[31 Pa.B. 3043]
[Continued from previous Web Page] Section 9.684. Continuity of care.
The Department received several comments on this proposed section. Six commentators stated that the proposed section should be consistent with Insurance's regulations. One commentator commented that since continuity of care was already covered by Insurance, reference to it should be deleted from the Department's regulations.
The Department and Insurance regulations are consistent. Each agency has different responsibilities, based upon its different expertise. Therefore, the regulations cannot and should not be exactly the same.
One commentator recommended that the Department address requirements for continuity of care to make sure a patient's change of health plans or employment status does not inappropriately impact upon the patient's access to healthcare.
The Department cannot address this concern. Act 68 does not provide authority for the continuation of coverage lost due to a person's change of plan or job. Section 2117(a) of Article XXI only provides for continuity of care ''if a managed care plan initiates termination of its contract with a participating health care provider.'' See section 2117(a) of Article XXI. These are the only circumstances under which Act 68 provides for continuity of care. To extend this benefit to other situations, the statute would have to be amended.
One commentator recommended adding language to subsection (a)(1) to clarify that this proposed paragraph would apply, except in the case of noncovered benefits addressed in subsection (j), now subsection (i), and termination for cause addressed in subsection (k), now subsection (j). The Department has added the suggested language for clarity.
The same commentator recommended changing the language of the proposed paragraph to read that enrollees may continue an ongoing course of treatment for up to 60 days. The commentator stated that ''up to'' is a direct reflection of Act 68, and would not lead enrollees to assume that the continuity of care period will automatically be 60 days. The Department has added the suggested language for clarity.
Another commentator requested clarification concerning when the 60-day time period would begin. The commentator noted that it is impractical and contrary to the intent of Act 68 to start the continuity of care period from the notice of termination.
While the Department understands the concern raised by the commentator, the clear language of the statute requires that the period of continuity of care run from notice to the enrollee of termination or pending termination of the provider. This period of up to 60 days, even if it will run from the notice of pending termination, will allow sufficient time for the enrollee to transition from one provider to another, which is an important aspect of continuity of care.
One commentator objected to the proposed requirement in subsection (a)(2) that plans provide written notice to enrollees of primary care provider terminations, and asked for that language to be deleted. The commentator commented that many member plans make contact with enrollees by telephone to begin work as expeditiously as possible with enrollees on selecting another primary care physician. The commentator requested that the Department allow the plans to maintain flexibility.
The Department has not changed the proposed paragraph. Since the continuity of care period runs from the date of notice of termination or pending termination, and is at the enrollee's request, the enrollee shall have written evidence of that date of notice to begin the process for requesting continuity of care. The written notice shall also tell enrollees how to exercise this option, along with clear notice of the continuity of care period's start and end date for enrollees. While the Department does not dispute the practicality of contacting enrollees by phone to initiate transfer, the Department needs to ensure that there is a reliable means of ensuring an enrollee is provided with consistent, accurate and unambiguous notice of the continuity options and instructions for initiating the process. Member services staff responsible for verbal notification are expected to make every effort to provide clear information and direction; however, the ability of the enrollee, plan and Department to effectuate and verify compliance requires written notification.
One commentator commented that the proposed paragraph is in conflict with Insurance's regulations since it requires the plan to notify patients of the right to continuity of care, or termination, and Insurance's regulations do not. The commentator credited the Department for recognizing the importance of notifying enrollees when their providers are being terminated.
One commentator requested that the Department clarify proposed subsection (b) by adding the phrase ''including fee schedules,'' after the phrase ''terms and conditions.'' The commentator interpreted the proposed subsection to mean that the plan would not be responsible for paying a nonpartipating provider charges, but only the fee on its fee schedule that would have been paid to a participating provider for the same services.
The Department has not made the requested change. If a plan chooses to make fees part of the terms and conditions, it may do so. The Department is not requiring that fees be included, nor is the Department regulating the subject of fees and payment between providers and plans.
One commentator has commented that the proposed subsection, particularly the phrase ''with the exception that a plan may not require nonparticipating health care providers to undergo full credentialing,'' is problemmatic. The commentator raised the concern that a shortened credentialing process, which requires the collection of only a limited amount of information, could have serious quality of care implications for members who are using nonnetwork, noncredentialed providers. If the Department included this language in the final regulation, the commentator requested that the following language be included as well: ''Managed care plans shall have no liability to enrollees who elect to receive care from nonparticipating noncredentialed providers.''
The Department cannot waive tort liability for managed care plans by adding this language to a regulation. Only a statutory provision enacted by the General Assembly can grant immunity to a group in a particular situation. The Department will not delete the proposed requirement prohibiting full credentialing, since it is necessary to ensure that enrollees are able to access providers to realize the continuity of care benefit provided by Act 68. If the plan chose to require full credentialing, which in all probability would take at least 90 days, and given that the continuity of care period extends for only 60 days, the process would operate to prevent the enrollee from exercising this benefit. The Department notes that if plans are concerned with liability for failing to fully credential nonparticipating providers under this subsection, despite the Department's regulation prohibiting full credentialing, they could require a waiver from an enrollee.
