[31 Pa.B. 3043]
[Continued from previous Web Page] The proposed subsection would not have eliminated the requirement that plans provide an evaluation for a specialist as a primary care provider and, if the standards of the plan are met, permit that specialist to serve as a primary care provider. For clarity, however, the Department has added a cross-reference to § 9.683 (relating to standing referrals or specialists as primary care providers) to the language in the proposed subsection.
One commentator recommended that the Department consider including doctors of chiropractic as primary care providers.
The Department is requiring the plan, through the quality assurance committee, to develop criteria for credentialing providers. The Department is not defining in regulations what healthcare providers, by specialty type, may or may not provide primary care or serve as a primary care provider. As discussed further in response to comments on § 9.683, the plan must consider the needs of all enrollees and those with chronic conditions when evaluating the appropriateness of a type of provider who proposes to serve as a primary care provider.
The Department received about ten comments on proposed subsection (d), which pertains to a CRNP serving as a primary care provider. Two were in support of it, and one was adamantly opposed to it, claiming that it had no statutory basis in Act 68. The remainder of the comments requested clarification on some aspect of the regulation.
One commentator recommended that the Department clarify that plans need not accept a CRNP as a primary care provider.
The Department has not changed the proposed subsection with respect to these comments. The language in proposed subsection (d) states that a plan ''may consider a CRNP. . . as a primary care provider, if the CRNP meets the plan's credentialing criteria. . . .'' The use of the word ''may'' is sufficient to indicate that plans are permitted to use discretion in making this decision.
Another commentator asked whether plans would be required to file and receive approval of a waiver to use CRNPs as primary care providers.
Plans are no longer required to request a waiver in order to use a CRNP as a primary care provider. The definition of health care provider in section 2102 of Article XXI specifically lists CRNPs as health care providers, and, depending upon the scope of a CRNP's practice, a CRNP could fit within the Act 68's definition of the term ''primary care provider.'' Therefore, there is no need to make provision for a waiver of regulatory requirements, since use of a CRNP as a primary care provider would be consistent with the regulations.
One commentator commented that if plans are permitted to use CRNPs, they should be permitted to allow enrollees to choose physicians as primary care providers rather than CRNPs. This commentator, along with IRRC, recommended that the Department consider requiring a written notice to alert an enrollee that the enrollee's primary care provider is a CRNP, and not a physician. IRRC recommended that the notice include name of the physician with whom the CRNP has a written agreement to provide services.
The Department has not changed the proposed subsection based on these comments. Enrollees are permitted to choose from a variety of provider types approved and credentialed by a plan as a primary care provider in such areas as pediatrics, family practice and general internal medicine. Any enrollee who has a choice of a CRNP also has a choice of all other types of primary care providers. Provider directories, which are reviewed by Insurance, list providers by practice area (specialty) and provider name, including credentials, address and telephone number. Practitioners are identified with their proper credentials as an M.D., D.O., CRNP and so on. Therefore, enrollees will know who and what they are selecting for their primary care provider.
IRRC has recommended that the Department either cross-reference to the State law and regulations which list the scope of licensure for a CRNP, or specifically state that CRNPs are only permitted to perform certain functions in collaboration with and under the direction of a licensed physician.
The Department is aware of the practice requirements attached to the practice of a CRNP in this Commonwealth. The Department has stated in this regulation that a CRNP must practice in accordance with State law, which, as IRRC commented, requires collaboration and direction of a physician for certain purposes. The Department intended to reference the scope of practice of a CRNP by including in the proposed section the language: ''practices in accordance with state law.'' To clarify this, the Department will replace the language which IRRC has suggested is unnecessary and should be deleted, with the specific citations to the Medical Practice Act (63 P. S. §§ 422.1--422.45) and the Nurse Practice Act (63 P. S. §§ 211--225) and the relevant regulations.
One commentator commented that in community-based nurse managed health centers, nurses practice as primary care providers independently in collaboration with a physician. Physician supervision is not consistent with current practice. It has requested that the Department's comments in its Preamble to this section concerning supervision be clarified.
The language to which the commentator refers regarding supervision was taken out of context from the Preamble. It was meant to refer to the supervision and coordination of the care of the individual patient's needs by a primary care provider. This is the role of the primary care provider in managed care.
One commentator recommended the revision of language in proposed subsection (e) to take into account concerns that it could be interpreted as requiring directories to advise members of the implications of any referral changes on a provider by provider basis. The commentator recommended using the following language: ''A plan shall include in its provider directory a clear and adequate notice of the possibility of limitations caused by the choice of a given provider as a primary care provider.''
The Department agrees with the recommendation, and has changed the language to clarify the subsection.
One commentator also recommended that the provider directory indicate which primary care providers refuse to allow, perform, participate, or refer for certain health care services on moral or religious grounds.
The Department has not made this change, since plans do not survey religious or moral opinions of their primary care providers. If the primary care provider does not intend to provide the full range of primary care services in the contract, for example, birth control, the provider is required to refer out for services the primary care provider does not provide. Additionally, an enrollee may transfer to another primary care provider if the enrollee chooses to do so.
IRRC commented that the language in proposed subsection (f) was vague, and that the Department should provide a specific time frame in which an enrollee must give a plan notice of the enrollee's intention to transfer.
The Department has not made the recommended change to the proposed subsection. The Department does not believe that setting a timeframe in this context would be useful. Plans set timeframes based on operational concerns, which can and are waived in unusual circumstances warranting an enrollee's immediate transfer. A Department standard could lock an enrollee into a relationship with a primary care provider beyond that which is prudent. This could be disadvantageous to the enrollee and would eliminate plan flexibility.
Section 9.679. Access requirements in service areas.
The Department received several comments on this proposed section. After reviewing all the comments on the proposed section, many of which raised issues with the Department's use of minute and mileage standards, the Department has determined to revise the proposed subsection to address those concerns. The Department has deleted proposed subsections (c) and (e), and added new language to proposed subsection (d). The changes are more fully explained.
