A Cautionary Tale: Self-Funded Plan Administrators Must Meaningfully and Effectively Communicate With Plan Participants and Their Providers on Appeal

Sponsors of self-funded ERISA plans have fiduciary obligations to plan participants, which includes the obligation to provide a full and fair review of claims and effectively and meaningfully communicate or engage with plan participants regarding claims denials. One district court recently clarified that this obligation may include the need for the plan administrator, which is usually the plan sponsor, to engage in a dialogue with health care providers who are providing health care services to plan participants when there is a dispute over denied claims.

In K.D. v. Anthem Blue Cross and Blue Shield, Group Health Plan of United Technologies Corporation, the plaintiff sued the plan administrator and Blue Cross and Blue Shield, the group health plan’s third party administrator (“TPA”), in the United States District Court for the District of Utah due to the plan’s denial of continued inpatient mental health treatment and transitional care for alleged lack of medical necessity. Plaintiff further alleged a violation of the Mental Health Parity and Addiction Act of 2008 (“MHPAEA”). This alert will focus on the ERISA claims review and appeals process and not the MHPAEA claims in the lawsuit.

As described in the District Court opinion, the terms of the plan sponsor’s medical plan generally required a medical necessity determination for continued inpatient/residential mental health treatment for plan participants, and provided that medically necessary services are those that are necessary for the participant and that are “rendered in the least intensive setting that is appropriate for the delivery of health care.” Once residential treatment is determined to be medically necessary, then there is a predetermined length of stay, and such benefits are then subject to concurrent review which may result in approval for additional care above and beyond those originally approved by the plan.

The District Court Magistrate reviewed the TPA’s own internal clinical guidelines and policies and procedures, which provide that mental health residential treatment is appropriate when the patient’s behavioral health condition is such that the patient demonstrates they are a danger to themselves or others, or it “causes a serious dysfunction in daily living.” If such conditions are present, then the guidelines provide that continued residential care should be approved if the condition is likely to deteriorate without continued treatment at the same level of care or if continued care at the current level is necessary. The clinical guidelines also provide that treatment should be available when “necessary, appropriate, and not feasible at a lower level of care.” If a claim is denied, then there are two levels of appeal that the plan participant must undergo before filing a lawsuit.

As set forth in the District Court’s opinion, the plan participant had a history of mental illness and the TPA initially determined that residential treatment was medically necessary. The participant underwent residential treatment in a program that could last from 9 – 12 months, though not all of it was intended to be residential, as the participant would step down from residential into transitional living. Ultimately, the participant’s discharge from treatment was contingent upon, and determined by, their progress on goals, participation, and clinical recommendations. The participant was initially approved for seven (7) days of residential treatment and then an additional nine (9) days. At that time, the TPA requested additional information from the provider via a peer-to-peer discussion, which the provider did not attend. Thus, the TPA independently reviewed the medical information and denied the claim for additional residential treatment based on a lack of medical necessity. Transitional living treatment claims were also denied for failing to obtain precertification.

After appealing the determinations, the participant sued for violation of ERISA and the MHPAEA. In asserting their claim for ERISA violations, the plaintiff alleged that the plan’s denial of their claims was arbitrary. The defendants alleged that while they were obligated to consider the letters and other records submitted as part of the claims appeal process, there was no obligation to “affirmatively respond” to them. The District Court magistrate disagreed and applied other, contrary caselaw that requires a plan administrator to “engage with and address” the opinions of the treating providers. As such, the District Court found that the TPA or plan administrator should have provided an explanation for rejecting health care provider opinions. As an example, the court suggested the claims administrator (the TPA) should have addressed why they did not find the treating providers’ opinions to be persuasive and provided factual support. The court reasoned that the plan and TPA had a fiduciary duty to plan beneficiaries to communicate the bases for their decisions, which includes addressing the provider opinions and communicate “effectively and meaningfully” with participants regarding the factual bases for denying coverage.

Ultimately the case was remanded back to the plan administrator for a new determination and the plaintiffs could seek recovery of their attorneys’ fees.