Further an enrollee who is just joining a managed care plan would most likely be accessing nonparticipating and, therefore, uncredentialed providers. As discussed previously, the Department cannot permit plans to require full credentialing as a term or condition, as that alone would vitiate the chances of an enrollee ever realizing this benefit. However, in the event that plans wish to ascertain at least licensure in good standing and current malpractice coverage as minimal credentialing requirements, the Department is not adverse to this basic health and safety precautions, and subsection (f) does not prohibit it.
One commentator recommended that, although Act 68 permits a plan to require a nonparticipating provider to accept the same terms and conditions as participating providers, the Department should affirmatively prohibit that requirement.
The Department cannot prohibit something that Act 68 permits, and so has made no change to this proposed subsection.
One commentator recommended that the Department add language requiring a provider to accept the plan's reimbursement as full payment for short continuity of care period.
The Department is not able to require providers to accept the plan's reimbursement as payment in full as was recommended. The nonparticipating health care provider and plan shall come to mutually acceptable terms on their own.
One commentator stated that it appreciated the Department's exclusion from the section of a requirement that nonparticipating provider accept the plan's reimbursement as payment in full.
IRRC commented that the term ''best efforts'' in proposed subsection (h) is vague, and proposed that the Department provide samples of what would constitute best efforts in the final-form regulations.
The Department agrees with the comments, and taking into consideration the changes it has made to proposed subsection (i), it has deleted the subsection. The Department has also added the term ''terminated'' to subsection (g), since that subsection is meant to apply to both nonparticipating and terminated providers.
The Department received two comments on proposed subsection (i), both requesting revisions.
One commentator requested clarification of the duration of the ''period of negotiation,'' commenting that it was confusing as written, and impractical in application. Another commentator stated that the proposed subsection presented quality-of-care and liability concerns. The commentator recommended eliminating this proposed subsection and replacing it with language from Insurance's regulations.
The Department does agree, after reviewing the comments, that the proposed subsection should be rewritten for clarity, and has renumbered it as subsection (h). The Department has decided to adopt Insurance's language and to require providers to notify affected enrollees that the provider has not agreed to the plan's terms and conditions prior to providing the service. This is the same as informing new patients prior to providing services that the provider does not accept the enrollee's insurance.
IRRC recommended that the Department cross-reference in subsection (k), (now subsection (j)), section 2117(b) of Article XXI, since the term ''cause'' is unclear. Section 2117(b) of Article XXI lists reasons providers can be terminated for cause under Article XXI. The Department agrees that referencing this section would clarify the term ''cause.'' The Department has made the change to the proposed subsection.
Section 9.685. Standards for approval or point-of-service options by HMOs.
The Department received several comments on proposed § 9.656, which has been renumbered as § 9.685 and moved to Subchapter H (relating to access and availability). The Department has removed the section from Subchapter G, since the revisions the Department has made to the section now address all plans, rather than simply HMOs.
One commentator commented that this proposed section would allow an HMO to offer a point-of-service (POS) without doing so through a licensed insurer, and that that arrangement is currently not allowed in statute.
One commentator noted that since this proposed section would apply specifically to HMOs, PPOs offering POS options would not be required to follow the approval standards in the proposed section.
These comments are correct. POS plans are offered by HMOs. The definition of ''POS'' has been changed to reflect the fact that PPOs may also offer POS products. The title of the section has been changed accordingly, and references to ''HMO'' throughout the section have been replaced with references to ''plan.''
One commentator recommended that the Department ensure that plans have in place effective quality assurance programs.
The Department has not added the recommended language. Out-of-network use of providers can reflect enrollee preference; however, this section requires a plan to investigate instances, not of enrollee preference, but of network adequacy.
One commentator commented that the proposed section would not establish a monitoring mechanism to determine if access problems existed, or if HMOs were complying with required procedures, and taking corrective action if there appeared to be problems.
The Department does not need to establish a separate monitoring mechanism for a POS product. Since Act 68 and the HMO Act apply to HMOs, they also apply to the POS product offered by an HMO. POS products shall also meet the minimum network access standards in § 9.679. Additionally, the Department has the same access to the books and records, and the ability to investigate complaints with respect to a POS product as it does with any plan. An POS is a type of benefit plan or product line offered by a plan.
The Department does not need a specific provision requiring corrective action in every section of the regulations. The requirements in § 9.606 apply to every section of the regulations. There is no need to repeat those provisions or cross reference that section in every other section of the regulations.
IRRC commented that proposed subsection (a) would require an HMO to submit a formal product filing for a POS product to the Department and Insurance. IRRC recommended that, for clarity, the Department cross reference Insurance's regulations. Language has been added to clarify that filings are only required if a plan proposes to offer a POS product. See subsection (a). The Department has already stated that plans must comply with Insurance's regulations as well as the Department's regulations.
Three commentators, including IRRC, raised concerns that informing an enrollee's primary care provider of care provided by another provider without referral from the primary care provider would breach confidentiality. IRRC questioned why the provision was necessary. Proposed subsection (b)(1)(i) would have permitted an HMO to offer a POS option to groups and enrollees if the HMO has a system for tracking, monitoring and reporting enrollee self-referrals for the purpose of periodically informing an enrollee's primary care provider of enrollee self-referred services.