Several commentators raised concerns with proposed subsection (a), stating that the provision would fail to take into account enrollees who live outside the service area but receive care within the service area.
The Department recognizes this concern, and has changed the language in the proposed subsection to take into account those enrollees who both work and reside in the approved service area.
One commentator suggested that the criteria the Department intended to use in proposed subsection (c) to determine adequacy of services, healthcare providers, access and availability were not specifically identified.
One commentator recommended that the Department modify subsection (c) to reflect the longstanding practice of only requiring contractual arrangements with primary care providers and frequently utilized specialties. The commentator stated that if nonfrequently utilized specialists are either not available within the geographic criteria or refuse to contract with the plan, it assumed that the Department would still approve the network on the condition that the plan has adequate provisions to address those specialties.
After reviewing the comments on this proposed subsection, the Department has decided to replace the proposed text with the more specific network requirements of subsections (d) and (e).
To the extent these comments still apply to the final-form regulations, the Department has always taken the position that if infrastructure did not exist in a service area, the Department would not require it to be built. The Department is, however, requiring a plan that cannot immediately meet the requirements in subsections (d) and (e) to explain to the Department why this problem is occurring, and what other alternate arrangements the plan intends to undertake to meet the standards. See subsection (d)(3). An acceptable arrangement would be to allow enrollee access to nonparticipating providers; however, this is suboptimal for frequently utilized specialties as the plan is disadvantaged not only financially but also in terms of credentialing and compliance with plan policies, procedures, and quality assurance initiatives and activities. The Department would not want this to be a permanent alternative.
One commentator commented on the propensity of plans to shut out optometrists from their networks because an ophthalmologist is in the service area, or because the plan does not cover routine eye examinations or glasses. The commentator stated that optometrists provide other medically related eye care services, and most primary eye care in medically underserved areas is provided by optometrists.
The Department has not included language to its regulations to require plans to take one of every type of provider who can provide a particular health care service. The act requires plans to assure the availability and accessibility of adequate health care providers in a timely manner which enables enrollees to have access to quality care and continuity of care. See section 2111(1) of Article XXI. Act 68 does not require a plan to have one of each type of provider, and the Department will not promulgate a regulation to the contrary.
One commentator, although recognizing the need for the Department to be aware of potential service disruptions, raised concerns that the immediate notification requirement in proposed subsection (d) would be burdensome. The commentator recommended that the Department require a report within a reasonable time.
The Department agrees with the comment, and has deleted the word ''immediately'' from the proposed subsection, which is now subsection (c). The Department has also changed the word ''potential'' to ''probable'' to reflect the Department's intention to only require notice of those threatened terminations that are likely to become actual terminations.
The commentator also commented that it was unclear how the proposed requirement to report a serious change in the plan's ability to provide services affecting 10% or more of the enrollees in a service area would be applied to plans with service areas that cover more than one county and different geographic regions.
The Department, after reviewing this comment, agrees that the 10% requirement could be broadly interpreted, and, therefore, difficult to apply. The Department has also decided that a service area is too broad an area that needs to be updated to trigger a reporting duty, and may allow plans to avoid providing notice when a provider in a small community with many enrollees terminates and the community and the plan are without alternatives. The remaining providers in the area might not be able to handle the influx, although the number of enrollees affected would not trigger the necessary 10% threshold for the entire service area. To address these concerns, the Department has deleted the proposed language, and has added language that requires a plan to notify the Department of a loss from the network of any acute care hospital and any primary care provider in either an individual practice or group practice with 2000 or more assigned members. See subsection (c). The Department recognizes that the loss of other types of providers in a network is always disruptive to the patient affected; however, access to primary care as the entre to all other services, and hospitals as the source of most urgently and severely needed services, are the main concerns of the Department.
Proposed subsection (e) generated several comments from a variety of commentators--plans, advocacy groups, legislators, and provider associations, as well as IRRC. One commentator commented that the subsection was too vague. Some commentators commented that the subsection contained no specific standards for frequently utilized specialists. Other commentators commented that the subsection lacked standards for infrequently utilized specialists. One commentator stated that criteria for less frequently utilized specialists should be based on need, and not on use. IRRC stated that the subsection should contain criteria used to determine network adequacy, or should reference § 9.653(b) (relating to HMO provision of limited networks to select enrollees). IRRC recommended that for some specialty areas, network adequacy be based on a case-by-case basis.
Several commentators took issue with the proposed mileage and time requirements. IRRC and others questioned these requirements in light of the Department of Public Welfare's different contractual requirements for Health Choices contractors.
Two commentators recommended clarifying the term ''access'' since it implied a use of motor vehicles, but did not take into account inaccessible or unaffordable transportation.
After having reviewed all the comments it received on this subsection, the Department has substantially revised the proposed section and subsection to address these concerns. First, to address concerns raised by commentators with respect to the Department of Public Welfare's Health Choices contractors, the Department has decided to use metropolitan statistical areas (MSA) to designate counties as rural or urban. The Department has altered its mileage and distance accessibility requirements to 20 miles/30 minutes in an MSA county otherwise considered urban, and 45 miles or 60 minutes in a nonMSA county otherwise considered rural. Further, the Department has required that services be accessible to 90% of the enrollees in that area. MSAs are Nationally designated based on census data, population density and the percentage of workers who commute to adjacent MSA counties.
The Department is continuing to require plans that cannot immediately meet the accessibility requirements to report that they cannot do so, explain why, and explain how they intend to provide access to covered health care services through alternate means. The Department has also provided examples of alternative arrangements in the regulation. See subsection (f)(3). The Department cannot and does not require plans to create providers where none exist. Additionally, the Department does not want to inadvertently create a situation that would allow one provider to block entry into a county by refusing to contract with the plan despite the desires of other providers to participate, employers to offer, and enrollees to join managed care plans. The Department can, however, require plans to consider alternative means of providing covered services and inform the Department as to how it intends to fulfill its obligations under section 2111(1) of Article XXI.
