[31 Pa.B. 3043]
[Continued from previous Web Page] Section 9.705. Internal grievance process.
The Department received more than 150 comments on this proposed section, which was titled ''Enrollee and provider grievance system'' in the proposed rulemaking.
One commentator recommended renaming this proposed section ''Enrollee grievance system.''
The Department agrees that it would be more consistent with the rest of the regulations and with Act 68 to change the title. Since health care providers with enrollee consent may file grievances as well as enrollees, however, the Department has declined to change the title as the commentator suggested. The Department has changed the title of the section to ''Internal grievance process.'' This title reflects the title of the corresponding section of Article XXI. See section 2161 of Article XXI.
Several commentators stated that the proposed regulations would not provide a fair and uniform plan for how grievance hearings would be conducted. They expressed concern that patient protections in what they believed to be existing regulations had not been included in the proposed regulations. These included provisions dealing with information available to the enrollee about nature of the grievance process, the composition of review panels and the roles of attorneys in the process. These commentators recommended that patient safeguards should be included in the final-form regulations.
The Department is including in its final-form regulations many of the 1991 guidelines recommended by commentators, and will reference those provisions in the discussions relating to specific regulations. The Department does point out, however, that these guidelines were not part of the regulations that are being repealed. They were simply guidelines.
One commentator recommended the addition of a new subsection requiring that if the plan fails to act within the time frames established in the regulations, the relief sought by the member shall be granted automatically by the plan. The commentator argued that this would redress the imbalance caused by the fact that if an enrollee fails to meet the time frames, the enrollee has no recourse, but if a plan fails to meet the time frames, it acts with impunity.
The Department has not added the recommended subsection. If a plan violates the time frames of Act 68, it is subject to sanctions under Act 68, including fines. Requiring a plan to provide the remedy sought by the individual in every instance when a time frame is violated is an extreme penalty, and removes discretion from the Department to fit the penalty to the violation.
IRRC recommended that the Department either explain its use of the phrase ''and is acceptable to the Secretary'' in proposed subsection (a) or delete it.
As discussed earlier, the Department has deleted this language.
Several commentators recommended that the Department include language in the final-form regulations that would require plans to accept an oral grievance from an enrollee and reduce it to writing. The Department had included language in proposed subsection (b) that would have required the grievance to be in writing.
One commentator commented that Act 68 provides that there shall be a toll free telephone line at the plan to provide help to enrollees in filing a complaint or grievance. The commentator stated that it was fundamentally unfair to require sick, disabled or overwhelmed enrollees who lack time, strength or ability to file a written grievance. According to the commentator, it also made no sense to limit providers to filing written grievances, since they were busy with other administrative tasks. Another commentator stated that Federal law required an accommodation for enrollees for whom writing would impose a barrier.
The Department agrees that it would be helpful to enrollees who are unable to file a written grievance to have someone at the plan able to reduce a grievance to writing, and has added a requirement that plans do so to subsection (b). Under the ADA, if a person were disabled, the plan would have to make a reasonable accommodation. The Department, which is required to regulate plans covering all populations, and not only the MA population, will not go so far as to require that plans provide this service for persons other than those with disabilities or language barriers. The DPW can, and does, have its own requirements for its contractors.
Three commentators recommended that proposed subsection (c)(1), which proposed requirements for first level grievance reviews, should be revised to require the plan to notify the enrollee of the plan's receipt of the grievance, to assist the Department in monitoring compliance with Act 68.
One of these commentators noted that there was frequent confusion about whether an enrollee's first contact with a plan constituted an inquiry, a complaint or a grievance. As with complaints, the commentator recommended that the Department require an acknowledgement from the plan to establish the date of the receipt for purposes of the Department monitoring compliance with Act 68 time frames and to clarify whether the plan views the case as a complaint or grievance so that the enrollee can obtain help from the Department if necessary.
Another recommended that the notice letter should be in a format that would encourage the enrollee to take time to read and understand enrollee rights to pursue an appeal. The commentator recommended that the notice should explain the differences between methods of dispute resolution (grievance and complaint) and should inform the enrollee of the consequences of choosing one over the other. The commentator recommended that the plan be required to tell an enrollee that a complaint is faster and can be filed orally, and can be reviewed without delays for reviews by medical specialists, while a grievance may be more thorough but may take more time, must be in written form and will include the review of a medical specialist. The commentator recommended that the notice should also inform an enrollee that if the enrollee chooses an inappropriate category, the plan may consult with the Department on whether the category is appropriate. The commentator recommended warning the enrollee that this consultation with the Department could take additional time and could result in reversal of the enrollee's designation of the matter as a complaint or a grievance.
As with complaints, the Department agrees that a notice letter should provide the enrollee with information necessary to present the enrollee's case, and, because of the deadlines in Act 68, it is important to know when the clock starts on a grievance. The Department has, therefore, required plans to confirm receipt of the grievance in writing. The Department has also required plans to include notice of the process, of the availability of help from the plan and of the option to contact the Department concerning the classification of the case. See subsection (c)(1)(i).
