[29 Pa.B. 6409]
[Continued from previous Web Page]
Annex A
TITLE 28. HEALTH AND SAFETY
PART I. GENERAL HEALTH
CHAPTER 9. MANAGED CARE ORGANIZATIONS
Subchapter A. (Reserved) (Editor's Note: Sections 9.1, 9.2, 9.31, 9.32, 9.51--9.55, 9.71--9.77 and 9.91--9.97 as they appear in 28 Pa. Code pages 9-2 to 9-18, serial pages (248720), (229397) to (229399), (213093) to (213096), (248721) to (248722), (213099) to (213104) and (239541) to (239542) are proposed to be deleted in their entirety.)
§ 9.1. (Reserved).
§ 9.2. (Reserved).
§ 9.31. (Reserved).
§ 9.32. (Reserved).
§§ 9.51--9.55. (Reserved).
§§ 9.71--9.77. (Reserved).
§§ 9.91--9.97. (Reserved).
Subchapter D. (Reserved) (Editor's Note: Sections 9.401--9.415 as they appear at 28 Pa. Code pages 9-41 to 9-53, serial pages (213130), (248723) to (248724), (213133) to (213140) and (248725) as proposed to be deleted in their entirety.)
§§ 9.401--9.416. (Reserved).
Subchapter E. (Reserved) (Editor's Note: Sections 9.501--9.519 as they appear at 28 Pa. Code pages 9-54 to 9-70, serial pages (248726) to (248742).)
§§ 9.501--9.519. (Reserved).
Subchapter F. GENERAL Sec.
9.601. Applicability. 9.602. Definitions. 9.603. Technical advisories. 9.604. Plan reporting requirements. 9.605. Department investigations. 9.606. Penalties and sanctions. § 9.601. Applicability.
(a) This chapter applies to managed care plans as defined by section 2102 of the act (40 P. S. § 991.2102) unless expressly stated otherwise. Plans are advised to consult the regulations of the Insurance Department on these topics. See 31 Pa. Code Chapters 154 and 301 (relating to quality health care accountability and protection; and health maintenance organizations) to ensure complete compliance with Commonwealth requirements.
(b) An entity, including an IDS, subcontracting with a managed care plan to provide services to enrollees shall meet the requirements of Article XXI of the act and Subchapters H--L for services provided to those enrollees.
(c) Section 9.742 (relating to CREs) applies to licensed insurers and managed care plans with certificates of authority.
(d) This chapter does not apply to ancillary service plans.
§ 9.602. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
Act--The Insurance Company Law of 1921 (40 P. S. §§ 361--991.2361).
Act 68--The act of June 17, 1998 (P. L. 464, No. 68) (40 P. S. §§ 991.2001--991.2361) which added Articles XX and XXI of the act.
Ancillary service plan--
(i) An individual or group health insurance plan, subscriber contract or certificate, that provides exclusive coverage for dental services or vision services.
(ii) The term also includes Medicare Supplement Policies subject to section 1882 of the Social Security Act (42 U.S.C.A. § 1395ss) and the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) supplement.
Ancillary services--A health care service that is not directly available to enrollees but is provided as a consequence of another covered health care service, such as radiology, pathology, laboratory and anesthesiology.
Article XXI--Sections 2101--2193 of the act (40 P. S. §§ 991.2101--991.2193) relating to health care accountability and protection.
Basic health services--The health care services in § 9.651 (relating to HMO provision and coverage of basic health care services to enrollees).
Certificate of authority--The document issued jointly by the Secretary and the Commissioner that permits a corporation to establish, maintain and operate an HMO.
CRE--Certified utilization review entity. An entity certified under this chapter to perform UR on behalf of a plan.
Commissioner--The Insurance Commissioner of the Commonwealth.
Complaint--
(i) A dispute or objection by an enrollee regarding a participating health care provider, or the coverage (including contract exclusions and noncovered benefits), operations or management policies of a managed care plan, which has not been resolved by the managed care plan and has been filed with the plan or the Department or the Insurance Department.
(ii) The term does not include a grievance.
Department--The Department of Health of the Commonwealth.
Drug formulary--A listing of a managed care plan's preferred therapeutic drugs.
Emergency service--
(i) A health care service provided to an enrollee after the sudden onset of a medical condition that manifests itself by acute symptoms of sufficient severity or severe pain so that a prudent layperson who possesses an average knowledge of health and medicine could reasonably expect the absence of immediate medical attention to result in one or more of the following:
(A) Placing the health of the enrollee or, with respect to a pregnant woman, the health of the woman or her unborn child in serious jeopardy.
