[31 Pa.B. 3043]
[Continued from previous Web Page] Section 9.652. HMO provision of other than basic health care services to enrollees.
One commentator requested that the Department clarify the extent to which an HMO may offer other product lines independently of the provision of basic health care services. For example, may an HMO offer its dental program/product to a member of an enrolled group who does not select enrollment in the basic HMO benefits package? May an HMO offer its dental plan to a group which does not offer its HMO benefits package as an option to employees? May an HMO offer a PPO product?
This proposed section was intended to apply to benefit packages offered by HMOs and those services, than can be offered in addition to basic health services not instead of basic health services. The other questions raised by the commentator are more appropriately addressed to Insurance.
One commentator commented that this proposed section failed to require the disclosure of basic services to potential enrollees.
This proposed section was intended to implement provisions of the HMO Act that discuss what services are to be provided to the enrollee, not what disclosures were to be made to potential enrollees. See section 4 of the HMO Act (40 P. S. § 1554). Section 2136(a) of Article XXI (40 P. S. § 991.2136(a)) does require managed care plans to make disclosure of benefits, limitations, and exclusions and other information to enrollees and potential enrollees upon written request. This is further addressed by Insurance in 31 Pa. Code § 154.16. The Department has made no change to the proposed section based on this comment.
Two commentators commented on the lack of access norms for appointments in the proposed section. One of these commentators commented that the definition of ''network'' would be inadequate. The commentator stated that the proposed section would not specify what providers and specialists would be required to be available, whether networks would be required to include adult and pediatric providers for each specialty, what appointment access standards would apply and how far an enrollee would have travel for a referral. Another provider also commented on the lack of access norms for appointments.
IRRC recommended that the Department define what would constitute reasonable access to a network as required by paragraph (1).
Another commentator commented that the proposed amendments should include sufficient standards for primary care provider training and for an adequate network.
The Department requires plans to develop access and availability standards, which are highly dependent on the individual patient's condition and not suitable for government regulation. Reasonable patient access to a magnetic resonance imagining or MRI scan could range from same day to within 2 weeks depending on the nature of the suspected illness or condition. An arbitrary standard such as 3 days could be much too long for some patients and much too aggressive for others.
With respect to access to pediatric and adult specialty providers, the proliferation of pediatric subspecialties is a relatively recent development that has not fully evolved. There are times when the patient's condition absolutely warrants a pediatric subspecialty, but that is not always the case. For example, there are very few, if any, otolaryngologists, (commonly known as ear, nose and throat specialists or ENTs) who have not provided care to children with otitis media. The fact that there is now a subspecialty called pediatric otolaryngology does not mean that a general ENT is no longer qualified to continue treating pediatric patients. The Department's focus is on requiring the plan to have adequate and accessible health care services, not on dictating treatment terms or appropriate providers.
Further, the Department's network access standards are included in § 9.679. The Department has cross-referenced that section in paragraph (1) for clarity. The Department is requiring the plans to set standards for provider training and specialists as primary care providers that they must audit against. See § 9.683 (relating to standing referrals or specialists as primary care providers).
One commentator requested clarification concerning what entity would be responsible for offering and conducting the complaint and grievance process with respect to nonbasic health services offered by the HMO through contracts with ancillary service plans, such as vision or dental, which would not be subject to the proposed regulations. See proposed paragraph (3).
If an HMO chooses to offer a nonbasic, or supplemental, health service as part of its benefits package, the HMO is responsible for providing the Act 68 grievance and complaint process, regardless of whether or not it subcontracts with an ancillary service plan to provide the network, benefits or administration. The Department has made no change to the proposed paragraph based on this comment.
Section 9.653. Use of copayments and coinsurances in HMOs.
The Department received several comments on this proposed section. Two commentators supported the Department's proposed repeal of the copayment language in § 9.72(b), now repealed. One of these commentators noted, however, that the proposed section would deal with copayment as well as coinsurance. The commentator stated that approval of coinsurance was not authorized by statute.
The commentator also recommended that the Department add language which would state that the Department's consideration of whether the request to charge copayments would detract from the availability, accessibility, or continuity of services would be from the economic position of the lowest wage enrollee in the plan.
One commentator commented that an HMO should have the freedom to meet the expectations of the market place in terms of the levels of copayment and coinsurance available as part of a benefits package.
Seven commentators raised concerns that the proposed section would not set standards for the review of copayments and coinsurances.
One recommended that language establishing standard or a maximum threshold be added to the regulation.
One stated its concern that the proposed section would fail to limit copayments.
One commented that the proposed amendments would not list criteria the Department would use to determine impact on availability, accessibility or continuity of services or how it would ensure that the request constructively would advance the purposes of quality assurance, cost effectiveness and access. If the Department intended to review these matters, it should alert the regulated community to standards it would use to make these decisions.
One stated that the proposed amendments would fail to provide for the review and monitor of copayments, set maximum limits, and provide for the HMO to periodically update and disclose copayments to potential enrollees and enrollees.
One stated that the proposed section would be too vague, and needed to be clarified to ensure patient access to care.
One commented that the proposed section would be weaker than the language of the regulations the Department is repealing because the proposed amendments would not include the percentages in repealed § 9.72(b), and because the Department would only review these matters if Insurance requested the Department to do so.
One commentator recommended that copayments and coinsurances should be the same for patients seeking emergency medical care at participating and nonparticipating facilities. The commentator recommended that the standards should not be set so high as to dissuade prudent laypersons from using emergency medical services.