For reasons discussed earlier regarding complaints, the Department is not creating a process in which the choice of how to characterize the issue is up to the enrollee. Consequently, the Department has not added language relating to the differences between complaints and grievances. The difference between the two is difficult enough for persons who deal with the issues on a daily basis. The Department is relying upon the plan to characterize the matter correctly, knowing that the Department can correct the classification if the plan is incorrect.
With respect to the recommendation that a plan be required to provide advice to the enrollee to enable the enrollee to choose the best method of appeal, the enrollee does not make the classification. It is the nature of the case that determines whether the subject is a complaint or a grievance; the plan is in the best position to determine which process to follow, and is required to choose the appropriate classification. Any suggestion that a complaint may be processed more quickly than a grievance would be incorrect, since the timeframes for both complaints and grievances are the same at both the first and the second level. Further, the Department is requiring plans to accept oral grievances for those enrollees unable to file a written grievance to alleviate disparities between the complaint and the grievance procedures. Subsection (b) has been revised to require a plan to make staff available to transcribe an oral grievance from an enrollee who is unable to file a written grievance due to a disability.
Several commentators recommended that the Department include language in the regulations requiring plans to make available to the enrollee all documentation relating to the enrollee's dispute. These commentators expressed concern that this information was necessary at the first stage of the process to ensure the fairness of the process.
One of these commentators recommended adding language that would require a plan to produce and provide copies of all related documents, including documents kept electronically, at no cost to the enrollee.
Another expressed concern that without access to specific information, including internal policies, nursing notes, extended evaluations and the like, the enrollee would be unable to present a case that addresses all relevant considerations.
The Department agrees the enrollee or the enrollee's representative should have access to information relating to the matter of which the enrollee has complained. This would enable the enrollee to determine what additional information is necessary to support the enrollee's case. The Department has declined to specify the information required to be released, but has required that the plan release what is relevant. If an enrollee or provider believes a violation of the regulations has occurred, they may notify the Department, which can then investigate if need be. See subsection (c)(1)(iii).
Three commentators, including IRRC, recommended that the Department clarify proposed subsection (c)(1)(iii), which stated that the investigation and review of the grievance was to be completed within 30 days of receipt of the grievance. The commentators recommended that the regulation state specifically when grievance decisions are required. The commentators stated that without this clarification there could be a gap of indeterminate length between the completion of the investigation and the issuance of a decision.
One commentator requested that the Department clarify that the 5-day notification period for the plan to notify the enrollee of the decision of the review committee would not run within the 30-day review period.
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 did not make 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 for either a first or second level grievance 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 within the specified time frame. The commentator was convinced 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 ask the enrollee for an extension of time 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.
Proposed subsection (c)(1)(iv) stated that the plan was to notify the enrollee of the decision of the initial review committee in writing within 5 business days of the committee's decision. The proposed subsection also would have required the notice 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. Several commentators raised issues concerning the lack of detailed standards on what should be included in a decision letter on a grievance.
Three of these commentators 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 of these commentators recommended that the regulations require that the decisions contain a statement that the decision is binding unless the enrollee appeals.
Two of these commentators recommended that the regulations require that the decisions be clear and detailed to permit a member to respond further.
One of these commentators recommended that the regulations contain a requirement that plans clearly articulate the reasoning behind decisions.
One of these commentators recommended that the Department should strengthen decision notices by requiring specific comprehensible information about decisional standards, while at the same time the commentator suggests that even this would be insufficient to allow enrollees to navigate the grievance process with some success without access to plan information.
IRRC commented that the phrase ''basis for decision'' was unclear, and could result in the denial of a grievance 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 explanation provided by the decision issued by the initial review committee should be. IRRC wanted to know, for example, whether the decision should reference contract citations.
One commentator recommended that the Department add the following language: ''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 language 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 the 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 should include 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; (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; and (5) an explanation of the scientific or clinical judgment for the decision, applying the terms of the plan to the enrollee's medical circumstances. These are the current requirements included in the new 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 the prohibition that the plan be prohibited from citing reasons for denying the claim that are different from those offered at an earlier stage of the process, as was discussed earlier when this comment was made pertaining to complaints. 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 by the plan.
One commentator commented that the regulations must detail more specifically what information a plan must provide in the decision letter as the basis for its denial. The commentator claimed that plans refuse to provide medical criteria they used in making UR decisions, claiming it is proprietary. The commentator urged that plans should be required to provide criteria used to deny service or level of service. Two commentators also recommended that the regulations should specifically state that such criteria may be used as tools in arriving at the decision, but may not be used as the sole basis for the decision.
The Department has specified, in § 9.750(b)(3) 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).
