[31 Pa.B. 3043]
[Continued from previous Web Page] § 9.603. Technical advisories.
The Department may issue technical advisories to assist plans in complying with the HMO Act, Article XXI and this chapter. The technical advisories do not have the force of law or regulation, but will provide guidance on the Department's interpretation of, and how a plan may maintain compliance with, the HMO act, Article XXI and this chapter. Notice of the availability of a technical advisory will be published in the Pennsylvania Bulletin.
§ 9.604. Plan reporting requirements.
(a) Annual reports. A plan shall submit to the Department on or before April 30 of each year, a detailed report of its activities during the preceding calendar year. The plan shall submit the report in a format specified by the Department in advance of the reporting date, and shall include, at a minimum, the following information:
(1) Enrollment data by product line--for example, commercial, Medicare and Medicaid and by county.
(2) Utilization statistics containing the following minimum data:
(i) The number of days of inpatient hospitalization on a quarterly, year-to-date and annualized basis.
(ii) The average number of physician visits per enrollee on a quarterly, year-to-date and annualized basis.
(3) The number, type, and disposition of all complaints and grievances filed with the plan or subcontractors.
(4) A copy of the current enrollee literature, including subscription agreements, enrollee handbooks and any mass communications to enrollees concerning complaint and grievance rights and procedures.
(5) A copy of the plan's current provider directory.
(6) A statement of the number of physicians leaving the plan and of the number of physicians joining the plan.
(7) A listing of all IDS arrangements and enrollment by each IDS.
(8) Copies of the currently utilized generic or standard form health care provider contracts including copies of any deviations from the standard contracts and reimbursement methodologies. Reimbursement information submitted to the Department under this paragraph may not be disclosed or produced for inspection or copying to a person other than the Secretary or the Secretary's representatives, without the consent of the plan which provided the information, unless otherwise ordered by a court.
(9) A copy of the plan's written description of its quality assurance program, a copy of the quality assurance work plan, and a copy of the quality assurance report submitted to the plan's Board of Directors.
(10) A listing, including contacts, addresses and phone numbers, of all contracted CREs that perform UR on behalf of the plan or a contracted IDS.
(b) Quarterly reports. Four times per year, a plan shall submit to the Department two copies of a brief quarterly report summarizing data specified in subsection (a)(2) and (6) and enrollment, and complaint and grievance system data. Each quarterly report shall be filed with the Department within 45 days following the close of the preceding calendar quarter. The plan shall submit each quarterly report in a format specified by the Department for that quarterly report.
§ 9.605. Department investigations.
(a) The Department may investigate plans as necessary to determine compliance with Act 68, the PPO Act, the HMO Act and this chapter
(b) Investigation may include onsite inspection of a plan's facilities and records, and may include onsite inspection of the facilities and records of any IDS subcontractor.
(c) The Department or its agents will have free access to all books, records, papers and documents that relate to the business of the plan, other than financial business.
(d) The Department will have access to medical records of plan enrollees for the purpose of determining the quality of care, investigating complaints or grievances, enforcement, or other activities relating to ensuring compliance with Article XXI, this chapter or other laws of the Commonwealth.
(e) The Department may request submission by the plan of a special report detailing any aspect of its operations relating to the provision of health care services to enrollees, provider contracting or credentialing, operation of the enrollee complaint and grievance system, or quality assessment.
§ 9.606. Penalties and sanctions.
(a) For violations of Article XXI and this chapter, the Department may take one or more of the following actions:
(1) Impose a civil penalty of up to $5,000 per violation.
(2) Maintain an action in the name of the Commonwealth for an injunction to prohibit the activity.
(3) Issue an order temporarily prohibiting the plan from enrolling new members.
(b) For violations of the HMO Act and this chapter, the Department may suspend or revoke a certificate of authority or impose a penalty of not more than $1,000 for each unlawful act committed if the Department finds that one or more of the following conditions exist:
(1) The HMO is providing or arranging for inadequate or poor quality care, either directly, through contracted providers or through the operations of the HMO, thereby creating a threat to the health and safety of its enrollees.
(2) The HMO is unable to fulfill its contractual obligations to its enrollees.
(3) The HMO has substantially failed to comply with the HMO Act.