One of these commentators stated that it was the enrollee's responsibility and privacy right to decide whether the specific nature of those services provided without a referral by a primary care provider should be communicated to the primary care provider. The commentator stated that the proposed amendments would provide ample quality safeguards to ensure that patient self-referrals were not a reflection of access or quality problems on the part of the primary care provider practice.
Another commentator objected to proposed subsection (b)(1)(i) as being administratively burdensome for the HMO, as well as possibly violating patient confidentiality, and recommended that it be removed.
IRRC also questioned what the time frame required by the word ''periodically'' was intended to be.
The Department has deleted this language because of the privacy concerns expressed by commentators, and because of the promulgation of Federal regulations on the privacy issue. The Department has replaced proposed subsection (b)(1)(i) with a requirement that a plan develop an alternate method of monitoring to ensure that self-referral activity in not a byproduct of an access problem, a deliberate attempt to keep some or all enrollees out of the office of the primary care provider for nonmedical reasons, or reflective of overrestrictive or burdensome plan requirements.
One commentator commented that POS options were created in response to consumer demand for the ability to self-refer outside the HMO's contracted network. Therefore, it contended higher than average usage would not necessarily reflect consumer dissatisfaction, but rather enrollee preference for a nonnetwork provider. The commentator stated that it was unclear as to how the Department would quantify and enforce higher than average usage of out-of-network care. The commentator recommended that the Department revise proposed subsection (b)(1)(ii).
Another commentator disagreed with the proposed subsection's requirement that HMOs monitor a practice when enrollee self-referrals to care are higher than average to ensure that self-referrals are not a reflection of access or quality problems on the part of the primary care provider practice. The commentator stated that in its experience, patients use nonreferred care due to the HMO's lack of approval of referrals, lack of adequate specialists in the network, lack of coverage for particular care or services offered through the more tightly managed care products. The commentator recommended that the section be revised to require investigations for the real reasons.
The Department understands that the reasons for self-referral can vary from being beyond provider access problems to general personal preference to administrative difficulties. The Department has revised the proposed subsection (b)(1)(ii) to require that the plan have the ability to review any primary care provider practice in which self-referrals are substantially higher than average, and to ensure that this is not reflective of access problems, inappropriate patient direction or burdensome plan requirements.
IRRC also asked the Department to define the word ''promptly'' in subsection (b)(1)(ii). The Department has not defined the word in the regulations, since it intends ''promptly'' to be given its common usage, that is, ready and quick to act as the occasion demands. See Webster's Ninth New Collegiate Dictionary, (1984) pg. 942. The Department believes that plans should investigate these situations quickly as on the patient's individual circumstances demand.
One commentator recommended that the Department add the following language to the end of proposed subsection (b)(2): ''such expenses shall be reasonable and not designed to unfairly restrict access to such services.'' The proposed subsection would state an HMO could offer POS options to groups and enrollees, if the HMO would provide clear disclosure to the enrollee of the enrollee's of out-of-pocket expenses.
Two commentators noted that Insurance was the lead agency on disclosure. One of these commentators recommended that the disclosure requirements should be coordinated with the requirements of Insurance's final-form regulations. The other expressed concern that further delineation of regulatory authority between the agencies will prove confusing and duplicative for regulated agencies, and recommended that the Insurance handle this issue.
The Department will defer to Insurance on matters relating to disclosure.
Subchapter I. Complaints And Grievances The Department received over 450 comments on this proposed subchapter.
Some commentators commented generally on the proposed subchapter unrelated to specific sections, and recommended certain actions to the Department. These general comments are as follows:
Regarding UR, one commentator recommended that the Department strengthen its standards regarding UR and UR decisions so that the Department could effectively monitor UR practices. This comment is addressed in discussions on §§ 9.749 and 9.750 (relating to UR system description; and UR system standards). The Department does include requirements for more and detailed information to be included in UR decision letters.
Regarding coordination with Insurance, one commentator noted that both Insurance and the Department have the authority to address complaints and grievances and that some plans have been informed that the Department will handle grievances only and Insurance will handle complaints only. This commentator recommended that this confusion be resolved by the agencies. In response, both agencies have the authority to address complaints under Act 68. The Department has the authority to assign grievances to a CRE for an external review.
Regarding retrospective UR denials, several commentators raised general concerns about plan's retrospectively denying coverage for inpatient days previously approved, suggesting the Department prohibit retrospective denials unless the provider was derelict in providing information to the plan needed by the plan to make an appropriate decision. The commentators further stated that to do otherwise would discourage providers from exercising due process rights to appeal decisions. One of these commentators expressed concern that the enrollee has no motivation to provide consent since the enrollee is not financially responsible for paying for the denied inpatient days. The commentator recommended that the Department adopt one of three options: (1) prohibit health plans from retrospectively denying coverage for services that were prospectively or concurrently approved unless the provider was derelict in providing information to the health plan which was needed to make a decision; (2) allow providers to obtain the patient's consent when treatment is initiated; or (3) remove the requirement for a patient's consent on retrospective denials.
