[31 Pa.B. 3043]
[Continued from previous Web Page] Section 9.706. Health care provider initiated grievances.
The Department received several comments on proposed § 9.703, which has been renumbered as § 9.706. One commentator supported the proposed section, and stated that it contained important protections that should be retained.
Three commentators, including IRRC, recommended that the Department move this proposed section to a different part of the subchapter. One commentator recommended that the Department merge it with proposed § 9.706. One commentator recommended combining it with proposed § 9.707 or placing it directly before that proposed subsection. IRRC recommended moving it to place it with proposed §§ 9.706--9.708.
The Department agrees that this section should be moved and renumbered, but has not merged it with another section, since the subject matter warrants a separate and distinct section. The Department has renumbered this section as § 9.706, and, as previously discussed, has renumbered the intervening sections as follows: §§ 9.703--9.705 (relating to internal complaint process; appeal of a complaint decision; and internal grievance process).
One commentator requested that the Department clarify whether the Department has ceased to recognize provider appeal processes established as part of provider contracts and recognized by NCQA. The commentator noted that the Department stated in the Preamble to proposed rulemaking that after implementation of the Department's regulations, provider dispute mechanisms will require prior approval by the Department, as will alternative external grievance dispute mechanisms. The Department's current position, according to the commentator, is that, until promulgation of final-form regulations, provider appeals will not necessarily be limited to those that fall under the parameters of Act 68.
The Department continues to recognize and encourage alternate dispute mechanisms, including provider appeal mechanisms wherever found, but would prefer them to be in contracts or at least referenced in contracts. Act 68 provides for a specific type of alternative dispute mechanism, one providing an alternative to the external grievance process, which may be used only if the Department approves it. Act 68 does not prohibit other alternative dispute mechanisms, as long as the requirements of Act 68 are not violated. The Department has also specifically recognized a provider dispute mechanism for administrative denials of coverage. See § 9.711 (relating to alternative provider dispute resolution systems.)
Three commentators, including IRRC, recommended that the Department develop a consent form for plans to use as a model, and adapt it to the specific needs of their consent processes.
The Department agrees that the inclusion of the required elements for a valid consent would eliminate disputes and streamline the grievance process. The Department has, therefore, included in the regulation the elements of a valid consent form to be used by providers to obtain consent from an enrollee to file a grievance. See subsection (e). These elements must be present in a consent form for it to be valid.
Four commentators questioned whether the enrollee's consent had to be written, or could be verbal. One of these commentators asked that the Department clarify when verbal consent or implied consent would be sufficient for Act 68 compliance. Another asked whether time would begin to run on a provider grievance on behalf of a member only when a written consent form was obtained. One commentator stated that the consent had to be in writing, since Act 68 required it.
Act 68 requires written consent from the enrollee for a health care provider to initiate a grievance. This ensures that the enrollee fully understands that the enrollee is giving up a right under Act 68. To leave out the word ''written'' in the Department's regulations was an oversight, and the Department has corrected the language to require written consent before a grievance may be filed. If the enrollee is a minor or incompetent, a legal representative may grant consent. See subsection (e).
Several commentators requested that the Department include specific language in proposed subsection (b) permitting providers to obtain written consent to file a grievance from the enrollee at the time of treatment. One commentator requested this language to ensure that providers are able to advocate for their patients. Several commentators stated that it was difficult to find certain enrollees after treatment to obtain consent, for example, MA enrollees. Proposed subsection (b) would prohibit an enrollee from providing consent as a condition precedent to treatment.
Another commentator stated that it was having difficulty having consent forms returned in time to file a grievance.
One commentator commented that providers should have to obtain consent from enrollees at each stage of the grievance process to avoid providers pursuing grievances based on blanket consents after the enrollee has been satisfied.
One commentator commented that this would be the appropriate section to underscore the fact that providers may not rely on standing consent obtained in advance of a disputed service or procedure to satisfy consent requirements.
IRRC noted that commentators have raised concerns about whether consent can be obtained at time of treatment, and requested that the Department clarify the proposed subsection.
The Department is willing to permit a health care provider to use an enrollee consent obtained prior to service, so long as that consent is not obtained as a condition precedent to the enrollee's receiving the service. The Department is aware that some providers serve populations who may be difficult to locate after the service has been rendered. The Department is also aware that some enrollees, not being held financially responsible for the service in any case, may have no motivation to support the provider's pursuit of a grievance. If the provider does not obtain consent at the time of the service, the provider may have difficulties in obtaining consents at a later date. The Department has, therefore, added specific language to the regulation stating that the provider may obtain a consent at the time of treatment. However, as proposed, the provider may not require the enrollee to sign a consent as a condition precedent to receiving treatment or service.
If the provider fails to file within the period of time allowed by the plan or by regulation, however, the enrollee will then be unable to file a grievance on the enrollee's own behalf. To protect the enrollee who gives a consent at the time of treatment, the Department is requiring that if the provider chooses not to pursue a grievance, the provider must notify the enrollee within 10 days of the receipt of the standard denial from the plan that the provider does not intend to file a grievance. See subsection (g). This will signal to the enrollee that the provider will not be pursuing the grievance and it is up to the enrollee to pursue it if the enrollee chooses to do so.
Once the health care service has been rendered, and the issue is purely one of retrospective payment, the provider and the enrollee are seldom in communication with each other about the intentions of one or the other to file a grievance. The practice of obtaining blanket consent from all enrollees is particularly troublesome when the provider fails to prosecute a case fully and effectively squanders the enrollee's right to file a grievance, which the enrollee has granted to the provider. The Department strongly supports plans and providers arriving at alternate means of settling payment disputes, other than blanket enrollee consent, in cases where enrollees are not financially responsible because of the plan-provider contract terms.
One commentator recommended that the Department delete the language ''assumes responsibility for filing'' in proposed subsection (c) and replace it with the word ''files.'' Proposed subsection (c) stated that ''Once a health care provider assumes responsibility for filing a grievance, the health care provider may not refuse to grieve the issue through the second level grievance review.''
The Department has not changed the language. The Department has used this language to underscore the fact that the provider has a responsibility to the enrollee as soon as the enrollee waives the right to grieve a matter by allowing the provider to do so.