(c) Before the Department may act under subsection (b), the Department will provide the HMO with written notice specifying the nature of the alleged violation and fixing a time and place, at least 10 days thereafter, for a hearing of the matter to be held. Hearing procedures and appeals shall be conducted in accordance with 2 Pa.C.S. (relating to administrative law and procedure).
(d) For violations of the HMO Act, the PPO Act, Act 68 and this chapter, the Department may require a plan to develop and adhere to a plan of correction approved by the Department that the plan shall make available to enrollees upon written request. The Department will monitor compliance with the plan of correction. Failure to comply with the plan of correction may result in the Department's taking action under subsection (a) or (b), as appropriate.
(e) The Department's actions under subsection (a)(1) or (3) are subject to 2 Pa.C.S. Chapter 5, Subchapter A (relating to practice and procedure of Commonwealth agencies).
Subchapter G. HMOS Sec.
GENERALLY
9.621. Applicability. 9.622. Prohibition against uncertified HMOs. 9.623. Preapplication development activities. APPLICATION FOR CERTIFICATE OF AUTHORITY
9.631. Content of an application for an HMO certificate of authority. 9.632. HMO certificate of authority review by the Department. 9.633. Location of HMO activities, staff and materials. 9.634. Delegation of HMO operations. 9.635. Issuance of a certificate of authority to a foreign HMO. OPERATIONAL STANDARDS
9.651. HMO provision and coverage of basic health services to enrollees. 9.652. HMO provision of other than basic health services to enrollees. 9.653. HMO provision of limited subnetworks to select enrollees. 9.654. HMO external quality assurance assessment.
GENERALLY § 9.621. Applicability.
(a) This subchapter applies to corporations that propose to undertake to establish, maintain and operate an HMO within this Commonwealth, with the exception of an HMO exempted under sections 16 and 17(b) of the HMO Act (40 P. S. §§ 1566 and 1567(b)).
(b) This subchapter is intended to ensure that HMOs certified by the Commonwealth offer increased competition and consumer choices that serve to advance quality assurance, cost effectiveness and access to health care services.
§ 9.622. Prohibition against uncertified HMOs.
(a) A corporation may not, within this Commonwealth, solicit enrollment of members, enroll members or deliver prepaid basic health services, by or through an HMO, unless it has received a certificate of authority from the Secretary and Commissioner to operate and maintain the HMO.
(b) A foreign HMO may not, within this Commonwealth, solicit enrollment of members, enroll members or deliver prepaid basic health care services unless it has received a certificate of authority from the Secretary and the Commissioner to operate and maintain an HMO.
§ 9.623. Preapplication development activities.
The Department will, upon request, provide technical advice and assistance to persons proposing to develop an HMO, including review of health care services provider contracts to be used to establish and maintain an acceptable health care services provider network. A network is required for issuance of a certificate of authority.
APPLICATION FOR CERTIFICATE OF AUTHORITY § 9.631. Content of an application for an HMO certificate of authority.
An application for a certificate of authority under the HMO Act shall include completed application forms as the Secretary and Commissioner may require. An application for a certificate of authority will not be deemed complete unless it includes at least the following information:
(1) Organizational information including a copy of the applicant's articles of incorporation, bylaws that include a description of the manner by which subscribers will be selected and appointed to the board of directors, an organization chart and clear disclosure of the relationship between the applicant and any affiliated entities owned or controlled by the applicant or which directly or indirectly own or control the applicant.
(2) A list of names, addresses and official positions of the board of directors of the applicant, and of persons who are responsible for the affairs of the applicant, including: president/chief executive officer; medical director; chief financial officer; chief operating officer; directors of quality assurance, UR, provider relations, member services; and the director of the enrollee complaint and grievance process if this responsibility does not fall under one of the previous directorships listed. Resumes shall be included for chairperson of the board and the positions listed in this paragraph.
(3) The address of the registered office, in this Commonwealth, where the HMO can be served with legal process.
(4) A copy of each proposed standard form health care services provider contract and each standard IDS contract including a detailed description of the reimbursement methodologies and types of financial incentives that the HMO proposes to utilize. Reimbursement information submitted to the Department under this paragraph may not be disclosed or produced for inspection or copying to a person other than the Secretary or the Secretary's representatives, without the consent of the plan which provided the information, unless otherwise ordered by a court.
(5) A copy of the HMO's proposed contracts with individual enrollees and groups of enrollees describing the health care coverage to be provided to each individual or group.