Several commentators commented that subsection (c)(1)(iv) would require notification to the enrollee but not the provider, which was contrary to the provisions of Act 68.
Act 68 requires written notification to the enrollee and the health care provider. See section 2161(c)(4) of Article XXI. The Department interprets this to mean that the provider should get notice only when the provider has filed the grievance. The Department has revised the subsection to require notice to the health care provider when the health care provider has filed a grievance on behalf of the enrollee. See subsection (c)(1)(vi). If the grievance was filed by the enrollee, the provider has no need of this information, and providing letters to the provider could be a breach of the enrollee's right to confidentiality.
IRRC also recommended that the Department reference § 9.702(d)(3), which gives an enrollee 45 days to file a second level complaint, in proposed subsection (c)(1)(iv).
The Department has not referenced that section. 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 request for a second level review of a grievance. Under that section, the plan must give the enrollee at least 45 days. The actual time frame may be greater than 45 days. Section 9.702 (d)(3) imposes requirements on the plan. A reference to that provision in this section would not provide useful information for the enrollee.
The Department received over 80 comments on proposed subsection (c)(2), which proposed requirements for second level reviews of grievances.
As previously discussed, the Department has included in the final-form regulations several requirements from its 1991 guidelines relative to the handling of complaints and grievances. For example, the Department has included a requirement in §§ 9.703(c)(2)(iii)(J) and 9.705(c)(2)(iii)(J) recognizing that the committee may have an attorney present. However, if there is an attorney present to represent the interests of the committee at the second level review hearing on a grievance, that attorney is not present to represent the interests of the plan. The committee's attorney must ensure the fundamental fairness of the review and that all disputed issues are adequately addressed. The attorney representing the committee may not argue the plan's position, or represent plan staff. See §§ 9.703(c)(2)(iii)(J) and 9.705(c)(2)(iii)(J). The Department has also reiterated the requirement in Act 68 that an enrollee may appoint a representative to act on behalf of the enrollee during the review process. See subsection (c)(1)(i)(B). The remainder of the Department's revisions regarding ''fundamental fairness'' will be discussed in commentary on the particular subsections to which they apply.
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 address the minimum size of the committee and the other part address prohibiting the involvement of committee members who participated in prior decisions relevant to the grievance.
The Department has revised the subsection as IRRC recommended. See subsection (c)(2)(ii).
IRRC also commented that the phrase ''reviewing a grievance appealed to the second level of review'' in the proposed subsection (c)(2)(i) was unnecessary and should be deleted. The Department agrees, and has revised the subsection as IRRC recommended. See subsection (c)(2)(ii).
Four commentators recommended that the proposed regulations be revised to include a requirement that the second level review committee members who were not plan employees should be enrollees. One commentator recommended that the enrollee be told which committee members were plan staff, and which were enrollees, and who could vote and who could not.
The Department has reconsidered the language in this subsection. In light of the language of Act 68, which states only that the committee be made up of persons not previously involved in any decision to deny payment (see section 2161(c)(1) of Article XXI), the Department has made no change to the regulation.
With respect to the comment concerning identification of persons at the review, the proposed regulations did require that the persons present at the review be identified for the enrollee, along with their roles. See proposed § 9.706(c)(2)(ii)(C). The Department has not deleted this language. See subsection (c)(2)(iii)(E).
One commentator commented that there should be some method for an enrollee or physician to ''discover'' whether the members of the second level review committee are unbiased.
The Department has already provided for enrollees to contact the Department if they feel the process is unfair (see § 9.702 (a)(2)) and added the requirement that the committee has a duty to impartial review. (See subsection (c)(2)(ii)(B)). The Department cannot put a ''discovery'' requirement in the regulation, as this is not a legal proceeding. The Department will, however, review any allegation of bias.
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 to the final-form regulations in subsection (c)(2)(ii)(B).
One commentator commented that the notification referred to in proposed subsection (c)(2)(ii) should go to both the health care provider and the enrollee. The proposed subsection stated: ''The plan shall notify the enrollee or the health care provider in writing of the right to appear before the second level review committee.''
The Department has changed the regulation to require notification to the enrollee, and the health care provider if the health care provider has filed a grievance with enrollee consent. The Department believes it would be improper to allow a health care provider to appear at a grievance review without the request of the enrollee, if the provider does not have the enrollee's consent to grieve the matter. Any other construction of the statute could lead to a breach of confidentiality.
Several commentators complained that the proposed regulations did not require plans to give enrollees at least 15 days advance written notice of the date of the review.
Four of these commentators recommended that the notice include the following: notice of the enrollee's right to appear, a description of the procedures before the review committee; and the right to prepare for the review, and to be advised by an uninvolved plan staff person in preparing the case.
One recommended adding a requirement that the review be scheduled at a mutually convenient time.