Another commentator recommended that the Department clarify its intent in this proposed subsection. The commentator noted that the provider is at risk when an external review is requested, since the losing party has to pay costs under Act 68. The commentator asked what would happen to a grievance if a provider decides not to pursue an external grievance. The commentator stated that the enrollee should be advised by the provider, since this should not be the plan's responsibility.
The commentator also stated that the plan should have the right to refuse to accept a request for an external grievance from an enrollee, even if the request was untimely due to failure of a provider to timely notify the member of the provider's refusal to grieve to that level.
The Department agrees that the enrollee should have notice of the provider's decision to cease pursuit of a grievance, so that the enrollee may choose to pursue a review of the grievance. The Department has, therefore, added subsection (g) to require that a provider notify the enrollee of its intention not to pursue a grievance or the next level of review. Further, if the external grievance is late in being filed, then the plan has the ability to refuse to accept the request for the external grievance. Act 68 sets the time frames for these requests (see section 2162(c)(1) of Article XXI), and if a grievance is not timely filed, regardless of the reason, the plan can refuse to accept it.
One commentator noted that since many appeals by providers occur where the enrollee is not required to pay for the service being grieved by the hold harmless terms of the provider contract, the provider should be permitted to drop the appeal after first level, and only go on if the enrollee requests.
Another commentator stated that to require physicians to continue challenging a decision through the second level grievance process is a disincentive for physicians to file grievances. The commentator stated that this requirement is not supported by Act 68 and should be removed.
The Department's intention in including this language in the proposed regulations was to prevent a health care provider from obtaining enrollee consent to file a grievance, squandering the enrollee's rights by failing to fully pursue the grievance review, and then billing the enrollee when the enrollee no longer has recourse through the Act 68 grievance procedures because the enrollee's grievance rights have terminated without the enrollee's informed opportunity to fully exercise them. It does not matter to the Department whether the provider prosecutes the grievance through the external grievance review. What matters to the Department is that the provider not bill the enrollee until the enrollee's grievance rights have been pursued to the extent of the enrollee's desire. The provider may choose to drop a grievance if it does not, and will not, bill the enrollee for the services that are the basis of the grievance. If the enrollee chooses to rescind consent and carry on the grievance directly, the provider may bill the enrollee at that point. The provider should not be allowed to routinely obtain consent from enrollees and half-heartedly carry out the appeals, using up the enrollee's right to grieve, and then billing the enrollee when the provider no longer feels like prosecuting the case. The Department has revised the language of the subsection to address these concerns. See subsection (c).
Two commentators have questioned the Department's authority to prohibit health care providers from billing enrollees until matters that are the subject of the grievance are completely reviewed through the grievance process. See proposed subsection (d). One commentator stated that this proposed regulation would appear to conflict with the prompt payment provisions of Act 68. See section 2166 of Article XXI. The commentator asked why the provider should have to take full risk because it appealed when the plan only approved partial payment because the plan believes the services should be of shorter duration. Further, it asked why the provider has to take full risk when the health care system commonly requires disengorgement of fees that were not appropriately paid if the plan's decision not to pay in full is eventually upheld.
Another commentator suggested that prohibiting physicians from billing enrollees until the external grievance process has been completed is a disincentive to file grievances.
The Department has the authority to determine what is acceptable in a grievance process because plans are required to establish and maintain grievance resolution systems, which are satisfactory to the Secretary. See section 364(e) of the HMO Act and section 630(e) of the PPO Act. Further, plans are required to adopt and maintain complaint and grievance processes that are compliant with Act 68 (see section 2111(8) and (9) of Article XXI), and the Department is charged with ensuring compliance with Act 68 (see section 2182(d) of Article XXI), specifically with respect to ensuring compliance to grievance and complaint review processes. See section 2181(a) of Article XXI.
This prohibition against billing is a common sense requirement intended to protect the enrollee. It is the provider that has determined to appeal the decision, and it is the provider controlling how the appeal is pursued, not the enrollee.
With respect to the comment made related to prompt payment, prompt payment applies to a plan and to clean claims, (see definition of ''clean claim'' in section 2102 of Article XXi), and not to the enrollee. See section 2166 of Article XXI (relating to prompt payment of claims). The claims in question in this subsection have been processed as ''clean claims'' and have been denied. The prompt payment provision does not apply once a claim has been submitted, adjudicated and denied. There is no conflict between this section and the prompt payment provision of Act 68 and Insurance's regulations.
Lastly, the provider is not at full risk, but is only unable to bill the patient until the reviews are completed. There is no reason why the patient should bear the full financial responsibility as opposed to the provider. In fact, the fee provisions of Act 68, with respect to external grievances, make it clear that the enrollee is not to be at risk for the cost of the external grievance review no matter what the outcome. See section 2162(c)(7) of Article XXI. The Department's regulations are fully in line with the intent of the statute, which is to benefit the enrollee in terms of quality health care accountability and protection.
IRRC notes that commentators have asked whether billing may occur if the grievance is filed by an enrollee. IRRC requested that the Department clarify whether this proposed subsection (d) (now part of subsection (c)) would apply regardless of who initiates the grievance.
One commentator stated that it read proposed subsection (d) to prohibit provider billing only when the provider initiated the grievance.
Subsection (c) applies solely to health care provider-initiated grievances, as the title of the section would suggest. Providers may bill if contractually they are able to do so, and they have chosen to pursue a grievance and exhausted the grievance process without success. The regulations do not prohibit billing when the enrollee initiates a grievance.
One commentator requested clarification as to whom the word ''it'' referred in the phrase ''until it chooses not to appeal an adverse decision'' in proposed subsection (e). The commentator recommended that it should be the enrollee.
The word ''it'' does not refer to the enrollee, it refers to the health care provider, which is the entity in control of the appeal at this stage. The Department has revised proposed subsection (e), now subsection (d), to clarify that fact.
One commentator recommended adding language to proposed subsection (f) which would state '' Pennsylvania law permits an enrollee of a managed care plan or, with the enrollee's written consent, a health care provider, to request that the plan reconsider a decision made concerning the medical necessity and appropriateness of a health care service. This request is known as a grievance.''