(6) A description of the proposed plan services area by county, including demographic data of prospective enrollees and location of contracted providers.
(7) A detailed description of the applicant's proposed enrollee complaint and grievance systems.
(8) A detailed description of the applicant's proposed system for ongoing quality assurance consistent with the requirements of § 9.674 (relating to quality assurance standards).
(9) A detailed description of the applicant's proposed UR system consistent with the requirements of §§ 9.749--9.751 (relating to UR system description; UR system standards; and time frames for UR).
(10) A copy of the applicant's proposed confidentiality policy.
(11) A detailed description of the applicant's proposed provider credentialing system, and standards for ongoing recredentialing activities incorporating quality assurance, UR and enrollee satisfaction measures.
(12) A description of the applicant's capacity to collect and analyze necessary data related to utilization of health care services and to provide the Department with the periodic reports specified in § 9.604 (relating to plan reporting requirements), including a description of the system whereby the records pertaining to the operations of the applicant, including membership and utilization data, are identifiable and distinct from other activities the entity undertakes.
(13) If the applicant intends to delegate any UR functions to a subcontractor, evidence of the subcontractor's certification as a CRE under Subchapter K (relating to CREs) if the certification is required.
(14) A detailed description of the applicant's ability to assure both the availability and accessibility of adequate personnel and facilities to serve enrollees in a manner enhancing access, availability and continuity of covered health care services.
(15) A copy of each contract with an individual or entity for the performance on the HMO's behalf of necessary HMO functions, including marketing, enrollment and administration, and each contract with an insurance company, hospital plan corporation or professional health services corporation for the provision of insurance or indemnity or reimbursement against the cost of health care services provided by the HMO.
(16) A job description for the medical director.
(17) A procedure for referral of enrollees to nonparticipating providers.
(18) A copy of the HMO'S proposed general subscriber literature including the member handbook.
(19) A copy of the HMO's most recent financial statement.
(20) Other information the applicant may wish to submit for consideration.
(21) Other information the Department requests as necessary to review the applicant's application for compliance with the HMO Act, Act 68 and this chapter.
§ 9.632. HMO certificate of authority review by the Department.
(a) The applicant shall submit a complete application to both the Department and the Insurance Department.
(b) Upon receipt of a complete application for a certificate of authority the Department will publish notification of receipt in the Pennsylvania Bulletin. The Department will accept public comments, suggestions or objections to the application for 30 days after publication. The Department may hold a public meeting concerning the application, with appropriate notification to the applicant, and notice to the public through publication of notice in the Pennsylvania Bulletin.
(c) Within 45 days of receipt of the application, the Department will notify the applicant of any additional information required to complete the application, and of any part of the application which must be corrected by the applicant to demonstrate compliance with the HMO Act or this chapter. A copy of requests for information sent to the applicant will be sent to the Commissioner.
(d) The Department will review the completed application for compliance with the HMO Act and this chapter. The application will not be considered complete until the required information is provided to the Department in writing, including evidence of a contracted and credentialed provider network of sufficient capacity to serve the proposed number of enrollees.
(e) The Department will visit and inspect the site or proposed site of the applicant's facilities or facilities of the applicant's contractors and its provider network, to ascertain its capability to comply with the HMO Act, Act 68 and this chapter.
(f) The Department will complete its review within 90 days of submission of the completed application.
(g) Within 90 days of receipt of a completed application for a certificate of authority, the Secretary and Commissioner will jointly take action as set forth in paragraph (1) or (2). A disapproval of an application may be appealed in accordance with 2 Pa.C.S. (relating to administrative law and procedure).
(1) Approve the application and issue a certificate of authority.
(2) Disapprove the application and specify in writing the reasons for the disapproval.
§ 9.633. Location of HMO activities, staff and materials.
To demonstrate its ability to assure both availability and accessibility of adequate personnel and facilities to effectively provide or arrange for the provision of basic health services in a manner enhancing access, availability and continuity of care, the HMO shall meet the following minimum standards:
(1) The HMO shall make available for review at a location within this Commonwealth, by the Department or an agent of the Department, the books and records of the corporation and the essential documents as the Department may require, including signed provider contracts, credentialing files, complaint and grievance files, committee meeting (quality assurance and credentialing) minutes and hearing transcriptions. Documents need not be permanently maintained in this Commonwealth but shall be made available within this Commonwealth within 30 days, unless the Department determines for matters of patient safety the documents must be provided within 2-business days.
