[31 Pa.B. 3043]
[Continued from previous Web Page] Section 9.703. Internal complaint process.
Proposed § 9.704 has been renumbered as § 9.703. The Department received over 120 comments on this proposed section.
The Department received several general comments on this proposed section, again referring to the Department's 1991 guidelines, and contending that the section lacks a fair and uniform procedure for how complaint and grievance hearings should be conducted, which had been included in those guidelines. One commentator also commented that the proposed regulations would not specifically provide procedures that would assure independent input in the complaint resolution process.
For reasons discussed earlier, the Department is adding to this section provisions from its 1991 guidelines to ensure a fair proceeding in the review of complaints. Those provisions are discussed in the discussion of the Department's response to comments on the individual subsections in this regulation.
Two commentators recommended generally that the Department add a new subsection which would state: ''If the plan fails to act within the time frames established herein, the relief sought by the member shall be granted automatically by the plan.''
The Department has not added this language to the regulations. If a plan violates the time frames of Act 68 or this subchapter, it is subject to sanctions under Act 68 and these regulations, including fines. Requiring a plan to provide the relief sought by the complaint in every instance when a plan fails to meet time frames is an extreme penalty, and removes discretion from the Department to fit the penalty to the violation.
One commentator recommended that the Department delete this section entirely, as complaints are under the sole jurisdiction of Insurance, not the Department. As stated earlier, both the Department and Insurance are given authority over complaints by Act 68.
IRRC commented that the second sentence of proposed subsection (a) lacked clarity. That sentence stated: ''The process shall address complaints concerning matters including participating health care providers, health plan coverage, plan operations, and plan management policies.'' IRRC recommended that the Department rephrase the sentence to follow the language of Act 68: ''An enrollee shall be able to file a complaint regarding a participating health care provider, or the coverage, operation, or management policies of the managed care plan.''
The Department's intention was to add clarity to the Act 68 definition; therefore, the Department did not track the language of Act 68 exactly. The Department has made revisions to the language to follow the language of Act 68 as suggested by IRRC.
IRRC also commented on the Department's use of the phrase ''and is acceptable to the Secretary'' in proposed subsection (a). IRRC noted that the complaint process shall meet the requirements of Act 68 and the regulations, and that the Department should either explain what additional requirements it means, or delete the phrase.
As discussed earlier, the Department's intention in including this phrase was to provide notice of its authority over the complaint and grievance process under both the HMO Act and the PPO Act, as well as under Act 68. As the regulations contain what would be acceptable to the Secretary, the Department has deleted the language.
Another commentator commented that the right to complain should be extended to former and potential enrollees who have contractual and legal rights for which there may be no other recourse but to file a complaint. For example, a former member may seek payment for a service that the plan denied as not covered, but was provided during a period of enrollment.
The Department has not changed its regulations to address this concern. Act 68 does not extend the right to file a complaint or grievance to a potential enrollee. See sections 2141(a) and 2161(a) of Article XXI. Therefore, the only persons able to file complaints or grievances are enrollees or, in the case of a grievance, providers with enrollee consent. Former enrollees have the same appeal rights as current enrollees, as long as there was a contract in effect at the time of the initial denial or event that triggered the complaint or grievance, even though the entire complaint or grievance process may run past the period of coverage. An enrollee must comply with the plan's time frame for the filing of a complaint or grievance. Once that time period passes, the individual no longer has the ability to file the complaint or grievance.
IRRC commented that the proposed regulations would allow oral or written complaints at both the first and second level review. IRRC noted that Act 68 only addresses oral complaints at the first level review. IRRC recommended that the Department revise the regulations to state that a written request would be required to initiate a second level review of a complaint.
Although Act 68 is silent on allowing oral complaints at the second level, the Department proposed to permit second level oral complaints and has not changed the language. The Department believes that a plan must take an oral complaint at the second level from a person who is unable to make the complaint in writing. The intent of Act 68 permits this, and the demands of fairness require it. Further, were a plan to refuse to allow an oral appeal where an individual is unable to make a written one because of a disability, the plan could be in violation of the ADA.
One commentator objected that the proposed regulations would not include a requirement that the plan provide notices to an enrollee at each step of the appeal process.
The regulations require such notice from the plan at the receipt of the complaint, and after every level of the complaint process. See subsection (c)(1)(i) and (vi) and (2)(i) and (vi).
One commentator stated that it was particularly troubling that there was no requirement for all members of a review panel to be present at the hearing on the complaint.
The proposal did not state that members of the complaint review committee are not required to be present. To clarify this, however, the Department has added language to the regulations requiring members of the second level complaint review committee to be present at the review either telephonically or by videoconference, and have the opportunity to review any additional information provided during the review in order to vote. See subsection (c)(2)(iii)(I).