Several commentators commented that the Department should review coinsurances and copayments for their impact on access to care, and the regulations should state specifically that the Department is doing so. These commentators stated that any potential negative effect of excessive copayments and coinsurance amounts would impact quality of care concerns, which are fully within the jurisdiction of the Department. These commentators recommended the removal of language, which would only permit the Department to review these matters at the request of Insurance. One commentator recommended that the Department retain the right to establish maximum coinsurance and copayment amounts.
One commentator stated that the proposed section should contain a much stronger statement that there was a need to limit copayment to avoid undertreatment. This commentator noted that the PPO regulations state that copays of over 20% can result in undertreatment. The commentator stated that if percentages were a problem in the Department's previous regulations, other methods should be used to accomplish the same result.
Two commentators questioned whether the proposed section was superfluous. One recommended deleting the copay section since Insurance may ask for the Department's opinion without it, and language to that effect should be in Insurance's regulations, and not the Department's. The other commented that since Insurance already reviews rates, this proposed section could impose two levels of review as part of the regulatory approval process, causing unnecessary delays and extra costs.
IRRC asked whether the Department had approval authority over an HMO's request to use copayments and coinsurances in its benefit structure. IRRC also asked why it was necessary for the Department to state in its proposed amendments that it could perform an interagency review on this particular issue. IRRC asked whether there were other aspects of HMO operations that the Department have reviewed at Insurance's request, what they were and how they were carried out.
The Department has decided to delete this section. The authority for the review of these matters rests with Insurance since approval of copayments and coinsurances is directly related to the approval of rates and benefits.
Section 9.654. HMO provision of limited networks to enrollees.
The Department received several comments on this proposed section, which has been renumbered as § 9.653.
IRRC recommended that the Department define the term ''limited subnetwork'' in the definition section. Several other commentators also requested a definition of the term.
One commentator requested clarification of the term ''limited subnetworks.'' The commentator commented that it was subject to many interpretations, and asked whether it meant closed panel products only.
IRRC also noted that the Department used both the term ''limited network'' and the term ''limited subnetwork'' in proposed subsections (a) and (b). IRRC recommended that the Department use one term.
The Department does not need to add a definition of ''limited subnetwork'' to § 9.602, as the definition is included in the language of subsection (a). It is a network that includes only selected participating health care providers. The Department has added language to the subsection to clarify the definition.
The Department agrees that it should be consistent with terms, and has chosen to use the term ''limited subnetwork.'' The Department has made the necessary changes to proposed subsections (a) and (b).
With respect to the question concerning closed panel products, the term ''limited subnetworks'' applies to both open and closed panel products. The limited subnetwork must still meet the minimum standards regardless of product line or model type.
One commentator raised concerns that the proposed section would have a negative impact on children with disabilities. The commentator criticized the proposed section for not imposing limits on how far an enrollee might have to travel to a provider, or how long the enrollee might have to wait to get an appointment. The commentator stated that failure to regulate these matters could result in burdensome travel and paperwork requirements on children with disabilities and their families, especially if they do not have a choice of plan.
Again, the limited subnetworks described in the proposed section would still be required to meet the minimum access requirements in § 9.679, which do limit travel for frequently utilized services. The Department has added paragraph (5) to clarify that a limited subnetwork shall meet standards for adequate networks and accessibility.
One commentator stated that there was no statutory basis for allowing HMOs to provide a limited network. The commentator stated that the process included in proposed subsection (b) was inadequate to protect consumers.
The statute neither mandates nor prohibits limited subnetworks, so that the Department can neither require an HMO to have them, nor prohibit it from using them. The Department can attempt to place some limitations on limited subnetworks, for example, requiring an HMO to notify enrollees of coverage so that they do not suffer out-of-pocket losses from failing to understand the terms of the plan and the network limitations.
One commentator commented that the proposed section would sanction discrimination on the basis of race or payment source. The commentator noted that plans can bid on Medicaid contracts, shield mainstream providers from serving the Medicaid population, provide lower capitations for higher risk enrollees and so on.
The Department's regulation does not allow discrimination. Any limited network must continue to meet the minimum access standards in § 9.679. Limited subnetworks are generally offered in cases when the employer wants to concentrate services in a smaller number of providers than the overall larger plan network. This could be to decrease costs and premiums, to keep benefits affordable or it could be because the employer believes the subnetwork represents the best performing, highest quality providers in the area. In all cases, the limited subnetwork must meet the minimum network standards, there must be clear notice to enrollees and enrollees cannot be financially penalized with lesser coverage when services are not available through the limited subnetwork.
One commentator recommended that proposed paragraph (3) could be strengthened by replacing the proposed language with language that states that the HMO is required to have ''an adequate number and distribution of network providers with the training and experience to provide care. . ..'' The commentator noted that the proposed paragraph would require an adequate number and distribution of providers, but expressed concern that HMOs often fail to include an adequate number or distribution of providers who have training and experiences to meet needs of enrollees. The commentator stated that the addition of this language would address that issue.
Adequate training and expertise must be determined by the plan in conjunction with the individual enrollee's circumstances and needs. The Department can not set into regulation standards for training and expertise sufficient to cover all possible and potential enrollee needs. In the event an enrollee has a concern regarding adequacy of the plan's providers, the Department will investigate.
One commentator raised concerns that the requirement in proposed subsection (a) that an HMO obtain prior approval of a limited network before offering it would negatively affect future development and implementation of the options. The commentator noted that these networks were a result of purchaser preference and demand. At a minimum, the commentator asked the Department to define ''limited subnetworks'' and give direction on when prior approval is necessary.