(2) The HMO shall identify a physician to serve as its medical director who is licensed in this Commonwealth and qualified to perform the duties of a medical director. The medical director shall be responsible for the following:
(i) Oversight of the UR and quality assurance activities regarding coverage and services provided to enrollees.
(ii) General coordination of the medical care of the HMO.
(iii) Appropriate professional staffing of the HMO's medical management operations.
(iv) Designing protocols for quality assurance.
(v) Implementation of quality assurance programs and continuing education requirments.
(3) The HMO's quality assurance/improvement committee shall include at least one health care provider licensed in this Commonwealth.
§ 9.634. Delegation of HMO operations.
(a) An HMO may contract with an individual, partnership, association, corporation or organization for the performance of HMO operations. A contract for delegation of HMO operations shall be filed with the Commissioner under section 1558(b) of the HMO Act and may not in any way diminish the authority or responsibility of the board of directors of the HMO, or the ability of the Department to monitor quality of care and require prompt corrective action of the HMO when necessary.
(b) An HMO shall delegate medical management authority in accordance with § 9.675 (relating to the delegation of medical management).
§ 9.635. Issuance of a certificate of authority to a foreign HMO.
(a) A foreign HMO may be authorized by issuance of a certificate of authority to operate or to do business in this Commonwealth if the Department is satisfied that it is fully and legally organized and approved and regulated under the laws of its state and that it complies with the requirements for HMOs organized within and certified by the Commonwealth. A foreign HMO shall submit a letter to the Department and a copy of its approved application for licensure or certification on file with its state of domicile.
(b) A foreign HMO shall submit a completed Commonwealth application for a certificate of authority in accordance with §§ 9.631 and 9.632 (relating to content of an application for an HMO certificate of authority; and HMO certificate of authority review by the Department) and the following:
(1) In lieu of the Commonwealth application, a foreign HMO may submit to the Department and the Insurance Department a copy of the application submitted and approved for certificate of authority or licensure in another state with cross references to requirements contained in the Commonwealth's application.
(2) The foreign HMO shall provide, along with the out-of-State application, documentation of any change or modification occurring since that certificate of authority or license was approved.
(3) The foreign HMO shall otherwise affirm that the information submitted to the Department remains current and accurate at the time of submission.
(c) The Department may waive or modify its requirements under the HMO Act, this subchapter and Subchapters F and J (relating to general; and health care provider contracts) insofar as they apply to HMOs, following a written request from the foreign HMO for the modification or waiver and upon determination by the Department that the requirements are not appropriate to the particular foreign HMO, and that the waiver or modification will be consistent with the purposes of the HMO Act, and that it would not result in unfair discrimination in favor of the HMO of another state.
(d) Foreign HMOs are required to comply on the same basis as Commonwealth certified HMOs with all ongoing reporting and operational requirements, including external quality assurance assessments.
(e) If the Department and the Insurance Department arrive at reciprocal licensing agreements with other states, the requirements of this subchapter may be waived or modified.
(f) Upon receipt of a complete application for a certificate of authority the Department will publish notification of receipt in the Pennsylvania Bulletin. The Department will accept public comments, suggestions or objections to the application for 30 days after publication. The Department may hold a public meeting concerning the application, with appropriate notification to the applicant, and notice to the public through publication of notice in the Pennsylvania Bulletin.
OPERATIONAL STANDARDS § 9.651. HMO provision and coverage of basic health services to enrollees.
(a) An HMO shall maintain an adequate network of health care providers through which it provides coverage for basic health services to enrollees as medically necessary and appropriate without unreasonable limitations as to frequency and cost.
(b) An HMO may exclude coverage for services, except to the extent that a service is required to be covered by State or Federal law.
(c) An HMO shall provide or arrange for the provision of and cover the following basic health services as the HMO determines to be medically necessary and appropriate according to its definition of medical necessity:
(1) Emergency services on a 24-hour-per-day, 7-day-per-week basis. The plan may not require an enrollee, or a participating health care provider advising the enrollee regarding the existence of an emergency, to utilize a participating health care provider for emergency services, including ambulance services. See § 9.672 (relating to emergency services).
(2) Outpatient services.
(3) Inpatient services for general acute care hospitalization for a minimum of 90 days per contract or calendar year.
(4) Preventive services.