The Department has not added the recommended language, since it appears to provide a definition of ''grievance,'' which is already included in § 9.602. The Department has decided, however, to delete the proposed text of the subsection since its subject matter will now be included in subsection (e), which includes the required elements for a valid enrollee consent to allow a provider to file a grievance on the enrollee's behalf.
Those elements include allowing a legal representative of the enrollee to provide the consent and automatic rescission if the provider fails to file a grievance. The consent to file a grievance shall identify the enrollee, the health care provider, and the managed care plan; shall provide a brief description of the service; and must include the dates of service. The consent to file a grievance must also clearly disclose to the enrollee in writing that the consent precludes the enrollee from filing a grievance on the same issue unless the enrollee, during the course of the grievance, rescinds in writing the previous written consent. The consent must also inform the enrollee of the right to rescind the consent at any time during the grievance process. These statements must be read by or to the enrollee, and be explained to the enrollee. The Department's intent in including these two latter requirements is to ensure that the enrollee is adequately informed as to what providing consent will mean.
Section 9.707. External grievance process.
The Department received several comments on this proposed section. One commentator supported the Department's removal of language from its draft regulations that would have permitted the Department to investigate plan definitions of ''medical necessity'' under evaluations by a CRE. The commentator also supported the elimination of language that stated that CREs could review a plan's definition of ''medical necessity'' and specifically comment as to whether it deviated from the usual and customary language regarding medical necessity.
One commentator commented that the proposed section was confusing and recommended that it should be simplified when possible.
One commentator repeated its earlier comment that it would be necessary to have a licensed peer of the health care provider who requested the review, or who made the request for services, on behalf of an enrollee participate in the review. The commentator stated that this would be appropriate since a clinical rationale must be given and such decisions are based on medical necessity and appropriateness. The commentator noted that nothing in the statute excluded the use of a ''same licensed clinician'' in the review process, and recommended revising the proposed regulations to include this requirement.
The Department has not made the recommended changes to the regulation. This section addresses procedures in obtaining an external review, and not substantive standards for the conduct of that review. The latter standards are included in § 9.708. This comment was more fully addressed in the discussion on the comments on proposed § 9.706.
Another commentator raised concerns that the language relating to standards for psychiatrist reviewers was not clear. The commentator recommended that the Department include the language in § 9.743(d) (relating to content of an application for certification as a CRE). The commentator recommended that the Department repeat this language in proposed §§ 9.706--9.708.
Because this section deals with procedural matters, it would not be appropriate to include language relating to the standards for reviewers in this section. This comment was more fully addressed in discussions of comments on § 9.705 (formerly § 9.706).
IRRC commented that proposed subsection (b)(1) would require an enrollee to appeal within 15 days of the receipt of the second level review decision. IRRC asked how the receipt of the decision was to be determined.
The Department has discussed this issue more fully in its response to comments on § 9.705. A plan will be required to make determinations on a case-by-case basis. Failure to do so fairly and consistently could lead to sanctions by the Department.
One commentator commented that an enrollee should have 30 days rather than 15 days to file for an external review. The Department cannot change this requirement, since the time frame is set by Act 68. See section 2162(c)(1) of Article XXI.
IRRC recommended that the Department clarify its use of the word ''or'' in proposed subsection (b)(2). The proposed subsection stated that notice should go to the Department, the enrollee or the health care provider. IRRC commented that the proposed subsection could be read to require provision of notice of the decision to either the enrollee or the provider.
Another commentator requested that the Department require that notice be provided to both the provider and the enrollee, even though the statute requires notice to the enrollee or the provider, if the provider is the one taking the appeal.
The Department has changed the language to require notification to the enrollee and the enrollee's representative always, and the health care provider also, if the health care provider is filing a grievance with enrollee consent. See subsection (b)(2).
IRRC and another commentator noted that the reference to subsection (k) in proposed subsection (b)(4) appeared to be in error.
The Department agrees that this reference is incorrect. The Department intended to refer to information included in subsection (b)(5). The Department has corrected the reference.
The Department is also changing subsection (b)(4) to clarify it and to use the terminology of Act 68. The subsection now reads ''Along with the notification and request for an assignment of a CRE and the information in subsection (b)(5), the plan shall provide the Department with the name, title and phone numbers of both a primary and alternative external grievance coordinator.''
One commentator asked whether a plan was still permitted to charge a nominal processing fee of $25 or less in connection with the external grievance.
The Department has not altered Act 68, which allows the imposition of a $25 or less filing fee for the filing of an external grievance.
IRRC also commented that proposed subsection (b)(4) referred to an ''external grievance coordinator,'' but that the term was not defined. IRRC recommended that the Department add a definition for this term.
The Department believes the phrase to be self-explanatory. The Department is not creating a job position, but rather is requiring plans to designate and name a primary and alternate staff person who will coordinate the processing of external grievances for the plan, so that the Department has a direct link to the plan, particularly in the event of an expedited review. It is up to the plan to decide who that person will be.
One commentator recommended that the Department develop a simple form for an enrollee to use to send a request to the plan for the assignment of a CRE, and that the Department should require plans to include the form with the second level grievance decision.
The Department agrees that a model form would be helpful, and has already developed a form for plans to distribute to enrollees with second level complaint decision letters. The Department does not want to require its use by regulation. This could create technical regulatory violations when enrollees and providers do not use the forms. The Department will develop and release a form by a technical advisory. It is possible plans may develop a method more ''user-friendly'' than what the Department would develop.
One commentator requested that the Department clarify that a member should send copies of correspondence that are readily available, but that the enrollee's failure to do so should not be considered grounds for the dismissal of the enrollee's external grievance request. The commentator stated that the requirement that an enrollee provide copies of any correspondence from the plan would be burdensome for the enrollee, and that the plan was in a better position to provide this information.
After reading this comment, the Department believes subsection (b) needs clarification. It is the plan that must provide copies of the correspondence, not the enrollee. For purposes of clarification, the Department has changed subsection (b)(5) to read ''The plan's request to the Department for assignment of a CRE shall include the following.'' The Department has also revised subsection (b)(1) to include a minimum of what must be in the enrollee's or the health care provider's request for an external review.