This case serves as a cautionary tale for plan sponsors to ensure they, or their claims administrators, are actively engaging with plan participants and/or their providers and meaningfully responding to their concerns when claims are denied. While it is unclear whether the participant will ultimately be entitled to the benefits sought under the plan, addressing why the claims administrator denied the claims and providing factual support for their rationale could have saved the claims administrator and/or plan administrator costs and legal fees.


About the Author. This alert was prepared for [Agency Name] by Barrow Weatherhead Lent LLP, a national law firm with recognized experts on the Affordable Care Act. Contact Stacy Barrow or Nicole Quinn-Gato at sbarrow@marbarlaw.com or nquinngato@marbarlaw.com.

The information provided in this alert is not, is not intended to be, and shall not be construed to be, either the provision of legal advice or an offer to provide legal services, nor does it necessarily reflect the opinions of the agency, our lawyers, or our clients. This is not legal advice. No client-lawyer relationship between you and our lawyers is or may be created by your use of this information. Rather, the content is intended as a general overview of the subject matter covered. This agency and Barrow Weatherhead Lent LLP are not obligated to provide updates on the information presented herein. Those reading this alert are encouraged to seek direct counsel on legal questions.

© 2024 Barrow Weatherhead Lent LLP. All Rights Reserved.

The Crucial Role of Comparative Analyses Under the Mental Health Parity Proposed Rule and Technical Guidance

On July 25, 2023, the agencies released an extensive proposed rule related to the Mental Health Parity and Addiction Equity Act (the “Proposed Rule”) as well as a Technical Release requesting comments on certain proposed data requirements for nonquantitative treatment limitations (“NQTLs”) and the potential for an enforcement safe harbor if certain data requirements are met. The Proposed Rule clarifies and solidifies requirements for group health plans and health insurance issuers (“plans and issuers”) to perform comparative analyses of the NQTLs imposed under their plans. To do this, plans and issuers must collect and evaluate data to reasonably assess the impact of NQTLs on access to mental health and substance use disorder (“MH/SUD”) benefits and medical/surgical (“Med/Surg”) benefits and demonstrate compliance with the MHPAEA as written and in operation. The Proposed Rule focuses on the following, which will directly impact plan design and analyses of those designs:

  • Applying the “substantially all” standard to NQTLs
  • Revising comparative analysis requirements
  • Enhancing definitions to better assist plans
  • Solidifying compliance deadlines

Applying the “substantially all” standard to NQTLS

The first significant change under the Proposed Rule is the application of the “substantially all” standard to NQTLS. Previously, this standard applied only to quantitative treatment limitations (QTLs). Specifically, group health plans that provide both Med/Surg and MH/SUD benefits may not apply any treatment limitation to MH/SUD benefits in any classification that is more restrictive (as written or in operation) than the predominant treatment limitation that applies to substantially all Med/Surg benefits in the same classification. The standard or test is determined separately for each type of treatment limitation.  As a reminder, the six permitted classifications under the MHPAEA are: (1) inpatient, in-network; (2) inpatient, out-of-network; (3) outpatient, in-network; (4) outpatient, out-of-network; (5) emergency care; and (6) prescription drugs. Additionally, there is a special rule for outpatient sub-classifications. For purposes of determining parity for outpatient benefits (in-network and out-of-network), a plan or issuer may divide its benefits furnished on an outpatient basis into two sub-classifications: (1) office visits; and (2) all other outpatient items and services. Accordingly, separate sub-classifications for generalists and specialists are not permitted.

Thus, any NQTL that imposes conditions, terms, or requirements that limit access to benefits under the terms of the plan or coverage is considered restrictive, and an NQTL that applies to MH/SUD benefits can be no more restrictive than those that apply to Med/Surg benefits. The Proposed Rule provides an illustrative, non-exhaustive list of NQTLs, which includes medical management standards such as medical necessity or prior authorization, formulary design for prescription drugs (including multi-tier networks), network composition and standards, preferred provider networks, methodology for determining out-of-network rates, fail first or step-therapy requirements, and geographic location or provider type restrictions.

Moreover, an NQTL is considered to apply to substantially all Med/Surg benefits in a classification of benefits if it applies to at least two-thirds of all Med/Surg benefits in that classification (determined without regard to whether the nonquantitative treatment limitation was triggered based on a particular factor or evidentiary standard).  If the NQTL does not apply to at least two-thirds of all Med/Surg benefits in a classification, then that type of NQTL cannot be applied to MH/SUD benefits in that classification. 

