[30 Pa.B. 1321]
[Continued from previous Web Page] 31. Section 9.703. Health care provider initiated grievances.--Economic Impact Clarity.
General
Health care provider grievances would be filed under Sections 9.706 to 9.708. For clarity, this section should be in sequence with those sections.
Subsections (f), (g) and (h) provide broad requirements for the content of a consent form. The written consent is between a health care provider and an enrollee. A health care provider may have patients in different plans. Without guidance from DOH, each plan could place its own requirements on consent forms. DOH should consider use of a universal consent form so that health care providers and plans do not waste time and resources resolving conflicts over enrollee consent.
Subsection (b) Consent to File Grievance
Commentators have raised questions over whether consent can be obtained at the time of treatment. Subsection (b) only prohibits a health care provider from making consent a condition of treatment. DOH should clarify in the regulation whether consent can be obtained at the time of treatment provided it is not a condition of treatment.
Subsection (d) Billing of Services Subject to Grievance
Subsection (d) prohibits a health care provider from billing the enrollee until an external grievance is completed. Commentators questioned whether billing can occur if the grievance is filed by an enrollee. DOH should clarify whether Subsection (d) applies to all grievances, regardless of whether the enrollee or the provider initiates the grievance.
32. Section 9.704. Internal complaint process.--Clarity.
Subsection (a) Requirements
Subsection (a) contains the phrase ''and is acceptable to the Secretary.'' The internal complaint process must meet Act 68 and this subchapter. DOH should either explain what additional requirements the Secretary intends to impose or delete this phrase.
The second sentence of Subsection (a) lacks clarity. The parallel Section 2141(a) of Act 68 states ''an enrollee shall be able to file a complaint regarding a participating health care provider or the coverage, operation or management policies of the managed care plan.'' Subsection (a) should be rephrased to follow Act 68.
Subsection (b) Complaints
Subsection (b) would allow written or oral complaints for both initial and second level review. However, Section 2141(b)(2) of Act 68 only addresses oral complaints for an initial review. Section 2141(b)(5) requires the plan to include the procedure ''to file a request'' for a second level review. The regulation should state that a written request is required to initiate a second level review.
Subsection (c) Paragraph (1) First level review.
For clarity, Subsection (c)(1)(i) should state ''. . . one or more employes of the plan'' to better reflect Section 2141(b)(1) of Act 68.
Subsection (c)(1)(iii) states review and investigation must be completed in 30 days, but does not specifically state when a decision is required by the plan. For clarity, DOH should state the required time frame for plan decisions.
Subsection (c)(1)(iv) should reference Section 9.702(d)(3) which requires the plan to give the enrollee a minimum of 45 days to file a second level complaint.
In Sections (c)(1)(iv) and (c)(2)(vii), commentators state the phrase ''basis for decision'' is unclear. Use of this phrase could result in a denial of a complaint that the enrollee may not be able to understand. It is unclear how much detail is required of the plan in the basis for the decision. For example, would the basis for the decision require contract citations? DOH should provide further guidance on how detailed the information from the plan regarding the decision.
Subsection (c)(1) does not state whether a first level decision is binding unless appealed. Under Subsection (c)(2)(iii), a second level decision is binding unless appealed. Is a first level decision binding unless appealed?
Subsection (c) Paragraph (2) Second level review.
Subsection (c)(2)(i) is unclear because there are two requirements in one sentence. The regulation would be clearer if one sentence describes the minimum size of the committee and a second sentence states the prohibition on members who participated in prior decisions.
In Subsection (c)(2)(ii)(A) the phrase ''reasonable flexibility in terms of time and distance'' is unclear. DOH should provide more specific requirements for scheduling reviews similar to the requirements in Section 9.679(e).
In Subsection (c)(2)(ii)(C), the word ''or'' causes confusion in the phrase ''. . . the enrollee's provider or applicable witnesses . . . .'' As written, it would allow either the provider to attend or applicable witnesses, not both. Both could be needed in certain circumstances and should be allowed. The word ''and'' should be substituted.
