Regulations Will Not Be Issued On ACA’s Provider Nondiscrimination, Clinical Trials Provisions: EBSA

The Employee Benefits Security Administration (EBSA) (in conjunction with the Departments of Health and Human Services (HHS) and the Treasury) (Departments) has issued Affordable Care Act Implementation FAQs Part XV. This set of frequently asked questions (FAQs) address the Patient Protection and Affordable Care Act’s (ACA) provisions regarding the annual limit waiver, provider nondiscrimination, coverage for individuals participating in approved clinical trials, and transparency reporting.

Annual limit waiver expiration date. The FAQs explain that if a group health plan or health insurance issuer that was granted a waiver from the annual limits requirements under Public Health Service Act (PHSA) Sec. 2711 changes its plan year prior to the waiver expiration date, that change does not modify the expiration date of the waiver.

Annual limit waivers under PHSA Sec. 2711 were approved by HHS for the plan or policy year in effect when the plan or issuer applied for the waiver. The same holds true for waiver extensions. HHS extended the waiver based on the date of the plan or policy year in effect when the initial application was submitted. As a result, waiver recipients that change their plan or policy years will not extend the expiration date of their waivers.

For example, if a waiver approval letter states that a waiver is granted for an April 1, 2013, plan or policy year, the waiver will expire on March 31, 2014, regardless of whether the plan or issuer later amends its plan or policy year. Note, however, that waiver recipients may terminate the waiver at any time prior to its approved expiration date, for example, on Dec. 31, 2013 rather than on March 31, 2014.

Provider nondiscrimination. The FAQs indicate that the Departments do not expect to issue regulations on PHSA Sec. 2706(a) in the near future because the statutory language is self-implementing. Until any further guidance is issued, group health plans and health insurance issuers offering group or individual coverage are expected to implement the requirements of PHSA Sec. 2706(a) using a good faith, reasonable interpretation of the law.

PHSA Sec. 2706(a) states that a “group health plan and a health insurance issuer offering group or individual health insurance coverage shall not discriminate with respect to participation under the plan or coverage against any health care provider who is acting within the scope of that provider’s license or certification under applicable state law.” PHSA Sec. 2706(a) does not require “that a group health plan or health insurance issuer contract with any health care provider willing to abide by the terms and conditions for participation established by the plan or issuer,” and nothing in PHSA Sec. 2706(a) prevents “a group health plan, a health insurance issuer, or the Secretary from establishing varying reimbursement rates based on quality or performance measures.”

To the extent an item or service is a covered benefit under the plan or coverage, and consistent with reasonable medical management techniques specified under the plan with respect to the frequency, method, treatment or setting for an item or service, a plan or issuer shall not discriminate based on a provider’s license or certification, to the extent the provider is acting within the scope of the provider’s license or certification under applicable state law.

This provision does not require plans or issuers to accept all types of providers into a network. This provision also does not govern provider reimbursement rates, which may be subject to quality, performance, or market standards and considerations.

Approved clinical trials. The Departments also indicate in the FAQs that they do not expect to issue regulations on PHSA Sec. 2709 in the near future because the statutory language is self-implementing. Until any further guidance is issued, group health plans and health insurance issuers offering group or individual coverage are expected to implement the requirements of PHSA Sec. 2709 using a good faith, reasonable interpretation of the law.

PHSA Sec. 2709(a) states that if a group health plan or health insurance issuer in the group and individual health insurance market provides coverage to a qualified individual (as defined under PHSA Sec. 2709(b)), then such plan or issuer:

(1) may not deny the qualified individual participation in an approved clinical trial with respect to the treatment of cancer or another life-threatening disease or condition;

(2) may not deny (or limit or impose additional conditions on) the coverage of routine patient costs for items and services furnished in connection with participation in the trial; and

(3) may not discriminate against the individual on the basis of the individual’s participation in the trial.

A qualified individual under PHSA Sec. 2709(b) is generally a participant or beneficiary who is eligible to participate in an approved clinical trial according to the trial protocol with respect to the treatment of cancer or another life-threatening disease or condition; and either:

(1) the referring health care professional is a participating provider and has concluded that the individual’s participation in such trial would be appropriate, or

(2) the participant or beneficiary provides medical and scientific information establishing that the individual’s participation in such trial would be appropriate.

Transparency reporting. ACA Sec. 1311(e)(3) requires qualified health plan (QHP) issuers to submit specified information to the health insurance exchange and other entities in a timely and accurate manner. Because QHP issuers will not have some of the data necessary for reporting under this requirement until during or after the first year of operation of their QHPs (e.g., QHP enrollment and disenrollment), the FAQs clarify that, in order to comply with this section, QHP issuers will begin submitting information only after QHPs have been certified as QHPs for one benefit year.

Similarly, because PHSA Sec. 2715A simply extends the transparency provisions set forth in ACA Sec. 1311(e)(3) to group health plans and health insurance issuers offering group and individual health insurance coverage, the FAQs also clarify that the reporting requirements under PHSA Sec. 2715A will become applicable to group health plans and health insurance issuers offering group and individual health insurance coverage no sooner than when the reporting requirements under ACA Sec. 1311(e)(3) become applicable.

The Departments will coordinate regulatory guidance on the transparency in coverage standards for coverage offered inside and outside of the exchanges.

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