan.
§ 9.679. Access requirements in service areas.
(a) A plan shall provide services to enrollees only in those service areas in which it has been approved to operate by the Department.
(b) A plan seeking to expand its service area beyond that which was initially approved shall file with the Department a service area expansion request.
(c) A plan shall demonstrate at all times that it has an adequate number and range of health care providers by specialty and service area to ensure that enrollees have adequate access to and availability of health care services covered by the plan.
(d) A plan shall immediately report to the Department any serious potential change in the plan's ability to provide services in a particular service area through termination, cancellation or nonrenewal of health care provider contracts potentially affecting 10% or more of the plan's enrollees in the service area.
(e) A plan shall ensure that services for hospitalization, primary care and frequently utilized specialty services shall be available to enrollees within 20 minutes or 20 miles in urban areas, and 30 miles or 30 minutes in rural areas, or based on the availability of health care providers, unless otherwise approved by the Department.
§ 9.680. Access for persons with disabilities.
(a) A plan shall file with the Department its policies, plans and procedures for ensuring that it has within its provider network participating health care providers that are physically accessible to people with disabilities, in accordance with Title III of the Americans with Disabilities Act of 1990 (42 U.S.C.A. §§ 12181--12188.)
(b) A plan shall file with the Department its policies, plans and procedures for ensuring that it has within its provider network participating health care providers who can communicate with individuals with sensory disabilities, in accordance with Title III of the Americans with Disabilities Act of 1990.
§ 9.681. Health care providers.
(a) A plan shall provide to enrollees a provider directory that shall include the name, address and telephone number of each participating health care provider by speciality.
(b) A plan shall include a clear disclaimer in the provider directories it provides to enrollees that the plan cannot guarantee continued access during the term of the enrollee's enrollment to a particular health care provider, and that if a participating health care provider used by the enrollee ceases participation, the plan will provide access to alternative providers with equivalent training and experience.
(c) A plan that has no participating health care providers available to provide covered health care services shall arrange for and provide coverage for services provided by a nonparticipating health care provider. The plan shall cover the nonnetwork services at the same level of benefit as if a network provider had been available.
(d) A plan shall have written procedures governing the availability and accessibility of frequently utilized health care services, including the following:
(1) Well-patient examinations and immunizations.
(2) Emergency telephone consultation on a 24 hour-per-day, 7 day-per-week basis.
(3) Treatment of acute emergencies.
(4) Treatment of acute minor illnesses.
§ 9.682. Direct access for obstetrical and gynecological care.
(a) The plan shall permit an enrollee direct access to participating health care providers for maternity and gynecological care without referral from a primary care provider.
(b) A plan may not require prior authorization for these services or any aspect of services considered as a routine part of obstetrical and gynecological care including related laboratory or diagnostic procedures.
(c) A plan may require that directly accessed participating health care providers seek prior plan authorization for nonroutine procedures or services and elective inpatient hospitalization.
(d) A plan shall develop policies and procedures that describe the terms and conditions under which a directly accessed health care provider may provide and refer for health care services with and without obtaining prior plan approval. The plan shall have these policies and procedures approved by its quality assurance committee. The plan shall provide these terms and conditions to all health care providers who may be directly accessed for maternity and gynecological care.
§ 9.683. Standing referrals or specialists as primary care providers.
(a) A plan shall adopt and maintain procedures whereby an enrollee with a life-threatening, degenerative or disabling disease or condition shall, upon request, receive an evaluation by the plan and, if the plan's established standards are met, the procedures shall allow for the enrollee to receive either a standing referral to a specialist with clinical expertise in treating the disease or condition, or the designation of a specialist to assume responsibility to provide and coordinate the enrollee's primary and specialty care.
(b) The plan's procedures shall:
(1) Ensure the plan has established standards, including policies, procedures and clinical criteria for conducting the evaluation and issuing or denying the request, including a process for reviewing the clinical expertise of the requested specialist. The plan shall have its standards approved by its quality assurance committee.
(2) Provide for evaluation by appropriately trained and qualified personnel.
(3) Be under a treatment plan approved by the plan and provided in writing to the specialist who will be serving as the primary care provider or receiving the standing referral.
(4) Be subject to the plan's utilization management requirements and other established utilization management and quality assurance criteria.