When MH/SUD benefits are offered in any classification of benefits for that MH/SUD condition must be provided in every classification in which Med/Surg benefits are provided.  Such benefits must be meaningful benefits for treatment of the condition or disorder in each such classification, as determined in comparison to the benefits provided for Med/Surg conditions in the classification.  If the plan provides benefits in a classification and imposes any separate financial requirement or treatment limitation (or separate level of a financial requirement or treatment limitation) for benefits in the classification, then the rules apply separately with respect to the classification for all treatment limitations (or financial requirements).

Revising Comparative Analyses Requirements

The devil is in the details, and the Proposed Rule enhances the content requirements for the comparative analyses required under the CAA, 2021 and existing DOL guidance.  Comparative analyses must include a high level of detail to demonstrate a plan’s compliance with the MHPAEA (as written and in operation).  Some exceptions apply to independent professional medical or clinical standards and standards to prevent and prove fraud, waste, and abuse.

Generally, plans are required to:

  • describe NQTLs applicable to MH/SUD and Med/Surg benefits with regard to the benefits in each classification;
  • identify the factors used and evidentiary standards relied upon to design the NQTLs (including the source from which each evidentiary standard is derived);
  • describe how the factors are used in the design and application of the NQTL;
  • demonstrate comparability and stringency as written and in operation; and
  • address the findings and conclusions as to the comparability of the processes, strategies, evidentiary standards, and other factors used in designing and applying the NQTL to MH/SUD benefits and Med/Surg benefits within each classification, and the relative stringency of their application, both as written and in operation.

The Proposed Rule expands upon each of the above categories to describe the information the DOL expects to see demonstrated in the comparative analyses. Further, the Proposed Rule requires the use of outcomes data when NQTLs are designed so that plans can establish that relevant data was used in a manner reasonably designed to assess the impact of any NQTL on access to MH/SUD benefits and Med/Surg benefits and to determine whether the plan complies in operation. This includes analyses of claims denials, in-network and out-of-network utilization rates (including provider claim submissions), network adequacy (time and distance data, information on providers accepting new patients), and provider reimbursement rates relevant to any NQTLs. As the Proposed Rule suggests, any material difference in this data for Med/Surg and MH/SUD benefits would be a strong indicator of noncompliance and, therefore, plans would be required to both take reasonable action to address the material differences in access and document any such action that has been taken to mitigate these material differences in access to MH/SUD benefits.

Accordingly, the comparative analyses must:

  • Identify the relevant data collected and evaluated;
  • Evaluate the outcomes that resulted from the application of the NQTL to MH/SUD benefits and Med/Surg benefits, including the relevant data set forth in the Proposed Rule
  • Provide a detailed explanation of material differences in those outcomes that are not attributable to differences in the comparability or relative stringency of the NQTL as applied to MH/SUD benefits and Med/Surg benefits and the bases for such a conclusion; and
  • Discuss any measures that have been or are being implemented by the plan or issuer to mitigate any material differences in access to MH/SUD benefits as compared to Med/Surg benefits, including the actions the plan or issuer is taking to address material differences in access to ensure compliance with MHPAEA.

The Technical Release addresses the requirements for completing comparative analyses but seeks feedback on, among other things, the required data elements, the difficulty in providing data elements, information technology needed to collect the data elements (including cost), and whether plans have access to these data elements.  Moreover, the Technical Release addresses the potential for an enforcement safe harbor if specific standards and data elements are met or exceeded by plans.

Enhancing Definitions to Better Assist Plans

To better facilitate complete, clear comparative analyses and compliance generally, the Proposed Rule aims to define terms previously not defined under the law and regulations.  Specifically, Proposed Rule newly defines certain terms to help guide plans and carriers to ensure parity in aggregate lifetime and annual dollar limits, financial requirements, and quantitative and nonquantitative treatment limitations between mental health and substance use disorder benefits and medical/surgical benefits.  This includes definitions for “DSM”, “ICD”, “evidentiary standards,” “processes”, “strategies, and “factors” and modifies the definitions of other terms for clarity, including “mental health,” “medical/surgical benefits”, treatment limitations, and “substance use disorder benefits.”