The Department must review the adequacy of the network for the population to be served. If the Department did not do so, HMOs could offer products with less than minimally adequate networks.
The Department received several comments on proposed subsection (b)(1), which would require the HMO to ensure adequate disclosure to potential enrollees of the limitations in the number of the provider's participating.
IRRC commented that the term ''adequate,'' which the Department used to describe disclosure of participating provider information to enrollees, is vague, and that the Department should provide more specific parameters. IRRC also commented that disclosure must be consistent with disclosure requirements in Insurance's final-form regulations. Four other commentators noted that the Department had failed to set disclosure standards. One of these noted that the standards should include requiring the inclusion of disclosure language in a provider directory, or marketing and enrollment materials.
Several commentators noted that the proposed amendments would not require disclosure to current as well as new enrollees. One of these commentators expressed concern that because of this, the regulations were not protective of older persons. By allowing plans to limit networks beyond the amount needed for certification, the commentator stated that the Department was taking a step backward from the legislative intent of the General Assembly.
One commentator commented that the disclosure to enrollees of limited networks would mean little since many employees have no choice.
The Department's regulations do not permit a plan to limit the network below the minimally acceptable threshold in a service area and retain the ability to operate in that area. The Department's prior approval process is intended to prevent this from occurring. Further, if the Department receives complaints of access problems, the Department has the ability to, and does, investigate and take action against the plan when warranted.
The Department did not intend to provide a notice requirement in this section that would allow enrollees to avoid limited networks. The Department is aware that is the employer's choice to offer these networks. The Department has no authority to forbid the networks from existing, but can ensure that HMOs provide adequate access and availability of services. The disclosure requirement is intended to protect enrollees from out-of-pocket costs by ensuring they are notified of the network's limitations, and the possible economic impact to them if they obtain services outside of the network. Therefore, the Department has changed the proposed amendments to require notice of coverage limitations in marketing and membership material that must be issued in advance of the effective date of coverage. This notice must also be contained in membership material to current enrollees, for example, in handbooks, newsletters and announcements. See subsection (b)(1).
The Department agrees that this disclosure should go to current as well as potential members, and has revised the proposed subsection (b)(1) to require this.
Further, these limited networks must meet the access standards in § 9.679. The Department has added language to clarify that fact, and to clarify that disclosure must be consistent with Act 68, and with Insurance's regulations. The Department has added a reference to 31 Pa. Code § 154.16. See subsection (b)(1).
Four commentators stated that the wording of proposed subsection (b)(2) made it clear that the Department would approve networks without a single provider in them, if the HMO could otherwise provide the service. They stated that proposed subsection (b)(2) would require an HMO to provide or arrange for the provision of services to an enrollee at no cost other than a routine copayment if a covered service were not available within the limited network. One of these commentators stated that this would permit an HMO to restrict enrollees to inadequate networks.
One commented that this would give an enrollee no choice in the matter of choosing a provider. One also commented that proposed subsection (b)(1) would allow an HMO to restrict access by limiting some enrollees to a potentially inadequate network.
One commentator also commented that the proposed subsection (b) would allow a plan to arrange for the service out-of-network without giving the enrollee a choice of provider. The commentator stated that the HMO could get the lowest price from a noncredentialed provider and force the consumer to receive services there.
The comments made by the commentators on this proposed subsection (b)(1) are incorrect. The Department cannot and would not permit a limited network without a single provider. Limited network products must meet the minimum network requirements. As the Department has stated, limited subnetworks are generally developed at the request of employers as discussed above to either reduce premiums and retain benefits or to develop a network of those providers viewed as most highly qualified. HMOs do not place enrollees in these limited network plans; the employer or the enrollee must select the plan. More importantly, the Department requires the limited network to meet minimum access standards. The Department has added subsection (b)(5) to clarify that the standards in § 9.679 apply.
With respect to out-of-network usage, it is not the intention of the Department to allow an HMO to force enrollees to obtain services from uncredentialed providers. In a basic 2-tier limited subnetwork arrangement, enrollees obtain their highest level of coverage when accessing care within the subnetwork. There may be no coverage available when the enrollee obtains care outside of the subnetwork, or there may be reduced coverage. There can be a multiple-tier plan that would provide the highest level of coverage when services are obtained through the subnetwork, reduced coverage when an enrollee goes to providers in the overall network who are not part of the subnetwork, and further reduced or no coverage when the enrollee goes to providers who do not participate at all with the HMO.
In any of these scenarios, the Department's position is that the enrollee cannot be penalized economically when the plan has no provider on the panel from whom the enrollee can receive care and the highest level of coverage. In other words, it is not the enrollee's fault if the enrollee needs something for which there is no network provider. The plan has the option to recruit a provider into the network or provide the benefit at a network rate when a nonnetwork provider is used. Having no provider option to offer, the plan is not in a position to force the enrollee to use any one nonnetwork provider over another. It was not the intention of the Department to allow this to occur. The Department has added language to subsection (b)(2) stating that the HMO is to provide for the service at no additional out-of-pocket cost to the enrollee.
IRRC commented that the Department used the term ''adequate'' to describe number and distribution of network providers in subsection (b)(3), and that the term was vague. Proposed subsection (b)(3) would require a limited subnetwork to have an adequate number and distribution of network providers to provide care that is available and accessible to enrollees within the service area.
Again, for reasons already discussed, the Department must consider adequacy based on the individual needs and circumstances of the patient. The Department has minimum standards for adequate networks set out in § 9.679. The Department has added language to subsection (b)(3) referencing § 9.679 to clarify that these requirements apply.