(5) Ensure that a standing referral to, or the designation of a primary care provider as, a specialist will be made to participating specialists when possible. Nonparticipating specialists may be utilized as appropriate.
(6) Ensure the plan issues a written decision regarding the request for a standing referral or designation of a specialist as a primary care provider within a reasonable period of time taking into account the nature of the enrollee's condition, but within 45 days after the plan's receipt of the request.
(7) Ensure the written decision denying the request provides information about the right to appeal the decision through the grievance process.
(c) A plan shall have mechanisms in place to review the effect of this procedure, and shall present the results to its quality improvement committee on an annual basis.
§ 9.684. Continuity of care.
(a) Provider terminations initiated by the plan shall be governed as follows:
(1) An enrollee may continue an ongoing course of treatment, at the option of the enrollee, for 60 days from the date the enrollee is notified by the plan of the termination or pending termination of a participating health care provider.
(2) If the terminating provider is a primary care provider, the plan shall provide written notice of the termination to each enrollee assigned to that primary care provider and shall request and facilitate the enrollee's transfer to another primary care provider.
(3) If the terminating provider is not a primary care provider, the plan shall notify the affected enrollees identified through referral and claims data.
(4) Written notice from the plan shall include instructions as to how to exercise the continuity of care option, including qualifying criteria, the procedure for notifying the plan of the enrollee's intention and how the enrollee will be notified that a continuing care arrangement has been agreed to by the provider and the plan.
(b) A new enrollee seeking to continue care with a nonparticipating provider shall notify the plan of the enrollee's request to continue an ongoing course of treatment for the transitional period.
(c) The transitional period for an enrollee who is a woman in the second or third trimester of pregnancy as of the effective date of coverage, if she is a new enrollee, or as of the date the termination notice was provided by the plan, shall extend through the completion of postpartum care.
(d) The transitional period may be extended by the plan if extension is determined to be clinically appropriate. The plan shall consult with the enrollee and the health care provider in making this determination.
(e) A plan shall cover health care services provided under this section under the same terms and conditions as applicable for services provided by participating health care providers.
(f) A plan may require nonparticipating health care providers to meet the same terms and conditions as participating health care providers with the exception that a plan may not require nonparticipating health care providers to under go full credentialing.
(g) A plan shall provide the nonparticipating health care provider with written notice of the terms and conditions to be met at either the earliest possible opportunity following notice of termination to the provider, or immediately upon request from an enrollee to continue services with a nonparticipating health care provider.
(h) A plan shall use best efforts to ascertain the health care provider's willingness to continue to provide health care services for the transitional period prior to the actual termination date.
(i) An enrollee shall be held harmless by the plan for services provided by nonparticipating providers post-termination of a participating provider, during the period of negotiations between the plan and the health care provider under subsection (f) up to the time affected enrollees are notified by the plan in writing that agreement is not possible.
(j) This section does not require a plan to provide health care services that are not covered under the terms and conditions of the plan.
(k) If the plan terminates a participating health care provider for cause, the plan will not be responsible for the health care services provided to the enrollee following the date of termination.
Subchapter I. COMPLAINTS AND GRIEVANCES Sec.
9.701. Applicability. 9.702. Complaints and grievances. 9.703. Health care provider initiated grievances. 9.704. Internal complaint process. 9.705. Appeal of a complaint decision. 9.706. Enrollee and provider grievance system. 9.707. External grievance process. 9.708. Grievance reviews by CREs. 9.709. Expedited review. 9.710. Approval of plan enrollee complaint and enrollee and provider grievance systems. 9.711. Alternative provider dispute resolution systems. § 9.701. Applicability.
This subchapter applies to the review and appeal of complaints and grievances under Act 68.
§ 9.702. Complaints and grievances.
(a) General.
(1) A plan shall have a two-level complaint and a two-level grievance procedure which meets the requirements of sections 2141, 2142, 2161 and 2162 of Article XXI of the act (40 P. S. §§ 991.2141, 991.2142, 991.2161 and 991.2162) and this subchapter and is satisfactory to the Secretary.
(2) The plan may not incorporate administrative requirements, time frames or tactics to directly or indirectly discourage the enrollee from, or disadvantage the enrollee in utilizing the procedures.
(3) A plan shall provide copies of its complaint and grievance procedures to the Department for review and approval. The Department will use the procedures as a reference when assisting enrollees who contact the Department directly.