IRRC commented that the proposed regulation did not state that the first level decision was binding unless appealed, as did proposed § 9.704(c)(2)(iii).
The Department believes this language is unnecessary. An enrollee can appeal the decision if the enrollee chooses. The plan will obviously not appeal its own decision. If the enrollee does not appeal the decision, it will stand. The Department has deleted the proposed provision.
One commentator noted that there was frequent confusion about whether an enrollee's first contact with a plan constituted an inquiry, a complaint or a grievance. The commentator recommended that the Department require an acknowledgement from the plan to establish the date of the receipt for purposes of monitoring compliance with Act 68 time frames and to clarify whether the plan views the enrollee's challenge as a complaint or grievance, so that the enrollee may obtain help from the Department if necessary. Another commentator also recommended that the plan be required to notify the enrollee of receipt of the complaint.
The Department agrees that it is necessary to have plans confirm that complaints or grievances have been received, to establish the start of the review period and to allow the enrollee the ability to challenge the classification as appropriate. Further, the Department agrees that it is necessary for the plan to provide certain information to the enrollee before the start of the process, to ensure that the enrollee is aware of and is able to take advantage of certain procedures put in place for the enrollee's benefit. These would include the ability to contact the Department, to review plan information related to the complaint upon request, to submit additional information to the plan for review and to appoint a representative. The Department has included these requirements in subsection (c)(1). These requirements were included in the Department's 1991 guidelines.
The Department has also included the requirement that if the plan agrees to allow attendance at the first level review, the enrollee, and the enrollee's representative, if applicable, may attend the first level complaint review. See subsection (c)(1)(i)(E)). The enrollee and the enrollee's representative, may attend the second level review as a matter of course. See subsection (c)(2)(iii)(A). The Department has also included language stating that the enrollee may request the aid of a plan employee who did not participate in previous plan decisions to deny coverage for the issue in dispute in preparing the enrollee's complaint. See subsection (c)(1)(iv) and (2)(iii)(F). These requirements were also included in the Department's 1991 guidelines.
IRRC commented that the Department should add ''one or more employees of the plan'' for clarity to proposed subsection (c)(1)(i). The Department has added the language as IRRC recommended. See subsection (c)(1)(ii).
One commentator commented that the proposed regulations did not include standards that would guarantee that the committee deciding complaints would remain unbiased.
The Department's proposed regulations would have prohibited involvement of any individual involved in a prior decision to deny the complaint. The Department has not changed that language. See subsection (c)(1)(ii) and (2)(ii).
Several commentators commented that the Department had failed to include language in the proposed regulations which would have given an enrollee access to information relating to the complaint. The commentators stated that without this information, the enrollee would be unable to prepare a case.
One commentator commented that the proposed regulations should require plans to provide access to documentation compiled on the specific matter being appealed, including, but not limited to, internal policies, nursing notes, extended evaluations, and the like.
The Department agrees that the enrollee or the enrollee's representative should have access to relevant information relating to the matter about which the enrollee has complained, and has added language to that effect to the regulations. See subsection (c)(1)(iii). This will enable the enrollee to determine what additional information the enrollee believes is necessary to support the case. The Department is, however, permitting the plan to charge a reasonable fee for the reproduction of any documents. Id.
Three commentators, including IRRC, requested that the Department clarify that a first level decision must be issued within 30 days, so that the 5-day notification period is not included in the 30-day review period. Proposed subsection (c)(1)(iii) stated that the plan was to complete its investigation and review within 30 days of receipt of the complaint.
It was not the Department's intention to add the 5-day notification period to the review period, and the proposed subsection did specify that notification was to occur after the committee's decision. Since this has created confusion, however, the Department has added the language ''and shall arrive at its decision'' after ''review and investigation of the complaint'' to clarify this issue. See subsection (c)(1)(v).
Two commentators commented that the proposed regulations do not include any allowance for postponements. One of these commentators commented that a plan should be able to ask an enrollee if the enrollee wished to extend the period for review when notifying the enrollee that despite using all due diligence, the plan would be unable to obtain the medical records needed to complete the review. The concern was that this could force the plan to proceed without the necessary medical information, and could force enrollees and plans into second level reviews unnecessarily.
The Department does not believe that any additional language is necessary. The plan has the ability to obtain an extension of time from the enrollee without the necessity of including this language in the regulations. The plan should, however, carefully document its request, and the reason for the request, as well as the enrollee's response in its case file, so that if necessary, the Department will be able to make a full review. The Department will be monitoring this closely to ensure plans are not exerting undue pressure on enrollees and are requesting extension with proper cause.
One commentator stated that if the complaint involved performance by a health care provider, the provider should be given a copy of the decision letter and instructions on how to appeal any adverse decisions.