IRRC requested that the Department replace the acronym ''Insurance'' in subsection (b)(5)(iv) with the word ''identification,'' and asked whether this meant an Insurance number assigned to enrollee by plan, or some other number.
The Department has made the correction requested. The word ''identification'' is intended to refer to an identification number assigned to the enrollee by the plan.
The Department has also added a requirement to subsection (b)(1) that if a health care provider is requesting an external review, it provide evidence of the enrollee's written consent along with the name of the enrollee. This will ensure that it is clear that the provider has authority to file the appeal.
IRRC recommended that subsection (b)(5)(viii) and (6)(ii) specify what the Department would consider to be ''reasonably necessary supporting documentation.''
The Department agrees that ''reasonably necessary documentation'' should be defined, and has included language to define it in subsection (b)(5)(viii). Reasonably necessary information will include UR criteria, technology assessments, care notes, information submitted by clinicians regarding the enrollee's health status as it relates to the issue on appeal, opinions from matched specialists or peer reviewers and information submitted by the enrollee and the treating health care providers.
One commentator recommended that copies of all supporting documentation should be provided to the enrollee and, if applicable, to the provider. The commentator stated that the enrollee should know what the plan considered in reaching its decision.
One commentator commented that a plan should be required to provide to the CRE the contractual definition of ''medical necessity'' and other documentation that the plan used to make its internal decision. The commentator recommended that the section be revised to require that the information be provided to the enrollee and enrollee's physician without request.
One commentator recommended that the Department delete the requirement that the plan describe the remedy being sought by the enrollee in proposed subsection (b)(5)(vi).
The Department has stated that plans must make all relevant information available to the enrollee, so it is unnecessary to make the plan send a duplicate case file to the enrollee or the provider. A document list will allow the enrollee or provider to recognize if information they consider necessary has not been sent. The regulations require that a list be provided. See subsection (b)(7).
The Department is deleting from subsection (b)(5)(v) and (vi) the proposed requirements that the plan summarize the issue and the remedy being sought by the enrollee, as this information is contained in the enrollee's second level appeal letters and the review committee's decision. The Department has required that these items be provided by the plan to the Department along with the request for a CRE. See subsection (b)(5)(v) and (vi). These items are already a part of the case file and will provide an accurate description of the case, without the plan summarizing it. The Department is concerned that the plan's paraphrasing or characterizing of the appeal would give rise to further issues for the enrollee.
The Department has also revised proposed subsection (b)(7) to delete language requiring the plan to provide the enrollee or health care provider with the plan's description of the issue being appealed and the remedy being sought. The Department had proposed this to allow the enrollee or provider to challenge the plan's characterization of these items. Since, however, the Department has deleted these items from subsection (b)(5), in favor of the enrollee's or the provider's appeal letters and the committee's decision letters, there is no need for this provision.
The Department has revised subsection (b)(6) to require the plan to forward the written documentation concerning the denial to the CRE performing the external review. This is intended to place the responsibility on the plan to get the information to the external CRE, rather than requiring any CRE that handled the matter for the plan internally to do so on its own.
One commentator recommended that the enrollee should be permitted to send information to the external CRE directly, rather than through the plan as required by proposed subsection (b)(8). The commentator commented that as the proposed regulation was written, with no specific time requirements for plan to send it on, there was a potential for unnecessary delay and for loss of documents.
The Department intended to have the information routed through the plan to ensure that the plan was in a position to consider it. If this were to take place, perhaps the need for an external grievance review would be eliminated. The commentator's point is well taken, however, and the Department agrees that an enrollee or provider should be able to send information directly to the CRE. The Department has revised subsection (b)(8) to state that the provider or the enrollee may submit information directly to the CRE, but must provide copies of those documents to the plan at the same time as the documents are provided to the CRE.
One commentator recommended that, although proposed subsections (c) and (d) stated that the plan would be responsible to notify the enrollee that a CRE had been chosen, the Department should notify the enrollee as well. As the proposed regulation was written, the commentator stated that the enrollee and the provider would be at the mercy of the plan to provide information.
Act 68 requires the Department to notify the CRE and the plan of the CRE's assignment to the case, and requires the plan to notify the enrollee or health care provider of the name and address of the CRE within 2-business days. See section 2162(b)(2) of Article XXI. The Department's proposed amendment tracked this provision. It is, however, much simpler for the Department to notify all parties at the same time, and in this way, the Department will be assured that the enrollee and provider have the necessary information. The Department has revised subsection (c) to state that the Department will provide notice to the enrollee, the health care provider if the health care provider has filed the grievance and the assigned CRE. The Department has deleted the proposed text of subsection (d), which would have required the plan to notify the enrollee and health care provider of the identity and address of the CRE.
The Department has also deleted the last sentence of proposed subsection (g) (now subsection (f)), since that sentence would have required the plan to provide notice of the assignment of the CRE, regardless of whether it choose to challenge the assignment. Since the Department is now providing notice of the CRE assignment, this language is unnecessary.
One commentator recommended that the Department provide information from the CRE's accreditation automatically, since enrollees will not know to request it. Proposed subsection (e) stated that the Department would make additional information from the CRE's accreditation application to the plan, the enrollee or the health care provider upon request.
Proposed subsection (e) (now subsection (d)) did not state that the Department would provide information concerning the CRE's accreditation upon request, but, rather, that it would provide additional information from the CRE's application to the Department. Notice of this will come directly from the Department to the enrollee at the time the Department notifies the enrollee and the health care provider, if the provider is filing the grievance, of the CRE assignment. See subsection (d). The Department has not made the revision that was requested.
One commentator supported the language in proposed subsection (f) (now subsection (e)) that would prohibit a plan from selecting a CRE to do the external review that was affiliated directly or indirectly with the plan. Under proposed subsection (f), if the Department would fail to select a CRE within the time frame provided, a plan could choose a CRE from the list of approved CREs. The commentator recommended clarification regarding the nature of direct or indirect affiliation.
The Department has added language to subsection (e) to clarify the meaning of direct or indirect affiliation. By direct or indirect affiliation, the Department meant having a current contract, or being in the process of negotiating a contract, with the plan or its affiliates to perform UR. The Department has simply added the language: ''The plan may not select a CRE that has a current contract or is negotiating a contract with the plan or its affiliates to perform UR to conduct the external grievance review or is otherwise affiliated with the plan or its affiliates,'' and has deleted the language ''affiliated directly or indirectly.'' See subsection (e).