IRRC and four other commentators commented that the Department failed to define ''reasonable traveling distance'' in proposed subsection (b)(4). The proposed subsection would state that enrollment would be limited to enrollees within a reasonable traveling distance to limited participating network providers. The commentators stated that this would permit limited networks.
The Department requires the limited network to meet minimum access standards. As stated previously, the Department is adding subsection (b)(5) to clarify that the standards in § 9.679 apply to the provisions of this section.
Section 9.655. HMO external quality assurance assessment.
The Department received several comments on this proposed section, which has been renumbered as § 9.654 in the final-form regulations.
Four commentators raised concerns about the Department's proposed repeal of repealed § 9.93(c)(5), particularly the provision which required a statistically significant sample of medical records be done during the external review. These commentators commented that the proposed section reduced the scope of the external review by dropping this requirement.
The Department has not changed the regulation to reinsert a requirement that statistically significant sampling be done. These reviews are done to monitor recordkeeping in the physician office. Statistical sampling is not necessary for this; rather, the random review of records will provide enough information to be able to assess the provider's adherence to the record keeping standards of the plan.
Seven commentators also raised concerns that the proposed section contained no requirement for corrective action when violations are detected.
The regulations in § 9.606 do include mechanisms for corrective action if problems are found during external reviews. There is no need to reiterate this at every step of the regulations where corrective action might be needed. Section 9.606 provides several options for how to compel correction, including the ability for the Department to require a corrective action plan from an HMO. How and when the Department chooses to use these options, however, is within the Department's discretion.
The Department received over 20 comments on proposed subsection (a). Proposed subsection (a) would require an HMO to have an external quality assessment conducted by an eternal quality review organization acceptable to the Department within 18 months of receipt of a certificate of authority, and every 3 years thereafter, unless otherwise required by the Department. These comments fell into three categories: (1) whether the review was an independent review; (2) the change from 1 year to 18 months; and (3) questions concerning the use of an independent review organization.
Independent External Quality Assurance Assessment
Several commentators raised concerns that the proposed subsection (a) would provide for an external review to be done by a reviewing organization hired and paid for by the HMO, and that the HMO, rather than the Department, would determine the scope of review. They averred that the review process was therefore flawed in that it was not an independent review.
The Department disagrees with the comments that the process is not independent, and is driven by the HMO. Although an HMO is required to pay for the review, the Department sets the standards for the review by approving the review organization performing the review and the standards used by that organization. The Department participates in the reviews to ensure compliance with the standards included in the HMO Act, Act 68 and these regulations. Also, the Department must review the findings of the independent organization, and decide whether to accept or reject those findings.
18-Month Review Period and 3-Year Review Period
Several commentators raised concerns that the proposed subsection would change the time frame for the initial quality assurance review from 12 months, under the regulations proposed for repeal, to 18 months. The commentators stated that this would leave consumers in new untested plans that had not been subjected to any scrutiny. They also stated that enrollees would not be protected from unacceptable practices, since there would be no readiness review and the Department might or might not perform a site visit.
Several commentators also raised concerns that proposed subsection (a) would not require ongoing reviews even if there were serious problems, and that the second external review required of a plan would not be until a period of 3 years after the first.
IRRC noted that the Preamble to the proposed rulemaking stated that the Department had chosen these time frames to be more consistent with Nationally recognized accrediting bodies. IRRC asked for the Department to identify these bodies.
One commentator recommended that the requirement for external quality review be at 18 months after enrollment of the first subscriber, rather than 18 months after receipt of a certificate of authority. The commentator stated that this would ensure sufficient data for a meaningful review.
The Department agrees that the first external review should occur within a certain time frame after the first enrollment has taken place, and has changed the language of proposed subsection (a) accordingly. The Department has not changed the proposed time frame, however. Subsection (a) requires an HMO to have an external review 18 months after enrollment begins. This reflects the NCQA requirements as the Department stated in the Preamble to its proposed rulemaking. The NCQA is currently the only organization approved by the Department to perform external quality assurance reviews. For the NCQA to do a valid review, it must base its review on 12 months of utilization data, which can only be gathered from the time enrollment begins.
Further, the Department does perform readiness reviews, and has added language stating that it will perform readiness reviews prior to approving a certificate of authority. See § 9.632(e). The Department has also added language to the regulation stating that it will conduct a site review 12 months following the approval of a certificate of authority even if there are no enrollees. See subsection (a)(1). The Department has also added language to allow it to perform site visits in instances where more than 18 months from the issuance of a certificate authority the plan continues to have no enrollment. See subsection (a)(2). Lastly, the Department has added language to make certain that if more than 24 months go by without enrollment, the HMO cannot enroll members until the Department has conducted a site visit. See subsection (a)(3). Because of these additional Department reviews, the impact of this 6-month change on enrollees should be negligible.
Further, the requirement of a site visit in the nature of a licensing visit every 3 years is not unusual in the area of health licensure. The Public Welfare Code (62 P. S. §§ 101--1553) limits the term of a license of a drug and alcohol abuse treatment facility to 1 year. See section 1009 of the Public Welfare Code (62 P. S. § 1009). The Health Care Facilities Act (35 P. S. §§ 448.101--448.904b) limits the length of a license to a 1-year period with respect to health care facilities other than hospitals and a 2-year period for hospitals, or to the dates of licensure which coincide with Nationally recognized accrediting agency accreditation (3 years for hospitals). See sections 804(d) and 809(a)(i) (35 P. S. §§ 448.804(d) and 448.809(a)(i)). The Department makes a licensure visit, or expects an accrediting body to make a licensure visit of a health care facility at 1, 2 or 3-year intervals, depending upon the type of facility. This does not mean that the Department never visits those facilities at any other time, nor does it mean that the Department does not have the authority to do so.