Subsection (c)(2)(iv) allows the deliberation of the second level review committee, including the enrollee's comments to be ''transcribed verbatim or summarized.'' Would a summary be sufficient for appeals under Section 9.705?
Subsection (c)(2)(v) states the second level review must be completed in 45 days, but does not specifically state when the plan is required to issue a decision. For clarity, DOH should specifically state when a decision must be issued by the plan.
Subsection (c)(2)(vii) requires a notice to include ''the procedures and time frame'' to file an appeal. The procedures are specified in Section 9.705 and the time frame is 15 days as specified in Section 2142 of Act 68. For clarity, Subsection (c)(2)(vii) should reference the procedures in Section 9.705 and state the specific 15-day time period.
Since an enrollee can have a representative, Subsections (c)(2)(vi) and (vii) should also require notice to the enrollee's representative, if known.
33. Section 9.705. Appeal of a complaint decision.--Statutory Authority; Clarity.
Subsection (a)
This subsection requires an enrollee to appeal within 15 days of receipt of the second level decision. How is receipt of the decision determined?
Subsection (a) contains the phrase ''or the Insurance Department.'' This phrase should be deleted since DOH has no authority over the Insurance Department.
Subsection (b)
Paragraph (b)(3) requires ''The enrollee's plan ID number.'' Does this mean the ID number assigned to the enrollee by the plan, or some other number, such as an NAIC number assigned to the plan? Also, ''ID'' should be replaced with ''identification.''
Subsection (c)
Subsection (c) requires notice to the plan. The regulation should also require notice to the enrollee of the status of the filing (that is, a timely filing or a late filing).
Subsection (d)
For clarity, the two sentences in Subsection (d) should be combined to state that upon confirmation of a timely filing, the plan shall forward the file within 5 business days.
Subsection (f)
This Section ends without any time constraint on DOH to rule on the appeal. The plan has 30 days to complete an initial review and 45 days to complete a second level review. DOH should consider adding a time period within which it will rule on an appeal.
Subsection (f) should state that the time requirements for review will not be affected by a decision to change the department reviewing the appeal.
34. Section 9.706. Enrollee and provider grievance system.--Clarity.
Subsection (a)
Subsection (a) contains the phrase ''and is acceptable to the Secretary.'' The internal complaint process must meet the requirements of Act 68 and this subchapter. DOH should either delete this phrase or explain what additional requirements the Secretary intends to impose.
Subsection (c) Paragraph (1) First level review.
Subsection (c)(1)(iii) states the first level review must be completed in 30 days, but does not specifically state when the plan is required to issue a decision. For clarity, DOH should state when a decision is required to be issued by the plan.
Subsection (c)(1)(iv) does not reference Section 9.702(d)(3) which requires the plan to give the enrollee a minimum of 45 days to file a second level grievance. DOH should reference the requirement of Section 9.702(d)(3).
Subsection (c)(1)(iv) should require notice to both the enrollee and the health care provider to be consistent with Section 2161(b)(3) of Act 68.
Subsection (c)(1) should indicate whether the initial decision is binding unless appealed.
Subsection (c) Paragraph (2) Second level review.
The phrase ''reviewing a grievance appealed to the second level of review'' in Subsection (c)(2)(i) is not needed and should be deleted.
Subsection (c)(2)(ii) actually encompasses two separate requirements. It should be split into two separate paragraphs for clarity.
Subsection (c)(2)(ii)(A) requires the plan to provide ''reasonable flexibility in terms of time and distance'' when scheduling a review. The phrase ''reasonable flexibility in terms of time and distance'' is unclear. DOH should provide more specific requirements for scheduling reviews similar to the requirements in Section 9.679(e).