In response to these comments, the Department disagrees with the concept that plans should not be permitted to retroactively deny reimbursement for services after preapproving them. In defining ''retrospective utilization review'' in Act 68, it is clear by statute that retrospective review that ''results in a decision to approve or deny payment for the health care service'' is permissible. The Department does allow providers to obtain consent at the time of treatment, and has specified in § 9.706 (relating to health care provider grievances) that such consent may be obtained at the time of service, if it is not a condition of the enrollee's obtaining treatment.
In another general comment, one commentator believed that the proposed regulations would eliminate the requirement that plans routinely tell dissatisfied members of their rights, and how to file a complaint or grievance. This was not the Department's intention. The Department has required that plans include in the initial UR decision letter and the subsequent complaint and grievance review decision letters an explanation of how to file a complaint or grievance. See §§ 9.703(c)(1)(v)(D) and (2)(vi)(D), 9.705(c)(1)(v)(D) and (2)(vi)(D), 9.708(a) and 9.750(f).
One commentator complained generally that the proposed amendments contained no penalty for plans that miss deadlines, or otherwise fail to adhere to the complaint and grievance process. Another raised concerns that there would be no verification of adherence to timelines in the regulations. The Department proposes to conduct regular audits to ascertain timeliness and will investigate complaints of this nature brought before it. Penalties are permissible under § 9.606.
Regarding overall fundamental fairness issues, several commentators expressed concern that the Department did not include its 1991 Guidelines and Technical Advice to HMO Applicants Regarding Member Grievance Procedure (1991 guidelines) for the conduct of complaint and grievance hearings in its proposed regulations.
One commentator complained that there would be no process for the Department's intervention in cases in which a member's rights were being ignored, noting the proposed amendments did not provide for Department assistance to enrollees in identifying and gathering information needed to proceed with the appeal at the agency level. This commentator stated that the absence of fundamental fairness guidelines in the proposed regulations was of particular concern.
IRRC asked the Department to explain whether complaint and grievance procedures established in the 1991 guidelines would change upon implementation of the proposed regulations, and whether the changes in the complaint and grievance procedures would diminish the rights of enrollees. IRRC also asked why the provisions of the 1991 guidelines that were consistent with Act 68 and the HMO Act were not codified, and how areas in the 1991 guidelines that were not included in regulation would be enforced by the Department.
Upon publication of final rulemaking, the 1991 guidelines that the Department has decided to retain will become part of its regulations. The 1991 guidelines never had the force of law, not having been promulgated as regulations. The 1991 guidelines were an expression of the Department's views of how a fair complaint or grievance proceeding should be conducted and have since been referred to as the Department's ''fundamental fairness'' rules. The Department believes that certain basic requirements are necessary to create a problem resolution process, for complaints and for grievances, in which both sides can participate and feel that their interests are fully presented and fully considered.
With the passage of Act 68 in 1998, a statute that detailed specific requirements of grievance and complaint procedures, the Department was under the impression that the General Assembly intentionally did not include the Department's fundamental fairness guidelines in Act 68. This was a mistake on the part of the Department. The Department is in agreement with numerous commentators that it would be beneficial to enrollees and plans to establish specific requirements for fairness. The Department has, therefore, incorporated portions of the 1991 guidelines in these regulations for the purpose of ensuring that fairness exists in the review process.
In response to IRRC's specific question, the regulations will supersede any other guidance document in existence, and those provisions in the guidelines that are not included in the regulations will not be enforced. The Department will discuss the specific changes made in discussions on comments to §§ 9.703 and 9.705 (relating to internal complaint process; and internal grievance process).
Four commentators raised general issues relating to access to the complaint and grievance process for enrollees with disabilities, non-English speakers, families of enrollees and public and nonprofit groups, presumably to advocate for enrollees. The Department will address these comments in specific sections later in the Preamble.
Section 9.701. Applicability.
One commentator requested that the Department clarify what entities were covered by this proposed section. The commentator asked whether PPOs were required to maintain grievance systems under these regulations or other regulations.
Any entity that meets the definition of ''managed care plan'' under Act 68 is required to have a complaint and grievance procedure in place. See section 2111(8) and (9) of Article XXI. Therefore, PPOs that use a gatekeeper, and are therefore plans under section 2102 of Act 68, are required to have a complaint and grievance system which complies with Act 68. PPOs are also required to have a grievance resolution system approved by the Commissioner in consultation with the Secretary under section 4.1(e) of the PPO Act (40 P. S. § 764a(e)).
Section 9.702. Complaints and grievances.
The Department received over 40 comments on this proposed section.
IRRC commented that the Department had failed to include a requirement of Act 68 that an enrollee may designate a representative to participate in the process. It recommended that since this requirement is for the entire complaint and grievance process, it should be mentioned here even though it is mentioned elsewhere. IRRC also expressed concern that the proposed regulations would not include Act 68's requirement that a plan have a toll-free number that enrollees could use to obtain information regarding the filing and status of complaints and grievances.
The Department agrees that both of these requirements are important, and has included them in subsection (a)(3) and (5). The Department has also added in subsection (a)(5) a requirement that the plan make reasonable accommodation to enable persons with disabilities and non-English speaking enrollees to secure the same information.
