New York State Seal
STATE OF NEW YORK
INSURANCE DEPARTMENT
25 BEAVER STREET
NEW YORK, NEW YORK 10004

Eliot Spitzer
Governor

Eric Dinallo
Superintendent

The Office of General Counsel issued the following opinion on July 6, 2007, representing the position of the New York State Insurance Department.

Re: Experimental Medical Services

Questions Presented:

1. Once an insurer covers a service for a specific medical condition, may it later deny coverage upon determining that the service is experimental?

2. If an insurer approves the use of a service for treating one medical condition, must it also approve the use of that service for other medical conditions, even if excluded under the insurance policy?

3. If medical journals and other medical publications state that a certain service is an effective treatment for a specific medical condition, may an insurer still insist that the service is experimental for that medical condition and, therefore, not covered under the insurance policy?

Conclusions:

1. Yes. An insurer may later determine that a service is experimental for a specific medical condition, even though the insurer formerly covered the service for that specific medical condition.

2. No. An insurer is not required to approve the use of a specific service as a treatment for other medical conditions simply because it approves the use of the service for one medical condition.

3. Yes. Pursuant to N.Y. Ins. Law § 3224-b (McKinney Supp. 2007), an insurer may refuse to cover a service that it determines is experimental. However, the insured may make an external appeal of a final adverse determination pursuant to Article 49 of the Insurance Law or Article 49 of the N.Y. Public Health Law (McKinney 2002).

Facts:

The inquirer reports that she is a biofeedback provider.1 In 2005, the inquirer received pre-approval from ABC, a health maintenance organization (HMO), to treat three patients suffering from migraine headaches using biofeedback services. In December 2005, ABC refused to extend treatment for one of the three patients who, in the inquirer’s opinion, had achieved a significant reduction in headache frequency, intensity, and duration, but who had not completed treatment. Now, additional patients who are requesting the inquirer’s services for migraine headaches are being denied coverage by ABC because, according to ABC, such treatment is experimental and has not been proven safe and effective.

The inquirer further states that in one case, a fourteen-year old boy was denied coverage for biofeedback services, which the inquirer appealed internally. ABC denied that appeal because “[t]he ABC UBI Biofeedback Resource Coordination Policy specifically excludes coverage of biofeedback for treatment of migraine or muscle contraction (tension) headaches.” Apparently, ABC covers biofeedback services for some medical conditions, but specifically excludes the use of biofeedback services for migraine or muscle contraction (tension) headaches. This exclusion was added in December 2005.

Analysis:

Insurance Law § 3224-b establishes the rules relating to the processing of health claims. This section states in relevant part that:

(3) Nothing in this section shall preclude a health plan from determining that any such claim is not eligible for payment, in full or in part, based on a determination that: (i) the claim is not complete as defined by 11 NYCRR 217; (ii) the service provided is not a covered benefit under the contract or agreement, including but not limited to, a determination that such service is not medically necessary or is experimental or investigational; (iii) the insured did not obtain a referral, pre-certification or satisfy any other condition precedent to receive covered benefits from the physician; (iv) the covered benefit exceeds the benefit limits of the contract or agreement; (v) the person is not eligible for coverage or is otherwise not compliant with the terms and conditions of his or her contract; (vi) another insurer, corporation or organization is liable for all or part of the claim; or (vii) the plan has a reasonable suspicion of fraud or abuse. In addition, nothing in this section shall be deemed to require a health plan to pay or reimburse a claim, in full or in part, or dictate the amount of a claim to be paid by a health plan to a physician. (Emphasis added.)

Thus, a health plan may deny a claim if it determines that the treatment is “experimental” or “investigational.”

In the facts presented, ABC covered biofeedback services rendered to treat migraine headaches prior to December 2005. In December 2005, ABC added an exclusion for migraine and tension headaches to its biofeedback policy because ABC determined that the use of biofeedback services to treat migraine and tension headaches is experimental and has not been proven safe and effective. Although ABC covered biofeedback services to treat migraine headaches prior to December 2005, ABC was not prohibited from deciding in December 2005 that the treatment of migraine headaches with biofeedback services is experimental, and thus not covered. Furthermore, nothing in the Insurance Law prohibits ABC from excluding the use of biofeedback services for one medical condition and not for others, if it determines that such treatment is experimental or investigational for that specific medical condition, and such a determination has a medical basis.

