Request for Information; Coverage of Over-the-Counter Preventive Services
Request for information.
CFR Part: "26 CFR Part 54"; "29 CFR Part 2590"; "45 CFR Part 147"
RIN Number: "RIN 1210-ZA31"; "RIN 0938-ZB81"
Citation: "88 FR 68519"
Document Number: "CMS-9891-NC"
Page Number: "68519"
"Proposed Rules"
Agency: "
SUMMARY: This document is a request for information (RFI) regarding the application of the preventive services requirements under section 2713 of the Public Health Service Act (PHS Act) to over-the-counter (OTC) preventive items and services available without a prescription by a health care provider.
DATES:
To be assured consideration, comments must be received at one of the addresses provided below, no later than
ADDRESSES: Written comments may be submitted to the address specified below. Any comment that is submitted will be shared with the
Comments will be made available to the public. Warning: Do not include any personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publicly disclosed. All comments are posted on the internet exactly as received and can be retrieved by most internet search engines. No deletions, modifications, or redactions will be made to the comments received, as they are public records. Comments may be submitted anonymously.
In commenting, please refer to file code 1210-ZA31.
Comments must be submitted in one of the following two ways (please choose only one of the ways listed):
1. Electronically. You may submit electronic comments on this regulation to https://www.regulations.gov. Follow the "Submit a comment" instructions.
2. By mail. You may mail written comments to the following address ONLY:
Always allow sufficient time for mailed comments to be received before the close of the comment period. Because of staff and resource limitations, the Departments cannot accept comments by facsimile (FAX) transmission.
Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. The comments are posted on the following website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to view public comments.
FOR FURTHER INFORMATION CONTACT:
Customer Service Information:
Individuals interested in obtaining information from the
SUPPLEMENTARY INFORMATION:
I. Background
A. Coverage of Preventive Services Under the Affordable Care Act and Implementing Regulations The Patient Protection and Affordable Care Act (Pub. L. 111-148) was enacted on
Section 2713 of the PHS Act, as added by section 1001 of the ACA and incorporated into ERISA and the Code, and its implementing regulations require that non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage provide coverage without imposing any cost-sharing requirements for the following items and services:
* Evidence-based items or services that have in effect a rating of "A" or "B" in the current recommendations of the
FOOTNOTE 1 The USPSTF published updated breast cancer screening recommendations in
* Immunizations for routine use in children, adolescents, and adults that have in effect a recommendation from the
* With respect to infants, children, and adolescents, evidence-informed preventive care and screenings provided for in comprehensive guidelines supported by the
* With respect to women, such additional preventive care and screenings not described in the USPSTF recommendations in PHS Act section 2713(a)(1), as provided for in comprehensive guidelines supported by HRSA.
The Departments' regulations under section 2713 of the PHS Act at 26 CFR 54.9815-2713, 29 CFR 2590.715-2713, and 45 CFR 147.130 require that plans and issuers provide coverage of recommended preventive services generally for plan years (in the individual market, policy years) that begin on or after
FOOTNOTE 2 26 CFR 54.9815-2713(a)(4), 29 CFR 2590.715-2713(a)(4), and 45 CFR 147.130(a)(4). END FOOTNOTE
FOOTNOTE 3 26 CFR 54.9815-2713(a)(3), 29 CFR 2590.715-2713(a)(3), and 45 CFR 147.130(a)(3). END FOOTNOTE
On
FOOTNOTE 4 Civil Action No. 4:20-cv-00283-O (
FOOTNOTE 5 The Braidwood court also concluded that the requirement under PHS Act section 2713(a)(1) to cover pre-exposure prophylaxis (PrEP) with effective antiretroviral therapy for persons who are at high risk of HIV acquisition, consistent with a
FOOTNOTE 6 No. 23-10326 (5th Cir.