Act 68 does not allow for appeals by providers of complaint decisions, only for appeals by providers of grievance decisions with the enrollee's consent. The plan may choose to investigate a complaint by notifying the health care provider and having the provider present at the complaint review. The decision of the Act 68 complaint review is not one to which the provider is a party, however. Any adverse action taken by the plan against a provider may be handled through the mechanisms set up by the plan and provider in their contractual arrangements, or through the credentialing procedure.
Several commentators raised issues concerning the lack of detailed standards for what is to be included in a decision letter. Proposed subsection (c)(1)(iv) would have required the notice letter to include the basis for the decision, and the procedures and time frame to file a request for a second level review of the decision of the initial review committee.
A few of these commentators further recommended that the notices of decisions contain a description of the reviewer's understanding of the substance of the dispute, and references to the evidence and documentation used as basis for the decision.
Two commentators recommended that the regulations require that the decisions contain a statement that the decision is binding unless the person appeals.
Two commentators recommended that the regulations require that the decisions be clear and detailed to permit an enrollee to respond further.
One commentator recommended that the regulations contain a requirement that plans clearly articulate the reasoning behind decisions.
One commentator recommended that the Department should strengthen decision notices by requiring specific comprehensible information about decisional standards, although even this would be insufficient to allow enrollees to navigate the process with some success without access to information.
IRRC commented that the phrase ''basis for decision'' in proposed subsection (c)(1)(iv) was unclear, and could result in the denial of a complaint that an enrollee was unable to understand. IRRC commented that it was not clear from the regulations how much detail would be required. IRRC recommended that the Department provide further guidance on how detailed the information from the plan should be, for example, would the basis for decision be required to include reference to applicable contract provisions.
One commentator recommended that the Department add the following language to the proposed subsection: ''The basis for the decision shall be detailed, and shall recite what information or documents were considered, what if any arguments were accepted and rejected, relevant contract provisions and the reasoning for accepting or rejecting the various arguments. The plan may not base a decision against the enrollee on any reason not stated in an initial decision.'' The commentator stated that this would show that the plan did more than rubber stamp its previous decision, and would prevent an unfair situation in which the enrollee has successfully addressed plan's rationale, but loses because plan has adopted a new, previously unarticulated reason for denial.
The Department agrees that a more detailed explanation of what is meant by ''the basis for the decision'' should be included in the regulations. The Department has added language that states the basis for the decision includes the following: (1) a statement of the issue being referred to the second level review committee; (2) the specific reason or reasons for the committee's decision; (3) references to the specific plan provisions on which the decision is based; and (4) if an internal rule, guideline, protocol, or other similar criterion was relied on in making the decision, either the specific rule, guideline, protocol or criterion, or instructions on how to obtain the internal rule, guideline, protocol or other similar criterion will be provided upon request. These are the current requirements included in regulations recently issued by the United States Department of Labor relating to new ERISA claims procedure rules (see 29 CFR Part 2560 (November. 20, 2000)) (ERISA rules). The Department is also requiring that the notice include a statement of when and how the enrollee may appeal to the second level. See subsection (c)(1)(vi).
The Department has not added a provision stating that the plan shall be prohibited from citing reasons for denying the claim that are different from those offered at an earlier stage of the process. The Department believes that in certain circumstances it may be necessary for a plan to deny a case based on a different reason than originally provided, due to additional information provided by the enrollee. The enrollee is not prohibited from introducing new and additional evidence throughout the process. Additional evidence may trigger other restrictions on services not previously cited by the plan.
One commentator commented that the proposed regulations should detail more specifically what information a plan shall provide as the basis for its denial, stating that plans refuse to provide medical criteria used in making UR decisions, claiming they are proprietary. The commentator stated that plans should provide criteria they rely upon to deny service or level of service. The commentator also recommended that the regulations should specifically state that such criteria may be used as tools in making the decision, but may not be used as the sole basis for the decision.
The Department has specified, in § 9.750(b)(3) (relating to UR system standards) that a plan must make available to the provider, upon request, copies of the UR criteria it uses. The Department has also added the requirement that the UR tools cannot be used as the sole basis for the decision. See § 9.750(c).
IRRC also recommended that the Department reference § 9.702(d)(3) (relating to complaints and grievances) which gives an enrollee 45 days to file a second level complaint.
The Department has not referenced that provision. A time frame, as discussed in § 9.702, may or may not be established by the plan, depending on whether a plan chooses to set a time frame for the filing of a second level review. Under that section, the plan must give the enrollee at least 45 days, so the actual time frame may be greater than 45 days. Section 9.702 is a requirement for the plan, and it would not be useful to the enrollee for the Department to reference that section here.
The Department received many comments on proposed subsection (c)(2), relating to requirements for second level reviews.
