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«Department of Health and Human Services has submitted this rule to the Office of the Federal Register. The official version of the rule will be ...»

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however, issuers should not fail to commence review if they have not yet received information that is largely procedural but not necessary to begin review. Further, issuers should not request irrelevant or overly burdensome information.

We believe an exigency exists when an enrollee is suffering from a health condition that may seriously jeopardize the enrollee's life, health, or ability to regain maximum function or when an enrollee is undergoing a current course of treatment using a non-formulary drug. Either the enrollee (or enrollee’s designee) or prescribing physician (or other prescribing provider as appropriate) may submit the request for an expedited review based on exigent circumstances.

Issuers must be equipped to intake these requests in writing, electronically, and telephonically.

As part of the request for an expedited review based on exigent circumstances, the prescribing physician or other prescriber should support the request by including an oral or written statement that (1) an exigency exists and the basis for the exigency (that is, the harm that could reasonably come to the enrollee if the requested drug were not provided within the timeframes specified by the issuer’s standard drug exceptions process), and (2) a justification supporting the need for the non-formulary drug to treat the enrollee's condition, including a statement that all covered formulary drugs on any tier will be or have been ineffective, would not be as effective as the non-formulary drug, or would have adverse effects.

Following a favorable decision on the expedited request, the enrollee must be provided access to the prescribed drug without unreasonable delay. Therefore, issuers need to be prepared to communicate rapidly with pharmacies and pharmacy benefit managers, as applicable. At a minimum, we expect issuers to update certificates of coverage to reflect the availability of this process and to be able to provide instruction to enrollees or their designees and providers or their

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expedited review process, we encourage issuers to have a similar type of review process in place for their non-expedited review under §156.122(c).

While some commenters recommended that issuers be required to provide coverage of the drug in question pending the outcome of the expedited request, we are also cognizant that some commenters opposed the proposal altogether and that we are finalizing an expedited timeframe for coverage determination under this process due to exigency as no more than 24 hours. Therefore, while we encourage issuers to provide the drug pending the outcome of the exceptions request, we are not requiring it at this time.

We are also concerned about enrollees having to continue to make requests under §156.122(c) throughout the plan year to access the same clinically appropriate drug not on the plan’s formulary, whether for each refill or otherwise, and for exceptions granted pursuant to the exigent circumstance exceptions process, issuers must make the drug available to the enrollee for the duration of the exigency. We will monitor this issue to consider whether we should propose additional standards through rulemaking.

Comment: Some commenters requested clarification as to whether drugs accessed through the exceptions process under §156.122(c) should count towards the plan’s annual limit on cost sharing as established under §156.130(a), and other commenters noted concerns about cost-sharing and tiering for drugs accessed through the exceptions process. Other commenters commented on a variety of other issues related to the EHB prescription drug policy that were not mentioned in the proposed rule.

Response: Because these issues are not specifically related to the exigent circumstance

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them to be outside the scope of the rulemaking but will take them under consideration for future rulemaking.

Comment: Commenters noted that there is no requirement to cover combination drugs considered first line therapy, but other commenters supported efforts to better ensure access to combination drugs, as well as requested requirements related to new drugs. Some commenters requested clarification that combination drugs do not have any special regulatory status in plans that must comply with EHB standards.

Response: The requirements at §156.122(a)(1) were intended to be the minimum standard for an issuer providing EHB. The intention of the exceptions process at §156.122(c) is for enrollees to request and gain access to clinically appropriate drugs that are not on the plan’s formulary, which could include combination drugs considered first line therapies and new drugs, particularly when these drugs are supported by sound science and widely accepted guidelines.

While there is no mandate that a health plan cover these drugs under §156.122(a)(1), in absence of coverage under §156.122(a)(1), combination drugs or new drugs may be determined to be clinically appropriate for an enrollee under §156.122(c). We do not intend for this policy to create any special regulatory status for combination drugs.

Comment: Some commenters recommended that HHS use its enforcement authority for non-compliance with the exceptions process. Some commenters also recommended that HHS collect tracking data on the use of the exceptions process and provide assistance to enrollees who were denied coverage through the exceptions process.





Response: Because States generally are the primary enforcers of the EHB prescription

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who are having difficulty accessing a health plan’s exceptions process should first contact the issuer and then contact the State’s Department of Insurance if necessary.

Summary of Regulatory Changes Based on comments received, we are finalizing revisions to §156.122(c) to require that a health plan’s procedures include an expedited exceptions process based on exigent circumstances that is defined as when an enrollee is suffering from a health condition that may seriously jeopardize the enrollee's life, health, or ability to regain maximum function or when an enrollee is undergoing a current course of treatment using a non-formulary drug and that the health plan must make its coverage determination on such requests within no more than 24 hours after receiving them and continue to provide the drug for the duration of the exigency.

b. Cost-Sharing Requirements (§156.130) Under §156.130(a), cost sharing for 2014 for self-only coverage may not exceed the annual dollar limit described in section 223(c)(2)(A)(ii)(I) of the Code. The proposed rule also provided that under §156.130(b), for a plan year beginning in calendar year 2014, the annual deductible for a health plan in the small group market for self-only coverage could not exceed $2,000. However, §156.130(b) is being removed from the regulation text to comply with Public Law 113-93, which eliminated the limits on deductibles for plans in the small group market.