The Braidwood decision did not enjoin enforcement of PHS Act section 2713 or vacate its implementing regulations and guidance related to immunizations recommended by ACIP or preventive care and screenings provided for in comprehensive guidelines supported by HRSA; therefore, those requirements are not impacted by the Braidwood decision. /7/
FOOTNOTE 7 See FAQs about Affordable Care Act and Coronavirus Aid, Relief, and Economic Security Act Implementation Part 59 (
B. Overview of Guidance Related to the Coverage of Recommended OTC Preventive Services
While most recommended preventive services require a health care provider to either provide a prescription /8/ for an item or service, or to directly furnish a service, several preventive products are available to consumers without the involvement of a provider (OTC preventive products). /9/ Some examples include certain types of tobacco cessation pharmacotherapy, which are currently recommended by the USPSTF with an "A" rating for nonpregnant adults who use tobacco, /10/ and folic acid supplements, which are recommended by the USPSTF with an "A" rating to prevent neural tube defects for all persons planning to or who could become pregnant. /11/ In addition, the guidelines for women's preventive health services adopted and released by HRSA (HRSA-supported Guidelines) include recommendations for OTC preventive products, such as breastfeeding supplies (for example, breast pumps and breast milk storage supplies) and certain contraceptives. /12/ As discussed further in section I.E of this
FOOTNOTE 8 This RFI's use of the term "prescription" encompasses an order for an item or service, as well as a medication order by a health care provider. END FOOTNOTE
FOOTNOTE 9 This RFI uses the term "OTC preventive products" to refer to preventive items or services recommended by the applicable recommendation or guidelines under PHS Act section 2713 and its implementing regulations and that may be made available to an individual without a prescription by a health care provider. END FOOTNOTE
FOOTNOTE 10 https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions. END FOOTNOTE
FOOTNOTE 11 https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/folic-acid-for-the-prevention-of-neural-tube-defects-preventive-medication. END FOOTNOTE
FOOTNOTE 12 https://www.hrsa.gov/womens-guidelines. END FOOTNOTE
Since publishing the regulations implementing PHS Act section 2713, the Departments have received questions from interested parties regarding coverage issues related to certain recommended preventive services, including with respect to OTC preventive products. On
FOOTNOTE 13 See FAQs about Affordable Care Act Implementation Part XII (
FOOTNOTE 14 See FAQs about Affordable Care Act Implementation Part 54 (
FOOTNOTE 15 Id. END FOOTNOTE
C. Coverage of OTC COVID-19 Diagnostic Tests Under the Families First Coronavirus Response Act and the Coronavirus Aid, Relief, and Economic Security Act
Under section 6001 of the Families First Coronavirus Response Act (FFCRA), /16/ as amended by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), /17/ and implementing guidance, /18/ plans and issuers were required to cover OTC COVID-19 diagnostic tests without a prescription by a health care provider or individualized clinical assessment, purchased on or after
FOOTNOTE 16 Pub. L. 116-127. END FOOTNOTE
FOOTNOTE 17 Pub. L. 116-136. END FOOTNOTE
FOOTNOTE 18 Under section 6001(c) of the FFCRA, the Departments were authorized to implement the requirements of section 6001 of the FFCRA through sub-regulatory guidance, program instruction, or otherwise. See FAQs about Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementation Part 42 (
On
FOOTNOTE 19 FAQs Part 51, available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf. END FOOTNOTE
FOOTNOTE 20 The direct coverage safe harbor established in FAQs Part 51, Q2, provides that the Departments will not take enforcement action against a plan or issuer that limited coverage of OTC COVID-19 diagnostic tests from non-preferred pharmacies or other retailers to no less than the actual price, or
FOOTNOTE 21 See FAQs Part 51, Q4. END FOOTNOTE
On
FOOTNOTE 22 FAQs Part 52, available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-52.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-52.pdf. END FOOTNOTE
FOOTNOTE 23 See FAQs Part 52, Q1. Under this modification, plans and issuers were required to provide direct coverage by ensuring participants, beneficiaries, and enrollees have adequate access to OTC COVID-19 tests with no upfront out-of-pocket expenditure, generally by establishing at least one direct-to-consumer shipping mechanism and at least one in-person mechanism. END FOOTNOTE
FOOTNOTE 24 See FAQs Part 52, Q3. END FOOTNOTE
FOOTNOTE 25 See FAQs Part 52, Q4. END FOOTNOTE
D. Executive Orders on the
On
FOOTNOTE 26 86 FR 7793. END FOOTNOTE
Furthermore, the President issued Executive Order 14070, "Continuing To Strengthen Americans' Access to Affordable, Quality Health Coverage" (E.O. 14070) on
FOOTNOTE 27 87 FR 20689. END FOOTNOTE
Similarly, following the
FOOTNOTE 28 597 U.S. _(2022). END FOOTNOTE
FOOTNOTE 29 87 FR 42053. END FOOTNOTE
FOOTNOTE 30 88 FR 41815. END FOOTNOTE
FOOTNOTE 31 88 FR 7236 (
E. FDA Approval of Daily OTC Oral Contraceptive
On
FOOTNOTE 32 FDA Approves First Nonprescription Daily Oral Contraceptive,
FOOTNOTE 33 Progestin-only oral contraceptives are a product that is already available in a prescription form and are a category of contraceptives listed in the HRSA-supported Guidelines. END FOOTNOTE
FOOTNOTE 34
FOOTNOTE 35 See Key, K., Wollum, A., Asetoyer, C., Cervantes, M., Lindsey, A., Rivera, R.,
FOOTNOTE 36 Grindlay, K., Grossman, D. (2016). Prescription Birth Control Access Among US Women At Risk of Unintended Pregnancy.