Solidifying Compliance Deadlines

The Proposed Rule solidifies the compliance deadlines for providing the comparative analyses to the DOL upon request.  Specifically, they must be provided:

  • Within 10 business days of receipt of a request (unless an additional period of time is specified by the DOL)
  • If additional information is required after the comparative analyses are deemed insufficient, then the DOL will specify additional information that must be submitted, and it must be submitted so within 10 business days (unless an additional period of time is specified by the DOL)
  • If the plan is determined to be out of compliance, the plan must respond to the DOL and specify the actions the plan will take to bring the plan into compliance and provide additional comparative analyses meeting the requirements within 45 calendar days after initial determination of noncompliance.
  • If the DOL makes a final determination of noncompliance, within 7 calendar days of the receipt of the final determination, the plan must notify all participants and beneficiaries enrolled in the plan or coverage that the plan has been determined to be out of compliance with the MHPAEA.  The plan must also provide the DOL, and any service provider involved in the claims process, with a copy of the notice provided to participants.  Content requirements for the notice are included in the Proposed Rule.

The Proposed Rule specifies that copies of the comparative analyses may be requested (and must be provided to) participants and beneficiaries (or their provider or authorized representatives) who have received an adverse benefit determination related to MH/SUD benefits and any state authorities. 

Conclusion

Once finalized, these requirements will apply to plan years beginning on or after January 1, 2025. Until then, the proposed rules require plans to continue to comply with existing MHPAEA laws and regulations, including completing their comparative analyses.

At this point, it is not a question of “if” the agencies will finalize the Proposed Rule, it is “when” it will be finalized.  While the Proposed Rule and Technical Guidance go a long way to advise plans, third party administrators (TPAs) and pharmacy benefit managers (PBMs) of the goals of the agency, the Proposed Rules is unlikely to resolve many of the frustrations self-funded plan sponsors have dealt with since 2021 in either obtaining draft comparative analyses from their TPAs or PBMs or ensuring the comparative analyses meet the DOL’s expectations.

TPAs and PBMs hold virtually all of the information necessary to complete the analyses, but much of the details are kept as closely guarded secrets until the DOL requests the information.  Accordingly, self-funded plan sponsors must be more assertive with their TPAs and PBMs to ensure (1) the analyses are completed, (2) the analyses are made available as required, and (3) that the analyses include all of the required detail, data, and elements in the CAA, 2021 and the Proposed Rule.  One way to do this is by negotiating the plan’s ability to access or request all necessary data and documentation from the TPA or PBM during the contract negotiation process.  Finally, as we wait release of the MHPAEA final rule plans are encouraged to ensure current MHPAEA comparative analyses are updated to meet the Proposed Rule requirements (even before it’s finalized) as it brings the plan one step closer to meeting the expectations of the DOL

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About the Author. This alert was prepared by Barrow Weatherhead Lent LLP, a national law firm with recognized experts on the Affordable Care Act. Contact Stacy Barrow or Nicole Quinn-Gato at sbarrow@marbarlaw.com or nquinngato@marbarlaw.com.
The information provided in this alert is not, is not intended to be, and shall not be construed to be, either the provision of legal advice or an offer to provide legal services, nor does it necessarily reflect the opinions of the agency, our lawyers, or our clients. This is not legal advice. No client-lawyer relationship between you and our lawyers is or may be created by your use of this information. Rather, the content is intended as a general overview of the subject matter covered. This agency and Barrow Weatherhead Lent LLP are not obligated to provide updates on the information presented herein. Those reading this alert are encouraged to seek direct counsel on legal questions. © 2023 Barrow Weatherhead Lent LLP. All Rights Reserved.

IRS Adjusts Health Flexible Spending Account and Other Benefit Limits for 2024

On November 9, 2023, the Internal Revenue Service (IRS) released Revenue Procedure 2023-34, which increases the health flexible spending account (FSA) salary reduction contribution limit to $3,200 for plan years beginning in 2024, an increase of $150 from 2023.  Thus, for health FSAs with a carryover feature, the maximum carryover amount is $640 (20% of the $3,200 salary reduction limit) for plan years beginning in 2024. Of course, when carrying over funds from 2023 to 2024, 20% of the $3,050 salary reduction limit for 2023 is $610.