In response to comments that the Department failed to define frequently or infrequently utilized health care services, the Department has added subsections (e)--(h). In subsection (e), the Department has listed the services that it considers to be frequently utilized health care services which must be provided in accordance with subsection (d). It has taken this list from the commonly accessed major specialty areas as designated by the American Board of Medical Specialties (ABMS). This does not mean the Department regards other ABMS specialties or subspecialties as unnecessary, but, rather, addresses the majority of a population's needs by assuring a network of at least the main specialty categories.
The Department has also addressed less frequently utilized health care services in subsection (h). That subsection states that less frequently utilized health care services may be provided by a nonparticipating health care provider or under a contract with a health care provider outside the approved service area. Those services, of which the Department uses a transplant for an example, are basic health care services other than those listed in subsection (e). Subsection (g) discusses health care services that can reliably be provided in the home, and exempts them from the travel requirements of subsections (d) and (f) as the services are provided in the home, and the location of the provider's administrative office is not an issue.
One commentator recommended that the Department include providers of assistive technology and services in its final-form regulations. The commentator stated that access to these services should be addressed the same as a frequently used specialist. The Department has declined to specifically include assistive technology and services in the regulation. Generally speaking, these are services of benefit to a small sub-set of the population; however, to the extent that they can be defined as nonbasic health care services, the plan would need to meet the standards in subsection (d) in providing them. The Department has included standards for nonbasic health care services, for example, prescription drugs, vision, dental and durable medical equipment, in subsection (i). Since these types of services are not defined as basic health care services, the Department does not see them as either frequently or less frequently used health care services, but, rather, as a third and separate category. The Department has, however, required that the plan meet the standards in subsections (d), (f) and (g) in providing nonbasic health care services for the reason that these benefits are generally offered as optional and supplemental, but limited to a single benefit category (such as vision or durable medical equipment) which is viewed as a stand alone network which must meet the minimum requirements to be of any benefit to enrollees.
In subsection (j), the Department has allowed plans to arrange for services at a distance greater than the travel times in subsections (d) or (c), if the plan does so for therapeutic reasons to provide access to quality health care services.
Act 68 changes how the Department must review and verify networks in several ways. Plans must have an adequate network of health care providers, and the term ''health care providers'' now includes everything from doctors to pharmacies to durable medical equipment suppliers. The Department does not want to discourage plans from contracting out-of-the-service area with centers of excellence for transplants and other specialized services. The Department's standards in this section are intended to permit this.
One commentator commented that the proposed section contained no access norms for appointments. Another commentator commented that access should not be limited to geographic access. The commentator cited, as an example, that if an ophthalmological office within 30 miles in a rural area was only open once a week, the standard should not be considered to be met.
As previously discussed, the Department will not set access norms for appointments. This issue is best handled by the plan's quality assurance committee and access auditing. Should an appointment not be available to an enrollee in what the enrollee considers to be a timely fashion, the enrollee has the option of filing a complaint against the plan or reporting the concern to the Department. The Department believes that plans should have flexibility to manage this operational issue within their limited ability to control it.
The Department has added subsection (k), which requires a plan to provide coverage for services provided by nonparticipating health care providers at no less than the in-network level of benefit for services provided when the plan has no available network provider. The Department is attempting to clarify that 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. Further, a plan is not required to pay a noncontracted provider at the same level of benefit as a network provider for basic health care services sought by and provided for an enrollee outside the service area.
Finally, in subsection (j), the Department has added language setting out standards for a plan to follow to obtain a service area expansion.
Section 9.680. Access for persons with disabilities.
The Department received several comments on this proposed section. The proposed section was intended to reiterate requirements in Act 68 that plans comply with Title III of the Americans with Disabilities Act of 1990 (42 U.S.C.A. §§ 12181--12188) (ADA). Proposed subsection (a) would require plans to have in network providers who are physically accessible to persons with disabilities in accordance with Title III of the ADA. Proposed subsection (b) would require plans to have in network providers who could communicate with persons with sensory disabilities in accordance with the ADA.
Several commentators complained that the proposed section would not include minimum requirements to assure that HMOs provide access to persons with sensory and physical disabilities. Commentators also stated that the proposed section would not ensure ADA monitoring and enforcement.
One commentator commented that the proposed regulations would not address the problem of providers refusing to serve persons because of their disabilities, and noted that it receives weekly calls concerning dentists who refuse to serve persons with retardation.
One commentator commented that the Department should include in the regulation minimum standards and a monitoring process governing not only access for persons with wheelchairs, but also assuring communication between providers and members who have hearing and visual problems. The commentator recommended that the Department take notice of a lawsuit on these issues against the Department of Public Welfare.
One commentator also mentioned the possibility of legal action against the Department and HMOs. According to this commentator, the Department is required to comply with the ADA, and is failing to do so by not promulgating specific regulations.
Although the Department is sensitive to concerns of persons with disabilities and their advocates concerning physical and sensory access to health care providers, the Department cannot set standards for how plans are to comply with a Federal statute. Act 68 specifically references the ADA in setting requirements for plans to ensure that they have providers that are physically accessible to persons with disabilities and who are able to communicate with persons with sensory disabilities. The ADA calls for reasonable accommodation for persons with disabilities; that is a standard interpreted by the Department of Justice and the courts, not the Department. No standard set by the Department purporting to ensure that a plan or provider would be in compliance with the ADA would be binding on the Federal government if it decided to the contrary.
With respect to issues concerning the ADA and Health Choices contracts, the Department of Public Welfare, unlike the Department in this instance, is a purchaser, and not a regulator. The question of whether the Department of Public Welfare would have been required to set standards for its contractors is different from whether a state regulator is required to set standards for compliance with a Federal statute. There is even a question as to whether the Department can, legally, undertake such regulations due to preemption issues.