The Department also agrees with other comments it has received with regard to including language in the regulations from its 1991 guidelines requiring the plan to make available a plan employe who did not participate in any previous plan decisions to deny coverage for the issue in dispute to aid in the preparation of the complaint or grievance. The Department believes that this is the most appropriate section in which to include that requirement, and has done so in subsection (a)(4). This requirement is not intended to require a plan to provide an employee to advocate for the enrollee, but, rather, to provide the enrollee with access to an individual who can explain the procedure involved in the plan's complaint or grievance process. An advocate is not necessary, since the enrollee has the ability to appoint someone to represent the enrollee during the complaint or grievance process.
Another commentator requested that the Department clarify how to treat an enrollee's cancellations or failures to participate in a meeting scheduled for a second level review. The commentator asked how an enrollee's failure to participate affected the compliance time frames.
The Department believes that an enrollee must be given ample opportunity to participate in the process, and that if the enrollee requests that a hearing be rescheduled, the plan should reschedule the hearing at least once as a courtesy to the enrollee. The plan should also reschedule the hearing after that if the enrollee has an unforeseen complication preventing the enrollee's attendance such as illness or transportation breakdowns. Since the plan sets the hearing date, often times without consulting the enrollee, the plan must make reasonable efforts to reschedule to accommodate the enrollee. If the enrollee fails to appear at the hearing after the plan has rescheduled the hearing for the convenience of the enrollee, the plan could put its case on the record, and may provide the enrollee with the ability to add information to the record prior to the review committee's decision. As the plan faces statutory deadlines, it must render a decision based on the record at the time of the deadline. As the deadline is for the benefit of the enrollee, the enrollee may agree to allow the plan to exceed this deadline to submit additional information or to facilitate enrollee participation at the review. Both parties must consent in order to extend the time. The Department will not impose a penalty if the plan refuses to agree to an extension of time and completes the review within the time period permitted in the statute.
One commentator suggested that proposed subsection (a) ignored Act 68's clear instructions that complaints were the responsibility of Insurance and not the Department, and stated generally that the other proposed provisions were unduly vague.
It is incorrect to say that Act 68 clearly requires complaints to be exclusively under the jurisdiction of Insurance. Act 68 specifically gives the authority over complaints to the appropriate agency, either the Department or Insurance. See section 2142(a) of Act 68. Act 68 also gives both agencies the authority to investigate violations of Act 68, including the sections relating to complaints. See section 2181(d) of Act 68. The Department disagrees that the remainder of the provisions are vague.
IRRC commented that Department should either explain what additional requirements the Secretary may impose on the complaint and grievance procedure, or delete the phrase: ''and is satisfactory to the Secretary'' from subsection (a)(1). IRRC also recommended that for clarity the Department should use the plural word ''procedures'' rather than the singular word ''procedure'' to emphasize that complaints and grievances are separate procedures.
The Department's intention in including the phrase ''and is satisfactory to the Secretary'' was to provide notice of its authority over complaint and grievance processes under section 10(e) of the HMO Act (40 P. S. § 1560(e)) and section 630(e) of the PPO Act (40 P. S. § 764a(e)) in addition to Act 68. Because, however, by definition, the regulations are what is acceptable to the Secretary, the Department has removed the language from subsection (a)(1). The Department has also changed the regulation to clarify that the two review procedures are separate procedures.
IRRC recommended that proposed subsection (b) be revised to include health care providers as well as enrollees among the persons plans cannot discourage through their administrative procedures from filing complaints and grievances since providers are able to file grievances.
The Department agrees and has made this change.
One commentator recommended that the Department include in the proposed subsection a mechanism for addressing the fairness of a plan's procedures as applied to an individual specific complaint or grievance in real time. The commentator noted that enrollees have no process for addressing the problem in a timely fashion.
The proposed subsection would prohibit a plan from incorporating administrative requirements, time frames, or tactics to discourage the enrollee from, or disadvantage the enrollee in utilizing, complaint and grievance procedures. The Department agrees that there should be a mechanism by which enrollees, and health care providers who file grievances, can make the claim that the plan is acting inappropriately. The Department is requiring plans to notify an enrollee through the denial letters that, in addition to the procedures and deadlines for continuing though the complaint and grievance procedures, the enrollee may contact the Department directly if the enrollee feels the plan is handling the review procedure inappropriately. The Department has the discretion to investigate the matter and take whatever appropriate action is required regardless of the level of the appeal. The Department has added language to this effect in subsection (a)(2)(i) and (ii).
Further, these investigations should not prevent the grievance or complaint process from going forward. The Department has added subsection (a)(2)(iii) to clarify this. If the enrollee believes that the plan's action adversely impacts the decision in the matter, the enrollee may raise that issue to the next level of review.
Two commentators recommended revising proposed subsection (a) to provide an enrollee access to records and other information necessary to adequately prepare for an appeal. One of these commentators recommended including the following: (1) the opportunity for timely advance review of his or her plan file, and copies of plan records whether or not they were relied upon by the plan in reaching its decision; (2) the identity and credentials of whomever participated in a decision to reduce or deny services; (3) and the opportunity to question plan employees or contractors whose action or inactions are at issue at the second level review.