With respect to the comments that the proposed section does not require a review to be done, even if a serious problem arises, the language of subsection (a) would give the Department the ability to require formal external reviews whenever it finds them necessary. The subsection specifically states that these formal external reviews will occur every 3 years, unless otherwise required by the Department. The Department may always, under the regulations, conduct an investigation, including a site visit, whenever that visit is necessary. As in the regulation of health care facilities, the Department has the ability to investigate any complaint (whether or not it is filed under Act 68) made against an HMO by conducting a site visit, as it has stated in § 9.605 (relating to Department investigations). The Department has the ability to investigate and conduct site visits as it sees fit, including to investigate problems uncovered during the external review or upon review of the quarterly or annual reports. The Department does not need to set in regulation what events will trigger such an investigation. In fact, for purposes of monitoring and investigation, it is more effective not to set these triggering events in regulations. It provides the Department with greater flexibility.
Review organizations approved by Department
Several commentators, including IRRC, recommended that the Department make the list of acceptable quality review organizations available to the public. Several commentators, including IRRC, recommended that the Department publish a list of these organizations in the Pennsylvania Bulletin or the instructions for obtaining the list.
One commentator asked that, if the Department expanded its list of review organizations, the Department include a provision in the regulations permitting plans to request review by an alternative organization if the plan can demonstrate good cause, such as a conflict of interest.
Another commentator asked whether the Department would make available criteria used to evaluate and identify acceptable external quality review organizations.
The Department agrees that the list of approved external quality review organizations (EQRO) should be published in the Pennsylvania Bulletin. It has added language to this section stating that the list will be published annually. At the present time, NCQA is the only approved EQRO. See subsection (g). The Department will consider making the criteria it uses to approve EQROs available, most likely through a request for qualifications (RFQ) process. The Department is currently considering issuing an RFQ.
When the Department has more than one EQRO approved, plans will be able to choose from those that are approved to the extent the EQRO and the plan do not have conflicts of interest. Any limitations or requirements will be published at the time the list is published.
The Department received three comments on proposed subsection (c), which would allow an HMO to combine the external quality assurance assessment with an accreditation review offered by an external quality review organization acceptable to the Department, if certain conditions are satisfied.
One commentator requested clarification on the latitude the Department would grant regarding external reviews conducted by National accrediting agencies. The commentator stated that the proposed provision seemed to imply that where the requirements of National agencies differed from the regulations, the Department could request the entity to incorporate areas specific to the regulations or assist Department staff in the review. This could occur, for example, with the processing of enrollee complaints and grievances as defined by the regulations.
IRRC and another commentator asked what the assessment factors required by the Department would be. IRRC also recommended that the Department list these specific factors that must be considered, for example, review of a statistically significant sample of medical records.
Although a plan is required to pay for the review, the Department sets the standards for the review by approving the review organization performing the review and the standards used by that organization. The Department has clarified this subsection by adding language that states acceptable reviews must include information that enables the Department to determine compliance with the HMO Act, the PPO Act, Act 68 and the regulations. The Department will supplement the standards of the reviewing organization as necessary by jointly performing reviews against the standards included in Act 68 and these regulations to ensure compliance with that act. The Department has added language to subsection (d) to clarify that the reviews are to assess the quality of care and effectiveness of the quality assurance program developed by the plan under § 9.674 (relating to quality assurance standards), and to assess compliance with Act 68, the HMO Act and these regulations.
As already stated, the only EQRO currently approved by the Department for performing external quality assurance assessments is NCQA. The Department's regulations contain much of what is required by NCQA. Its standards are well known and they are available to the regulated community and to any interested person. There are areas in which the NCQA process is not sufficient for the Department to gauge compliance with Act 68, the HMO Act and these regulations. Therefore, to the extent necessary, the Department will be supplementing the external review with agency audits as appropriate. With respect to the specific comment concerning statistically significant samples, the Department does not intend to include this requirement in the regulations for the reasons discussed in the general commentary on this section.
The Department received several comments on proposed subsection (d), which would state that the assessment would study the quality of care being provided to enrollees and the effectiveness of the quality assurance program established by the HMO.
One commentator recommended that the Department add the language ''as measured by patient outcomes'' to the end of the proposed subsection.
Several commentators complained that proposed subsection (d) does not include any standards other than that the external assessment would be conducted on the quality of care being provided to enrollees and the effectiveness of a quality assurance program. The commentator noted that no mention was made of regulatory compliance under Act 68. The commentators recommended that the proposed subsection should include the scope of the review in detail.
The Department will perform reviews along with the external review organization to ensure that the plan is in compliance with the requirements set out in Act 68, the HMO Act and these regulations. As stated previously, the Department has added language to the proposed subsection to stress that the assessment is being done for these reasons. The Department has explained its decision not to include patient outcomes more fully in the discussion on comments on proposed § 9.674 (relating to quality assurance standards). While the Department is concerned with the question of patient outcomes, the state-of-the-art concerning measuring, quantifying and analyzing outcomes is less well developed than would be prudent to address in these regulations.
The Department received several comments on proposed subsection (e), which would set requirements for who is to receive a copy of the external quality review assessment.
Several commentators commented that proposed subsection (e) would not provide for public access to the external review report.