One commentator recommended that proposed subsection (g) should state that the 3 business days to object to the assignment of a CRE included in the proposed subsection applies whether the CRE is assigned by the Department or is designated by the plan under proposed subsection (f).
Another commentator recommended that the Department provide language stating how an objection is to be made, including the acceptable grounds for an objection, and to whom.
The Department agrees that proposed subsection (g) should be clarified to allow an enrollee or provider to object when the plan designates a CRE. It has added language to take that situation into account. See subsection (f).
The Department has added language to subsection (f) to provide the conditions under which a challenge may be made. The only acceptable reason for challenge to a CRE is on the grounds of conflict of interest. The Department does not require proof of conflict since the point is to arrive at a CRE both parties can accept as impartial. If both parties accept the impartiality of the CRE, the CRE's decision becomes more trustworthy. The Department's intention is not to provide a mechanism by which the enrollee or provider may prove that a claimed conflict is reasonable or unreasonable, but to create a process in which both parties can trust to resolve claims equitably.
The Department has also decided to change the time period in which either party may challenge a CRE assignment from the date of receipt of notice of the assignment to the date on the notice of assignment. The Department was concerned that it would be impossible to determine date of receipt of the notice. The Department is compensating for the change by increasing the time period from 3-business days to 7-business days.
One commentator requested that the Department reconsider its position requiring the plan to pay for the health care service regardless of whether or not it chooses to appeal. The commentator stated that the plan should be able to request that implementation of the external review decision be stayed pending appeal, or that the implementation of the decision proceed subject to certain agreed limitations or protective arrangements that preserve the dispute as live. The commentator stated that the language of proposed subsection (k) would undercut a plan's right to judicial review by making the issue moot, even when expedited or injunctive relief could be sought.
The language of subsection (k) is taken from section 2162(c)(6) of Article XXI. The plan may always request a stay pending appeal from the court of competent jurisdiction to which it appeals. Neither the Department nor the CRE have any way of granting a supersedeas or a stay in such matters. The external review decision is not the decision of the Department, but of the CRE. The CRE is not a court of law, nor does it sit as a quasijudicial body. It proceeds by statute to review the plan's decision. The statute does not provide the CRE with authority to grant a supersedeas.
One commentator recommended that the Department add a provision from Act 68 that was omitted from the proposed regulations: ''If the enrollee files the external grievance and the plan prevails, the plan shall pay all fees and costs.''
The Department agrees that this language should be added, and has included it in subsection (k).
One commentator commented that proposed subsection (l) (now subsection (k)) would be a biased disincentive to health care providers to seek an external grievance, since this ability to assume fees and costs associated with external grievance is far less than the plan's if they are not the prevailing party. The commentator recommended that this proposed subsection be reviewed to determine a more equitable penalty process.
Section 2162(c)(7) of Article XXI sets the responsibility for the payment of fees and costs relating to external grievances. The Department cannot alter the statutory responsibility of a provider to pay fees and costs when the provider is the nonprevailing party.
One commentator recommended that the regulations should state how fees are to be handled in split decisions.
The Department agrees that language should be added to the proposed regulations to address split decisions, and has done so. If a decision is against the health care provider in its entirety, the health care provider shall pay the fees and costs associated with the external grievance. If the plan is not the prevailing party in that the decision is against the plan in full or in part, the plan must pay the fees and costs associated with the external grievance review, regardless of the identity of the grievant. See subsection (l). If a provider is responsible for payment of the fees when the appeal substantiates the services were not medically necessary or appropriate under the terms of the plan, it is a disincentive for providers to request external review for questionable or frivolous cases. If, on the other hand, the plan's denial is insupportable to any degree, the plan should pay for the entire cost of the external review.
Another commentator stated that the Department did not have the statutory authority to determine that attorney fees are not included in the fees imposed on the prevailing party, and recommended the deletion of the language. The commentator recommended that attorney fees be passed on to nonprevailing party
The statute specifically states that for purposes of the section, fees and costs do not include attorneys fees. See section 2162(c)(7) of Article XXI. The Department did not specifically use the term ''fees and costs'' in its regulation, and it will use this term to mirror the statute.
Section 9.708. External grievance reviews by CREs.
The Department received several comments on this proposed section.
IRRC recommended that the Department add to proposed subsection (a), which would include requirements for the issuance of an external review decision, a requirement that notice be provided to an enrollee's representative as well, since an enrollee can have a representative.
The Department agrees, and has made the change.
The Department has also included more specific requirements for an external grievance review decision. These requirements--credentials of the individual reviewer, a list of the information considered in reaching the decision and a brief statement of the decision (see subsection (a)), are in accord with recommendations made by commentators with regard to decisions issued by plans.
Several commentators also, in comments made on proposed §§ 9.704 and 9.706, requested that the enrollee be provided access to the credentials of the individual making the decision.
Although the Department has declined to require the production of credentials in complaint decisions for plan personnel and enrollee committee members, and in the standard UR decision prior to the grievance process, the Department is requiring the production of credentials of the matched specialist. See § 9.705(c)(3)(v). The Department believes that the production of the credentials of the external reviewer is also necessary to ensure that the match was apt, and to provide the enrollee and provider with information to support the inherent trustworthiness of the decision. Further, the Department believes that the information it is requiring in the external review decision allows the plan, enrollee and provider to invest in the system and believe in its inherent trustworthiness, and is therefore essential for the ultimate success of the external review process.
One commentator recommended that the Department define the word ''appropriate'' in proposed subsection (b). Proposed subsection (b) would require that the CRE review the second level grievance decision based on whether the health care service denied by the internal grievance process was medically necessary and appropriate under the terms of the plan. The commentator questioned whether the word ''appropriate'' was intended to mean appropriateness of site or service. The commentator also questioned who would review the ''appropriateness of site'' questions. It further commented that the ''appropriateness of service'' review was a part of the medical necessity review and this should be clarified. The commentator recommended that ''appropriate'' should be defined to mean ''appropriateness of site'' and not ''appropriateness of service,'' since the latter was part of the definition of ''medical necessity.''