The Department agrees that plans should make documents used in making the decision available to the enrollee. The plan may choose to charge a reasonable copying fee for these documents. Because these issues are specific to procedure, the Department has chosen to address them specifically in the sections dealing with review processes. See §§ 9.703(c)(1)(iii) and 9.705(c)(1)(iii). The Department received 6 comments on proposed subsection (a)(3) (moved to subsection (a)(6)), which would require a plan to provide copies of its complaint and grievance procedures to the Department for review and approval.
One commentator supported the Department's advance review of complaint and grievance systems. Several others took issue with this proposed requirement.
One commentator requested that the Department clarify its authority to require prior review and approval.
The Department has addressed this issue in its discussion of comments on § 9.710 (relating to approval of plan enrollee complaint and enrollee and provider grievance systems).
All plans should currently be operating under policies and procedures that are in compliance with Act 68. The Department will review any new policies and procedures due to requirements in the regulations; the Department will provide for a period of transition to allow plans to implement any necessary changes once the regulations are final.
One commentator raised concerns that this proposed requirement for prior approval would create problems for managed care plans enrolling Medical Assistance (MA) recipients. The commentator noted that plans currently submit copies of grievance and complaint procedures to the DPW for review and approval. The commentator was concerned not only about the cost of duplicative requirements, but also that different agencies might have different determinations regarding the adequacy of the complaint and grievance procedures, placing the plan in precarious position in terms of regulatory compliance. The commentator recommended that the Department work with the DPW to eliminate duplicative reviews and clarify regulatory authority.
There should be no confusion as to regulatory authority. The DPW is in the role of purchaser, and buys certain products from HMOs with certificate of authority for its MA population. To the extent that a plan has contracted with DPW to provide services, it is required to meet DPW's contractual requirements. It is the Department, however, along with Insurance, that has regulatory oversight over HMOs in this Commonwealth. Therefore, an HMO must have a certificate of authority from the Department and Insurance to be eligible to contract with DPW. In other words, the HMO bidding on DPW's request for proposal must meet the Department's and Insurance's standards for a certificate of authority, and must comply with the Department's and Insurance's regulations to maintain compliance with Act 68 and the HMO Act and to retain its certificate of authority to operate. The DPW communicates with the Department concerning the Department's regulatory requirements and, to the fullest extent possible, coordinates both agencies coordinate activities.
It should also be noted that a plan serving an MA population must not only offer procedures and processes that comply with the terms of Act 68, but also a fair hearing process, in accordance with Federal law and regulations. The enrollee has a choice of pursuing either procedure, or both, in challenging a plan decision. The Department and DPW treat these as separate procedures; the Department has no authority over the DPW fair hearing process and DPW has no jurisdiction over the Act 68 process.
One commentator stated that the proposed subsection ignored Act 68's clear instructions that complaints are the responsibility of Insurance, and not the Department, and that the other provisions were unduly vague.
Another commentator commented that since the Department has the authority to approve complaint and grievance procedures as part of its Act 68 compliance and review activities, and the authority to review and approve forms, Insurance should not. The contention was that both agencies should not have approval over complaint and grievance procedures.
Act 68 gives authority over complaints to both agencies. See section 2142(a) of Act 68. Which one is appropriate depends upon the subject matter of the complaint. Act 68 also gives both agencies the authority to investigate violations of Act 68. See section 2181(d) of Act 68. The Department and Insurance will work together to ensure that the documents approved are in compliance with Act 68 requirements, and the standards for grievances as developed by the Department.
IRRC commented that this proposed subsection was unclear because it would not provide any specific requirements for the approval of procedures. IRRC recommended that the Department add a reference in this subsection to § 9.710 (relating to approval of plan enrollee complaint and enrollee and provider grievance systems). The Department has added the reference.
One commentator supported proposed subsection (b) since it would require a plan to immediately correct procedures found to be noncompliant or creating unacceptable administrative burdens on the enrollee.
IRRC commented that since the Department has the authority to require a plan of correction, this proposed subsection should be revised to specifically require a plan to develop and adhere to a plan of correction.
IRRC also asked for an explanation of the difference between a noncompliant plan and a plan that would create an unnacceptable administrative burden on an enrollee. IRRC recommended that the Department delete the phrase ''or to create unacceptable administrative burdens on the enrollee.''
The Department agrees that the phrase ''create unacceptable administrative burdens on the enrollee'' is redundant, and should be deleted. The Department has replaced that phrase with the phrase ''with the act or this chapter.''
The Department has not included language in the proposed subsection specifically stating that the plan must develop and adhere to a plan of correction, since that language already appears in § 9.606. The Department may choose to use a plan of correction in this instance, or it may choose to prosecute violations in other ways permitted by § 9.606.
IRRC commented that the use of the term ''appeal'' in proposed subsection (c) was vague and would conflict with the use of the term in proposed § 9.705. IRRC recommended that the Department use another term in the proposed subsection.
The Department agrees, and has replaced the word ''appeal'' with the phrase ''request for an internal review'' as a more descriptive term.