Two commentators raised concerns that the Department had taken away many of the fundamental fairness standards contained in its 1991 guidelines, which the commentators stated governed the complaint and grievance process prior to the passage of Act 68. One of these commentators noted that these standards were extremely important to children with disabilities who often face HMO denials of their more costly and more specialized care. The other commented that the proposed regulations required a thorough revision to uphold the rights of enrollees.
Three commentators recommended including in the regulations a requirement that the second level review committee be prohibited from basing a decision against an enrollee on a reason not specifically raised in the first level review.
Three commentators recommended including in the regulations a requirement that enrollees have the right to appear at the review and the right to prepare for the review.
Two commentators recommended including in the regulations a requirement that enrollees have the right to be advised that they could be assisted by an uninvolved HMO staff person if they need help preparing the case.
Three commentators recommended including in the regulations a requirement that enrollees be given a description of the review committee's procedures.
Several commentators recommended including in the regulations a requirement that plans schedule second level complaint and grievance hearings at mutually convenient times and with 15 days advance written notice. One commentator noted that this was important for children with disabilities, who may require time to make travel arrangements, to be present at a hearing.
One commentator recommended that the Department include a requirement that the second level review committee base its decision solely on materials and testimony presented at the hearing.
The Department's 1991 guidelines did require notice to the enrollee of the procedures to be followed during the second level review proceedings, and that the enrollee could be present. The Department agrees that this information is valuable to the enrollee, and that the enrollee should be notified of that information at the time the request for the second level review is made. The Department had originally included this requirement of notification of the right to appear in proposed subsection (c) (2)(ii), but has moved that requirement to subsection (c)(2)(i)(B).
The Department also agrees that the enrollee should be provided 15 days advance written notice of the review (subsection (c)(2)(iii)(B), the ability to be present at the second level review and to present the enrollee's case (subsection (c)(2)(iii)(A)), and have a plan employe not previously involved in the plan's decisions to deny coverage for the issue in dispute available to assist in the preparation of the complaint (subsection (c)(2)(iii)(F). These requirements were included in the Department's 1991 guidelines.
As discussed earlier, the Department has not added a prohibition against the plan citing to reasons for denying the claim that are different from those offered at an earlier stage of the process. The Department believes that in certain circumstances it may be necessary for a plan to deny a case based on a different reason than originally provided, due to additional information provided by the enrollee. The enrollee is not prohibited from introducing new and additional evidence throughout the process. Additional evidence may trigger other restrictions on services not previously cited by the plan.
One commentator recommended that the Department should provide the same flexibility, as with attendance, to time allotted for the enrollee's presentation and the committee's chance to ask questions while the enrollee is present. The commentator commented that HealthChoices HMOs are scheduling hearings too close together, causing committees to rush and not to fully digest information.
The Department has not changed the regulations to address this concern, as it pertains to Health Choices HMOs only. This concern may be best addressed by DPW through its oversight of HealthChoices contractors.
Several commentators recommended including a requirement that a plan staff person knowledgeable about the complaint be present at second level review to present the HMO's view of why the denial should be upheld, and that the staff person should be available for questions by the member and the committee.
The Department believes that a requirement that the plan have employees available for questioning by enrollees is too burdensome for a plan. The Department has declined to include this requirement in the regulations.
One commentator recommended that the plan be required to present the entire case in full at the hearing, before the enrollee. The commentator further stated that for the enrollee to be able to prepare a meaningful response, the enrollee shall have access to information in the possession of the plan.
The Department is adding language to prohibit the committee's discussion of the case prior to the review meeting, and has also required that the decision be based solely upon the evidence presented at the review. See subsection (c)(2)(iii)(H) and (L). For the committee to discuss the case prior to hearing the enrollee on the matter could prejudice the committee and cause them to unfairly filter what the enrollee presents at the review through preconceived notions of the substance of the case.
IRRC commented that proposed subsection (c)(2)(i) was unclear because it contained two requirements, and recommended that it be broken into two parts. IRRC recommended that one part include the minimum size of the committee, and the other part include the prohibition on including persons as members of the review committee who had participated in earlier plan decisions on the matter.
The Department has revised the subsection as IRRC requested. See subsection (c)(2)(ii).
One commentator expressed concern that the proposed regulations would fail to include standards that guarantee that the committee deciding complaints remains unbiased.
One commentator also commented that there should be some method for an enrollee or physician to ''discover'' whether the members of the second level review committee were unbiased.
The Department has already provided for enrollees to contact the Department if they feel the process is unfair. The Department has added the requirement that the committee must be impartial. The Department will not put a ''discovery'' requirement in the regulation, as the review process before the plan is not a legal proceeding. The Department will, however, review any allegation of bias made to it.
One commentator raised a concern that the proposed regulation would allow the same persons who made the initial decision to make the second level review decision. This commentator recommended that the Department change the language ''in first level review,'' to ''with the initial matter being complained of.''