One of these commentators noted that a requirement that the plan provide advance notice to an enrollee of the right to appear is only a requirement that notice be given, and not a statement that the enrollee has this right. The commentator stated that enrollees need sufficient advance notice to arrange work schedules, assure availability of witnesses and representatives, and generally prepare for the review. The commentator felt that this was especially important since an enrollee has no mechanism to complain to the Department if a plan is not flexible or accommodating in its scheduling. The commentator recommended adding an advance notice requirement of at least 15-days prior to the review.
The Department agrees that the enrollee should have advance notice of the date scheduled for the second level review, as well as the right to be present at the review. The Department has added language to the regulations requiring the plan to send the enrollee and the enrollee's representative an explanation of the procedures to be followed during the second level review. The notice is to include statements that the enrollee may request the aid of a plan employee who had not previously been involved in the plan's decisions to deny coverage for the issue in dispute in preparing a grievance, and how to do so, that the enrollee and the enrollee's representative have the right to appear before the second level review committee and that the plan will provide the enrollee with 15 days advance written notice of the time scheduled for that review. The Department has also required the notice to be given to the enrollee and the enrollee's representative and to the health care provider if the provider has filed a grievance with enrollee consent. See subsection (c)(2)(iii)(A), (B) and (C). The Department has also included in the final-form regulations specific requirements that the enrollee, the representative or the health care provider be able to appear and present a case, and that the enrollee and the representative be given the aid of a plan employee who has not participated in previous plan decisions to deny coverage for the issue in dispute for the purpose of assisting the enrollee in preparing the grievance. See subsection (c)(2)(iii)(A) and (F).
Several commentators commented that the proposed regulations did not require the plan to make staff persons involved in the plan's decision to deny the services available for questioning by the enrollee and the plan at the second level grievance hearing. They recommended the addition of this language.
The Department will not require a plan to make employees available for questioning by enrollees. The Department believes that requiring a plan to have employees present during reviews would cause operational problems for a plan in terms of work assignments and other matters.
Several commentators objected that the proposed regulations did not require the plan to provide the enrollee with the identification and credentials of the person or persons who made the decision.
The Department is not requiring the plan to release the names, positions and credentials of all those individuals involved in issuing the previous denials, as their status as plan employees or members of the committee conveys sufficient authority to render review decisions. An enrollee filing a grievance should focus on the medical necessity and appropriateness of the requested service, and not on other circumstances, since medical necessity and appropriateness are what the enrollee needs to show to prevail in the matter.
Four commentators commented that the proposed regulations did not require the plan to make available to the enrollee all documentation related to the dispute.
The Department agrees that enrollees and providers should have access to information, and has included this requirement in subsection (c)(1)(iii). The Department has also added language that would permit the plan to charge a reasonable fee for the reproduction of documents. The necessity for the information occurs during the first level of the process, when the enrollee or provider needs to review the plan's information relating to the denial. Therefore, this issue is addressed in that particular provision. See subsection (c)(1)(i)(C).
One commentator applauded language in proposed subsection (c)(2)(ii)(A) that would require a plan to provide reasonable flexibility in terms of time and travel distance to enable enrollee participation at second level hearings. IRRC and another commentator raised concerns that the term ''reasonable flexibility in terms of time and distance'' used in this subsection was unclear. IRRC recommended that the Department provide more specific requirements for scheduling reviews similar to requirements in proposed § 9.679(e) (relating to access requirements in service areas). The other commentator also recommended that the regulations should be revised to require a plan to schedule a second level grievance review meeting at a time and place that accounts for the enrollee's condition or other factors that warrant a shorter time or distance.
One commentator recommended including a reference to health care providers in this section.
Another commentator asked whether the proposed regulation would have required the location for the second level review to change based on the enrollee's county of residence. The commentator stated that if this were so, this would place unreasonable hardships on those plans that currently allow members to appear by telephone.
The Department is not requiring that the location of the review meeting be the enrollee's home county. The Department has declined to attempt to set a minimum travel standard given the difficulty to set a standard that would be acceptable to everyone involved. Therefore, the Department has included language in subsection (c)(2)(iii)(C) to require a plan to make reasonable accommodations to facilitate enrollee participation and the health care provider's participation when the provider has filed a grievance.
One commentator commented that an enrollee should be permitted to bring persons other than representatives, witnesses, appropriate plan representatives or members of the committee to the review, so long as the process is not disrupted. Proposed subsection (c)(2)(ii)(C) would have limited attendance to those individuals and the health care provider. The commentator stated that an enrollee might wish to bring a friend or relative, or an attendant.
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 turning the review into a circus, 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 for moral and physical support. See subsection (c)(2)(iii)(E).
Three commentators commented that the regulations should include a requirement that the entire second level review hearing be transcribed by the HMO and a requirement that the enrollee be guaranteed the right to transcribe and record the proceeding. One commentator noted that this would be the only record for an appeal to the Department or Insurance. The commentators were concerned that without transcription, there would be no ability to rebut the plan's characterization of the testimony.