Three commentators recommended that the Department add language to the proposed section requiring it to review a plan's policies and procedures to ensure compliance. One of these commentators commented that the proposed regulations should be amended to ensure that HMOs do not use fiscal disincentives to underserve persons with disabilities. The commentator recommended that actual reimbursement methods should be provided to the Department, and these methods should be monitored and reviewed for their impact on persons with disabilities.
Act 68 contains a clear directive that plans may not use incentives to provide less than medically necessary and appropriate care to an enrollee. See section 2113 of Article XXI (relating to prohibition on financial incentives). The Department will enforce this for all enrollees, including those with disabilities.
Further, section 2111(1) of Article XXI does require that all enrollees have access to adequate health care providers in a timely fashion. The Department does investigate allegations that access is being denied. Again, however, the Department cannot hold anyone responsible under the ADA. That would require a referral to the Department of Justice.
One commentator requested that the Department clarify that providers not plans must comply with the ADA.
Because the Department does not enforce the ADA, it cannot speak to whether a plan must comply with the ADA or not. That is a matter for the Department of Justice and the courts. Act 68 requires plans to have procedures in place that comply with the ADA.
Section 9.681. Health care providers.
The Department received several comments on this proposed section.
Several commentators recommended language changes to this proposed subsection. IRRC recommended the addition of the language ''updated annually'' to proposed subsection (a), and stated that the Department should explain whether a plan was required to distribute an entire provider directory annually, or just updates, or whether a plan could make updates available upon request.
Another commentator also commented concerning publication times, and stated that the provider directory should be published annually and updated quarterly, that there should be telephone responses or 24-hour verification, or both, and that the directory should include the identity of all associated health care providers, their hospital privileges, and CRNPs' collaborating physicians.
One commentator recommended that the Department add the language: ''or area of practice concentration substantiated by clinical training and experience,'' to the end of subsection (a).
One commentator recommended deleting the proposed requirement that providers be listed by specialty. The commentator noted that provider directories are arranged by different methods, some by specialty, others by other methods. The commentator stated that this was a specific problem for plans that enroll Medical Assistance (MA) recipients because such directories often list providers by zip code for ease of enrollment. Eliminating this requirement would have no effect on consumers being provided with appropriate information, as required under Act 68, but would allow for flexibility on plan's behalf.
One commentator recommended deleting the proposed subsection on the basis that the subject matter is already covered in Insurance's regulations.
After considering these comments, the Department agrees that the information is covered in Insurance's regulations, and is including Insurance's language here. Section 154.16 of 31 Pa. Code handles this topic, including timing of publication. The Department has adopted the language in 31 Pa. Code § 154.16(c)(2).
Three commentators commented on proposed subsection (b). One commentator commented on the proposed language, which would require a plan to provide access to an alternative provider if the participating provider ceases participation. The commentator stated that the standard could not always be met, and recommended the addition of language stating that the plan would make every effort to provide access.
The Department has not changed the proposed subsection. A plan is obligated to arrange for covered services. Whether it does this through contracted providers or noncontracted providers, the coverage must be provided. A plan that is unable to meet this standard through its provider network must allow enrollees to access covered services though nonparticipating providers with no penalty, as the network is inadequate for the service required.
The commentator also commented that the term ''alternative provider,'' in proposed subsection (b) could be misconstrued as allowing the enrollee access to practitioners of alternative medicine. Although the intention was not to reference alternative forms of medicine, to ensure that there is no confusion, the Department has replaced the word ''alternative'' with ''other.''
Two commentators noted that disclaimers were typically the responsibility of Insurance. One commentator recommended that the agencies ensure their regulations are consistent, and the other recommended deleting proposed subsection (b) in its entirety as already being covered by Insurance.
The Department sees no reason to delete this provision, as it is not inconsistent with Insurance's regulations. Further, as stated earlier, plans must be in compliance with both sets of regulations.
Although the Preamble discussion relating to proposed subsection (c) stated that the plan must cover nonnetwork services under the same terms and conditions as it would a participating provider, the proposed subsection requires coverage at the same level of benefit. Three commentators raised concerns about the language in the Preamble being inconsistent with language in the proposed subsection. These commentators all commented that the language could create serious problems for plans and providers.
The language in the Preamble was incorrect, and the language of the proposed subsection was accurate. Plans shall cover nonnetwork services at the same level of benefit as if a network provider had been available. The enrollee shall have access to covered services and cannot be penalized by lesser coverage when the network is inadequate.
Two commentators commented that the proposed subsection provided for going out-of-network when there were no providers available. They recommended that the final regulation define the circumstances under which the plan must pay for out-of-network care, and the procedure for doing so.
To address these comments, the Department has added language to clarify that a plan is required to provide access to services within the approved service area and is also required to set standards for availability approved by the physicians of the quality assurance committee. When the network has a deficiency, a plan must extend nonnetwork benefit levels to the out-of-network event because the plan had no network alternative. It is not possible for the Department to define every circumstance of network failure that would allow enrollees to obtain services from nonnetwork providers without financial penalty. The Department and plans can only address access from the standpoint of objective need and not subjective personal tolerances, preferences and perceptions. The Department has added language to clarify that covered services and availability is reviewed based on the approved service area. Plans are not expected to have every specialty under contract everywhere in the world to take into account enrollee travel or location outside of the approved service area. IRRC commented that the criteria for determining whether a health care provider exists, is available, or is participating were not clear. IRRC recommended that the Department further define ''no available participating health care providers'' or provide the criteria for determining whether a health care provider is available or participating.
The Department added language to clarify the network expectations pertaining to the approved service area, but has not changed the regulation with respect to this concern. As long as the plan has one provider in the network who can perform the health care service within the time frame recommended, the plan has an available participating provider. Enrollees who do not want to go to the participating provider may file a grievance if the basis of the grievance would be the medical necessity and appropriateness of the provider, or a complaint if the basis is personal preference.