The Revenue Procedure also contains the cost-of-living adjustments that apply to dollar limitations in certain other sections of the Internal Revenue Code. 

Qualified Commuter Parking and Mass Transit Pass Monthly Limit

For 2024, the monthly limits for qualified parking and mass transit are increased to $315 each, an increase of $15 from 2023.

Adoption Assistance Tax Credit Increase

For 2024, the credit allowed for adoption of a child is $16,810 (up $860 from 2023). The credit begins to phase out for taxpayers with modified adjusted gross income in excess of $252,150 (up $12,920 from 2023) and is completely phased out for taxpayers with modified adjusted gross income of $292,150 or more (up $12,830 from 2023).

Qualified Small Employer Health Reimbursement Arrangement (QSEHRA) Increase

For 2024, reimbursements under a QSEHRA cannot exceed $6,150 (single) / $12,450 (family), an increase of $300 (single) / $650 (family) from 2023.

Reminder: 2024 HSA Contribution Limits and HDHP Deductible and Out-of-Pocket Limits

Earlier this year, in Rev. Proc. 2023-23, the IRS announced the inflation-adjusted amounts for HSAs and high deductible health plans (HDHPs).

 2024 (single/family)2023 (single/family)
Annual HSA Contribution Limit$4,150 / $8,300$3,850 / $7,750
Minimum Annual HDHP Deductible$1,600 / $3,200$1,500 / $3,000
Maximum Out-of-Pocket for HDHP$8,050 / $16,100$7,500 / $15,000

The ACA’s out-of-pocket limits for in-network essential health benefits have also been announced and have increased for 2024.  Note that all non-grandfathered group health plans must contain an embedded individual out-of-pocket limit if the family out-of-pocket limit is above $9,450 (2024 plan years). Exceptions to the ACA’s out-of-pocket limit rule are available for certain small group plans eligible for transition relief (referred to as “Grandmothered” plans). While historically CMS has renewed the transition relief for Grandmothered plans each year, it announced in March 2022 that the transition relief will remain in effect until it announces that all such coverage must come into compliance with the specified requirements.

 2024 (single/family)2023 (single/family)
ACA Maximum Out-of-Pocket$9,450 / $18,900$9,100 / $18,200

ACA Reporting Penalties (Forms 1094-B, 1095-B, 1094-C, 1095-C)

The table below describes late filing penalties for ACA reporting.  The 2025 penalty is for returns filed in 2025 for calendar year 2024, and the 2024 penalty is for returns filed in 2024 for calendar year 2023.  Note that failure to issue a Form 1095-C when required may result in two penalties, as the IRS and the employee are each entitled to receive a copy.

Penalty Description2025 Penalty2024 Penalty
Failure to file an information return or provide a payee statement$330 for each return with respect to which a failure occurs$310 for each return with respect to which a failure occurs
Annual penalty limit for non-willful failures$3,978,000$3,783,000
Lower limit for entities with gross receipts not exceeding $5M$1,329,000$1,261,000
Failures corrected within 30 days of required filing date$60$60
Annual penalty limit when corrected within 30 days$664,500$630,500
Lower limit for entities with gross receipts not exceeding $5M when corrected within 30 days$232,500$220,500
Failures corrected by August 1$130$120
Annual penalty limit when corrected by August 1$1,993,500$1,891,500
Lower limit for entities with gross receipts not exceeding $5M when corrected by August 1$664,500$630,500
Failure to file an information return or provide a payee statement due to intentional disregard$660 for each return with respect to which a failure occurs (no cap)$630 for each return with respect to which a failure occurs (no cap)

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About the Author. This alert was prepared for [Agency Name] by Barrow Weatherhead Lent LLP, a national law firm with recognized experts on the Affordable Care Act. Contact Stacy Barrow or Nicole Quinn-Gato at sbarrow@marbarlaw.com or nquinngato@marbarlaw.com.
The information provided in this alert is not, is not intended to be, and shall not be construed to be, either the provision of legal advice or an offer to provide legal services, nor does it necessarily reflect the opinions of the agency, our lawyers, or our clients. This is not legal advice. No client-lawyer relationship between you and our lawyers is or may be created by your use of this information. Rather, the content is intended as a general overview of the subject matter covered. This agency and Barrow Weatherhead Lent LLP are not obligated to provide updates on the information presented herein. Those reading this alert are encouraged to seek direct counsel on legal questions. © 2023 Barrow Weatherhead Lent LLP. All Rights Reserved.