Subsection (c)(2)(iii) allows the deliberation of the second level review committee, including the enrollee's comments to be ''transcribed verbatim or summarized.'' Would a summary be sufficient for appeals under Section 9.708?
Subsection (c)(2)(vi) requires a notice to include ''the procedures and time frame'' to file an appeal. The procedures are specified in Section 9.707 and the time frame is 15 days as specified in Section 2162 of Act 68. For clarity, Subsection (c)(2)(vi) should reference the procedures in Section 9.707 or state the specific 15-day time period.
Since an enrollee can have a representative, Subsection (c)(2)(vi) should also require notice to the enrollee's representative, if known.
Subsection (c)(2)(v) should require notice to both the enrollee and the health care provider to be consistent with Section 2161(c)(4) of Act 68.
Subsection (c) Paragraph (3) Same or similar specialty.
Subsection (c)(3) uses the term ''similar.'' The similarity of specialties could be broadly interpreted. DOH should define or specify the scope of a ''similar specialty.''
35. Section 9.707. External grievance process.--Statutory Authority; Clarity.
Subsection (b)
Paragraph (b)(1) requires an enrollee to appeal within 15 days of receipt of the second level decision. How is receipt of the decision determined?
Paragraph (b)(2) uses the word ''or.'' This could be read to require notification to only one entity. For clarity, DOH should indicate whether notification should be given to the enrollee or provider, depending on who filed.
The reference to ''subsection k'' in Subsection (b)(4) appears to be in error. DOH should review this reference.
Paragraph (b)(4) mentions an ''external grievance coordinator.'' This position is not defined or explained in the regulation. DOH should add a definition of ''external grievance coordinator.''
Paragraph (b)(5)(iv) requires ''The enrollee's plan ID number.'' Does this mean the ID number assigned to the enrollee by the plan, or some other number, such as an NAIC number assigned to the plan? Also, ''ID'' should be replaced with ''identification.''
In Subparagraphs (b)(5)(viii) and (b)(6)(ii) it is unclear what ''reasonably necessary'' supporting documentation is. These provisions should specify the information required.
36. Section 9.708. Grievance reviews by CRE.--Clarity.
Since an enrollee can have a representative, Subsection (a) should also require notice to the enrollee's representative, if known.
37. Section 9.709. Expedited review.--Clarity.
Subsection (a)
Subsection (a) requires expedited review ''. . . if the enrollee's life, health or ability to regain maximum function will be placed in jeopardy by delay . . .'' The intent of an expedited review could be negated by disagreement over the prognosis of the enrollee. The regulation should state who makes this determination.
Subsections (c) and (f)
Subsections (c) and (f) should specify ''upon receipt of the enrollee's request.''
Subsection (i)
Subsection (i) requires ''receipt on the next business day.'' What constitutes ''receipt on the next business day''?
Subsection (i) uses the term ''response'' and Subsection (j) uses the term ''decision.'' For clarity, a single term should be used consistently.
38. Section 9.710. Approval of plan enrollee complaint and enrollee and provider grievance systems.--Clarity.
Timeframes for approval
Section 9.710 does not have a timeframe or formal process for approval of the complaint and grievance systems or changes to them.
* Is approval required prior to implementation?
* How must changes initiated by the plan be approved?
DOH should add the specific requirements and timeframes for system approval.
Subsection (a)
Subsection (a) should require approval by DOH rather than use the phrase ''satisfactory to the Secretary.''
Subsection (b)
Subsection (b) should state how far in advance DOH expects these filings.
Subchapter J. Health Care Provider Contracts 39. Sections 9.722, 9.724 and 9.725.--Consistency with the statute; Reasonableness; Need; Clarity.
Timeframe for approval
Overall, the subchapter provides no time period for DOH review and approval. Plans, HMOs and Integrated Delivery Systems (IDSs) should be given notice as to the length of time DOH will need to review and approve the contract forms.