Three commentators commented that proposed subsection (d) would not include standards for less frequently used specialists, or for providers who are not hospitals, primary care providers, or specialists, for example, drug stores, home health agencies, and durable medical equipment providers.
This subsection is intended to only address access to those services which are commonly used, and to which access is necessary as the first step in obtaining additional services. The Department has addressed access for pharmacy and durable medical equipment in § 9.679. The Department has not changed the proposed subsection with respect to this concern because standards for infrequently utilized services are difficult to set in regulation for several reasons. First, by definition, they are infrequent and may not occur for more than one patient. Appropriate access is directly related to the patient's medical situation. For example, reasonable and necessary access to a transplant could range from a time period of 24 hours to several months dependent upon the patient's diagnosis and health status. Secondly, while travel distance is a concern, in unusual circumstances such as transplant, the qualification of the provider generally override travel considerations. The Department does not wish to set a standard for access for infrequently utilized services that inadvertently limits the number of available providers or unduly restricts a plan in contracting with specialized centers of excellence with Nationally recognized expertise.
One commentator commented that the requirement for written procedures should reflect the definition of ''emergency services,'' specifically serious injury, impairment or dysfunction. The Department has not changed the proposed subsection to address this comment because the term ''emergency services'' has already been defined in the regulations.
One commentator commented that if proposed subsection (d) was intended to imply that plans may impose some limits on the availability and accessibility of these services, it was troubling. It recommended that the Department clarify the proposed subsection, and state that availability and access to these services must be assured.
The Department has added language to state that the procedures must ensure the availability and accessibility of these services. The Department has also included routine appointments in subsection (d)(5) as a frequently utilized health care service. This is necessary to ensure plans address enrollee's ability to obtain timely appointments.
Section 9.682. Direct access for obstetrical and gynecological care.
The Department received several comments on this proposed section. One commentator commented that it did not understand why the Department had issued proposed amendments on this topic.
The Department issued the proposed amendment because the Department has the responsibility to ensure direct access to, and availability of, obstetrical and gynecological services. It is the Department's intention to carry out this responsibility by this regulation.
Five commentators commented that the Department's standards should be consistent with Insurance's standards. One commentator stated that the standards were consistent with Insurance's standards. One commentator commented that although Insurance's regulations do specifically state that no time frames will apply, the Department's do not. One commentator commented that obstetrical and gynecological services should be regulated by the Department, and not Insurance, since the Department has the expertise to determine what services are outside a health care provider's scope of practice.
Even though the Department's proposed standards would be consistent with the regulations promulgated by Insurance, these comments indicate that the Department's intentions are not clear. The Department has, therefore, adopted the language of Insurance in subsections (b) and (c) of the final-form regulations, including language prohibiting time limitations on the direct access of these services. See § 9.682(b). With respect to the other subsections, both agencies have responsibilities in regulating direct access to these services. Since each department has different responsibilities based upon its different expertise, the regulations of both agencies should not be exactly the same.
One commentator commented that the proposed section should be expanded to provide for direct access to chiropractic services. The commentator noted that because chiropractic care is most beneficial immediately after the onset of an injury or trauma, patients should be able to have immediate access to chiropractic care. The commentator recommended allowing direct access subject to regulatory or monitoring oversight by the HMO, its gatekeeper or its delegated medical management team.
Act 68 requires direct access only to obstetrical and gynecological health care services. See section 2111(7) of Article XXI. The Department may not require direct access to chiropractic services in its regulation. Legislation would be required to accomplish this.
One commentator recommended that the Department add language stating that providers may advocate for patients, and may obtain written consent to do so at the time of treatment.
The Department has not changed the proposed section to add the requested language. Providers may always advocate for patients and do not need regulations from the Department to allow them to do so. The issue of consent to file a grievance is addressed in § 9.706 (relating to health care provider initiated grievances). The Department has revised that section to specifically permit providers to obtain consent to file a grievance on the enrollee's behalf at the time of treatment, as long as the provider does not condition treatment on the enrollee's consent.
One commentator commented that Insurance's regulations prohibit a plan from paying less for directly accessed obstetrical and gynecological services than for authorized services, but that the Department's proposed regulations would not. It is not, however, a conflict for one agency to make a requirement, which the other agency does not. Plans shall comply with both sets of regulations, and not one in lieu of the other. The Department has decided against adding this language to the regulation.
One commentator also commented that both Insurance's and the Department's regulations contradict Act 68 because they seek to limit direct access to obstetrical and gynecological services, whether for routine or other care. The commentator stated that this was not what the General Assembly intended.
Insurance's regulations were approved and are final. The Department did not intend to place any restriction on access to care not contemplated by the statute, and does not believe that this regulation does so.
The Department received several comments on proposed subsections (b) and (c). Commentators included legislators, advocacy groups, trade associations and IRRC. All recommended revision of the proposed subsections. Most comments involved the Department's use of the terms ''routine'' and ''nonroutine.'' The commentators questioned what these terms meant, and commented that to create the concept of routine services, and then require prior authorization for nonroutine services, would limit an enrollee's direct access in violation of the Act 68.
One commentator commented that the proposed subsections (b) and (c) were inconsistent with the regulations promulgated by Insurance.
One commentator commented that it recognized that Act 68's intent was not to include direct access for gynecologic subspecialty care, including, for example, reproductive endocrinology, oncologic gynecology, and maternal and fetal medicine. It recommended that the Department add language stating that these subspecialty services were the only restrictions for direct access.
One commentator commented that inclusion of related laboratory or diagnostic procedures exceeded the scope of Act 68.