(b) Correction of plan. A plan shall immediately correct any procedure found by the Department to be noncompliant or to create unacceptable administrative burdens on the enrollee.
(c) Complaints versus grievances.
(1) The plan may not classify the appeal as either a complaint or a grievance with the intent to adversely affect or deny the enrollee's access to the process.
(2) If there is any doubt as to whether the appeal is a complaint or a grievance, the plan shall consult with the Department or the Insurance Department as to the most appropriate classification.
(3) An enrollee may contact the Department or the Insurance Department directly for consideration and intervention with the plan, if the enrollee disagrees with the plan's classification of an appeal.
(4) If the Department determines that a grievance has been improperly classified as a complaint, the Department will notify the plan and the enrollee and the case will be redirected to the appropriate level of grievance review. Filing fees shall be waived by the plan.
(5) If the Department determines that a complaint has been improperly classified as a grievance, the Department will notify the plan and the enrollee, and the case will be redirected to the appropriate level of complaint review.
(6) The Department will monitor plan reporting of complaints and grievances and may conduct audits and surveys to verify compliance with Article XXI and this subchapter.
(d) Time frames.
(1) A plan may not impose unreasonable time limitations on an enrollee's ability to file an appeal or grievance.
(2) If a plan establishes a time limit for an enrollee to file the initial complaint or grievance, the plan shall allow the enrollee at least 30-calendar days to file the complaint or grievance from the date of the occurrence of the issue being complained about.
(3) If a plan establishes a time frame for an enrollee to file a second level complaint or grievance, the plan shall allow the enrollee at least 45 days to file the second level complaint or grievance from the date of the enrollee's receipt of notice of the plan's decision.
(4) A health care provider seeking to file a grievance with enrollee consent under § 9.703 (relating to health care provider initiated grievances) shall have the same time frames in which to file as an enrollee.
§ 9.703. Health care provider initiated grievances.
(a) A healthcare provider may, with the consent of the enrollee, file a written grievance with a plan.
(b) A health care provider may not require an enrollee to sign an document authorizing the health care provider to file a grievance as a condition of providing a health care service.
(c) Once a health care provider assumes responsibility for filing a grievance, the health care provider may not refuse to grieve the issue through the second level grievance review.
(d) The health care provider may not bill the enrollee for services provided that are the subject of the grievance until the external grievance review has been completed.
(e) If the health care provider elects to appeal an adverse decision of a CRE, the health care provider may not bill the enrollee for services provided that are the subject of the grievance until it chooses not to appeal an adverse decision to a court of competent jurisdiction.
(f) A health care provider, seeking to obtain written consent from an enrollee to file a grievance on behalf of the enrollee, shall clearly disclose to the enrollee in writing that the consent precludes the enrollee from filing a grievance on the same issue unless the enrollee, during the course of the grievance, rescinds in writing the previous written consent.
(g) The written consent form shall inform the enrollee in writing of the right to rescind a consent at any time during the grievance process.
(h) The enrollee may rescind consent to a health care provider, to file a grievance on behalf of the enrollee, at any time during the grievance process. If the enrollee rescinds consent, the enrollee may continue with the grievance at the point at which consent was rescinded. The enrollee may not file a separate grievance. An enrollee who has filed a grievance may, at any time during the grievance process, choose to provide consent to a health care provider to allow the health care provider to continue with the grievance instead of the enrollee.
§ 9.704. Internal complaint process.
(a) A plan shall establish, operate and maintain an internal complaint process which meets the requirements of section 2141 of the act (40 P. S. § 991.2141), and this subchapter, and is acceptable to the Secretary. The process shall address complaints concerning matters including participating health care providers, health plan coverage, plan operations and plan management policies.
(b) A plan shall permit an enrollee to file with it a written or oral complaint.
(c) A plan's internal complaint process shall include the following standards:
(1) First level review.
(i) The first level complaint review shall be performed by an initial review committee which shall include one or more employes. The members of the committee may not have been involved in a prior decision to deny the enrollee's complaint.
(ii) A plan shall permit an enrollee to provide written data or other material in support of the complaint. The enrollee may specify the remedy or corrective action being sought.
(iii) The plan shall complete its review and investigation of the complaint within 30 days of receipt of the complaint.