(B) Serious impairment to bodily functions.
(C) Serious dysfunction of any bodily organ or part.
(ii) Transportation and related emergency care provided by a licensed ambulance service shall constitute an emergency service if the condition is as described in subparagraph (i).
Enrollee--A policyholder, subscriber, covered person, member or other individual who is entitled to receive health care services under a managed care plan.
External quality assurance assessment--A review of an HMO's ongoing quality assurance program and operations conducted by a nonplan reviewer such as a Department-approved external quality review organization.
External quality review organization--An entity approved by the Department to conduct an external quality assurance assessment of an HMO.
Foreign HMO--An HMO incorporated, approved and regulated in a state other than the Commonwealth.
Gatekeeper--A health care provider, managed care plan or agent of a managed care plan, from which an enrollee must receive referral or approval for covered health care services as a requirement for payment of the highest level of benefits.
Gatekeeper PPO--A PPO requiring enrollee use of a gatekeeper from which an enrollee must receive referral or approval for covered health care services as a requirement for payment of the highest level of benefits.
Grievance--
(i) A request by an enrollee, or a health care provider with the written consent of the enrollee, to have a managed care plan or CRE reconsider a decision solely concerning the medical necessity and appropriateness of a health care service. If the managed care plan is unable to resolve the matter, a grievance may be filed regarding the decision that does one of the following:
(A) Disapproves full or partial payment for a requested health service.
(B) Approves the provision of a requested health care service for a lesser scope or duration than requested.
(C) Disapproves payment of the provision of a requested health care service but approves payment for the provision of an alternative health care service.
(ii) The term does not include a complaint.
HMO--Health maintenance organization--An organized system that combines the delivery and financing of health care and which provides basic health services to voluntarily enrolled members for a fixed prepaid fee.
HMO Act--The Health Maintenance Organization Act (40 P. S. §§ 1551--1568).
Health care provider--A licensed hospital or health care facility, medical equipment supplier or person who is licensed, certified or otherwise regulated to provide health care services under the laws of the Commonwealth, including a physician, podiatrist, optometrist, psychologist, physical therapist, certified nurse practitioner, registered nurse, nurse midwife, physician's assistant, chiropractor, dentist, pharmacist or an individual accredited or certified to provide behavioral health services.
Health care service--A covered treatment, admission, procedure, medical supply, equipment or other service, including behavioral health, prescribed or otherwise provided or proposed to be provided by a health care provider to an enrollee under a managed care plan contract.
IDS--Integrated delivery system--A partnership, association, corporation or other legal entity which does each of the following:
(i) Enters into a contractual arrangement with a plan.
(ii) Employs or contracts with health care providers.
(iii) Agrees under its arrangement with the plan to provide or arrange for the provision of covered health care services to enrollees.
(iv) Assumes under the arrangement with the plan full or partial responsibility for conducting any or all of the following activities: quality assurance, UR, credentialing, provider relations or enrollee services.
Inpatient services--Care at a licensed hospital, skilled nursing or rehabilitation facility, including preadmission testing, diagnostic testing performed during an inpatient stay, nursing care, room and board, durable medical equipment, ancillary services, inpatient drugs, meals and special diets, use of operating room and related facilities, use of intensive care and cardiac units and related services.
Licensed insurer--An individual, corporation, association, partnership, reciprocal exchange, inter-insurer, Lloyds insurer and other legal entity engaged in the business of insurance; fraternal benefit societies as defined in the Fraternal Benefit Societies Code (40 P. S. §§ 1142-101--1142-701), and PPOs as defined in section 630 of the act (40 P. S. § 764a).
Managed care plan or plan--
(i) A health care plan that uses a gatekeeper to:
(A) Manage the utilization of health care services.
(B) Integrate the financing and delivery of health care services to enrollees by arrangements with health care providers selected to participate on the basis of specific standards.
(C) Provide financial incentives for enrollees to use the participating health care providers in accordance with procedures established by the plan.
(ii) A managed care plan includes health care arranged through an entity operating under any of the following:
(A) Section 630 of the act.
(B) The HMO Act.
(C) The Fraternal Benefit Society Code.
(D) 40 Pa.C.S. §§ 6102--6127 which relates to hospital plan corporations.
(E) 40 Pa.C.S. §§ 6301--6334 which relates to professional health services plan corporations.
(iii) The term includes an entity, including a municipality, whether licensed or unlicensed, that contracts with or functions as a managed care plan to provide health care services to enrollees.
(iv) The term does not include ancillary service plans or an indemnity arrangement which is primarily fee for service.