Fiscal Impact
The requirement in Section 9.722 mirrors existing regulations that cover HMOs but extends the requirements to other managed care plans that are not HMOs. For plans not covered by the HMO Act, DOH states in the Preamble that its statutory authority for this requirement is Section 2111(1) of Act 68 (40 P. S. § 991.2111(1)). This section of the statute states that a plan shall ''assure availability and accessibility of adequate health care providers in a timely manner, which enables enrollees to have access to quality care and continuity of health care services.'' Unlike the HMO Act, Act 68 does not contain any specific language addressing the review of contracts by DOH.
What fiscal impact will Subchapter J have? The Preamble and the Regulatory Analysis Form for this regulation do not contain any information regarding the cost of this requirement for the plans or DOH. This information should accompany the final-form regulation. In addition, DOH should consider whether there are less cumbersome and less expensive alternatives for implementing Act 68.
40. Section 9.722. Plan and health care provider contracts.--Consistency with the statute; Reasonableness; Need; Clarity.
Subsection (a) DOH Review
This subsection requires plans and HMOs to submit standard forms for each provider contract to DOH for review and approval. There are two concerns.
First, commentators indicated that many contracts simply require general compliance with State and Federal regulations and laws, and a provider manual published by a plan. For some plans, the provisions of this section may be included in their provider manuals rather than in each contract form. Rather than require each contract form to be submitted, it may reduce paperwork requirements if DOH reviews and approves provider manuals that are referenced by contracts.
Second, the requirements of this section may be duplicative for HMOs participating in the Medical Assistance (MA) program. They are required to submit contracts to the Department of Public Welfare (DPW). If the MA requirements are similar, then DOH may be able to reduce paperwork costs by allowing HMOs to use the same documents that they submit to DPW, or DOH could accept DPW's notice of approval of the contracts rather than undertake a separate review.
Subsection (b) Contract Changes and Amendments
This subsection requires the plan to ''submit any change or amendment'' to a contract to DOH 10 days ''prior to implementation of the change or amendment.'' There are two concerns.
First, this requirement will be burdensome for plans handling and mailing paperwork to DOH. Is it necessary for DOH to review every change or amendment? DOH should consider limiting this subsection to avoid unnecessary filing and review costs.
Second, the regulation should specify whether DOH will review and approve the amendments or changes. In addition, the regulation needs to set a time period for DOH review.
Subsection (c) Provider Protection Provisions
Subsection 9.722(c) states that a provider contract cannot contain provisions allowing the plan to sanction, terminate or fail to renew a health care provider for certain reasons including taking an action specifically permitted by Section 2113 of Act 68. There are two concerns.
First, Subsection 2121(e) of Act 68 states ''no managed care plan shall exclude or terminate a health care provider from participation in the plan due to'' two activities not mentioned in Section 2113. They include:
(2) The health care provider has a practice that includes a substantial number of patients with expensive medical conditions.
(3) The health care provider objects to the provision of or refuses to provide a health care service on moral or religious grounds.
Therefore, Subsection 9.722(c)(4) should reference both Section 2113 and Subsection 2121(e).
Second, if a plan terminates, or fails to renew a contract with a provider, what is the mechanism to insure that Sections 2113 and 2121(e) of Act 68 were not violated?
Subsection (e) Consumer Protection Provisions
This subsection sets forth ''consumer protection provisions'' that contracts must contain. There are two concerns.
First, Subsection 9.722(e)(5) states that the contract will include ''language requiring the health care provider to adhere to State and Federal laws and regulations.'' What is the purpose of the general reference to ''State and Federal laws and regulations''? This regulation should reference the specific laws and regulations with which providers must comply.
Second, Subsection 9.722(e)(6) requires contracts to include ''language concerning prompt payment of claims.'' What type of language is being required? Is this a reference to the prompt payment of claims provisions of Act 68 or 31 Pa. Code § 154.18 of Regulation #11-195 from the Insurance Department? If so, DOH should reference Act 68 or the pertinent regulatory provision.