After review of these comments, the Department has decided to delete the proposed texts in subsections (a), (b) and (c) of its proposed regulations, and replace them with language contained in 31 Pa. Code § 154.12(a) and (b) (relating to direct enrollee access to obstetrical and gynecological services) of Insurance's regulations. It was not the Department's intention to limit access to services. Act 68 prohibits prior authorization in certain circumstances, but does not prohibit prior authorization for any services other than those specified services. It was the Department's intention to attempt to interpret and explain for what services prior authorization may be required by a plan. Adoption of Insurance's language will ensure consistency between the agencies on these issues, and eliminate the confusion over the terms ''routine'' and ''nonroutine.'' Further, subsection (b) will permit a plan to require prior authorization of certain diagnostic testing and subspecialty care, for example, reproductive endocrinology, oncologic gynecology, and maternal and fetal medicine, as was recommended by one commentator. This was the Department's original intent. The subsection now defines by example for what types of services a plan may require preauthorization.
Two issues were raised with respect to proposed subsection (a), which still remain despite the Department's deletion of that proposed subsection. One commentator recommended that the term ''health care provider'' be replaced with term ''obstetrical and gynecological provider'' to ensure that practitioners with the appropriate training and scope of practice are providing these services.
Another commentator recommended that language be added to the proposed subsection to state that the plan cannot penalize a family physician economically, or in any other manner, which includes refusing to credential that provider, since an enrollee is required to be afforded direct access to obstetrical and gynecological services. The commentator also commented that plans refuse to recognize that family physicians can provide these services, and are taking the position that Act 68 requires plans to credential providers for the provision of obstetrical and gynecological services where they have requisite experience. The commentator stated that this position operated to the detriment of the enrollee, and recommended that the Department expressly require plans to credential family physicians for these services, and that plans inform enrollees of their availability.
Even though subsection (a) has been deleted, the Department believes that these comments need to be addressed. Act 68 already states that the health care services must be within the scope of practice of the provider to which the enrollee has access. See section 2111(7) of Article XXI. Plans are free to determine who may be directly accessed for these services, since it is direct access to the service that is required by the statute, and not direct access to a particular type of provider. Id. Nothing in Act 68 requires that the plan credential every health care provider capable of providing the service as a provider who may be directly accessed for these services. A plan is required to maintain an adequate and accessible network and to credential the providers in that network. The Department is not in a position to review the training and expertise of every specialty and subspecialty area and issue judgements about what health care services certain providers can and cannot be allowed to perform. The Department will not regulate to that level of detail.
The Department is redesignating proposed subsection (d) as subsection (c). The proposed subsection would require a plan to develop policies and procedures that describe the terms and conditions under which a directly accessed health care provider may provide and refer for health care services with and without obtaining prior plan approval. The proposed subsection would have also required the plan to have these policies and procedures approved by its quality assurance committee, and to provide the terms and conditions to all health care providers who may be directly accessed for maternity and gynecological care.
Two commentators raised issues with this proposed subsection. One commentator stated that there is no statutory authority for requiring plans to have policies and procedures addressing when referrals are necessary, no statutory authority to require the plan to have these policies and procedures approved by the plan's QA committee, and no statutory authority to require the plan to provide the policies and procedures to providers.
With respect to direct access, the Department has the statutory authority to require plans to submit policies and procedures to a quality assurance committee. Act 68 need not specifically include language authorizing the Department to take an action for the Department to have the authority to do so. The Department has the ability to interpret the statute to enforce the statute's requirements, as required by the legislature. To implement the direct access requirements of section 2111(7) of Article XXI, the Department is requiring plans to develop policies and procedures (credentialing and quality assurance) for the provision of direct access. Further, the Department is requiring that these policies be reviewed by the quality assurance committee to ensure that the most up-to-date medical and clinical information is considered in determining when and how prior authorization will be required. All this is necessary to ensure that enrollees obtain direct access to services which is meaningful and clinically appropriate. These requirements are well within the parameters of the statute.
IRRC commented that the Department had required no other policies and procedures to be approved by a plan's QA committee, and asked why the Department had singled out obstetrical and gynecological care. The Department did not single out obstetrical and gynecological care for review by a plan's QA committee. The QA committee is concerned with the UR function, among other things. The Department has required QA committee approval of a specialist as a primary care provider or standing referral policies and procedures. See § 9.683(c) (relating to standing referrals or specialists as primary care providers). The Department has included this requirement in the regulation because the Department believes clinical determinations, for example, the identification of those services for which prior approval may be obtained, which may, in fact, change rapidly as the course of medicine changes, are inappropriate for definition by the Department, or for inclusion in regulation. Therefore, the Department determined that review by the plan's quality assurance committee was the most appropriate way to allow for clinical review and for flexibility, including the addition of new services, without the need for regulatory amendment.
Section 9.683. Standing referrals or specialists as primary care providers.
The Department received several comments on this proposed section. One commentator noted general concerns with the regulation, but did not specify them. Two commentators supported the regulation. One commentator commented that the Department's proposed amendments were far more detailed than Insurance's regulations concerning the process for deciding whether an enrollee could have a standing referral or specialist. The commentator stated that this was one more example of why the regulations should have been considered at the same time. Another commentator stated that Insurance should not regulate standing referrals, rather the Department should since they involved issues of medical necessity.
The issue of whether Insurance's regulations should have been reviewed with the Department's proposed amendments is now moot. Insurance's regulations are already final. In any case, the regulations do not contradict each other, they complement each other and contain what is necessary for both agencies to carry out their responsibilities under Act 68.
One commentator commented that the proposed amendments were inadequate and would fail to assure compliance with Act 68. The commentator specified the problems with the proposed regulations as follows: (1) they would fail to set criteria for when plans should grant standing referral requests; (2) they would fail to set time frames for plans to decide on such requests; and (3) they would fail to require disclosure to consumers and providers of the criteria for approving these requests.
In response to the first point, the criteria would involve different standards for each and every possible disease or condition and the provider combinations that could or would be appropriate for a standing referral. These determinations are complex, clinical and can change over time. The Department believes that this information is improper for regulation, which does not allow for the necessary flexibility required to match individuals with the most appropriate provider.