(d) An HMO shall provide other benefits as may be mandated by State and Federal law.
§ 9.652. HMO provision of other than basic health services to enrollees.
An HMO may provide coverage for other than basic health services including dental services, vision care services, prescription drug services, durable medical equipment or other health care services, provided:
(1) The HMO establishes, maintains and operates a network of participating health care providers sufficient to provide reasonable access to and availability of the contracted nonbasic health services to enrollees in accordance with § 9.679 (relating to access requirements in service areas).
(2) The health care provider contracts it uses to contract with participating providers meet the requirements of § 9.722 (relating to plan and health care provider contracts.)
(3) The provision of those health services is subject to the same complaint and grievance procedures applicable to the provision of basic health services.
§ 9.653. HMO provision of limited subnetworks to select enrollees.
(a) An HMO that wants to offer benefit plans based on limited subnetworks, that is, networks which include only selected participating health care providers, shall request approval from the Department to do so.
(b) The Department will approve a request to offer limited subnetworks if the proposal meets the following requirements:
(1) There is adequate disclosure to potential enrollees and any current enrollees who would be affected by a change to a limited subnetwork benefit package of the economic penalties that apply when enrollees do not obtain health care services through the limited subnetwork. Disclosure of the limitations in the number of the HMO's participating providers must be consistent with the act and the requirements of 31 Pa. Code § 154.16 (relating to disclosure of information).
(2) If a covered service is not available within the limited subnetwork, the HMO shall provide or arrange for the provision of the service at no additional out-of-pocket cost to the enrollee, other than the routine co-payments which would have been applicable if the service had been provided within the limited subnetwork.
(3) The limited subnetwork meets the minimum healthcare provider standards in § 9.679 (relating to access requirements in service areas) and has an adequate number and distribution of network providers to provide care which is available and accessible to enrollees within a defined area.
(4) Enrollment is limited to enrollees within a reasonable traveling distance to the limited participating subnetwork providers.
(5) The limited subnetwork meets the standards for adequate networks and accessibility in § 9.679.
§ 9.654. HMO external quality assurance assessment.
(a) Within 18 months after enrollment of the first enrollee, and every 3 years thereafter unless otherwise required by the Department, an HMO shall have an external quality assurance assessment conducted using an EQRO acceptable to the Department. Department personnel may participate in the external quality assurance assessment. The following also apply to external quality assurance assessments:
(1) The Department will perform a site visit of the HMO 12 months after the issuance of a certificate of authority whether or not the HMO has enrollees, to ensure that the HMO is complying with the requirements of the HMO Act, Act 68 and this chapter.
(2) If the HMO has no enrollees more than 18 months from the issuance of a certificate of authority the Department will peform a site visit to ensure that the HMO is in compliance with the HMO Act, Act 68 and this chapter.
(3) If, following the site visit in paragraph (2), the HMO has no enrollees for the next 6 months, the HMO may not begin to enroll members until the Department performs an additional site visit.
(b) Costs for the required external quality assurance assessment shall be paid by the HMO.
(c) An HMO may combine the external quality assurance assessment with an accreditation review offered by an EQRO acceptable to the Department, if the review adequately incorporates information required by the Department to determine the HMO's compliance with Act 68, the HMO Act and this chapter, and allows for Department staff to actively participate in the external quality assurance assessment.
(d) The external quality assurance assessment shall study the quality of care being provided to enrollees and the effectiveness of the quality assurance program established by the HMO under § 9.674 (relating to quality assurance standards) and shall assess the HMO's compliance with the HMO Act, Act 68 and this chapter.
(e) The EQRO shall issue a copy of its findings to the HMO's senior management, which shall provide a copy to the board of directors. It is the responsibility of the HMO to ensure that a copy of all interim and final reports regarding the external quality assurance assessment are filed within 15 days with the Department, either directly by the HMO, or by the EQRO.
(f) The Department's requests for corrective action plans resulting from the external quality assurance assessment concerning deficiencies found requiring an HMO response, and the HMO's ensuing responses, including correspondence between the plan and the Department, plans of correction and follow-up documentation, will be made available to the public upon request as required under the Right to Know Law (65 P. S. §§ 66.1--66.4). The remainder of the assessment containing proprietary information may not be disclosed or produced for inspection or copying to a person other than the Secretary or the Secretary's representatives, without the consent of the plan which provided the information, unless otherwise ordered by a court.