(iv) The plan shall notify the enrollee in writing of the decision of the initial review committee within 5 business days of the committee's decision. The notice shall include the basis for the decision and the procedures and time frame to file a request for a second level review of the decision of the initial review committee.
(2) Second level review.
(i) The second level complaint review shall be performed by a second level review committee made up of three or more individuals who did not participate in the first level review. At least one third of the second level review committee may not be employes of the plan. The members of the second level review committee shall have the duty to be unbiased in their review and decision.
(ii) The plan shall notify the enrollee in writing of the right to appear before the second level review committee. The second level review committee shall satisfy the following:
(A) The plan shall provide reasonable flexibility in terms of time and travel distance when scheduling a second level review to facilitate the enrollee's attendance.
(B) If an enrollee cannot appear in person at the second level review, the plan shall provide the enrollee the opportunity to communicate with the review committee by telephone or other appropriate means.
(C) Attendance at the second level review shall be limited to members of the review committee; the enrollee or the enrollee's representatives, or both; the enrollee's provider or applicable witnesses; and appropriate representatives of the plan. Persons attending the second level review and their respective roles at the review shall be identified for the enrollee.
(iii) The decision of the second level review committee shall be binding upon the parties unless appealed by the enrollee.
(iv) The deliberation of the second level review committee, including the enrollee's comments, shall be either by transcribed verbatim or summarized, and maintained as a part of the complaint record to be forwarded to the Department or the Insurance Department upon appeal.
(v) The plan shall complete the second level review within 45 days of the plan's receipt of the enrollee's request for review.
(vi) The plan shall notify the enrollee of the decision of the second level review committee in writing, within 5 business days of the committee's decision.
(vii) The plan shall include in its notice to the enrollee the basis for the decision and the procedures and time frame for the enrollee to file an appeal to the Department or the Insurance Department, including the addresses and telephone numbers of both agencies. The decision shall be sent in a manner so that the plan can document the enrollee's receipt of the decision.
(d) The Department of Health address for purposes of this section is: Bureau of Managed Care, Pennsylvania Department of Health, P. O. Box 90, Harrisburg, PA 17108, (717) 787-5193. The Department may change this address upon prior notification in the Pennsylvania Bulletin.
§ 9.705. Appeal of a complaint decision.
(a) An enrollee shall have 15 days from receipt of the second level review decision of a complaint to file an appeal of the decision, in writing, with either the Department or the Insurance Department.
(b) The appeal from the enrollee shall include the following:
(1) The enrollee's name, address and telephone number.
(2) Identification of the plan.
(3) The enrollee's plan ID number.
(4) A brief description of the issue being appealed.
(5) Correspondence from the plan concerning the complaint.
(c) Upon receipt of the appeal, the Department will verify with the plan that the appeal was submitted within 15 days of the enrollee's receipt of the notice of the decision by the second level review committee.
(d) The plan shall forward the complaint file within 5 business days of the Department's request. Upon confirmation that the appeal was filed within the appropriate time frame, the Department will request the complaint file from the plan.
(e) The plan and the enrollee may provide additional information for review and consideration as appropriate.
(f) Both the Department and the Insurance Department will determine the appropriate agency for the review.
(g) The Department may decide to hold an administrative hearing on the appeal. The hearing shall be conducted in accordance with the procedures in 1 Pa. Code Part II (relating to General Rules of Administrative Practice and Procedure).
(h) The enrollee may be represented by an attorney or other individual before the Department.
§ 9.706. Enrollee and provider grievance system.
(a) A plan shall establish, operate and maintain an internal enrollee grievance system in compliance with sections 2161 and 2162 of the act (40 P. S. §§ 991.2161 and 991.2162) and this subchapter and acceptable to the Secretary, for the purposes of reviewing a denial of coverage for a health care service on the basis of medical necessity and appropriateness.
(b) The enrollee, or a health care provider with written consent of the enrollee, may file a written grievance with the plan.
(c) The plan's grievance process shall include the following standards:
(1) First level review.
(i) The first level grievance review shall be performed by an initial review committee which shall include one or more individuals selected by the plan. The members of the committee may not have been involved in any prior decision relating to the grievance.
(ii) The plan shall permit the enrollee or the health care provider to provide written data or other material in support of the grievance. The enrollee or health care provider may specify the remedy or corrective action being sought.