The Department understands this concern, and has changed the language to read ''did not previously participate in the matter under review.'' See subsection (c)(2)(ii).
One commentator commented that the terminology typically used in reviews is ''impartial'' rather than ''unbiased,'' and recommended that the Department change the language in its proposed regulation.
The Department has made this change. See subsection (c)(2)(ii)(B).
Three commentators recommended that the Department require the second level review committee to be made up of at least 1/3 HMO enrollees who were not employees of the plan, and that the consumer attending be told which members of the committee are staff and which are plan members.
Act 68 only requires that 1/3 of the members of the second level review committee not be employees of the plan. See section 2141(c)(1) of Article XXI. The Department has not changed the regulation to address this comment. The Department would recommend that committee members who are not plan employees have some familiarity with managed care and the functioning of the plan and take the position as a member of the committee seriously. The Department has added language prohibiting these nonemployee members from being employees of any related subsidiary or affiliate of the plan. See subsection (c)(2)(ii)(A).
With respect to the comment recommending that the enrollee be notified of the position of the individuals present at the review, the proposed regulation did include language stating that the persons present at the committee should be identified for the enrollee. See proposed subsection (c)(2)(ii)(C). The Department has maintained that language. See subsection (c)(2)(iii)(E).
One commentator stated that the proposed section would have omitted a number of provisions necessary to provide an enrollee a full and fair chance to present the enrollee's complaint. This commentator recommended that the Department add the following to proposed subsection (c)(2)(ii): ''The plan shall permit the member to review the file and records of the plan as they relate to the matter at issue, and the plan shall produce and provide copies of related documents, including documents kept electronically, at no extra cost. The plan shall identify, state the position, if any, relative to the plan, and provide the qualifications of any individual who rendered the decision, if any, under review. The plan shall permit the member to request the presence of plan employees, and the plan shall assure the presence of plan employees at the review for questioning by the member.''
The Department has included in the regulations a requirement that the plan provide an opportunity for the enrollee to obtain material relevant to the case; however, the Department is permitting that a fee be charged. See subsection (c)(1)(iii). The Department will not require plans to have employees present for questioning. Such a requirement would be too disruptive of plan operations.
With respect to the comment recommending that the enrollee be notified of the position of the individuals present at the review meeting, and their qualifications, the Department is, as it has said, retaining language from the proposed regulation which states that the persons present at the committee should be identified for the enrollee. See subsection (c)(2)(iii)(E). The only qualification for serving on the review committees is status as an employe or as a nonemploye. Employment, background, education, years of training or other qualifications are immaterial. The Department is requiring identification as to their role with respect to the plan. This is the only information the Department is requiring other than names of the committee members.
One commentator applauded the Department's proposed requirement that the plan provide reasonable flexibility in terms of time and travel distance when scheduling a second level review to enable enrollee participation at that review. See proposed subsection (c)(2)(ii)(A).
One commentator stated that the regulations would not require plans to accommodate enrollees when scheduling second level reviews.
IRRC and another commentator raised concerns that the term ''reasonable flexibility in terms of time and distance'' used in proposed subsection (c)(2)(ii)(A) was unclear. IRRC recommended that the Department provide more specific requirements for scheduling reviews similar to requirements in § 9.679(e). The other commentator also recommended that the regulations should be revised to require a plan to schedule a second level review hearing at a time and place that accounts for the enrollee's condition or other factors that warrant a shorter time or distance.
The Department has declined to attempt to set a minimum standard, given the difficulty to set a standard that would be acceptable to everyone involved. Therefore, the Department has changed the language of the subsection to require a plan to make reasonable accommodations to facilitate enrollee participation, and to take into account the enrollee's access to transportation and any other disability of the enrollee that might impede the enrollee's ability to travel. See subsection (c)(2)(iii)(C).
Two commentators recommended that it should be specified that the enrollee may be accompanied by a medical or a legal advocate. Proposed subsection (c)(2)(ii)(C) would have limited attendance at the second level review to members of the review committee; the enrollee or the enrollee's representatives, or both; the enrollee's provider or applicable witnesses; and appropriate representatives of the plan.
The Department agrees it is important to clarify that the enrollee's representatives could include legal representatives, as well as medical personnel or other attendants necessary to the enrollee. The Department did not intend to prohibit an enrollee from bringing an attendant to the review. Clearly, if an attendant is necessary to ensure that the enrollee can fully participate in the review then the plan must allow that individual or individuals to be present. It was the Department's intention to prevent either side of the matter from creating confusion at the review, or attempting to intimidate through numbers. After having considered the comments, however, the Department agrees that it would be beneficial to the enrollee for the regulation to specify that the enrollee will be permitted to bring individuals necessary for the enrollee to fully participate in the review meeting, which could include persons providing moral as well as physical support. See subsection (c)(2)(iii)(E).