(g) The Department will publish annually in the Pennsylvania Bulletin a list of EQROS acceptable to it for the purpose of performing external quality assurance assessments.
Subchapter H. AVAILABILITY AND ACCESS Sec.
9.671. Applicability. 9.672. Emergency services. 9.673. Plan provision of prescription drug benefits to enrollees. 9.674. Quality assurance standards. 9.675. Delegation of medical management. 9.676. Enrollee rights. 9.677. Requirements of definitions of ''medical necessity.'' 9.678. PCPs. 9.679. Access requirements in service areas. 9.680. Access for persons with disabilities. 9.681. Health care providers. 9.682. Direct access for obstetrical and gynecological care. 9.683. Standing referrals or specialists as primary care providers. 9.684. Continuity of care. 9.685. Standards for approval of point-of-service products. § 9.671. Applicability.
This subchapter is applicable to managed care plans, including HMOs and gatekeeper PPOs, and subcontractors of managed care plans, including IDSs, for services provided to enrollees.
§ 9.672. Emergency services.
(a) A plan shall utilize the definition of ''emergency service'' in section 2102 of the act (40 P. S. § 991.2102) in administering benefits, adjudicating claims and processing complaints and grievances.
(b) A plan may not deny any claim for emergency services on the basis that the enrollee did not receive permission, prior approval, or referral prior to seeking emergency service.
(c) A plan shall apply the prudent layperson standard to the enrollee's presenting symptoms and services provided in adjudicating related claims for emergency services.
(d) Coverage for emergency services provided during the period of the emergency, shall include evaluation, testing, and if necessary, stabilization of the condition of the enrollee, emergency transportation and related emergency care provided by a licensed ambulance service. Use of an ambulance as transportation to an emergency facility for a condition that does not satisfy the definition of ''emergency service'' does not constitute an emergency service and does not require coverage as an emergency service.
(e) A plan may not require an enrollee to utilize any particular emergency transportation services organization or a participating emergency transportation services organization for emergency care.
(f) The emergency health care provider shall notify the enrollee's managed care plan of the provision of emergency services and the condition of the enrollee.
(g) If the enrollee is admitted to a hospital or other health care facility, the emergency health care provider shall notify the enrollee's managed care plan of the emergency services delivered within 48 hours or on the next business day, whichever is later. An exception to this requirement will be made where the medical condition of the patient precludes the provider from accurately determining the identity of the enrollee's managed care plan within 48 hours of admission.
(h) If the enrollee is not admitted to a hospital or other health care facility, the claim for reimbursement for emergency services provided shall serve as notice to the enrollee's managed care plan of the emergency services provided by the emergency health care provider.
§ 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, a prospective enrollee, or health care provider may make a written or verbal 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. If the drug that is the subject of the inquiry is not on the plan's formulary, the plan's response shall include a listing of the drugs in the same class that are on the formulary or instruct the enrollee how to access the formulary.
(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. The following standards apply when an exception is sought:
(1) Exception requests are to be considered requests for prospective UR decisions and shall be processed within 2-business days.
(2) If the exception is granted, the plan shall provide coverage in the amount disclosed by the plan for the nonformulary alternative under section 2136(a)(1) of the act (40 P. S. § 991.2136(a)(1)).
(3) A letter denying the request shall include the basis and clinical rationale for the denial and instructions on how to file a complaint or a grievance.
(d) The plan shall distribute its policy and process to each participating health care provider who prescribes. A plan shall provide a description of the process to be used to obtain coverage of a drug that is an exception to the formulary to an enrollee or prospective enrollee upon request. If a drug, class of drugs or drugs used to treat a specific condition are specifically excluded from coverage in the enrollee contract, appeals for coverage of specific exclusions shall be considered complaints. If no specific exclusion exists, the appeal of a denial of a physician's request for an exception to the formulary based on medical necessity and appropriateness, shall be considered to be a grievance.
(e) A plan shall provide at least 30 days notice of formulary changes to health care providers, except when the change is due to approval or withdrawal of approval of the Food and Drug Administration of a drug.
§ 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 outlining its structure and content.
(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 health care providers 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 documenting studies undertaken, evaluation of results, subsequent actions recommended and implemented, and aggregate data annually to the plan's board of directors, and shall provide a copy of the report to the Department.