For 2015 and later years, the annual limitation on cost sharing is to be increased by an amount equal to the product of the annual dollar amount described in section 223(c)(2)(A)(ii)(I) of the Code and the premium adjustment percentage established pursuant to paragraph (e) of that section. (The limitation for other than self-only coverage is twice the limitation for self-only coverage.) Under §156.130(d), any increase in these annual limits that does not result in a

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Section 156.130(e) provides that the premium adjustment percentage is the percentage (if any) by which the average per capita premium for health insurance coverage for the preceding calendar year exceeds such average per capita premium for health insurance for 2013, and that this percentage will be published annually in the HHS notice of benefit and payment parameters.

The 2015 Payment Notice established our methodology for calculating the premium adjustment percentage.

In calculating limitations on cost sharing and small group deductible in the proposed 2015 Payment Notice, we rounded these limitations up to the next lowest multiple of $50.

However, we subsequently learned that the IRS convention for interpreting similar language for a number of longstanding tax parameters – such as indexing methodologies for the alternative minimum tax and the standard deduction – is to round down to the nearest applicable multiple.

For example, the Department of the Treasury, in a rule on how employers should calculate average annual full-time-equivalent wages for purposes of the small employer health insurance tax credit, provides that if the result is not a multiple of $1,000, employers should round the result to the next lowest multiple of $1,000.32 As a result, we proposed to align our rounding rules with those used by the Department of the Treasury and the Internal Revenue Service, by amending §156.130(d) to specify that when indexing the annual limitation on cost sharing and the annual limitation on small group deductibles for years after 2014, we will round to the multiple of 50 dollars that is lower than the number calculated by the formula.

Under the proposed amendment, using the 2015 premium adjustment percentage of 4.213431463 percent we established in the 2015 Payment Notice and the 2014 maximum annual

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limitation on cost sharing of $6,350 for self-only coverage, which was published by the IRS on May 2, 2013,33 the 2015 maximum annual limitation on cost sharing would be $6,600 for selfonly coverage and $13,200 for other than self-only coverage.

Similarly, under the proposed amendment to §156.130(d), we applied the premium adjustment percentage for 2015 to calculate the annual limit on deductibles for the small group market for 2015. However, after the proposed rule was published, on April 1, 2014, the President signed into law Protecting Access to Medicare Act for 2014, which includes a provision that eliminates the annual limitation on deductibles for plans in the small group market. Therefore, there is no annual limitation on deductibles for small group plans, and the premium adjustment percentage is no longer applicable.

Comment: A number of commenters supported our proposal to round the annual limitation on cost sharing down to a lower multiple of $50, to be consistent with the practice at the Department of the Treasury. A few commenters requested that HHS use this final rule to amend the regulation to reflect new law, which eliminates the annual limit on deductibles for small group plans.

Response: We agree with the comments and are removing references to an annual limit on deductibles for plans in the small group market from our regulations. We also note that issuers do not need to make any changes to their 2014 plan cost-sharing structures as a result of this change.

Summary of Regulatory Changes We are finalizing our proposal regarding rounding as proposed, and we are removing from our regulations references to the annual limit on deductibles for plans in the small group

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market under §156.130(b) from §156.130(c) and (d), and are removing §156.130(b). The 2015 maximum annual limitation on cost sharing is $6,600 for self-only coverage and $13,200 for other than self-only coverage.

2. Subpart C – General Functions of an Exchange a. QHP Issuer Participation Standards (§156.200) In §156.200(b)(5), we proposed technical amendments to clarify that implementing and reporting for the QRS and implementing a quality improvement strategy are conditions of participation in an Exchange. Specifically, we proposed to include a reference to sections 1311(c)(3) and (c)(1)(E) of the Affordable Care Act to correctly align with other quality standards listed as part of QHP certification standards, including the ESS.

We also proposed to amend §156.200 to add paragraph (h) to require that, in order to receive QHP certification, the offering issuer attest that, subsequent to receiving such certification, it will comply with all operational requirements contained in Part 156, Subparts D, E, H, K, L, and M. We proposed to add paragraph (h) to ensure that issuers seeking QHP certification understand and have fully committed to compliance with all operational requirements.

Summary of Regulatory Changes We received comments in support of the proposed amendments and therefore are finalizing §156.200(b)(5) and (h) as proposed.

b. Enrollment Process for Qualified Individuals (§156.265) We refer readers to the preamble in connection with §155.400 of this final rule for a discussion of comments on §156.265.

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a. Other Coverage That Qualifies as Minimum Essential Coverage (§156.602) The Affordable Care Act added section 5000A of the Code, which requires all nonexempt individuals to maintain minimum essential coverage or pay the individual shared responsibility payment. Section 5000A(f) of the Code defines minimum essential coverage as any of the following: (1) Coverage under a specified government sponsored program; (2) coverage under an eligible employer-sponsored plan; (3) coverage under a health plan offered in the individual market within a State; (4) coverage under a grandfathered health plan. In addition, section 5000A(f)(1)(E) of the Code directs the Secretary, in coordination with the Secretary of the Treasury, to designate other health benefits coverage as minimum essential coverage.

The Treasury Department and the IRS published final regulations under Code section 5000A on August 30, 2013 (78 FR 53646).34 On July 1, 2013, HHS published final regulations implementing certain functions of an Exchange for determining eligibility for and granting certain exemptions from the individual shared responsibility payment (78 FR 39494). 35 The HHS final regulations, codified in 45 CFR 156.602 and 156.604, also designate certain types of coverage as minimum essential coverage, and outline substantive and procedural requirements for other types of coverage to apply for recognition as minimum essential coverage.

We proposed to amend §156.602 by adding paragraph (e) to designate certain types of foreign group health coverage for expatriates as minimum essential coverage. These proposed

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provisions would codify previous CMS guidance published on October 31, 2013,36 with some additional detail.



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