The Department has made no change to the proposed regulations. Appropriateness pertains to both place and to service, and is all a part of the medical necessity and appropriateness review required by Act 68. See section 2162(c)(5) of Article XXI.
One commentator recommended that the Department clarify the language of proposed subsection (c) as follows: ''The CRE may not make coverage decisions such as requiring plans to cover services not covered under the policy, or specifically excluded under the policy.'' The commentator noted that plans could exclude services by contract, and nothing in the CRE's review should be deemed to authorize it to breach a contract. The commentator noted that the CRE was statutorily prohibited from making coverage decisions.
The standard for CRE review is in section 2162(c)(5) of Article XXI and in subsection (b). There is no need to add further language. There is no presumption in Act 68 or in the Department's regulations that a service that is necessary is therefore covered. CREs are not authorized to require coverage of service that are specifically excluded. If, in the event of, a nonspecific exclusion, for example, an exclusion for experimental or investigational services, a CRE determines that a service is not experimental or investigational, then a CRE may require coverage, and the standard of review of Act 68 has not been ignored, or the contract breached.
One commentator noted that proposed subsection (c) would require the CRE to consider all information considered by the plan. The commentator recommended that the CRE be required to review all information submitted to the plan, whether or not the plan had considered it.
The Department has not changed the language of the regulation. The CRE is to consider all information considered by the plan, and information included in § 9.707. Both the plan and the enrollee, or a health care provider that has filed the grievance, have the ability to submit additional information to the CRE for its review under § 9.707(b)(8). If the enrollee or provider believe that a plan failed to review important information, they have the ability to resubmit that information to the CRE.
One commentator raised concerns that proposed subsection (d) seemed to allow for a lower standard for external reviews than for internal review. The commentator noted that proposed § 9.706(d)(2) would state that a reviewer can either be a physician in the same or similar specialty that typically manages or recommends treatment for the health care service being reviewed, or a physician in active clinical practice. The commentator asserted that this meant that a physician with no experience in a particular area, but active clinically in another totally unrelated area, could be reviewing a case in an area about which the physician knows nothing. The commentator acknowledged that this is what section 2162(c)(4) of Article XXI states, but suggested that this construction of the statute made little sense. The commentator stated that drafters of the bill with whom it has spoken have agreed that this is a drafting error. The commentator stated that the statute was intended to offer a combination of active clinical practice and in the same or similar specialty as an alternative to board certification and the same or similar specialty. The commentator recommended revision of the proposed regulations to take into account this mistake.
Another commentator also commented that the use of the word ''or'' after the phrase ''in active clinical practice'' appeared to be a mistake in the statute, and in proposed subsection (d)(2).
The Department, after reviewing the comments on this issue, believes that principles of statutory construction would permit it to ignore the use of the word ''or'' in the statute. If an interpretation of a statute would be clearly absurd, as it would in this case to read the word ''or'' in its place, that interpretation may be ignored to effectuate the intent of Act 68. See Zimmerman v. O'Bannon, 442 A.2d 674, 676-677 (1982) (it is axiomatic that the General Assembly does not intend a result that is absurd or unreasonable). Since the intent of Act 68, and this provision, is clearly to provide the greatest protection possible to enrollees by providing them with the best level of review possible, to read the statute otherwise would be a violation of that intent. The Department has revised its regulations accordingly.
One commentator recommended including language from § 9.743(d) to clarify the language of the proposed regulations relating to standards for psychologist reviewers.
The Department addressed the issue in discussion of comments on proposed § 9.706 (now § 9.705).
One commentator repeated its earlier comment that it would be necessary to have a licensed peer of the health care provider who requested the review or who made the request for services on behalf an enrollee participate in the review. The commentator stated that this would be appropriate since a clinical rationale must be given and such decisions are based on medical necessity and appropriateness. The commentator noted that nothing in the statute excluded the use of a ''same licensed clinician'' in the review process, and recommended revising the regulations to include this requirement.
Another commentator noted that the absence of peer review was evident, and should be corrected. The commentator recommended that a health care provider with the same professional preparation as the grieving provider should be included in the review.
The Department has not made the recommended changes to this section. Act 68 does not require that the reviewer have the same license, but that the reviewer be in the same or similar specialty. The statute's intent is to allow flexibility within certain parameters and not to force the CRE to obtain an opinion from a peer of the provider requesting the service. As discussed earlier, there are instances when a neurosurgical opinion may not be inappropriate and indeed may be more relevant than an orthopedic opinion given the nature of the case. Further, the Department will not require, as part of the reviewing group, a person in the same profession as the provider who recommended the health care service in question. The issue is not one of professional bias, but one of whether the enrollee was denied medically necessary and appropriate treatment. For this purpose, it is not necessary to have a provider with the same professional license to review the case.
Further, Act 68 requires the inclusion of the physician or psychologist as a reviewer. See section 2162(c)(4) of Article XXI. No other type of provider may perform this review. A CRE that used a provider other than a physician, or as Act 68 permits, a psychologist, would be in violation of Act 68, and in jeopardy of losing its accreditation.
One commentator recommended that the Department add a definition of ''active clinical practice'' to the definition section of the regulations.
The Department agrees that this should be done, and has added the definition from Act 68 to § 9.602: ''The practice of clinical medicine by a health care provider for an average of not less than 20 hours per week.'' See definition of ''active clinical practice'' in section 2102 of Article XXI.
Three commentators recommended that the Department delete the reference to the definition of ''emergency'' in the enrollee's certificate of coverage, since the standards for emergency services in Act 68 are what should be used. Proposed subsection (e) would require the CRE to utilize the emergency service standards of Act 68 and this chapter, and the definitions of ''medical necessity'' and ''emergency'' in the enrollee's certificate of coverage in reviewing a grievance decision relating to emergency services.
The Department included a reference to the certificate of coverage in proposed subsection (e) because that is where the benefit levels and exclusions appear. The Department has clarified this in the regulation by deleting references to the definitions of medical necessity and emergency in that certificate, and requiring the CRE to review the certificate itself. The Department has also included the requirement that the prudent layperson standard of Act 68 be used by the CRE for the purposes of clarity.
Section 9.709. Expedited review.