Relative to this same provision, IRRC commented that the word ''or'' could cause confusion in the phrase ''enrollee's provider or applicable witnesses.'' IRRC recommended that the word ''or'' be replaced with ''and.''
The Department agrees and has made the change, but has also added language to clarify that, for purposes of confidentiality, the enrollee's provider should not be present at the review unless the enrollee has consented.
Three commentators commented that the regulations should include a requirement that the entire second level review hearing be transcribed by the HMO and the guarantee of the enrollee's right to transcribe and record the proceeding. One of these commentators noted that this was the only record which the Department or Insurance would have. This commentator stated that transcription was necessary, because, otherwise, mischaracterization of the facts to the plan's advantage is inevitable. The commentator urged that the member should also be guaranteed a right to record the hearing or have it transcribed. It contended that, otherwise, there would be no ability to rebut the characterization of testimony.
Another commentator commented that use of the word ''deliberations'' in proposed subsection (c)(2)(iv) implied something different than a recording of the proceeding. The commentator noted that deliberations were the part of the review where the committee voted and deliberations were off the record.
IRRC commented that the proposed regulation would allow deliberation of the second level review committee to be summarized or transcribed verbatim. IRRC asked whether a summary would be a sufficient record for appeals before the agencies.
The Department did not intend to require the transcription of the deliberations of the second level review committee which, like the deliberations of a jury, judge, hearing officer or agency, are not made public. The Department has added language requiring that the proceedings be recorded, either through an electronic recording, verbatim transcription or written minutes. See subsection (c)(2)(iv). This is in accordance with the Department's original guidelines on maintaining a record of a complaint hearing required some type of record, but made verbatim transcription optional.
Three commentators, including IRRC, requested that the Department clarify proposed subsection (c)(2)(v) and (vi). Proposed subsection (c)(2)(v) would have required the plan to complete the second level review within 45 days of the plan's receipt of the enrollee's request for review. Proposed subsection (c)(2)(vi) would then have required the plan to notify the enrollee of the decision within 5 business days of the decision.
IRRC and other commentators requested that the Department clarify that the 5-day notification period is not included in the 45-day review period.
It was not the Department's intent to include the 5-day notification period within the review period, and the proposed subsection did specify that notification was to occur after the committee's decision. Since this has created confusion, however, the Department has added language ''and shall arrive at a decision'' after ''complete the second level review'' to clarify this issue. See subsection (c)(2)(v).
IRRC and two other commentators recommended that the Department revise proposed subsection (c)(2)(vi) to require the plan to send notice of the second level review decision to an enrollee and the enrollee's representative.
The Department agrees that requiring notification of the enrollee's representative would be useful for enrollees who have obtained help through the process, and has added that language. See subsection (c)(2)(vi). To ensure that plans are aware that such a notification should be sent, the Department has also added language to subsection (c)(2)(vi) requiring that an enrollee or the enrollee's representative wishing to receive notification inform the plan of that fact prior to, or at, the second level review.
Several commentators commented on proposed subsection (c)(2)(vii). That proposed subsection would have required a plan to include in its notice to the enrollee the basis for the decision and the procedures and time frame for the enrollee to file an appeal to the Department or Insurance, including the addresses and telephone numbers of both agencies.
One commentator recommended requiring the notice to include the reasoning for accepting or rejecting the various arguments made.
Four commentators complained that the proposed regulations would not include a requirement that a plan clearly articulate the reasoning behind decisions, including references to standards used, references to the evidence considered and a description of the reviewer's understanding of the substance of the dispute.
One commentator recommended that the Department include a requirement that the second level review make available (in person or by telephone) those persons involved in the decision.
One of the commentators noted that the Department's proposed regulation would only require that the basis for the decision be included, stating that this was insufficient detail to ensure patient protections.
IRRC commented that the phrase ''basis for decision'' in the proposed subparagraph was unclear, and could result in the denial of a complaint that an enrollee was unable to understand. IRRC and another commentator recommended that the Department provide further guidance on how detailed the decision from the plan should be.
Two commentators commented that the enrollees should have access to all plan documents and information, or the enrollee would be unable to effectively discuss plan standards at the review meeting.
IRRC also recommended that since the procedures for appeal are specified in proposed § 9.705, that section should be referenced, and the 15-day time frame stated specifically.
Two commentators recommended a prohibition against a plan changing its reasons after the review process has begun.
The Department agrees that clarification of the meaning of ''basis for the decision'' is useful to ensure the decision letters clearly articulate the plan's decision and how it is related to its policies and the contract provisions. This will give the enrollee an understanding of why the requested service is covered or is being denied. The Department has included the same requirements for the second level review decision as for the first level review decision. See subsection (c)(2)(vii). The Department has discussed similar comments to those raised here in more detail in the discussion of comments on proposed subsection (c)(1)(iv).