Subsection (f) Health Care Provider Contract Requirements
This subsection requires the contract to include information concerning reimbursement systems for providers. There are two concerns.
First, Subsection 9.722(f)(1) requires the contract to describe the reimbursement methods, including systems and factors for the types of economic or bonus incentive systems used. What level of detail will DOH require? As a part of the reimbursement method description, the regulation should require details concerning the amounts and percentages used in the methods.
Second, Subsection 9.722(f)(2) sets forth specific proportions for incentive reimbursement systems. It states that no system can weigh utilization performance as a single component more highly than the other factors collectively. These other factors include quality of care and enrollee services. This would allow low utilization to equal almost one half of the incentive. How did DOH determine these proportions? In addition, DOH should consider standards promulgated by the Health Care Financing Administration at 42 CFR 417.479.
41. Section 9.723. IDS. and Section 9.724. HMO-IDS provider contract.--Reasonableness; Clarity.
These two sections relate to contracts between an IDS and HMO, and contracts between the IDS and health care providers. There are two concerns.
First, Subsection 9.723(b) requires an HMO and IDS to notify DOH in writing at least 60 days in advance of any proposed action that would stop the IDS's providers from treating enrollees, including institution of litigation, termination or nonrenewal. Commentators noted that an HMO or IDS may not always receive 60 days advance notice of litigation. DOH should consider revising this subsection to allow for flexibility when an HMO or IDS does not receive 60 days advance notice of litigation.
Second, both sections are confusing because they intermix requirements for contracts between an IDS and HMO, and requirements for contracts between an IDS and health care providers. For example, Subsection 9.724(c) includes the requirement that the HMO provide DOH with copies of the contracts between an IDS and health care providers, and sets forth a list of 14 detailed standards for contracts between IDSs and HMOs. To clarify the requirements for these two different types of contracts, they should be set forth in separate sections.
42. Sections 9.723, 9.724 and 9.725.--Consistency; Reasonableness; Clarity.
These sections establish standards and requirements for IDSs and HMOs. The definition of an IDS in Section 9.602 of this regulation defines an IDS as a partnership or other legal entity that ''[e]nters in to a contractual arrangement with a plan.'' Why is the term ''HMO'' used in these sections rather than plan or managed care plan?
Subchapter K. CREs
43. Section 9.742. CREs.--Clarity.
Subsection 9.742(c) states that a licensed insurer or plan with a certificate of authority shall comply with the requirements of Act 68 but is not required to obtain certification as a CRE. However, the requirements for a certificate of authority include assessment by an external quality review organization. It is our understanding that this assessment would include a review of the plan's utilization review component that is equivalent to certification of a CRE. For this reason, this subsection should reference Section 9.655 relating to HMO external quality assurance assessment.
44. Section 9.743. Content of an application for certification as a CRE.--Consistency with the statute; Reasonableness; Need; Clarity.
Subsection (b)
Subsection 9.743(b) allows DOH to change the application form by publishing notice of the changes in the Pennsylvania Bulletin. Any changes to the application form must be non-substantive in nature. Substantive changes must be made by a new rulemaking. This subsection should include language that any changes would be in accordance with this regulation or consistent with the content requirements in this section.
Subsection (c)
This subsection sets forth content requirements for the CRE application form. There are five concerns. First, Subsection 2151(c) of Act 68 states that DOH ''may adopt a nationally recognized accrediting body's standards to certify utilization review entities to the extent the standards meet or exceed the standards set forth in this article.'' Subsection 9.743(c)(5)(vii) requires a CRE's application to include: ''Evidence of approval, certification or accreditation received by a Nationally recognized accrediting body in the area of UR [utilization review], if it has secured the approval, certification or accreditation.''
What accrediting bodies meet the standards set forth in this regulation and Act 68? DOH should designate these organizations in the regulation or publish a list of accrediting bodies that is available to the public.