Another commentator commented that use of the word ''deliberations'' in proposed subsection (c)(2)(iii) 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 should be off the record.
The Department did not intend to require the transcription of the deliberations, which, like the deliberations of a jury, judge, hearing officer or agency, are not made public. The Department has replaced the word ''deliberations'' with ''proceedings.'' See subsection (c)(2)(iv).
The Department is requiring that the proceedings be recorded, either through an electronic recording, verbatim transcription or summary. This is in accordance with the Department's original guidelines that maintaining a record of a grievance hearing required some type of reliable record, but that verbatim transcription would be optional. Further, with respect to the comment that transcription is necessary for the record on appeal to the agencies, the appeal from a second level grievance review goes to a CRE, not the Department or Insurance. A CRE's standard of review during an external grievance review does not turn on the characterization of testimony, but on whether the health care service denied was medically necessary or appropriate under the terms of the plan. For these purposes, a reliable summary is sufficient.
The Department has also made minor changes to reflect the fact that a health care provider may also be involved in the review, and to replace the word ''appeal'' with the more accurate term ''request for an external grievance review.'' See subsection (c)(2)(iv).
The Department received several comments on proposed subsection (c)(2)(iv) and (v). Proposed subparagraph (iv) would have required that the plan complete the second level grievance review within 45 days of the plan's receipt of the enrollee's request for the review. Proposed subparagraph (v) would have required that the plan notify the enrollee of the decision of the second level review committee in writing, within 5 business days of the committee's decision. Two commentators requested clarification concerning the review period and the time by which a decision need be made.
It was not the Department's intent to include the 5-day notification period within the 45-day review period, and the proposed regulations did specify that notification was to occur after the committee's decision, which occurs on or before the 45th day. For clarity, however, the Department has revised proposed subsection (iv) to state that the plan must complete the review and arrive at a decision within 45 days. The Department has also renumbered this subparagraph as subparagraph (v) to take into account other revisions to the regulation.
Three commentators commented that proposed subsection (c)(2)(vi) would require the plan to provide notification of the committee's decision on the grievance to the enrollee, but not the provider. The commentators stated that this was contrary to the provisions of Act 68.
The Department has revised the subparagraph to require notice to the health care provider when the health care provider has filed a grievance on behalf of the enrollee. See subsection (c)(2)(vi) and (vii). Act 68 requires written notification to the enrollee and the health care provider. See section 2161(c)(4) of Article XXI. The Department interprets this to mean that the provider should get notice only when the provider has filed the grievance. If the grievance were filed by the enrollee, the provider would have no need of this information, and providing letters to the provider could be a breach of the enrollee's right to confidentiality.
The Department has also added language to require that notice is to go to the enrollee's representative, if the enrollee has appointed one. To prevent confusion, and make certain the plans are aware that an enrollee has a representative, the Department has added language to § 9.702 that requires the enrollee or the enrollee's representative to notify the plan of the designation.
The Department received several comments on proposed subsection (c)(2)(vi). That proposed subsection stated that a plan shall include in its decision letter the basis and clinical rationale for the second level decision on the grievance and the time frames for filing a request for an external grievance review.
Three commentators commented that the proposed regulations lacked standards to state specifically what a plan shall provide as the basis for its denial. One commentator noted that there was no requirement to issue decisions that were clear and detailed so that an enrollee would be able to respond further.
One commentator recommended that the decision letter be required to include the reasoning for accepting or rejecting the various arguments made.
Four commentators commented that the proposed regulations lack a requirement that plans clearly articulate the reasoning behind decisions and refer to the standard used and the evidence considered.
Three commentators raised concerns that the proposed regulations would not include 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. One of the commentators noted that the Department's proposed regulations would only require that the basis for the decision be included. According to the commentator, this was insufficient in detail to ensure patient protections.
IRRC commented that the phrase ''basis for decision'' was unclear, and could result in a denial letter that was incomprehensible to the enrollee. IRRC and another commentator recommended that the Department provide further guidance on how detailed the decision from the plan should be.
Several commentators 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.
One commentator recommended including a prohibition against a plan changing its reasons after review process has begun.
The Department agrees that the phrase ''basis for the decision'' should be clarified, and has included the same requirements for the second level review decision letter as it required for the first level review decision letter, and the decision letters in complaint reviews, with one addition. Because a grievance is based in medical necessity and appropriateness, the Department has added a requirement, similar to that included in the ERISA rules, that the decision letter include an explanation of the scientific or clinical judgment for the decision, applying the terms of the plan to the enrollee's medical circumstances. The Department has discussed similar comments to those raised here in more detail in discussions on the comments to proposed § 9.704(c)(1)(iv) (now § 9.703(c)(1)(vi)).