One commentator recommended that the Department strengthen its standards regarding UR and UR decisions so that the Department could effectively monitor UR practices.
Two commentators commented that the proposed regulations should also specifically state that such UR criteria may be used as tools in the complaint decision, but could not be used as the sole basis for the decision.
The Department is revising its section on UR entities to specifically set out standards for UR. The content of UR decision letters is addressed in that section. See § 9.750. The Department has also stated in § 9.750(c) that utilization review criteria cannot be the sole basis for a decision. Specific standards for complaint and grievance decision letters are set out in §§ 9.703 and 9.705. Several commentators commented that one of the fundamental fairness provisions that was missing from the proposed regulations was a requirement that the plan identify the individual making the decision by name, position or credentials. One commentator stated that it was impossible for the Department or the enrollee to determine whether the decision maker had an adequate degree of knowledge necessary to render a decision about the special area of medicine in question.
The Department has not changed the regulations to require that this information be made available. Because complaint decisions do not involve the medical necessity and appropriateness of a service, complaint decisions are not required to be made by licensed physicians or approved licensed psychologists. The Department will, therefore, not require a statement of what credentials are held by the persons making the complaint decisions. As discussed earlier, the only requirements for inclusion on the review committee is status as an employe or nonemploye. Education, training and expertise are immaterial.
Two commentators raised concerns with the last sentence of proposed subsection (c)(2)(vii), which stated that a decision shall be sent in a manner so that the plan can document receipt of the decision. One commentator commented that previous experience with such a process showed that members found it burdensome and inconvenient, and that it caused unnecessary delay in timeliness of receipt of the information. Both commentators stated that the requirement would increase costs.
One commentator asked whether the Department would accept as the receipt date either actual proof of receipt or the expiration of 5 business days after the date of the notification letter as proof of receipt.
The Department has decided to eliminate this requirement. Since the plan issues the decision letter, it will be up to the plan to object to the timeliness of the enrollee's appeal before the Department. Depending upon the plan's reasons for contesting the timeliness of the appeal and the information provided to support the plan's position, the Department may issue an order to show cause to the enrollee to make a case against dismissing the appeal.
One commentator recommended that the Department add the toll-free telephone, fax and TDD numbers to the Department's address and telephone numbers included in proposed subsection (d).
The Department agrees that this would be advisable, and has added to this subsection its TDD number, fax number and toll free telephone number for the taking of complaints.
Section 9.704. Appeal of a complaint decision.
The Department received approximately 20 comments on this proposed section.
Three commentators, including IRRC, commented that the proposed regulations included no time frame for the Department's review and issuance of a decision. The commentators stated that specifying a time frame would help clarify the process and build appropriate expectations for plans and members regarding this stage of the appeal. One commentator suggested that the norm could be specified and provisions made for notice regarding delay.
Act 68 does not require the Department to specify a time frame. Because some cases are more complex than others, it would be difficult to set a time in which the Department must act. The Department intends to complete its review, on average, within a 60-day time period.
One commentator recommended adding the following language to the proposed section: ''The Department will assist enrollees to identify and gather any of this information and material as is necessary to proceed with the appeal.'' The commentator stated that it was too burdensome to require enrollees to provide things like copies of all correspondence with the plan in its appeal to the Department. The commentator stated that this is particularly true for those enrollees who are frail or have some level of cognitive impairment. The commentator recommended that the Department should provide guidance for such individuals in the absence of an ombudsman.
The Department has not added the recommended language to the regulation. In these appeals, the Department sits as the arbiter of the case between the plan and the enrollee. The statute does not place the Department in the role of an ombudsman, nor is such a role practical or appropriate in an appeal process in which the Department is to act as the impartial judge. The enrollee has the opportunity to be represented before the Department by an attorney or by another individual.
One commentator recommended that the Department delete this proposed section, since complaints are under the jurisdiction of Insurance.
The Department and Insurance both have authority over complaints under Act 68.
IRRC asked how the receipt of the decision by an enrollee would be determined. Proposed subsection (a) would have required an enrollee to file an appeal with either agency within 15 days of receipt of the second level complaint review decision.
The Department had proposed that plans issue the decision in a manner that would enable them to determine the date of receipt of the decision. See proposed § 9.704(c)(2)(vii). There was some comment on this matter, however, with commentators being concerned about whether enrollees would accept receipt of a certified letter and whether the cost to the plan would be wasted.
The Department has decided to eliminate this requirement. A plan will be able to object to the timeliness of an enrollee appeal filed with the Department. The Department will make determinations of timeliness on a case by case basis, depending on the facts presented to it by the plan and the enrollee.