One of these commentators noted that other health care providers were required to post deficiencies in public places, and that outcomes were available to the public on the Department's website. The commentator suggested that the Department was permitting private reviewers to do the review instead of the State and keeping the outcome private.
One commentator commented that the public should have access to reviews in a format that is understandable and provides a basis for consumers to compare plans.
The Department's requests for plans of correction, correspondence between the Department and the plan relating to the plan of correction and follow-up documentation from the plan are available to the public. See subsection (f). The external review organization will always provide feedback to the plan. It is important to note that the reviews are not structured as pass or fail.
Subsection (f) also provides that the Department will not make the review containing proprietary information available, unless authorized by the HMO or directed to do so by a court of law. To take advantage of this provision, the HMO must, however, request that the Department maintain specific information as confidential and proprietary, since the Department cannot determine on its own what information the HMO may consider to be proprietary. Those areas of commendation or positive performance recognized in the report, such as patient outreach programs that improve birth outcomes, generally reflect plan innovations that are proprietary trade secrets, the details of which HMOs do not want made available to their competitors. While the public may benefit from selecting plans with such initiatives, enrollees are generally made aware of such programs and offerings in the marketing literature without the detailed information on the program operations and performance benchmarks.
The Department is attempting to coordinate the resources to develop information that would be useful to the public in this way. The Department hopes to be able to achieve this goal within the next 2 years. There does not need to be language in regulation for this to occur.
IRRC recommended that the Department either add a subsection regarding penalties to this section, or cross reference § 9.606, since proposed subsection (e) would not include a penalty if the HMO would fail to file a copy of all interim and final reports on the assessment with the Department.
Another commentator commented that although proposed subsection (e) would require that a copy of the external review report go to the Department within 15 days, the subsection would not require the HMO to provide a corrective action plan.
The Department has not added language referencing a penalty to this proposed subsection. The regulations and statute have sufficient language to permit the taking of corrective action as necessary by the Department should the HMO fail to comply with this section. With respect to the comment regarding corrective action plans, the Department has added language to proposed § 9.606 to acknowledge that HMOs may be required to provide corrective action plans with respect to violations of the HMO Act or the regulations implementing that act. There is no need to repeat that language here.
One commentator commented that proposed subsection (e) would not require that a copy of the assessment report go directly to the board, but rather, the proposed regulation would require it to go to the plan's senior management. Since the board is responsible for policy, the commentator stated that the board should be given the report.
As the senior managers are often responsible for day-to-day HMO operations, including correcting problems, they should also have a copy of the report. The Department has added language to the proposed subsection requiring senior management to provide a copy to the board.
Subchapter H. Access and Availablility The Department received more than 400 comments on this proposed subchapter.
Section 9.672. Emergency services.
The Department received several comments on this proposed section. One commentator found the regulation to be generally positive. Two commentators commented that the proposed regulation should be consistent with Insurance's regulation on the same topic.
The Department's regulation is consistent with Insurance's. The Department and Insurance have different responsibilities, based upon their different functions, expertise and authority. Consequently, the regulations are not and should not be exactly the same. Plans covered by the regulations are required to comply with both Insurance's and the Department's regulations.
One commentator commented that the proposed section would limit access to emergency services; however, it did not explain how or why this was so. The Department believes that this regulation implements Act 68, and ensures that plans afford coverage for emergency services.
One commentator recommended that the Department include language stating that providers may advocate for patients and that they may obtain written consent to do so at the time of treatment.
The Department has not changed the regulation to incorporate the recommended addition. Providers may always advocate for patients. The Department has included language that would permit providers to obtain consent to file a grievance on the enrollee's behalf at the time of treatment, in § 9.706 (relating to health care provider initiated grievances).
One commentator raised general issues with respect to coverage and payment for emergency services not necessarily tied to the wording of the proposed section. The commentator requested that the Department state in the regulations that providers of ambulance services are to be paid directly for services rendered. The commentator stated that direct payment should be made to both participating and nonparticipating providers. The commentator noted that, since 911 responders are often nonparticipating, payment is made to the patient. Further, the commentator commented that it, by law, was unable to directly bill city residents. The commentator asked what recourse a nonparticipating provider has to pursue when an HMO denies the claim and the bill is uncollectable.
The Department does not have the authority to address the issue of whether the provider or patient should receive payment from the plan. A contracted provider can bill patients but only when the service or amount is not covered by the plan. The Department does not prohibit, either by regulations or through statute, the billing of city residents.
The commentator also asked whether a 911 call precipitating an ambulance transport could be considered a binding unwritten contract between the enrollee and the ambulance service so that an ambulance service could appeal plan referrals to pay for ambulance trips. The commentator asked whether the proposed regulations would require all 911 calls to be considered emergencies, and who would determine what an emergency was. The commentator stated that it was having a difficult time obtaining enrollee consent to allow it to appeal grievances.
The Department has no authority to compel enrollees to cooperate with collection activities or consent to allow a provider to initiate a grievance. Act 68 requires that consent be obtained from an enrollee before a provider may file an appeal. See section 2161(a) of Article XXI. The enrollee must have the opportunity to consider whether or not the enrollee wishes to cede appeal rights to another party. The Department would not support the concept of a 911 call creating a binding contract allowing the provider to appeal without enrollee consent. This would violate the terms of Act 68, which requires a written consent.