One commentator commented that plans are refusing to provide medical criteria used in making UR decisions, and are claiming that they are proprietary. The commentator recommended that a plan should be required to provide criteria it relies upon to deny a service or level of service. The commentator also recommended that the regulations specifically state that such criteria could be used as tools in making the decision, but could not be used as the sole basis for the decision.
The Department has specified in § 9.750(b)(3), 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 commented that, since enrollees may have a representative, the Department should require notice to the representative as well.
The Department agrees that notice should be sent to the representative, if the enrollee has one. The Department has added this language to subsection (c)(2)(vi).
Two commentators recommended that the regulations should require that the enrollee be advised of the decision in all cases, regardless of whether the provider is pursuing the grievance, and that the provider should be notified in all cases as well. Another commentator stated that this was required by Act 68. The commentator stated that since the enrollee may be financially liable, the enrollee should receive a copy of the denial letter as well.
Because the provider must notify the enrollee if the provider decides not to pursue the grievance further, the plan denial letter will give the enrollee notice of what has occurred in the case and the reasons the plan is citing for continuing denials. The Department is, therefore, requiring that the enrollee receive a copy of the decision letter regardless of whether the enrollee or the provider filed the grievance.
One commentator commended the Department for including in its proposed regulations language requiring the second level review committee to remain unbiased, but recommended that the Department go further. This commentator, along with three others, recommended that the Department require that the second level review committee base its decision solely on the materials and testimony presented at the meeting.
The commentator raised concerns about plans and representatives engaging review committees in private, and placing the entire burden upon the enrollee, who would not be permitted to question the plan's spokesperson. The commentator stated that the purpose of Act 68 would be defeated by reviewers prejudiced by a one-sided, open-ended presentation by the plan occurring without the enrollee being permitted to take part in that presentation.
The Department agrees that the regulations should contain more requirements aimed at ensuring the impartial nature of the review. The Department has included language requiring that the second level review committee base its decision on the grievance on the materials and testimony presented at the review. See subsection (c)(2)(iii)(L). The Department has also included language in this subsection prohibiting the committee from basing its decision on any document obtained on behalf of the plan that sets out medical policies, standards or opinions or that specifies opinions supporting the decision of the plan unless the plan makes available for questioning at the review by both the committee and the enrollee an individual who is familiar with those policies, standards or opinions included in the document. The plan may choose the individual who will appear, so long as the individual is familiar with the information in question, and the individual need not appear in person, but may be present at the review by telephone.
The Department has also included several recommendations from its 1991 guidelines in the regulations for the purpose of emphasizing the need for a fair and impartial review of the case. A committee member who does not personally attend the review meeting may not vote on the case unless that person actively participates in the review meeting by telephone or videoconference, and has the opportunity to review any additional information introduced at the review meeting prior to the vote. See subsection (c)(2)(iii)(I). The Department has required that the committee proceedings at the second level review be informal and impartial to avoid intimidating the enrollee, and the Department has prohibited the committee members from discussing the case to be reviewed prior to the second level review. See subsection (c)(2)(iii)(H). As the Department has previously noted, it has prohibited the committee's attorney from representing the plan, and has required that if the committee has an attorney, the attorney will represent the interests of the committee, including ensuring a fair and impartial proceeding. See subsection (c)(2)(iii)(J).
Three commentators have raised concerns that the proposed regulations would not prohibit a plan from changing its reasons for the denial after review process has begun. The commentators recommend that the Department add this prohibition.
The Department has not added a prohibition that the plan be unable to cite 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 grievance based on a different reason than originally provided, due to additional information provided by the enrollee. The enrollee is not prohibited from presenting new and additional evidence throughout the process. Additional evidence may trigger other restrictions on services.
One commentator raised concerns with the last sentence of proposed subsection (c)(2)(vi), which states that a decision shall be sent in a manner so that the plan can document receipt of the decision. The commentator stated that previous experience with such a process showed that enrollees found it burdensome and inconvenient, and that it caused unnecessary delay in timeliness of receipt of the information. Further, both commentators stated that the requirement would increase costs.
The Department has decided to eliminate this requirement from subsection (c)(2)(vii). Instead, plans will be required to make the decision concerning the timely nature of the request on a case by case basis. An enrollee may then raise the issue with the Department, or take whatever legal action the enrollee finds to be necessary under the circumstances.
The Department received several comments on proposed subsection (c)(3), which included proposed requirements for licensed physicians and approved licensed psychologists to sit on grievance review committees.
One commentator recommended that protections be added to the regulations to permit plans to safeguard the identity of the matched specialist who does not participate in the review meeting. The commentator noted that disclosure of the matched specialist's report and credentials could be made without disclosing the name.
The Department has not required the identification of the name of the matched reviewing specialist. The Department is, however, requiring the reviewing specialist's credentials within that individual's report since that is the only way to verify the appropriateness of the plan's choice of reviewing specialist. See subsection (c)(3)(iv).