IRRC recommended that the Department remove the reference to Insurance in subsection (a) since the Department has no authority over Insurance.
The Department feels the reference is necessary since under Act 68 appeals may be sent to either the Department or Insurance. This section is intended to remind enrollees and plans of that fact.
Two commentators recommended that enrollees be given a minimum of 30 days to file an appeal of a second level review complaint decision with the agencies.
One commentator stated that the ADA requires accommodation for enrollees with respect to the 15-day statutory time frame to file an appeal with Insurance or the Department.
The Department cannot alter the time frame in this section for filing an appeal of a plan decision on a second level review complaint, since the time frame is required by statute. See section 2142(a) of Article XXI. For enrollees who cannot write, the Department will make staff available to transcribe the complaint.
IRRC asked what the term ''Insurance number'' referred to in proposed subsection (b)(3). IRRC recommended replacing the word ''Insurance'' with ''Identification.''
The plan Insurance number is the number assigned by the health plan to the enrollee. The Department has written out the word ''identification'' as IRRC has recommended.
Another commentator recommended changing the word ''shall'' to ''should'' in proposed subsection (b), since minor omissions were bound to occur, and the proposed regulation should not penalize the enrollee by throwing out the appeal when this occurs. Proposed subsection (b) stated that ''the appeal from the enrollee shall include the following:'' and listed five items that were to be included in the appeal.
The Department sees no reason to alter this provision. The proposed subsection lists the information the Department will require with an appeal: The enrollee's name, address and telephone number; identification of the plan; the enrollee's plan Insurance number; a brief description of the issue being appealed; and correspondence from the plan concerning the complaint. The Department cannot process an appeal without being able to identify the enrollee and the plan, and it must have a statement from the enrollee as to what is the basis for the appeal. It is not the Department's intention to use this section, or permit plans to use this section, to move to quash appeals on the basis that enrollees fail to meet the requirements of the regulation.
IRRC recommended that the proposed regulations include Department notice to the enrollee of the status of the enrollee's filing (that is, late or timely).
Proposed subsection (c) did not state that the Department would provide notice to the plan. It stated that the Department would check with the plan to determine whether or not the enrollee's filing was timely, since under the proposed regulations it would have been the plan's responsibility to send the decision in a manner in which date of receipt could have been documented. This language is no longer necessary, since the Department has decided to delete language requiring a plan to verify receipt of the decision letter. The Department has deleted the substance of proposed subsection (c).
The Department agrees, however, that the notice suggested by IRRC would be useful to the enrollee; it can, however, provide that notice without including that requirement in regulation.
IRRC recommended that the Department revise proposed subsection (d). Proposed subsection (d) stated that ''The plan shall forward the complaint file within 5-business days of the Department's request. Upon confirmation that the appeal was filed within the appropriate time frame, the Department will request the complaint file from the plan.'' IRRC recommended that the two sentences in the proposed subsection be combined to state that upon confirmation of a timely filing, the plan shall forward the file within 5-business days.
One commentator commented that the proposed subsection would not indicate what the complaint file was to contain. The commentator recommended that the minimum contents be listed. The commentator also recommended that the Department include a requirement that the plan automatically provide the case file to the enrollee when it is sent to the Department.
The Department will reverse the order of sentences in the subsection for clarification. The Department will also change the 5-day requirement to a 30-day requirement, since that is the timeframe required by Insurance. With respect to the question concerning what needs to be included in a complaint file, a complaint file needs to include all relevant documentation, including the contract language and any material considered in the previous two reviews of the case. The Department has also added this language to subsection (c), formerly subsection (d).
Proposed subsection (e), now subsection (d), would allow the plan and the enrollee to provide additional information for review and consideration to the Department as appropriate. One commentator recommended that both the plan and member provide simultaneous copies of any additional information to one another.
The Department has decided that either party sending additional information will copy the other. This will afford each party the opportunity to review materials not previously considered, and possibly enable the parties to resolve the appeal without the need of further Department intervention.
IRRC recommended that proposed subsection (f), now subsection (e), be revised to state that time requirements for review would not be affected by a decision to change the agency reviewing the appeal. It is correct that the time requirements for review will not be affected by the decision to transfer a case from one agency to the other. The Department does not believe that this need be stated in regulation.
One commentator noted that, in proposed subsection (g), the Department states it has discretion to hold a hearing. The commentator stated that if no hearing were held, there would be no record to certify to the Commonwealth Court. This commentator suggested that a more prudent approach would be for the Department to notify the appellant of the right to a hearing, and the obligation to request one. The commentator noted that if an appellant did not request a hearing, the right to a hearing would be waived.
The Department has deleted the substance of proposed subsection (g), since it is unnecessary to restate what the law already requires, and since there is no corresponding language in Insurance's regulations.
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