IRRC and another commentator commented that proposed subsection (c) would not provide guidance on how to distinguish between complaints and grievances. IRRC noted that Insurance included examples in its final-form regulations, and recommended that the Department consider adding language that explains the difference between a complaint and a grievance, along with examples. The other commentator suggested that the Department could state that it would provide updates on its interpretation in its website or in technical advisories. The commentator urged that this was necessary in addition to providing the opportunity for individual plan consultations as described in the proposed regulations.
The Insurance regulation referred to by IRRC (31 Pa. Code § 154.17(a)(3)) includes types of complaints the Insurance would review upon appeal, and not examples of complaints versus grievances. The Department agrees that further guidance should be given to plans, enrollees and providers. It believes that it will be more appropriate to provide such guidance and examples through a technical advisory, which will allow it more flexibility in terms of the narrative explanations and examples. The Department will also include this information on its website.
IRRC recommended that the Department review Insurance's regulations to ensure there are no conflicts in the classification of complaints and grievances. The Department has reviewed the regulations and is satisfied that no conflict exists.
IRRC commented that, to be consistent with subsections (a) and (b), the Department should change the word ''process'' in proposed subsection (c)(1) to ''procedure.''
The Department has made the change.
One commentator recommended that the Department change the language in proposed subsection (c)(1) to permit the Department to correct situations where there may not have been deliberate action by the plan to deny or affect the enrollee's access to the complaint or grievance process, but the classification nevertheless resulted in access being affected or denied.
The Department has the ability under the regulations to change a complaint to a grievance when it finds that classification is more appropriate. That decision, however, is not predicated upon whether or not the plan intended to harm the enrollee by its classification of the request for review. The Department has not changed the regulation.
IRRC commented that proposed subsection (c)(2) would only require the plan to consult with the Department or Insurance concerning whether the case was a complaint or grievance, and that it was unclear whether the Department's decision is binding. IRRC recommended that the regulation should state whether determination is binding or not.
The Department agrees, and has added language to the regulation that states that the decision is final and binding.
One commentator welcomed the Department's recognition that its intervention would be necessary when the enrollee believes that the plan has improperly classified the request for an internal review. Three commentators recommended that language be added to the proposed regulations to provide for the disclosure of this right.
The Department agrees that the enrollees should be informed of their ability to question the classification of the request for an internal review. Therefore, the Department will require plans to add language in their letter acknowledging receipt of the matter from the enrollee that the enrollee can contact the Department to question the classification of the case. This is addressed in §§ 9.703(c)(1)(i)(A) and 9.705(c)(1)(i)(A).
One commentator commented that rather than orienting the regulations to establish the enrollee's choice of classification as a complaint or grievance, the final-form regulations should at least guard against enrollee ignorance, plan's perverse incentives and passive oversight. The commentator recommended two changes: establishment of affirmative enrollee rights to information, and a disincentive against misclassifications of request by plans. The commentator recommended that if the plan misclassified a request, the plan should have to provide the benefit or what is being contested until the appropriate complaint or grievance procedure had been completed.
The same commentator commented that the proposed regulation obscured the intent of Act 68 to allow enrollees to challenge a plan's decision by allowing enrollees to choose whether to file a complaint or grievance of a plan's decision. According to the commentator, Act 68 states that an enrollee can file a complaint and that an enrollee can file a grievance; therefore, Act 68 gives the right to enrollees, not to plans, to decide whether the matter should be a complaint or a grievance. The commentator recommended that the final-form regulations should say that the initial classification should belong to the enrollee, that the plan should respect this unless it is unclear, and then the plan can discuss the issue with the Department and make a decision.
The same commentator also recommended that the Department require a plan to counsel the enrollee as to whether to file a complaint or a grievance by including information in the notice, and discussing the matter with the enrollee. The commentator further suggested that the plan should have the burden of contacting the Department for reclassification, not the enrollee, as it states in the proposed regulations.
Several commentators also suggested that the proposed regulation would pervert the intent of Act 68 by allowing plans to classify any request for internal review they receive as they please, to their possible advantage, as either a complaint or a grievance, noting that the Department recognized this possibility in its Preamble. The commentators stated that Act 68 provides no authority for assigning this decision to the plan.
The Department has not changed the regulation to state that the enrollee may make the determination of the classification as a complaint or grievance. Under Act 68, the plan is responsible for processing complaints and grievances in accordance with prescribed requirements for complaint procedures and grievance procedures. The plan must bring the right procedure to bear and can be sanctioned or penalized if it does not. Not providing for plans to classify the issue as a complaint or grievance would mean that the plan is subject to penalty for following the wrong procedure when an enrollee has misclassified the issue in dispute. The Department has no desire to penalize the enrollee for such a mistake, but to penalize the plan for an enrollee's error would be unjust. The most reasonable way to implement Act 68 and ensure compliance is to place the duty to classify as a complaint or a grievance with the plan, provide for notice to enrollees with an appeal mechanism to the Department and to hold plans accountable for their classification decisions by penalties and sanctions.
Because time frames for complaints and grievances are equal, improper classification should not delay the proceedings. If the Department finds that a case has been classified incorrectly, it will instruct the plan to continue the process at the same level of review, but for the appropriate classification.