Two commentators raised issues concerning the scope of the review of a psychologist and asked for clarification. One commentator recommended that the standard included in § 9.743(d) (relating to CREs) be including in this section, and in §§ 9.707--9.709. Section 9.743(d) states that an applicant for CRE certification must certify that an approved licensed psychologist may perform a review of a behavioral health care service under certain conditions. The psychologist may only perform the review if the psychologist is in the same or similar specialty as the health care provider of the service in question, if the review is of a behavioral health care service within the scope of the psychologist's practice and if the psychologist's clinical experience provides sufficient experience to review that specific behavioral health care service.
The Department has not included the language in § 9.743(d) in this section or in § 9.708. Section 9.743(d) is taken from section 2152(d) of Article XXI (relating to operational standards), which gives the operational standards for UR, not for grievance reviews. This section and § 9.708 deal with grievance reviews, and not general UR. The matched specialist is not denying a service, but acting as part of a reviewing committee, and the standards are different for these functions.
The Department has not added the language to § 9.707, since that section deals mainly with how an external grievance review is sought and obtained, and the language would not be relevant.
The Department has not added the language to § 9.709, since that section already requires the use of a certified CRE, which has met the Department's requirements for certification in § 9.743, the rest of Subchapter K and the standards of Act 68. See sections 2151 and 2152 of Article XXI. Again, § 9.709 does not deal with UR, but with grievance reviews.
Two commentators commented that it would be appropriate to require a plan to place on the review committee a reviewer in the same profession as the provider who performed the service being reviewed on the review committee. One of these commentators recognized that Act 68 requires a denial to be made by a physician, but recommended that the Department require reviewers to consult with ''peer'' reviewers to determine whether the service in question fell within the standard of care for the particular profession of the individual that recommended the service. The other commentator stated that this would reduce professional discrimination against a provider who was not in the same profession as the reviewer.
The Department has not changed the proposed regulation. Act 68 requires the inclusion of the physician or psychologist in the review process. See section 2161(d) of Article XXI. The plan may always include a peer of the provider on the committee if it so chooses, or may obtain input from a provider. There is no necessity to require that the same type of provider be on the committee. The General Assembly realized the logistical difficulties in doing this when it enacted provisions permitting a review by an individual in the same or similar specialty.
One commentator commented that Act 68 created a different standard for physicians and for licensed psychologists in terms of type of provider subject to review, and that the proposed regulation followed Act 68. The commentator stated that both Act 68 and the regulations violated the equal protection clauses of both the Federal and State constitutions. U. S. Const. amend. XIV, § 1; PA. CONST. art. I, § 26. The commentator recommended that to avoid a constitutional challenge, the Department should change proposed subsection (c)(3)(i) to state that the reviewer should be licensed by the Commonwealth in the same profession and board certified in the specialty of the provider subject to review. The commentator stated that case law in the Commonwealth allows a constitutional defect to be cured by regulation.
The Department disagrees that either Act 68 or the regulations are constitutionally infirm. There is no suspect classification involved in this matter, nor is there a fundamental right in question. The rational basis test called for by equal protection analysis only requires that the Commonwealth's classification be rationally related to Act 68's purpose of protecting enrollees. The General Assembly has taken the position that a UR decision to deny a service must be made by a licensed physician, unless the decision involves a behavioral health issue. In that case, the denial may be made by a psychologist who has clinical experience in the area that provides sufficient expertise to review that health care service. The General Assembly clearly believed that psychologists, who are not medical doctors, should have additional experience before being permitted to deny a health care service. This does not prohibit any psychologist from reviewing behavioral health services as part of a UR decision. It merely places additional requirements on that psychologist, and it does not prevent a psychologist from practicing the psychologist's profession.
One commentator commented that it would be difficult if not impossible to have a professional in same or similar specialty as part of the review committee, particularly on the first level review.
The Department has said that the individual need not be present, but that the individual may not vote if not present, unless that person actively participates in the review meeting by telephone or videoconference and has the opportunity to review any additional information introduced at the review meeting prior to the vote. See subsection (c)(3)(ii). The matched specialist's opinion shall be read into the record, however, to become part of the review proceedings.
IRRC and another commentator have requested that the Department clarify the term ''same or similar'' in proposed subsection (c)(3)(i). That proposed paragraph stated that both the initial and second level grievance review committees were to include a licensed physician, or an approved licensed psychologist, in the same or similar specialty as that which would typically manage or consult on the health care service in question.