However, an insured may externally appeal a final adverse determination2 made by a health plan. See Ins. Law § 4910. Specifically, Insurance Law § 4910(b) provides for an external appeal right when an insurer denies coverage for a benefit based on the theory that the drug, procedure, or service is experimental or investigational in nature. When a health plan denies treatment on this basis, Article 49 of the Insurance Law provides the insured, the insured’s designee, or in the case of a retrospective adverse determination,3 the insured’s health care provider, the right to request an external appeal. Article 49 of the Public Health Law also provides identical external appeal rights for subscribers of HMOs.

The standards for an external appeal agent’s review of a health plan’s denial are set forth in Insurance Law § 4914. Pursuant to Insurance Law § 4914(b)(2)(A), external appeal requests must be initiated by the insured within 45 days from the health plan’s final adverse determination. The Superintendent reviews external appeal requests for eligibility and completeness, and randomly assigns the requests to one of three certified external appeal agents who have networks of clinical peer reviewers available to review the appeal. See also N.Y. Comp. Codes R. & Regs. tit. 11, Part 410 (2001) (Regulation 166).

The external appeal standards differ depending upon the basis of the health plan’s denial. When a health plan denies treatment because the plan considers it to be experimental or investigational, Insurance Law § 4910(b)(2)(B) provides that, in order for an insured to be eligible for an external appeal, an insured’s attending physician must attest that the insured has a life-threatening or disabling condition or disease for which standard health services have been ineffective or medically inappropriate, or for which there does not exist a more beneficial standard health service. In addition, the insured must show that his or her attending physician recommended a procedure that, based on two documents from the available medical and scientific evidence, is likely to be more beneficial than any covered standard treatment, or that his or her attending physician recommended a clinical trial for which he or she is eligible. See Ins. Law § 4910(b)(2)(C).

A panel of clinical peer reviewers must then review the applicable medical and scientific evidence, the insured’s medical record, and any other pertinent information, and make a determination as to whether the treatment is likely to be more beneficial than any standard treatment for the insured’s life-threatening or disabling condition or disease, or, in the case of a clinical trial, is likely to benefit the insured in the treatment of the insured’s condition or disease. See Ins. Law § 4914(b)(4)(B). Of course, each external appeal, while undertaken in accordance with the statutory parameters discussed above, is fact-specific, and turns on the specific medical condition and patient involved. See OGC Opinion 07-05-05 (May 9, 2007).

To request an external appeal, an insured, an insured’s designee, or an insured’s health care provider must complete a “New York State External Appeal Application,” which is available from the Department’s website at External Appeals - Frequently Asked Questions, Instructions and Applications.

For further information you may contact Assistant Attorney Joana Lucashuk at the New York City Office.

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1 According to the Mayo Clinic, biofeedback is a type of complementary and alternative medicine called mind-body therapy.  Using feedback from a variety of monitoring procedures and equipment, a biofeedback provider will try to teach the patient to control certain involuntary body responses, such as blood pressure or muscle tension, to treat the specific condition.  See “Biofeedback:  Using your mind to improve your health” at http://www.mayoclinic.com/health/biofeedback/SA00083.

2 “Final adverse determination” means an adverse determination that was upheld by a utilization review agent with respect to a proposed health care service, following a standard appeal, or an expedited appeal where applicable, pursuant to Insurance Law § 4904.  If a health plan offers two levels of internal appeals, a final adverse determination means the adverse determination of the first level appeal.   See Ins. Law § 4900(d-4); § 410.2(e) of N.Y. Comp. Codes R. & Regs. tit. 11, Part 410 (2001) (Regulation 166).

3 “Retrospective adverse determination” means a determination for which utilization review was initiated after health care services were provided.  It does not mean an initial determination involving continued or extended health cares services, or additional services for an insured undergoing a course of continued treatment prescribed by a health care provider pursuant to Insurance Law § 4903(c).  See 11 NYCRR § 410.2(i) (Regulation 166).