Medical management--A function that includes any aspect of UR, quality assurance, case management and disease management and other activities for the purposes of determining, arranging, monitoring or providing effective and efficient health care services.
Member--An enrollee.
Outpatient services--Outpatient medical and surgical, emergency room and ancillary services including ambulatory surgery and all ancillary services pursuant to ambulatory surgery, outpatient laboratory, radiology and diagnostic procedures, emergency room care that does not result in an admission within 24 hours of the delivery of emergency room care and other outpatient services covered by the plan.
Outpatient setting--A physician's office, outpatient facility, ambulatory surgical facility or a hospital when a patient is not admitted for inpatient services.
PCP--Primary care provider--A health care provider who, within the scope of the provider's practice, supervises, coordinates, prescribes or otherwise provides or proposes to provide health care services to an enrollee; initiates enrollee referral for specialist care; and maintains continuity of enrollee care.
POS plan--Point-of-service plan--
(i) A health care plan which requires an enrollee to select and utilize a gatekeeper to obtain the highest level of benefits with the least amount of out-pocket expense for the enrollee.
(ii) A POS plan may be provided by an HMO or by a gatekeeper PPO.
PPO--A preferred provider organization.
Preventive health care services--
(i) Services provided by the plan to provide for the prevention, early detection and minimization of the ill effects and causes of disease or disability.
(ii) The services include prenatal and well baby care, immunizations and periodic physical examinations.
Provider network--The health care providers designated by a plan to provide health care services to enrollees.
Secretary--The Secretary of Health of the Commonwealth.
Service area--The geographic area in which the plan has received approval to operate from the Department.
UR--Utilization review--
(i) A system of prospective, concurrent or retrospective UR, performed by a utilization review entity or health care plan, of the medical necessity and appropriateness of health care services prescribed, provided or proposed to be provided to an enrollee.
(ii) The term does not include any of the following:
(A) Requests for clarification of coverage, eligibility or health care service verification.
(B) A health care provider's internal quality assurance or UR process unless the review results in denial of payment for a health care service.
§ 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 how a plan may maintain compliance with the HMO Act, Article XXI and this chapter.
§ 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 and disenrollment data by product line--for example, commercial, Medicare and Medicaid and by county.
(2) Health care services utilization data.
(3) Data relating to complaints and grievances.
(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.
(9) 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 the contracted CREs that perform UR on behalf of the plan or a contracted IDS.
(11) Other information which the Department may request, upon advance notice to the plan.
(b) Quarterly reports. Four times per year, a plan shall submit to the Department two copies of a brief quarterly report summarizing key utilization, 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 information contained in annual, quarterly or special reports, enrollee complaints relating to quality of care or service, or the deficiencies identified in the course of external quality reviews.
(b) Investigation may include onsite inspection of an HMO's facilities and records, and may include onsite inspection of the facilities and records of any IDS subcontractor.
(c) The Department or its agents shall have free access to all books, records, papers and documents that relate to the business of the HMO, other than financial business.
(d) The Department will have access to medical records of HMO enrollees for the sole 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 HMO 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 that violates the provisions.
(3) Issue an order temporarily prohibiting the plan from enrolling new members.
(4) Require the plan to develop and adhere to a plan of correction approved by the Department which the plan shall make available to enrollees upon written request. The Department will monitor compliance with the plan of correction.
(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 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 advertised its services in an untrue, misrepresentative, misleading, deceptive or unfair manner either directly or through any person on its behalf.
(4) 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, when a hearing of the matter shall be held. Hearing procedures and appeals shall be conducted in accordance with 2 Pa.C.S. (relating to administrative law and procedure).
(d) A plan may appeal the decision to impose a penalty under subsection (a)(1) or to issue an order under subsection (a)(3) under 2 Pa.C.S. Chapter 5, Subchapter A (relating to practice and procedure of Commonwealth agencies).
Subchapter G. HMOS
GENERALLY Sec.
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. HMO board requirements. 9.634. Location of HMO activities, staff and materials. 9.635. Delegation of HMO operations. 9.636. 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. Use of co-payments and co-insurances in HMOs. 9.654. HMO provision of limited networks to select enrollees. 9.655. HMO external quality assurance assessment. 9.656. Standards for approval of point-of-service options by HMOs.
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 choice which 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 approval 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, Utilization Review, 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 IDS contract including a detailed description of the types of financial incentives that the HMO may utilize.
(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.
(9) A detailed description of the applicant's proposed UR system.
(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 detailed description of the applicant's incentives and mechanisms for cost-control within the structure and function of the applicant.