One commentator raised concerns over the handling of complaints regarding noncovered services. The commentator noted that services excluded by contract are not covered, even when medically necessary; however, some of these services have been handled inappropriately as grievances.
The Department takes the position that if there is a specific contract exclusion for a specific service, the matter is a complaint. However, if a requested service is covered by the plan in certain circumstances that relate to clinical or medical criteria, and if it is necessary to obtain the opinion of a physician to determine whether or not the requested service should be covered according to the contract terms, then the matter must be reviewed by another physician, and not by Insurance or the Department, in order for the enrollee to obtain an informed and relevant review of the enrollee's request. For example, the plan's contract may exclude weight loss programs except when medically necessary. The enrollee's provider documents the medical necessity for weight loss yet the plan determines there is insufficient evidence, or the enrollee's condition does not meet clinical thresholds. In both instances, the plan is rejecting the medical necessity assertions of the enrollee's provider in favor of, or according to, the plan's medical policy. The only possible way to intelligently and effectively evaluate the merits of the enrollee's provider's arguments for coverage versus the validity of the plan's denial is to have a physician objectively and clinically evaluate both sides of the argument. Neither Insurance nor the Department is in a position to determine if an enrollee's weight or cholesterol count is sufficiently high enough to warrant coverage of a weight loss program as medically necessary. The Department has treated these matters as grievances.
IRRC noted that proposed subsection (c)(4) waives the filing fee if a grievance is improperly filed as complaint. IRRC questions why paragraph (5) would not require a refund if a complaint were improperly filed as a grievance.
It is rare that a complaint will be improperly classified as a grievance simply because the plan incurs more cost in a grievance process particularly through obtaining the opinion of a matched specialist, a specialist who practices in the same or similar specialty as would typically manage or consult on the requested health care service, in the internal review, than in the complaint process. Further, the external grievance review may cost anywhere from $300 to $3,000. The Department agrees, however, that for the sake of consistency with paragraph (4), where a complaint has been filed as a grievance, the fee should be refunded. It has included language to this effect in subsection (c)(5).
One commentator supported the provision requiring Department monitoring of plan reporting of complaints and grievances in proposed subsection (c)(6), and recommended that this should include, under an enrollee controlled designation procedure, monitoring of the frequency with which plans seek reconsideration by the Department, and whether the pursuit of reconsideration is done in good faith and not so as to delay the proceedings and deny due process to an enrollee.
The Department is not creating an enrollee-controlled designation procedure. The Department is aware that there are concerns that improper classification, particularly of a grievance as a complaint, may harm the enrollee. Delay in the proceedings, however, should not be a factor, since both the complaint and grievance procedures adhere to the same time frames at all levels. The Department intends to monitor this situation closely, and will issue technical advisories as appropriate to clarify how to distinguish between complaints and grievances in greater detail than is possible in regulations.
One commentator took issue with proposed subsection (c)(6), which provides that the Department might audit or survey to verify compliance with Act 68 and Subchapter I. The commentator recommended that the audits and surveys be a regular part of auditing process rather than an option. The commentator also recommended that if the Department decided that this would be an option, then standards should be articulated as to when a survey would occur.
The Department has the responsibility under Act 68 to ensure compliance with that act. The Department needs flexibility to choose when audits or surveys are necessary. The Department also reviews plans' quarterly and annual reports for data concerning first and second level complaints and grievances, and makes determinations if there are problems at that time as well.
IRRC commented that proposed subsection (d)(1) would duplicate the requirements of proposed subsection (2)(d) and (3) as it applied to grievances. IRRC also commented that the term ''unreasonable'' in paragraph (1) was unclear. IRRC recommended that the Department either delete paragraph (1), or add the 15-day time period Act 68 permits for agency appeals.
One commentator stated that the Department should extend the ''business day'' definition to all time frames in the proposed regulations and under Act 68. The commentator stated that the same pressures that make business days a reasonable time period in short time frames apply in other time periods as well. The commentator also noted that NCQA uses business days.
IRRC recommended that the Department delete the term ''calendar day'' in paragraph (2) since time limitations in terms of days are considered to be calendar days. Another commentator also recommended deletion of this term, as Act 68 and regulations typically refer to ''business'' or to ''days'' without a modifier.
That commentator also recommended that the time frames proposed in paragraphs (2) and (3) be the same and mirror Insurance's regulations.
One commentator noted that these time frames for enrollees to file complaints and grievances (45 days) differ from time frames under DPW's contracts, which allow 30 days. The commentator expressed concern that plans would have to go to considerable expense to change booklets and other documents. It also asked that the Department consider DPW's requirements when the Department audited plan compliance.
After reviewing all the comments on proposed subsection (d), the Department recognizes that the proposed subsection was inadvertently inconsistent with Insurance's final regulation. Since both agencies are responsible for the review of complaints, the regulations must be consistent on this topic. Therefore, the Department is adopting the text of Insurance's final regulation, and has deleted the substance of proposed subsection (a)(1) and (2). The Department has adopted Insurance's language relating to time frames in subsection (d), which provides at least 45 days for enrollees to file complaints and grievances. Plans not in compliance with this standard, even for DPW enrollees, are not in compliance with Act 68.
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