IRS Releases PCORI Fee For Plan Years Ending Before October 1, 2024

The IRS has released Notice 2023-70, which sets the applicable PCORI fee for plan years ending between October 1, 2023, and September 30, 2024, at $3.22 per covered life.

As a reminder, the PCORI was established as part of the Affordable Care Act (ACA) to conduct research to evaluate the effectiveness of medical treatments, procedures, and strategies that treat, manage, diagnose, or prevent illness or injury.  Under the ACA, most employer sponsors and insurers were required to pay PCORI fees until 2019 or 2020, as it only applied to plan years ending on or before September 30, 2019.  However, the PCORI fee was extended to plan years ending on or before September 30, 2029, as part of the Further Consolidated Appropriations Act, 2020. 

The amount of PCORI fees due by employer sponsors and insurers is based upon the number of covered lives under each “applicable self-insured health plan” and “specified health insurance policy” (as defined by regulations) and the plan or policy year-end date.  The fee must be paid on or before July 31 each year.  The fees due by July 31, 2024, are for plan years ending in 2023 and are as follows:

Insurance carriers are responsible for calculating and paying the PCORI fee for fully insured plans.  The employer is responsible for paying the fee on behalf of a self-insured plan, including an HRA.  In general, health FSAs are not subject to the PCORI fee.

Employers that sponsor self-insured group health plans must report and pay PCORI fees using the second quarter IRS Form 720, Quarterly Federal Excise Tax Return.  The second quarter form is generally not released by the IRS until the second quarter of the applicable filing year (usually in or around May of the applicable filing year).  Therefore, the Form 720 used for the 2024 filing deadline will not likely be available until in or around May 2024, and employers who sponsor self-insured group health plans subject to the PCORI fee must wait to file until the correct Form 720 is available. 

The average number of covered lives for the plan year is generally calculated using the snapshot, snapshot factor, actual count, or Form 5500 method.  These counting methods will be described in more detail in a future alert as we approach the 2024 filing deadline. 

Also note that because the PCORI fee is assessed on the plan sponsor of a self-insured plan, it generally should not be included in the premium equivalent rate that is developed for self-insured plans if the plan includes employee contributions.  However, an employer’s payment of PCORI fees is tax deductible as an ordinary and necessary business expense.

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About the Author. This alert was prepared by Barrow Weatherhead Lent LLP, a national law firm with recognized experts on the Affordable Care Act. Contact Stacy Barrow or Nicole Quinn-Gato at sbarrow@marbarlaw.com or nquinngato@marbarlaw.com.
The information provided in this alert is not, is not intended to be, and shall not be construed to be, either the provision of legal advice or an offer to provide legal services, nor does it necessarily reflect the opinions of the agency, our lawyers, or our clients. This is not legal advice. No client-lawyer relationship between you and our lawyers is or may be created by your use of this information. Rather, the content is intended as a general overview of the subject matter covered. This agency and Barrow Weatherhead Lent LLP are not obligated to provide updates on the information presented herein. Those reading this alert are encouraged to seek direct counsel on legal questions.
© 2023 Barrow Weatherhead Lent LLP. All Rights Reserved.

Agencies Issue Additional FAQs Regarding the Transparency in Coverage Final Rules

On September 27, 2023, the DOL, IRS, and HHS released FAQs About Affordable Care Act Implementation Part 61 (“FAQ Part 61”) which addresses lingering questions about enforcement of the Transparency in Coverage Final Rules (TiC Final Rules), specifically the provisions of the TiC final rules requiring plans and carriers to post machine-readable files for in-network negotiated rates and historical net prices for all covered prescription drugs by plan or issuer at the pharmacy location level (“Rx rates”), and the status of a previously announced enforcement safe harbor applicable to in-network (“INN”) provider rates for covered items and services which allowed plans with percentage-of-billed-amount contracts or other alternative reimbursement arrangements to report this information differently if the dollar amount could not be determined in advance.