(17) Other information the applicant may wish to submit for consideration.
(18) 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 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 any 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 may visit or 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. HMO board requirements.
(a) A corporation that has received a certificate of authority shall, within 1 year of its receipt of the certificate, establish and maintain a board of directors at least one-third of whom are enrollees of the HMO. The process to select enrollee members of the board shall be structured to prevent undue influence in the selection process by nonenrollee members of the board and to obtain diverse representation of broad segments of the enrollees covered under HMO contracts issued by the corporation.
(b) A member of the board shall execute a conflict of interest statement certifying that the board member will not engage in forms of self-dealing including the sale, exchange, leasing or furnishing of property, goods, services or facilities between the HMO and the board member, the board member's employer or an organization substantially controlled by the board member, in a manner more favorable to the board member or to the HMO than would be provided to the general public.
(c) The board of the HMO shall be responsible for the operations of the HMO, and shall have the ability to take corrective action when deficiencies are noted in any of its functions regardless of where and by whom the function is performed.
(d) The board shall review and approve the quality assurance plan of the HMO on an annual basis.
§ 9.634. 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 in 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 48 hours.
(2) The HMO shall ensure that the medical director responsible for overseeing the UR and quality assurance activities regarding coverage and services provided to enrollees who are residents of this Commonwealth is appropriately licensed in this Commonwealth, and qualified to oversee the delivery of health care services in this Commonwealth.
(3) The HMO's quality assurance/improvement committee shall include health care providers licensed in this Commonwealth.
§ 9.635. Delegation of HMO operations.
(a) An HMO may contract with any 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 and does 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).
§ 9.636. 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.
(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).
(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 and this chapter 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.
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 the services as are customarily excluded by indemnity insurers, except to the extent that a service is required to be covered by State or Federal law.
(c) An HMO shall provide 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.
(2) Outpatient services.
(3) Inpatient services.
(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.
(2) The health care provider contracts it uses to contract with participating providers meets 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. Use of co-payments and co-insurances in HMOs.
Upon the request of the Insurance Department, the Department will review requests by an HMO to incorporate co-payments and co-insurance in the HMO benefit structure, to determine whether these requests would detract from availability, accessibility or continuity of services and to ensure that the request constructively advances the purposes of quality assurance, cost-effectiveness and access.
§ 9.654. HMO provision of limited networks to select enrollees.
(a) An HMO that wants to offer limited subnetworks which include only selected 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 of the limitations in the number of the HMO's participating providers.
(2) If a covered service is not available within the limited network, the HMO shall provide or arrange for the provision of the service at no additional cost to the enrollee, other than the routine co-payments which would have been applicable if the service had been provided within the limited network.
(3) The limited network 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 limited participating network providers.
§ 9.655. HMO external quality assurance assessment.
(a) Within 18 months of receipt of a certificate of authority, and every 3 years thereafter unless otherwise required by the Department, an HMO shall have an external quality assessment conducted using an external quality review organization acceptable to the Department. Department personnel may participate in the external quality assurance assessment.
(b) Costs for the required external review shall be paid by the HMO.
(c) An HMO may combine the external quality assurance assessment with an accreditation review offered by an external quality review organization acceptable to the Department, if the review adequately incorporates assessment factors required by the Department, and allows for Department staff to actively participate in the external review process.
(d) The assessment shall study the quality of care being provided to enrollees and the effectiveness of the quality assurance program established by the HMO.
(e) The external quality review organization shall issue a copy of its findings to the HMO's senior management. It is the responsibility of the HMO to ensure that a copy of all interim and final reports regarding the external quality assessment are filed within 15 days with the Department, either directly by the HMO, or by the external quality review organization.
§ 9.656. Standards for approval of point-of-service options by HMOs.
(a) An HMO shall submit a formal product filing for a POS product to the Department and the Insurance Department.
(b) An HMO may offer POS options to groups and enrollees, if the HMO:
(1) Has a system for tracking, monitoring and reporting enrollee self-referrals for the following purposes:
(i) Periodically informing an enrollee's primary care provider of enrollee self-referred services.
(ii) Promptly investigating 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.
(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.
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. Standards for enrollee rights and responsibilities. 9.677. Requirements of definitions of ''medical necessity.'' 9.678. Primary care providers. 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. § 9.671. 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 from a gatekeeper or the plan itself prior to seeking emergency service.
(c) A plan may 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 shall include 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) A plan shall cover emergency services provided by a nonparticipating health care provider at the same level of benefit as that provided by a participating health care provider when the plan determines the emergency services were necessary based on the prudent layperson standard.
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