The intent of Act 68, by leaving the language open in section 2161(d) and 2162(c)(4) of Article XXI was to provide plans some flexibility in obtaining individuals in a same or similar specialty to review grievances. The Department has chosen not to attempt to refine this language, because of the great danger of setting in regulation comparisons between specialties, subspecialties, education, experience and so forth. For example, by introducing this language, the Department would be regulating when an orthopedist must be used as opposed to a neurosurgeon for spine surgery cases, and whether an ordinary orthopedist will do, or whether the orthopedist must have a fellowship in spine surgery, and whether a Harvard degree is comparable to a Yale degree. This is not appropriate material for regulation. The Department will require that plans use a specialist in a same or similar specialty when the service was provided by a specialist who is a physician or psychologist. See subsection (c)(3)(v). The Department's intention is to have physician-specialists and psychologist-specialists reviewing specialty areas, and primary care providers reviewing primary care areas. Family practitioners should not be providing expert medical opinion on brain surgery, pediatricians should not be providing expert medical opinion on cancer treatment, and general internists should not be providing expert medical opinion on spine surgery. Every enrollee in a managed care plan has a primary care provider who serves as the enrollee's medical manager, providing treatment as appropriate and managing the enrollee's care through referrals to specialists as necessary. This does not make the provider a specialist in the ''same or similar specialty'' by virtue of the fact that the provider coordinates referrals.
The Department received several comments on proposed subsection (c)(3)(ii), which stated that the matched specialist need not personally attend at the review, but had to be included in the hearing, discussion and decisionmaking by written report, telephone or videoconference.
Two commentators requested that the Department clarify whether a matched specialist has to be a voting member of the committee.
One commentator stated that the proposed regulations would allow the matched specialist to vote without being present at the review. The commentator commented that this would seriously erode the protections of the statute.
One commentator noted that Act 68 does not require physical presence at the review committee meeting, and requested clarification.
One commentator objected to the matched specialist being permitted to provide an opinion in writing. The commentator stated that the specialist should either participate in person or by conference call.
One commentator recommended deleting proposed subsection (c)(3)(ii) altogether.
The Department does not intend to delete this paragraph. It is necessary to require input from the physician or approved licensed psychologist in the review of a grievance, since Act 68 requires it (see section 2161(d) of Article XXI), and it is necessary for the Department to set standards for how that input is to occur.
The Department has already taken the position that it is not practical to require physical or telephonic presence of a ''matched'' specialist and had included this in the proposed regulation. See proposed subsection (c)(3)(ii). The Department did take the position, however, that the ''matched'' specialist's report could be read into the record and the opinion of the matched specialist would then become part of the record for the committee's review. The Department believes that allowing a written report is necessary to obtain the most specialized individuals, taking into consideration the possibility of a paucity of experts in the more specialized fields, and taking into consideration time constraints on these individuals and the unpredictable schedules they face providing services to patients.
The Department has also clarified subsection (c)(3)(ii) by adding language that states that a licensed physician or approved licensed psychologist who does not personally attend the review meeting may not vote on the grievance, unless that person actively participates in the review meeting by telephone or videoconference and has the opportunity to review any additional information introduced at the review meeting prior to the vote. A specialist in the same or similar specialty who cannot vote on the grievance must, however, provide input by written opinion as stated in subparagraph (ii). The report of the specialist must be part of the record, regardless of whether the specialist is permitted to vote or not.
One commentator opposed the requirement in proposed subsection (c)(3)(iii) that plans provide the specialist's report to the enrollee, or the health care provider if the provider has filed the grievance, at least 7 days prior to the review date. The commentator recommended the elimination of that requirement. The commentator stated that the requirement represented a challenging time frame for a specialist's review. The commentator further stated that this requirement exacerbated the fact that the reviewer was not protected under the Peer Review Protection Act (63 P. S. §§ 425.1--425.4). The commentator noted that reviewers have been threatened with physical harm for their medical decisions. The commentator suggested that requiring the report to be provided will make it more difficult for plans to secure physician input.
The Department has not required plans to reveal the reviewer's name; it has required them merely to provide a copy of the reviewer's report to the enrollee or provider. The plan will also have to reveal the reviewer's credentials, either as part of the report, or at the review. See subsection (c)(3)(iv).
Two commentators recommended that the Department require that an expert's report be automatically shared with the enrollee and prescribing provider, without the necessity for a request, written or otherwise. One of these commentators stated that the regulations should require that the report be provided 2 weeks prior to the review date.
That commentator also stated that it was unclear whether the last sentence of subsection (c)(3)(iii), requiring a plan to disclose the report, is conditioned upon the reviewer not participating in the review.
The proposed subparagraph specifically deals with what would occur when the physician or approved licensed psychologist was not present during the review meeting. The Department has not changed this subparagraph in response to this comment. The Department believes that requiring a request for any report is not burdensome on the enrollee, or the health care provider, and that the 7-day time period is sufficient time for an enrollee or provider to review the report.
[Continued on next Web Page]
No part of the information on this site may be reproduced for profit or sold for profit.This material has been drawn directly from the official Pennsylvania Bulletin full text database. Due to the limitations of HTML or differences in display capabilities of different browsers, this version may differ slightly from the official printed version.