Further, Act 68 requires the plan to set these criteria and develop procedures for, first, an evaluation of the patient, and then for the provision of the standing referral. The threshold standard for a standing referral is already in Act 68. Act 68 states that the enrollee must have a life-threatening, degenerative or disabling disease or condition to make a request and obtain an evaluation. See section 2111(6) of Article XXI. Secondly, the Department did set time frames for the plan to act on the request--a reasonable amount of time given the individual's disease or condition, but within 45 days. Lastly, Act 68 already requires disclosure of procedures. Section 2136(a)(13) of Article XXI.
One commentator recommended that the Department use its criteria as the standards for evaluating whether physicians in nonprimary care specialties can serve as primary care physicians.
The Department has declined to adopt those criteria. Act 68 leaves the determination of whether or when to request an evaluation for a standing referral to a specialist for care or to have a specialist function as a primary care provider up to the enrollee. The plan is required to set standards for these evaluations and for determining whether or not to grant the enrollee's request, but it is the enrollee who initiates the request. The plan may include the primary care provider (Act 68 provides for a primary care provider, not necessarily a physician) in this evaluation; that is up to the plan to determine, in accordance with the Department's regulations. The Department does not intend to place additional restrictions on the plan or the enrollee by requiring the plan to defer to the primary care physician in making its determination of whether to allow a standing referral, or designate a specialist as a primary care provider.
One commentator complained that the proposed regulations would not require the plan to notify or seek Department approval of policies, procedures, clinical criteria or any amendments for referral.
The Department has not changed the proposed regulations with respect to this concern. The Department believes the setting of clinical standards, such as those that shall govern a determination under this section, are more properly reviewed by the plan's quality assurance committee.
The Department received one comment on this proposed subsection (a). The commentator recommended that the Department clarify that plan was not obligated to offer eligible members a choice between a specialist as a primary care provider or a standing referral to a specialist. The commentator stated that the plan should be permitted to determine which of the two approaches that would be most consistent with its program, and pointed out that either approach would achieve the same goal.
The Department sees no need to clarify the subsection. The Department takes the position that Act 68 permits either approach. The Department also believes that the plan must establish standards for evaluating, issuing or denying a request for either approach. Which approach is provided by the plan should depend upon which is appropriate given the particulars of the patient and the nature of the request. A plan must develop policies for providing either approach as is appropriate. A plan will not meet the terms of Act 68 or the Department's regulations by only setting out standards for one or the other. The enrollee may request one approach, although the plan, under it standards, directs a different approach because it determines it is preferable given the circumstances of the enrollee's condition. The plan may want to approve a standing referral rather than designate a specialist as a primary care provider if the specialist in question does not have adequate office hours or on-call arrangements to ensure that the enrollee has access to primary care. Granting approval of one approach over another is permissible under Act 68, although the enrollee may choose to file a complaint or a grievance if the approach approved is not acceptable to the enrollee.
The one comment that the Department received on proposed subsection (b)(1) recommended that the Department delete the phrase ''including a process for reviewing the clinical expertise of the requested specialist.'' The commentator stated that this was the purpose of the existing credentialing process.
The Department has not deleted the language. The requirement of the proposed paragraph would be beyond the scope of the regular credentialing process. A plan cannot anticipate every type of request that may be made to it in advance and cannot be expected to determine the extent to which every specialist can or should serve as a primary care provider. The regular credentialing process will not tell a plan whether a cardiologist should serve as a primary care provider for a patient with rheumatoid arthritis, whether an obstetrician/gynecologist should serve as a primary care provider for a patient with a heart condition or whether a chiropractor should serve as a primary care provider for a diabetic. A provider may be credentialed through the credentialing process as a specialist, but the provider's training may not be appropriate for the needs of the individual patient making the request. This is what the plan's procedures should address.
The Department received several comments on proposed subsection (b)(3), three of which noted that the Department had failed to include the statutory language in the proposed paragraph which requires the treatment plan to be approved in consultation with the primary care provider, the enrollee and as appropriate, the specialist. Section 2111(6) of Article XXI. The Department acknowledges the oversight, and has included the language ''in consultation with the primary care provider, the enrollee, and as appropriate, the specialist'' in the regulation.
One commentator also requested that the Department specify who would develop the treatment plan, and what it would include. The commentator recommended that if the plan is a clinical plan of care, the member's physician, primary care provider or specialist should develop the treatment plan. The commentator recommended that the Department add the following language to the proposed paragraph: ''The specialist physician will develop a treatment plan in coordination with the member's primary care physician as applicable. This treatment plan will be presented to the managed care plan for approval.''
The Department has made no change to the proposed paragraph to address this concern. Who develops the treatment plan is not as significant as who participates in the development and who approves the treatment plan. The Department does not feel the need to dictate this level of detail on what is essentially a plan of action agreed to by the enrollee, the specialist and the plan arrive at an acceptable arrangement. The primary care provider is not the controlling factor, but should be included in the process so that the provider is able to coordinate care of the patient when the specialist is no longer acting as the primary care provider, or more importantly, during the course of the standing referral so that each provider and the enrollee understand who to contact for what services.
One commentator recommended that the Department include language in subsection (b)(4) stating that subjecting the procedures to the utilization management requirements and quality assurance criteria would in no way eliminate the right of the enrollee to an evaluation for a standing referral to a specialist or designation of a specialist as the enrollee's primary care provider. The commentator was concerned that without this language, there would be ambiguity as to the enrollee's right to request an evaluation.
The Department has not added the language. This paragraph does not impact the enrollee's right to request an evaluation. Rather, it refers to the operational guidelines, terms and conditions a provider must follow once the arrangement is approved. Regardless of the absence or presence of plan procedures, the enrollee always has the right to request an evaluation to determine specialist involvement.