(iii) The investigation and the review of the grievance shall be completed within 30 days of receipt of the grievance.
(iv) The plan shall notify the enrollee or the health care provider of the decision of the internal review committee in writing, within 5 business days of the committee's decision. The notice shall include the basis and clinical rationale for the decision and the procedures and time frame for the enrollee or provider to file a request for a second level review of the decision of the initial review committee.
(2) Second level review.
(i) The second level review committee reviewing a grievance appealed to the second level of review shall be made up of 3 or more individuals who did not previously participate in the decision to deny coverage or payment for health care services. The members of the second level review committee have the duty to be unbiased in their review and decision.
(ii) The plan shall notify the enrollee or health care provider in writing of the right to appear before the second level review committee. The second level review committee shall satisfy the following:
(A) The plan shall provide reasonable flexibility in terms of time and travel distance when scheduling a second level review to facilitate the enrollee's attendance.
(B) If an enrollee or health care provider cannot appear in person at the second level review, the plan shall provide the enrollee or the health care provider the opportunity to communicate with the review committee by telephone or other appropriate means.
(C) Attendance at the second level review shall be limited to members of the review committee; the enrollee, or the enrollee's representatives, or both; the health care provider; applicable witnesses; and appropriate representatives of the plan. Persons attending and their respective roles at the review shall be identified for the record.
(iii) The deliberation of the second level review committee, including the enrollee's comments, shall be either transcribed verbatim or summarized, and maintained as a part of the grievance record to be forwarded upon appeal.
(iv) The plan shall complete the second level grievance review within 45 days of receipt of the request for the review.
(v) The plan shall notify the enrollee, or in the case of a grievance filed by a health care provider, the provider, of the decision of the second level review committee in writing within 5 business days of the committee's decision.
(vi) The plans shall include the basis and clinical rationale for the decision, and the procedures and time frames for the enrollee or the health care provider to file a request for an external grievance review in its response to the enrollee or health care provider. The decision shall be sent in a manner so that the plan can document the enrollee's or health care provider's receipt of the decision.
(3) Same or similar specialty.
(i) Both the initial and second level grievance review committees shall include a licensed physician or an approved licensed psychologist, in the same or similar specialty as that which would typically manage or consult on the health care service in question.
(ii) The physician or approved licensed psychologist, in the same or similar specialty, need not personally attend at the review, but shall be included in the hearing, discussion and decisionmaking by written report, telephone or videoconference.
(iii) If the licensed physician or approved licensed psychologist, in the same or similar specialty, will not be present or included by telephone or videoconference at the review attended by the enrollee or health care provider, the plan shall notify the enrollee or health care provider of that fact in advance of the review and of the enrollee or health care provider right to request a copy of the report. The plan shall provide the enrollee or the health care provider, upon written request, a copy of the report of the licensed physician or approved licensed psychologist at least 7 days prior to the review date.
§ 9.707. External grievance process.
(a) The plan shall establish and maintain an external grievance process by which an enrollee, or a health care provider with the written consent of the enrollee, may appeal the denial of a second level grievance following receipt of the second level grievance review decision.
(b) The external grievance process shall adhere to the following standards:
(1) An enrollee or health care provider shall have 15 days from receipt of the second level grievance review decision to file an appeal of the decision with the plan.
(2) Within 5 business days of receiving the external grievance request, the plan shall notify the Department, the enrollee or health care provider, and a CRE that conducted the internal grievance review that a request for an external grievance review has been filed.
(3) The plan's notification to the Department shall include a request for assignment of a CRE.
(4) Along with the request, and the information in subsection (k), the plan shall provide the Department with the name, title and phone numbers of both a primary and alternative external grievance coordinator. One of these individuals shall be available to the Department so that expeditious communication may be had regarding the assignment of a CRE both for the purpose of performing external grievance reviews and of tracking the status of the reviews.
(5) The request to the Department shall include the following:
(i) The enrollee's name, address and telephone number.
(ii) If the external grievance is being filed by a health care provider, the health care provider shall provide both the name of the enrollee involved, and its own identifying information.
(iii) The name of the plan.
(iv) The enrollee's plan ID number.
(v) A brief description of the issue being appealed.
(vi) The remedy being sought.