The Department received several comments on this proposed section.
One commentator stated that additional language should be added to the section to require the plan to act on requests for nonformulary prescription drug coverage in an expedited manner, within 1 business day of the receipt of the request. The commentator recommended that the denial of such a request be subject to the expedited review process in this proposed section.
As the Department stated in its response to comments on proposed § 9.673, some objections to the denial of a request for a formulary exception could be considered to be grievances, depending upon the circumstances. The Department has added language to § 9.673 to require plans to treat requests for formulary exceptions as concurrent UR, and to reach a decision within 2 business days. Further, if the enrollee meets the qualifying criteria included in this section, the enrollee may request and obtain an expedited grievance review.
Another commentator raised concerns about the practicality of the time frames involved. The commentator stated that it could be physically impossible to gather all necessary case records for transfer to a CRE by the end of the next business day. The commentator also stated that confidentiality of medical records could be breached in a rush to complete the case file.
The plan does not have to create an entirely new file. The plan had sufficient documentation to issue the original denial, and to issue any other internal grievance denials, therefore it is not ''starting from scratch.'' It is the enrollee requesting the review, and asking that the information be provided to an expedited reviewer. It is difficult to see how referral of the record already considered by the plan would breach confidentiality of medical records. Further, it should be noted that section 2131(c)(2)(i) of Article XXI specifically states that nothing in that section shall prevent disclosure necessary to review complaints or grievances, conduct UR, determine coverage or pay a claim.
One commentator commented that under the 1991 guidelines, disputes regarding denials of care alleged to be necessary and pressing were required to be decided within 48 hours regardless of whether the issue was one of medical necessity, and that similar language should be included in the regulations.
Act 68 now sets out requirements for grievances and complaints, and for expedited reviews. Act 68 requires a showing that the life, health or ability to regain maximum function of an enrollee is in jeopardy to secure an expedited review. The Department cannot go beyond this and create a different standard for an expedited review, by saying that any time the service is necessary and pressing, if only in the opinion of the enrollee, an expedited review must be conducted.
Several commentators stated that the regulations should include an expedited review process for those matters that do not involve issues of medical necessity, but which, if not resolved quickly, would jeopardize enrollee's health, life, or ability to regain maximum function. These commentators also expressed concern that there was no expedited review for complaints.
In fact, the review process proposed by the Department does not limit expedited review to those matters involving medical necessity. The words ''medical necessity'' or ''grievance'' do not appear in § 9.709. Instead, the language reads: ''A plan shall make an expedited review process available to an enrollee if the enrollee's life, health, or maximum function would be placed in jeopardy by delay occasioned by the review process set out in this subchapter.'' The subchapter, of course, covers both complaints and grievances.
Three commentators strongly supported the proposed regulations allowing for an expedited review in all cases where life, health or ability to regain maximum function could be jeopardized by a delay in obtaining the recommended services.
One commentator questioned the Department's authority to impose standards for an expedited review process, since Act 68 does not include language requiring these reviews. This commentator also recommended that the Department modify this proposed section to reflect the process adopted by most of the managed care industry. The commentator stated that the next step after the plan's expedited review decision would be for the grievance to proceed to second level grievance review and then to an external grievance review.
The Department has not changed the proposed regulations. Act 68 does provide for an expedited internal grievance process when the life, health or ability to regain maximum function of an enrollee is in jeopardy. See section 2161(e) of Article XXI. To ensure that this provision is effectuated, the Department is requiring an expedited external process whenever the enrollee meets the necessary criteria, that is, the enrollee's the life, health or ability to regain maximum function of an enrollee is in jeopardy. It would be absurd, and, therefore, legally impermissible, to construe the General Assembly to have created an expedited internal process, the benefit of which could be destroyed by a return to the normal 60-day external review process if the internal decision were appealed further. Further, it makes little sense to allow the categorization of the case to drive the enrollee's ability to obtain an expedited review. If the enrollee's life, health and ability to regain maximum function are in jeopardy, the review should be expedited.
One commentator recommended that grievances should also be subject to an expedited review when necessary.
The expedited review process does apply to grievances.
One commentator recommended that the regulations address how an enrollee appeals a plan's denial of an expedited review.
Three commentators recommended that the regulation identify the person responsible for determining if the enrollee meets requirements for expedited review. One of these commentators commented that the intent of an expedited review could be negated by a disagreement over the prognosis of the enrollee.
Another of these commentators recommended that the Department add language requiring the matter of whether an expedited review should be granted be decided by a nurse or physician primary care provider, and requiring that such a decision be conclusive. The commentator also recommended adding ''and the plan shall grant'' after the word ''request'' in proposed subsection (a). Proposed subsection (a) stated that ''An enrollee may request an expedited review at any stage of the plan's review process.''
One commentator recommended that the regulations make it clear that a plan makes the decision regarding whether or not the matter will be expedited.
The 1991 guidelines required plans to grant an expedited review at the enrollee's option. The Department is requiring that the request for an expedited review be accompanied by a statement from the enrollee's physician that the enrollee meets the qualifying criteria, which are included in section 2161(e) of Article XXI. The statement must also include the physician's clinical rationale for the opinion, and facts to support it. This is intended to prevent expedited reviews from being abused by either party. The Department is requiring that an expedited review be granted automatically upon presentation of such a statement. See subsection (c).
Given the haste with which an expedited case must be processed, the Department would expect the substantiating physician to seriously and critically evaluate the need for the enrollee to obtain the service within 48 hours. Substantiation from a physician as proof positive of the need for a 48-hour review imparts great responsibility on the physician to carefully evaluate the wants versus the needs of the enrollee. To do otherwise may prevent the enrollee from presenting the best case in such a short time span and may force the plan to make a decision it may not have made had it more time to investigate and deliberate. The focus of these cases should not be whether the substantiation is accurate but rather should be on determining the medical necessity and appropriateness of the request within the context of the terms of the plan. By requiring the plan to grant an expedited review upon receipt of the physician's statement, the Department is eliminating, as an appealable issue, a decision of whether to grant a review.
One commentator questioned language in proposed subsection (b) that stated that the internal expedited review process must meet the requirements of the second level review. The commentator asked whether this meant that the enrollee would bypass the first level review as indicated in proposed § 9.705(c)(1). The commentator commented that it would be more effective if plans were to meet requirements of the first level, and recommended making that change to the regulations.