Two commentators requested alterations to subsection (b)(5). One commented that since a primary care provider could be designated as a specialist, the language was not quite correct. The commentator recommended changing the word ''specialist'' to ''provider.'' Both commentators also recommended changing the last sentence of the proposed subsection to take into account the plan's need to keep the services in network. One suggested replacing ''as appropriate'' with ''if no participating provider is available.'' The other recommended ''When possible, the specialist must be a health care provider participating in the plan.''
The Department agrees with the comments. It has changed the word ''specialist'' to ''provider.'' It has also added to the regulation the following language: ''when possible, the specialist must be a health care provider participating in the plan.''
Two other commentators suggested that the proposed paragraph should contain language requiring an expedited review when the decision to disallow the request could impact the life, health or maximum function of the enrollee. The Department has not made this change. Subsection (b)(7) designates the denial of the request for a specialist as a grievance and requires the plan to provide individual information on how to appeal a denial through the grievance process. The regulations already provide an expedited review for certain grievances, see § 9.709 and there is no need for a special expedited review process in this section.
It is important to underscore the fact that an enrollee making this type of request is not being denied care or services. Services are available through the enrollee's designated primary care provider; however, the enrollee wishes to have them provided by a specialist. The Department is requiring a plan to review the enrollee request in a time frame that takes into consideration the enrollee's situation, but on no account to exceed 45 days. Even if the plan takes the full 45 days to conduct the evaluation and reach a decision, the enrollee is able to receive care through the primary care provider and traditional referrals during that time period.
One commentator supported the time limits on responding to requests in subsection (b)(6).
Several commentators commented on this time period. IRRC requested that the Department explain why 45 days would be an appropriate time period in which to respond to the request for a standing referral to a specialist, or designation of a specialist as the enrollee's primary care provider. Another commentator recommended that the Department reduce the 45-day time limit for final decision to 30 days. The commentator noted early intervention promotes timely recovery.
One commentator stated that the Department had failed to ensure timely access to specialists for both acute and long-term disease management of brain diseases. This commentator noted that best practice standards require access to array of medically necessary medical and rehabilitation treatments.
The Department has not changed the proposed paragraph to address these issues. A plan review of an enrollee request generally requires consideration of the requested specialty provider's suitability given the enrollee's condition, availability to serve 24 hours, 7-days-per-week, the scope of the proposed treatment and a determination as to whether a standing referral or primary care provider designation is most appropriate in the circumstances. This review will generally include the medical records of the requesting enrollee and a specific treatment plan. As stated previously, a review of this type of request does not mean that services are not being provided. Services are not denied during the review period but are made available by the participating care provider or ''by referral,'' arrangements less preferred by the enrollee. Further, the Department requires the plan to take no more than 45 days and to take into consideration the nature of the enrollee's condition in arriving at its decision. Plans could and should take less that 45 days to review the request if the enrollee's condition warrants it.
One commentator commented that proposed subsection (b)(6) contradicted Insurance's regulations, since Insurance did not address these issues.
The Department's regulation regarding time frames contradicts nothing in Insurance's regulations. The fact that one agency issues a regulation on which the other agency chooses to be silent does not create a contradictory regulation. To be in compliance for the purposes of Act 68, a plan must be in compliance with both sets of regulations.
One commentator supported the proposal in subsection (b)(7) that a denial of the request would give rise to a grievance. Another commentator disagreed with this, and stated that since these decisions would be based on plan policies, which are operations and management decisions, they should be complaints. This commentator also noted that the Department's current statement of policy and Insurance/Department grid of complaints and grievances treats them as complaints.
The Department has reviewed its proposal to designate these denials as grievances in its policy statement. The statement of policy is repealed by these regulations. The grid remains a tool for guidance, and is not dispositive of these issues. The grid has long since been acknowledged by the Department as inaccurate and obsolete in many cases. The nature of the request and the underlying decision in these matters focus on medical necessity; that is, whether the enrollee's request for a specialist to serve as a primary care provider or a standing referral is medically necessary or appropriate. In considering such a request, the plan shall weigh the clinical appropriateness of the alternate arrangement, whether the specialist is appropriate for the condition, and whether the enrollee's condition is such that care can be better delivered or managed by a specialist. In rejecting such a request, a request that a specialist must have agreed with and supported, the plan is either disagreeing with the appropriateness of the specialist in favor of the primary care provider, or making a determination that the enrollee's condition does not warrant such an arrangement. These matters should be grievances. Therefore, the Department has not changed the proposed paragraph to address the concern.
One commentator recommended that the enrollee be required to get the consent of a specialist to be the enrollee's primary care provider so that the plan could avoid reviewing cases when a particular specialist does not want to be the primary care provider.
The Department acknowledges that there is some merit in this suggestion, because the arrangement cannot and should not take place without the consent and support of the specialist. However, the Department believes that the burden placed on the enrollee to articulate the request, negotiate the terms and gain the consent of a specialist would be too great for the Department to make this a condition for requesting such an arrangement. Additionally, the enrollee need not request a specific specialist by name in making a request for a standing referral or designation of a specialist. It is conceivable, in fact, that an enrollee may not have a particular specialist in mind when the request is made. The Department would expect the plan not to approve such an arrangement without first ascertaining the willingness of a specialist to agree to such an arrangement.
If an enrollee has a specialist the enrollee intends to suggest in making the request, and with whom the enrollee has a prior relationship, it would be useful to both the enrollee and the plan to determine that the specialist is willing to operate in this capacity. It is not required that the enrollee do so, however.
A commentator again raised the issue that Insurance has no regulation concerning the need to include information concerning appeal rights in the plan's decision. The Department reiterates its position: the fact that one agency issues a regulation on which the other agency chooses to be silent does not create a contradictory regulation. The Department's regulation regarding appeal rights information contradicts nothing in Insurance's regulations. To be in compliance with Act 68, a plan must comply with both sets of regulations.
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