(c) In administering a quality assurance plan, the plan shall do the following:
(1) Include in its quality assurance plan regularly updated standards for the following:
(i) Health promotion.
(ii) Early detection and prevention of disease.
(iii) Injury prevention for all ages.
(iv) Systems to identify special chronic and acute care needs at the earliest possible time.
(v) Access to routine, urgent and emergent appointments that shall be approved by the plan's quality assurance committee. The plan shall conduct annual studies of access and availability, the results of which shall be incorporated into the report referenced in subsection (b)(10).
(2) Notify health care providers and enrollees of these standards.
(3) Involve health care providers and enrollees in the updating of its quality assurance plan.
§ 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 be responsible for assuring that the medical management contract meets the requirements of all applicable laws. The plan shall submit the medical management contract to the Department for review and approval. The Department will review a medical management contract within 45 days of receipt of the contract. If the Department does not approve or disapprove a contract within 45 days of receipt, the plan may use the contract and it shall be presumed to meet the requirements of all applicable laws. If, at any time, the Department finds that a contract is in violation of law, the plan shall correct the violation. Reimbursement information submitted to the Department under this paragraph may not be disclosed or produced for inspection or copying to a person other than the Secretary or the Secretary's representatives without the consent of the plan which provided the information, unless otherwise ordered by a court.
(b) If the contractor is to perform UR, the contractor shall be certified in accordance with Subchapter K (relating to CREs).
(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 on at least a quarterly basis regarding the delegated activities concerning the arrangement or provision of health care services and the impact of the delegated activities on the quality and delivery of health care services to the plan's enrollees.
(3) Annual 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 will cooperate with and participate in quality assurance activities and studies undertaken by the plan that pertain to the enrollee populations served by the contractor, including submitting written reports of activities and accomplishments on plan directed and any contractor initiated activities 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 § 9.654 (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. Enrollee rights.
(a) A plan shall have a written policy that shall state the plan's commitment to treating an enrollee in a manner that respects the enrollee's rights and shall include the plan's expectations of a member's responsibilities.
(b) An HMO shall offer to each enrollee, who becomes ineligible to continue as a part of a group subscriber agreement, a nongroup subscription agreement offering the same level of benefits as are available to a group subscriber.
(c) An HMO may not expel or refuse to reenroll an enrollee solely because of the enrollee's health care needs, nor refuse to enroll individual subscribers of a group on the basis of health status or health care needs of the individuals.
§ 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. The definition shall comply with the HMO Act, the PPO Act, Act 68 and this chapter.
§ 9.678. PCPs.
(a) A plan shall make available to each enrollee a PCP to supervise and coordinate the health care of the enrollee.
(b) A PCP shall meet the following minimum standards, unless a specialty health care provider is approved by the plan to serve as a designated PCP as provided for in § 9.683 (relating to standing referrals or specialists as pimary care providers):
(1) Provide office hours accessible to enrollees of a minimum of 20 hours-per-week.
(2) Be available directly or through on-call arrangements with other qualified plan participating PCPs, 24 hours-per-day, 7 days-per-week for urgent and emergency care and to provide triage and appropriate treatment or referrals for treatment. A participating provider may arrange for on-call services with a nonparticipating provider if the plan approves the arrangement, agrees to provide the level-of-benefit for the service provided by the nonparticipating provider, and agrees to hold the enrollee harmless for any errors committed by the nonparticipating provider that would result in noncoverage of covered benefits or would mislead the enrollee into believing a noncovered service would be covered.
(3) Maintain medical records in accordance with plan standards and accepted medical practice.
(4) Maintain hospital 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. The plan shall comply with § 9.683.
(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 PCP, if the CRNP meets the plan's credentialing criteria and practices in accordance with the Medical Practice Act (63 P. S. §§ 422.1--422.45) and its applicable regulations, 49 Pa. Code Chapter 18, Subschapter C (relating to certified registered nurse practitioners), and the Nurse Practice Act (63 P. S. §§ 211--225) and its applicable regulations, 49 Pa. Code Chapter 21, Subchapter C (relating to certified registered nurse practitioners).
(e) A plan shall include in its provider directory a clear and adequate notice of the possibility that the choice of a given provider as a PCP may result in access to a limited subnetwork based on the PCP's employment or other affiliation arrangements.