Further, since Act 68 defines ''emergency services'' by using the prudent layperson standard, and not all 911 calls may meet that standard, neither 911 ambulance transport or 911 calls can automatically be considered to be emergencies under Act 68. The plan is required, under Act 68 and the regulations, to apply the prudent layperson standard in determining whether or not an emergency existed. If the plan fails to do so, the plan is liable for sanctions under Act 68.
The commentator also expressed concern with the denial of ambulance transport bills. It noted that it must respond to emergency calls regardless of whether the call is later determined to be an emergency. The commentator stated that if it is denied payment, it has no recourse.
An ambulance transport that meets the prudent layperson standard for an emergency service is a covered service under Act 68, without more regulation on the Department's part. If the plan fails to apply this standard, the plan may be sanctioned under Act 68.
Two commentators commented that the proposed amendments should include language concerning notification from the emergency provider to the enrollee's plan that an emergency service was provided, as Insurance did in its regulations. Notification requirements are a part of section 2116 of Article XXI, and were included by Insurance in 31 Pa. Code § 154.14(e).
Because Insurance was issuing language on the issue relating to plan notification by providers, the Department did not want to inadvertently contradict or undermine it. Upon reviewing the comments, however, because hospital notice is a utilization review issue over which the Department does have responsibility, and for clarity, the Department has added to this regulation language regarding hospital notice from 31 Pa. Code § 154.14(e). See subsections (f)--(h).
IRRC also commented that the proposed section should include the language of 31 Pa. Code § 154.14(f) in its section on emergency services. Because this section requires disclosures to enrollees and providers, the Department has not added the language from 31 Pa. Code § 154.14(f) to its regulation on emergency services.
One commentator commented that although section 2116 of Article XXI states that a plan shall pay all reasonable and necessary costs, the proposed amendments did not propose criteria for determining what constitutes a reasonable and necessary cost. The commentator recommended that the regulation states how the Department will monitor reasonable and necessary costs.
The Department has made no change to the regulation to address this concern. The plan must honor coverage for the enrollee at the covered level of benefit and must exercise judgement in determining what claims for services reasonably relate to the emergency situation regardless of whether the provider is a participating provider, or a nonparticipating provider. Plans may retrospectively deny payment for services provided that the services were not medically necessary or appropriate. The provider or enrollee may then file a complaint or grievance.
One commentator recommended that the regulation include a limited set of signs and symptoms that could reasonably precipitate a visit to the emergency room, and suggested that these could be limited to those that occur most commonly but might or might not be an ''emergency,'' for example, dizziness. The commentator stated that this would allow for the consistent application of the prudent layperson standard by providers and payers.
The Department has not made this change to the regulation. It is impossible to specify each and every symptom that would justify an emergency room visit under the prudent layperson standard. This type of clinical information, which may change from time to time, is not the type of information that lends itself to regulation. Further, the Department would have to list every symptom for every condition as related to the individual enrollee, and those that were not on the list, even if they should have been, would not need to be considered emergencies. That would serve to inadvertently deny coverage in situations where it is warranted.
Secondly, the prudent layperson standard is to benefit the enrollee, not the plan or provider. The enrollee should not have to memorize a list of symptoms and conditions that could permit him to go to the emergency room and be covered by his insurer. The whole purpose of the prudent layperson standard was to avoid this type of categorization, and to enable the enrollee to go to the emergency room when the enrollee reasonably felt seriously threatened by illness.
One commentator recommended that the Department add language to proposed subsection (a) requiring plans to respond in a timely fashion for the authorization of post-stabilization care. The Department has made no change to this subsection, since the topic of preauthorization or concurrent authorization requests is addressed in § 9.751 (relating to timeframes for UR).
One commentator recommended that proposed subsection (a) be revised to address access to emergency services by requiring all insurance plans, not just managed care plans, to adopt the prudent layperson standard, and include the definition of that standard in all marketing materials, policies, and consumer and provider communications.
The Department has not made this change to the regulation, since Act 68 does not give the Department the authority to mandate that all insurance companies utilize the prudent layperson standard.
One commentator supported proposed subsection (b), which proposed to prohibit denial of claims for lack of prior authorization for emergency services.
One commentator suggested that plan coverage of services in the emergency department should be required without preauthorization by the primary care provider. The commentator stated that to require otherwise would be burdensome for the hospital and would interfere with the efficient delivery of care in the emergency department. The commentator stated that preauthorization should be unnecessary given the suspicious nature of signs and symptoms with which the patient presented.
It was not the Department's intention to imply that conditioning plan coverage for emergency services on preauthorization from a primary care provider was permissible. The Department has deleted the language ''from a gatekeeper or the plan itself'' from the proposed subsection to clarify that a plan may not require prior authorization from a primary care provider in this situation.
Three commentators stated that proposed subsection (c) should have used the words ''a plan shall'' use the prudent layperson standard, rather than ''a plan may use'' the standard. The Department has made no change to the regulation, since the word ''may'' in this subsection was a misprint, and was corrected by a publication in the Pennsylvania Bulletin the week following the publication of the proposed rulemaking. One commentator made mention of the correction.
Several commentators, including IRRC, commented on the phrase ''adjudicating related claims . . . '' in subsection (c). One commentator claimed the reference was unnecessary. IRRC and another commentator stated that the term ''related'' was unclear and should either be eliminated or clarified. Other commentators recommended that the Department use the word ''adjudicating'' rather than ''adjudication.''
One commentator recommended that the Department use language in section 2(c) of the act of July 11, 1996 (P. L. 655, No. 112) (40 P. S. § 3042(c)) (Act 112) for clarity, since the language in the proposed subsection could be misconstrued. Section 2(c) of Act 112 states in pertinent part that ''an insurer shall consider both the presenting symptoms and the services provided in processing a claim for reimbursement of medical services.''