If you recall, the TiC Final Rules required non-grandfathered group health plans (other than those consisting of excepted benefits or account-based plans) to make available to the public three separate machine readable files (“MRFs”) including detailed pricing information related to (1) negotiated rates for all covered items and services between the plan or issuer and in-network providers (“INN provider rates”), (2) historical payments to, and billed charges from, OON providers (“OON allowed amounts”), and (3) the Rx rates.

Beginning on July 1, 2022, machine readable files for INN provider rates and OON allowed amounts were required to be posted by plans; however, in Q1 of FAQs About Affordable Care Act Implementation Part 49 released by the agencies in August of 2021 (“FAQ Part 49”), the agencies delayed the requirement to release Rx rates machine readable files as they evaluated whether the requirement would be duplicative of other transparency and reporting obligations related to prescription drugs, specifically the RxDC reporting required under the Consolidated Appropriations Act of 2021 (“CAA”). In FAQ Part 61, the agencies report that, after reviewing the Rx DC reporting results, they have determined “there is no meaningful conflict between the reporting requirements” under the RxDC reporting and the TiC Rx rates machine readable file requirement as the CAA requires disclosure of different and additional information than required in the TiC Final Rules.

Therefore, the agencies have rescinded Q1 of FAQ part 49 and intend to develop technical guidance and an implementation timeline for plans to post their Rx rates machine readable files. Thus, the machine readable files for prescription drugs will be due once that technical guidance and timeline are released. This does not impact the requirement for plans to continually update (on a monthly basis) their machine readable files for the OON allowed amounts and INN rates for covered items and services.

FAQ Part 61 also addresses another enforcement safe harbor, which was previously announced in FAQs About Affordable Care Act Implementation Part 53 (“FAQ Part 53”) released by the agencies in April 2022, which applied to INN provider rate MRFs for plans with alternative reimbursement arrangements (such as reference-based pricing) or percentage of billed charges contracts. Under FAQ Part 53, the agencies indicated that where contractual arrangements are for a percentage of the billed charge or use a different, alternative funding arrangement, then plans were to use the applicable percentage in the rate box or the open text box to describe the nature of the negotiated rate, respectively.

FAQ Part 61 clarifies that the agency did not intend to apply a “categorical exception” to this reporting requirement. Whether a plan can comply with the requirement to provide a specific dollar amount is a facts and circumstances test and a safe harbor only applies in circumstances where a plan can demonstrate it is extremely difficult or impossible for a plan or issuer to determine and report a rate for a specific item or service (for the reasons specified in FAQ Part 53). In these instances, plans may continue to follow the technical guidance on GitHub.

Conclusion
No action with regard to the prescription drug machine readable files is required right now. The FAQ was essentially a “heads up” from the agencies indicating that they will request this reporting be completed, but they intend to provide guidance and some lead time after the guidance is issued for plans to post the files. We will release another update once the technical guidance and timeline are released. In the meantime, plans must continue to update their INN rates and OON allowed amount machine readable files monthly.

Plans with percentage of billed charges contracts or other alternative reimbursement arrangements should consult with counsel to review the FAQ and TiC Final Rules in light of their funding arrangement to determine whether they may still be able to use the standard set forth in Q2 of FAQ Part 61 (i.e., that they can demonstrate it is extremely difficult or impossible to determine and report a rate for a specific item or service) for their INN rate machine readable files, and to ensure they understand whether there is any risk in doing so.


About the Author. This alert was prepared by Barrow Weatherhead Lent LLP, a national law firm with recognized experts on the Affordable Care Act. Contact Stacy Barrow or Nicole Quinn-Gato at sbarrow@marbarlaw.com or nquinngato@marbarlaw.com.

The information provided in this alert is not, is not intended to be, and shall not be construed to be, either the provision of legal advice or an offer to provide legal services, nor does it necessarily reflect the opinions of the agency, our lawyers or our clients. This is not legal advice. No client-lawyer relationship between you and our lawyers is or may be created by your use of this information. Rather, the content is intended as a general overview of the subject matter covered. This agency and Barrow Weatherhead Lent LLP are not obligated to provide updates on the information presented herein. Those reading this alert are encouraged to seek direct counsel on legal questions.

© 2023 Barrow Weatherhead Lent LLP. All Rights Reserved.