(vii) Correspondence from the plan relating to the matter in question.
(viii) Other reasonably necessary supporting documentation.
(ix) If the external grievance is being requested by a health care provider, verification that the plan and the health care provider have both established escrow accounts in the amount of half the anticipated cost of the review.
(6) Within 15 days of receipt of the external grievance, the plan or the CRE that conducted the internal grievance review shall forward to the CRE the written documentation regarding the denial, including the following:
(i) The decision.
(ii) All reasonably necessary supporting information.
(iii) A summary of applicable issues.
(iv) The contractual language supporting the denial including the plan's definition of ''medical necessity'' used in the internal grievance reviews.
(7) Within the same 15-day period as provided by paragraph (6), the plan shall provide the enrollee or the health care provider with its description of the issue, the remedy being sought by the enrollee and the list of documents being forwarded to the CRE for the external review.
(8) The enrollee or the health care provider, within 15 days of receipt of notice of appeal sent by the plan, may supply additional information for consideration in the external review but shall route it through the plan to the CRE so that the plan has an opportunity to consider the additional information. The plan shall expeditiously provide the enrollee's or health care provider's information to the CRE.
(c) Within 2 business days of receiving a request for an external grievance review, the Department will assign a CRE from its list of CREs on a rotation basis and will provide notice of the assigned CRE to the plan and CRE.
(d) The plan shall notify the enrollee or health care provider with the name, telephone number and address of the CRE assigned within 2 business days of its receipt of that information from the Department.
(e) The Department will make available additional information from the CRE's accreditation application to the plan, the enrollee or health care provider upon request.
(f) If the Department fails to select a CRE within 2 business days of receipt of the external grievance, the plan may designate a CRE to conduct a review from the list of CREs approved by the Department. A CRE affiliated directly or indirectly with the plan may not be selected by the plan to review the external grievance.
(g) Either party may have 3 business days from the date of its receipt of the notice of assignment of the CRE to object to the CRE assigned based on conflict of interest, and may request the assignment of another CRE. If the plan chooses to object to the CRE, this does not eliminate its responsibility to provide the required information to the enrollee or health care provider within the time frames in this section.
(h) If a party objects, the Department will assign a second CRE in accordance with this subsection. The parties may object to the second CRE in accordance with this subsection.
(i) If either party objects to the second CRE assigned, the 60-day time period allowed for the CRE's review will be calculated from the date on which the CRE is accepted by both parties.
(j) The Department will assign a uniform tracking number, which shall be utilized by the plan, CRE, enrollee and health care provider to communicate with or report data to the Department.
(k) The plan shall authorize a health care service and pay a claim determined to be medically necessary and appropriate by the CRE whether or not the plan has appealed the CRE's decision to a court of competent jurisdiction.
(l) If the health care provider that filed the external grievance is not the prevailing party, the health care provider shall pay the fees and costs associated with the external grievance. If the plan is not the prevailing party, the plan shall pay the fees and costs associated with the external grievance review regardless of the identity of the grievant. For purposes of this section, fees do not include attorney's fees.
§ 9.708. Grievance reviews by CRE.
(a) The assigned CRE shall review and issue a written decision within 60 days of the filing of the request for an external grievance review request. The decision shall be sent to the enrollee, health care provider, plan and the Department. The decision shall include the basis and clinical rationale for the decision.
(b) The assigned CRE shall review the second level grievance review decision based on whether the health care service denied by the internal grievance process is medically necessary and appropriate under the terms of the plan.
(c) The assigned CRE shall review all information considered by the plan in reaching any prior decision to deny coverage for the health care service in question, and information provided under § 9.707 (relating to external grievance process).
(d) The assigned CRE's decision shall be made by either of the following:
(1) One or more physicians certified by a board approved by the American Board of Medical Specialties or the American Board of Osteopathic Specialties, practicing within the same or similar specialty that typically manages or recommends treatment for the health care service being reviewed.
(2) One or more licensed physicians or approved licensed psychologists in active clinical practice or in the same or similar specialty that typically manages or recommends treatment for the health care service being reviewed.
(e) In reviewing a grievance decision relating to emergency services, the CRE shall utilize the emergency service standards of Act 68 and this chapter, and the definition of ''medical necessity'' and ''emergency'' in the enrollee's certificate of coverage.
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