The Department has changed the regulation to use the word ''adjudicating'' rather than ''adjudication,'' found in the December 25 correction. (See 29 Pa.B. 6470). The Department has not deleted the word, however. ''Adjudication'' or ''adjudicating'' is the process of evaluating a claim for payment in terms of the enrollee benefit contract and applicable provider contract (if any). It is important for the regulation to convey that a plan must provide for the prudent layperson standard in such a decision-making process. Without it, the prevailing contract could require an exclusion that would violate Act 68. Related claims are those claims from ambulance, facility and professional services that were reasonable and necessary for treatment during the emergency.
Further, payment for services that were not medically necessary may be denied and the provider or enrollee may then file a complaint or grievance to contest the determination and obtain coverage. To require coverage of all services would bind a plan to cover services that were extreme, unnecessary, unrelated or dramatically different from the emergency event. For example, a patient could go to the emergency room for a possible heart attack, and while there receive services for the removal of a mole, which is an unrelated condition.
One commentator also commented that it was essential that a plan review documentation including presenting symptoms and services provided. The commentator recommended that this be done through the use of a universal form on which symptoms and services could be documented.
Although the Department acknowledges that a universal form would be sensible, the Department has no authority under Act 68 to develop and require use of a form.
One commentator supported proposed subsection (d) for including emergency transportation and related emergency care provided by ambulance services as emergency services.
Several commentators raised issues concerning lack of language in the proposed subsection referencing stabilization, evaluation, and testing. IRRC and another commentator noted that these services had been defined differently by Insurance. Insurance's regulation states that a plan must pay all necessary costs, including evaluation, testing, and, if necessary, the stabilization of the enrollee. IRRC commented that the Department's proposed regulations were less comprehensive that Insurance's. IRRC recommended that the Department reference section 2116 of Article XXI to ensure payment for all services properly classified as ''emergency services.''
The Department agrees that language referencing stabilization, evaluation and testing from section 2116 of Article XXI should be included in this section. The Department has revised subsection (d) to include language from Insurance's regulations which states that coverage for emergency services, provided during the period of the emergency, will include evaluation, testing, and if necessary, stabilization of the condition of the enrollee.
One commentator also stated that Act 68 and the regulations could create problems with respect to the EMTALA. First, it commented that language in Act 68 which states that ''if an enrollee's condition has stabilized and the enrollee can be transported without suffering detrimental consequences or aggravating the condition . . . '' requires more than stabilization before transfer can occur. See section 2116 of Article XXI. The commentator recommended adopting EMTALA, which states that stabilized means that no material deterioration of the condition is likely, within reasonable medical probability, to result from or occur during the transfer of the individual from a facility. The commentator stated that the physician treating the patient must decide whether and when the patient is considered to be stabilized for purposes of transfer or discharge, and that decision must be binding on plan.
Further, the commentator stated that Act 68 may give the provider the option not to treat, since it states that ''if an enrollee seeks emergency services and the emergency health care provider determines that emergency services are necessary, the emergency health care provider shall initiate necessary intervention to evaluate and, if necessary, stabilize the condition of the enrollee . . . .'' See section 2116 of Article XXI. The commentator stated that Federal law requires a medical screening examination for all persons that present to an emergency room. It recommended that the Department make it clear that Federal law must be followed.
The Department has not changed the regulation. All Federal and Commonwealth laws must be satisfied, with or without the statement in the regulations. Presumably, the initial screening required by EMTALA is how the provider will ''determine'' if emergency services are necessary as required by Act 68. There is no conflict between EMTALA and Act 68, and the provider is charged with complying with both statutes.
The Department received one comment in support of proposed subsection (e). Another commentator commented that the word ''may'' in this subsection should be replaced with the word ''shall.'' The Department has not changed the regulation, since use of the words ''may not'' is appropriate. For statutory construction purposes, the phrase ''may not'' is more prohibitive that the phrase ''shall not.''
One commentator took exception to the Department's use of ''rate'' in the preamble and ''benefit'' in the regulations which would suggest that the Department was requiring noncontracted hospitals to accept the ''rate'' paid by the health plan as payment in full. One commentator supported the proposed amendment for requiring payment at the same benefit level for services provided regardless of whether the provider is contracted with the plan or not.
Several commentators suggested that the Department should clarify that enrollees receive the same benefit level for either emergency services provided by a nonparticipating provider, or for services for which there are no participating providers capable of performing the service.
One commentator recommended the addition to proposed subsection (f) of language regarding what services are covered under emergency services and what the plan's payment obligations are for those services. The commentator raised concerns that because plans must cover services provided by nonparticipating providers at the same level of benefit as services provided by participating providers, there would be no incentive for organizations to become participating providers, and costs would increase. The commentator recommended that the Department add language requiring nonparticipating providers refusing to contract with plans to accept plan rates for services.
Based upon reexamination of the language in the statute and Insurance's regulations, along with consideration of the comments, the Department is deleting section (f) and modifying section (d) to more accurately reflect the statute and Insurance's regulations. The Department does not have sufficient authority under Act 68 to require noncontracted providers to accept plan reimbursement rates as payment in full nor can the Department require plans to pay the full amount charged if the provider does not have a contract with the plan. This would be tantamount to a benefit mandate and could easily lead to facilities refusing to contract with plans for emergency department services in an effort to force plans to pay full billed charges for emergency services. The Department is not prepared to issue a benefit mandate.
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