The Department has not made the recommended change to the regulations. The proposed subsection was intended to require plans to meet the requirements of the second level review with respect to the holding of a hearing, the committee composition, the contents of the decision letter, the rights accorded the enrollee, and so forth. The Department has chosen the second level review standards, because of these heightened fairness requirements, which are necessary, given the serious nature of the issues involved. The Department realizes, however, that with the addition of fairness requirements to § 9.705, the need to review and respond to the enrollee with 48 hours may create problems for plans in meeting requirements other than timeframes. The Department has specified in subsection (b) what requirements of the second level review process may be altered, in an expedited review, to comply with the enrollee's need for an expedited decision.
One commentator recommended that the Department clarify proposed subsection (c) (now subsection (e)) to require a decision to be issued ''48 hours from time the plan receives the appeal either by fax, mail or other electronic transmission.''
IRRC commented that the subsection should specify that the plan would conduct an expedited internal review ''upon receipt of the enrollee's request.''
The Department has made the change that IRRC requested for the sake of clarity. The Department does not see the need to make the other recommended change to the subsection, since the language specifically requires the decision to be issued with 48 hours from the plan's receipt of the request. There is no need to specify how the request is to arrive. It may arrive in any manner. The Department has added language, however, to require that the request be accompanied by the physician's statement required by subsection (c).
One commentator requested that the Department clarify proposed subsection (e) (now subsection (g)). That proposed subsection would provide the enrollee with 2-business days from the expedited internal grievance review decision to contact the plan to request an expedited external review. The commentator questioned whether this meant that the plan only had one level of internal review in an expedited grievance. The commentator also asked whether this one level of review was to meet the first or second level review process. The commentator recommended that the second level be bypassed, and the enrollee go straight to an external review.
The plan only has one chance to review the matter internally. The expedited review must be conducted under the rules and procedures that govern the normal second level reviews, with some exceptions, as discussed previously. After that review, the decision may be appealed externally on an expedited basis as the regulations state.
Two commentators have commented that the implementation of the proposed section will require revision to member materials such as benefit documents, member handbooks and policies and procedures. One of these commentators requested that the Department show flexibility in terms of plan deadlines, and that it specifically address this in its final form-regulations.
There are many means of distributing information, for example, by special notices, announcements in member newsletters, revised subscriber contracts and additions to denial notices. The Department will not fine plans for noncompliance immediately upon adoption of the final-form regulations. The Department will work with plans to bring them into compliance as quickly as possible. This may involve some ''stop-gap'' measures until standard documents can be revised.
The other commentator noted that the concept of an expedited review did not appear in the Department's statement of policy. The commentator commented that having procedures reviewed and approved by Insurance, and distributing the new Act 68 grievance process in policy form changes, member handbook modifications and notices to members and providers had been a costly process. The commentator stated that the change in the handling of expedited grievance appeals would create significant costs for the managed care industry. If these changes are made, the commentator recommended that they should be coordinated with Insurance with sufficient lead-time prior to implementation.
The Department is aware that changes will need to occur to meet the requirements of the regulations. However, most notices regarding this subchapter are made through the review decision letters, and those changes involve a small number of letters (according to data from the 1999 plan annual reports, a total of 5,804 first level grievances and 12,379 first level complaints were filed in this Commonwealth and thereafter, the second number of second level cases drops to between 10-15%). These changes can be made by manual intervention, and must be made immediately. It should be noted that the policy statement was just that, policy, and that these regulations, including the expedited review requirement, were provided for public comment and have been before the public since December of 1999. The Department is not adverse to a longer timeframe for plans to come into compliance as long as the appropriate notices are made in the denial letters which will give the enrollee the information most necessary to exercise the right to appeal.
One commentator noted that not every request from an enrollee for an expedited review would meet the plan's definition of an expedited grievance. The commentator recommended the addition of the following language: ''which has been determined to be an expedited appeal'' in proposed subsection (f) (now subsection (h)), after the phrase ''Within 1 business day of the enrollee request, the plan shall submit a request for an expedited external review . . . .''
The Department has added language to the regulation that requires a plan to provide an expedited appeal if the enrollee provides a letter from the enrollee's physician that the enrollee meets the qualifying criteria. Therefore, there is no need for the Department to make the requested change.
IRRC recommended that the Department specify in subsection (f) that submission will occur within 1 business day of receipt of the enrollee's request.
One commentator requested that the Department consider extending time frames in which the plan would be required to forward an enrollee's request for an expedited review to the Department, and for a plan to forward the complete case file to the CRE. The commentator recommended 2 business days for notification and 5 days for collection and forwarding as more practical.
The Department has made the change IRRC requested for clarity. See subsection (h). The Department has not changed the time frames included in the regulation to reflect the comment, since most information will already be in the plan's possession, and since the nature of the case warrants a more expeditious time frame for the collection and forwarding of materials than 5 days. The Department has, however, changed ''1-business day'' to ''24 hours'' to emphasize the need for expedition in these matters.
IRRC requested that the Department clarify language in proposed subsection (i) (now subsection (k)), which would require the plan to transfer a copy of the case file to the review entity for receipt on the next business day. IRRC questioned what would constitute receipt on the next business day.
The Department means that the documents arrive at the CRE by 5 p.m. the following business day.
One commentator noted that although the Department had referenced an appeal right for expedited external reviews in proposed subsection (j), it had not included similar language in proposed § 9.707. The commentator questioned whether the appeal right was only applicable to enrollees or providers, or whether the plan had a right to appeal. The commentator recommended that the appeal process be explained in more detail or be deleted.
The Department is deleting the language from this section as well, on the theory that a plan or enrollee may attempt to appeal the matter to a court if they choose without the Department's stating that fact in regulation.
IRRC commented that proposed subsection (i) used the term ''response'' and proposed subsection (j) used term ''decision.'' IRRC recommended that the Department change one or the other for consistency.
Since the Department has deleted proposed subsection (j), this comment is moot. The Department has, however, changed the language in subsection (i) from ''response'' to ''decision'' as ''decision'' is a more accurate term.
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