Subchapter H. AVAILABILITY AND ACCESS

 (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.

 (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.

 (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.

 (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 comply 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).

 (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.

 (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.

 (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.

 (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.)

 (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.

 (a)  A plan shall permit enrollees direct access to obstetrical and gynecological services for maternity and gynecological care, including medically necessary and appropriate follow-up care and referrals, for diagnostic testing related to maternity and gynecological care from participating health care providers without prior approval from a primary care provider. Time restrictions may not apply to the direct accessing of these services by enrollees.

 (b)  A plan may require a provider of obstetrical or gynecological services to obtain prior authorization for selected services, such as diagnostic testing for subspecialty care—for example, reproductive endocrinology, oncologic gynecology, and maternal and fetal medicine.

 (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 improvement or quality assurance committee.

   (2)  Provide for evaluation by appropriately trained and qualified personnel.

   (3)  Include a treatment plan approved by the plan in consultation with the primary care provider, the enrollee and as appropriate, the specialist, 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 specialist as, a primary care provider will be made to participating health care providers when possible.

   (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 or quality assurance committee on an annual basis.

 (a)  Provider terminations initiated by the plan shall be governed as follows:

   (1)  Except as noted in subsections (i) and (j), an enrollee may continue an ongoing course of treatment, at the option of the enrollee, for up to 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 provider who is terminated 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 provider who is terminated is not a primary care provider, the plan shall notify all 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 notice of termination or pending termination 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 undergo full credentialing.

 (g)  A plan shall provide the nonparticipating or terminated 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)  To be eligible for payment by a plan, a nonparticipating or terminated provider shall agree to the terms and conditions of the plan prior to providing service under the continuity of care provisions. If the health care provider does not agree to the terms and conditions of the plan prior to providing the service, the provider shall notify the enrollee of that fact.

 (i)  This section does not require a plan to provide health care services that are not covered under the terms and conditions of the plan.

 (a)  If a plan offers a point-of-service product, it shall submit a formal product filing for the POS product to the Department and the Insurance Department.

 (b)  A plan may offer POS options to groups and enrollees, if the plan:

   (1)  Has a system for tracking, monitoring and reporting enrollee self-referrals for the following purposes:

     (i)   To ensure that self-referral activity is not occurring because of an access problem, a deliberate attempt to force an enrollee to bypass a primary care provider for nonmedical reasons or over restrictive or burdensome plan requirements.

     (ii)   To promptly investigate any PCP practice in which enrollees are utilizing substantially higher levels of non-PCP referred care than average, to ensure that enrollee self-referrals are not a reflection of access or quality problems on the part of the PCP practice, inappropriate patient direction or burdensome plan requirements.

   (2)  Provides clear disclosure to enrollees of out-of-pocket expenses.

   (3)  Does not directly or indirectly encourage enrollees to seek care without a PCP referral or from out-of-network providers due to an inadequate network of participating providers in any given specialty.