Second, Subsections 2152(a)(4)(i)--(iii) of Act 68 set forth specific ''turnaround'' time requirements for UR decisions. There are two issues related to these statutory requirements. The first concern is that the specific statutory time requirements for UR decisions should be referenced or included in the regulation. Second, how will DOH determine whether a CRE has the ability or capacity to meet these ''turnaround'' time requirements?
Third, Subsection 9.743(c)(5)(ii) states that the application should include a description of the applicant's ''acceptable selection and credentialing procedures and criteria for physician and psychologist clinical peer reviewers.'' What is meant by ''acceptable''? Do these procedures and criteria include the requirement in Section 2152(a)(5) of Act 68? What is included in ''other required credentials''? DOH should clarify.
Fourth, Subsection 9.743(c)(5)(ix) will limit applicants to those who are already in the business of CREs. This subsection requires that the application include a list of three clients for which the applicant conducted UR. Is it the intent of DOH to prevent entry into this market by new CREs? If not, this subsection needs to be revised.
Subsection (d)
Subsection 9.743(d)(3) asks the applicant to certify that a plan is not providing compensation to a CRE employe or other person performing UR on its behalf that contain direct or indirect incentives to approve or deny payment for health care services. However, Subsection 2152(b) of Act 68 simply states: ''Compensation to any person or entity performing utilization review may not contain incentives, direct or indirect, for the person or entity to approve or deny payment for delivery of any health care services.'' The regulation should not limit the application of the statutory language to plans. The subsection should reference the language of Act 68.
45. Section 9.744. CREs participating in internal and external grievance reviews.--Reasonableness; Clarity.
Subsection 9.744(a)(3) requires disclosure of any potential conflict of interest. Why isn't this requirement a part of the application in Section 9.743? A CRE may avoid this disclosure requirement if it uses the application procedures in Section 9.743. Since DOH needs to identify CREs that meet the requirements of Section 2162 of Act 68, wouldn't it be useful to have this information for all CREs?
46. Section 9.748. Maintenance and renewal of CRE certification.--Clarity.
This section should contain specific language providing DOH with access to the same records and other information concerning a CRE as described in Subsection 9.747(b). In addition, this subsection should state that DOH will have access to and review UR decisions developed by the CRE. This is necessary to allow DOH to monitor CREs for compliance with Act 68 and this subchapter.
Subchapter L. Credentialing 47. Section 9.761. Provider credentialing.--Clarity.
Subsection (b) should require DOH approval to be consistent with Section 2121(a) of Act 68. In addition this subsection should provide the process and time frame for approval of the provider's credentialing plan.
48. Miscellaneous Clarity Issues.
Section 9.702. Complaints and grievances.
Paragraph (a)(1) uses the singular word ''procedure.'' For clarity, we suggest using the plural word ''procedures'' to emphasize that complaints and grievances are separate procedures.
Section 9.711. Alternative provider dispute resolution systems.
The title of this Section could imply there is an alternative provider rather than an alternative dispute resolution system. Since this system is an agreement between the provider and the plan, the word ''provider'' should be deleted from the title.
Section 9.711. Alternative provider dispute resolution systems.
There is a typographical error in Subsection (e). It should state ''. . . alternative dispute resolution system. . . .''
Subsections 9.721. Applicability.
In this section, why are the terms ''health care providers'' and ''IDSs'' repeated twice?
Subsections 9.722(a), 9.722(b), 9.724(b) and 9.743(b).
On its page 44, the Pennsylvania Code and Bulletin Style Manual recommends the use of the word ''before'' instead of the word ''prior.'' In these three subsections, DOH should replace the words ''prior to'' with ''before.''
JOHN R. MCGINLEY, Jr.,
Chairperson
[Pa.B. Doc. No. 00-400. Filed for public inspection March 3, 2000, 9:00 a.m.]
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