(f) A plan shall establish and maintain a policy and procedure to permit an enrollee to change a designated PCP with appropriate advance notice to the plan.
§ 9.679. Access requirements in service areas.
(a) A plan shall only provide coverage to enrollees who work or reside in a service area when the plan has been approved to operate in that service area 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 report to the Department any probable loss from the network of any general acute care hospital and any primary care provider, whether an individual practice or a group practice, with 2,000 or more assigned enrollees.
(d) Except as otherwise authorized in this section, a plan shall provide for at least 90% of its enrollees in each county in its service area, access to covered services that are within 20 miles or 30 minutes travel from an enrollee's residence or work in a county designated as a metropolitan statistical area (MSA) by the Federal Census Bureau, and within 45 miles or 60 minutes travel from an enrollee's residence or work in any other county.
(e) A plan shall at all times assure enrollee access to primary care providers, speciality care providers and other health care facilities and services necessary to provide covered benefits. At a minimum, the following health care services must be available in accordance with the standards in subsection (d):
(1) General acute inpatient hospital services.
(2) Common laboratory and diagnostic services.
(3) Primary care.
(4) General surgery.
(5) Orthopedic surgery.
(6) Obstetrical and gynecological services.
(7) Ophthalmology.
(8) Allergy and immunology.
(9) Anesthesiology.
(10) Otolaryngology.
(11) Physical medicine and rehabilitation.
(12) Psychiatry and neurology.
(13) Neurological surgery.
(14) Urology.
(f) If a plan is unable to meet the travel standards in subsection (d), it shall inform the Department in writing and provide a written description of why it is unable to do so and its alternative arrangements to ensure access to health care providers of these services. The plan shall include in its description a specific explanation of exactly how it intends to provide access to health care services including:
(1) The use of participating or nonparticipating providers.
(2) Applicable payment arrangements.
(3) Measures to secure health care provider cooperation with plan policies and procedures concerning UR, case management, claims payment and access to medical information necessary to authorize payment of covered health care services.
(4) Travel arrangements, if any.
(g) A plan using a health care provider of services delivered in the home need not meet the requirements of subsection (d) or (f) as long as the services can be reliably provided in the enrollee's home regardless of distance between the home and the provider's location.
(h) For infrequently utilized health care services, such as transplants, a plan may provide access to nonparticipating health care providers or contract with health care providers outside of the approved service area.
(i) A plan offering coverage for nonbasic health care services, either as part of the basic benefit package or through supplemental coverage, such as prescription drugs, vision, dental, and durable medical equipment, shall ensure that its network of health care providers for these services meets the standards for frequently utilized services in subsections (d)--(g).
(j) If there is a therapeutic reason to arrange for services at a distance greater than the travel standards in subsections (d) and (f), whether for frequently or infrequently utilized health care services, the plan may make arrangements necessary to provide access to quality health care services.
(k) A plan shall cover services provided by a nonparticipating health care provider at no less than the in-network level of benefit when the plan has no available network provider. A plan is not required to have network providers available outside of the approved service area for the purposes of enrollees seeking basic health care services while outside of the service area. A plan is not required to pay a noncontracted provider at the same benefit level as a network provider for basic health care services sought by and provided an enrollee while outside the service area when in-network providers were available.
(l) A plan seeking to expand its service area beyond that which was initially approved shall file with the Department, for the Department's approval, a service area expansion request that meets the requirements of this section and includes:
(1) Projected enrollment for the first year of operation.
(2) A provider listing of contracted and credentialed health care providers.
(m) A plan shall provide the Department with a description of its provider network in a format specified by the Department, annually, and at other times at the Department's request to enable the Department to analyze network disruptions or investigate complaints.
§ 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 list by specialty of the name, address and telephone number of participating health care providers to which an enrollee may have access either directly or through a referral. The list may be a separate document, which may be a regional or county directory, and shall be updated at least annually. The plan shall satisfy the following in providing the list:
(1) If it provides a regional or county directory, the plan shall make enrollees aware that other regional directories or a full directory are available upon request.
(2) If it provides a list of participating providers for only a specific type of provider or service, the plan shall include in the list all participating providers authorized to provide those services. Information shall be provided as required under 31 Pa. Code § 154.16 (relating to information for enrollees).
(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 other providers with equivalent training and experience.
(c) A plan that has no participating health care providers within the approved service area 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 and ensuring 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.
(5) Routine appointments.
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