FOOTNOTE 37 A recent study found that over 12 million adult women and nearly two million young women aged 15-17 would be interested in using an OTC oral contraceptive if it were free to them, but the numbers declined to 7.1 million adult women and 760,000 young women if the out-of-pocket cost of the contraceptive was
II. Solicitation of Comments
In light of E.O. 14009, E.O. 14070, E.O. 14076, E.O. 14101, and the FDA approval of a progestin-only oral contraceptive as the first daily oral contraceptive available without a prescription by a health care provider, the Departments are of the view that requiring plans and issuers to cover, without cost sharing, OTC preventive products without a prescription by a health care provider under section 2713 of the PHS Act is an important option to consider for expanding access to contraceptive care. The Departments are also of the view that this option would align with the goals of the ACA as well as the
The Departments are seeking to gather input from the public to better understand the potential benefits and challenges to individuals, plans, issuers, health care providers, retailers, and other interested parties that may be realized by or arise in promoting greater access to OTC preventive products, including contraceptives, without cost sharing and without a prescription by a health care provider. For example, the Departments would like to understand the current barriers individuals face to receiving OTC preventive products with a prescription. Additionally, the Departments are interested in input on any operational challenges to plans, issuers, third-party administrators, pharmacy benefit managers (PBMs), and retailers if plans and issuers are required to cover, without imposing cost-sharing requirements on the consumer, OTC preventive products purchased without a prescription by a health care provider, including other OTC preventive products as they might become available on the market. The Departments are also interested in lessons learned from these interested parties' experiences providing coverage for and facilitating the provision of OTC COVID-19 diagnostic tests during the COVID-19 PHE. The Departments request information on the potential obstacles and benefits that would be associated with interpreting the preventive services coverage requirement under PHS Act section 2713 to require coverage of OTC preventive products without cost sharing and without a prescription by a health care provider, and estimates of the impact of any such potential changes, both generally and with respect to the following specific areas:
A. Access to and Utilization of OTC Preventive Products
* What is the current cost differential for consumers between an OTC preventive product purchased without a prescription by a health care provider, and the same OTC preventive product (for example, breast pumps and breastfeeding supplies) when it is prescribed? How common is it for plans and issuers to provide coverage for OTC preventive products without requiring a prescription by a health care provider? Share any available measurements of utilization of coverage for OTC preventive products when prescribed and when not prescribed by a health care provider.
* When coverage is offered for OTC preventive products that are prescribed by a health care provider, do cost sharing or other aspects of coverage vary by type of OTC preventive product? For example, are different cost-sharing requirements or medical management techniques imposed for OTC tobacco cessation products than for OTC breast pumps? Do coverage requirements or medical management techniques differ across different types of OTC contraceptives, such as between emergency contraception and condoms, or between medications and devices? What medical management techniques do plans and issuers commonly apply to OTC preventive products when the items are prescribed? If plans and issuers impose quantity and/or frequency limits or establish brand preferences for equivalent products, how do they determine such limits and preferences?
* How does a plan's or issuer's practice of covering OTC preventive products only when prescribed by a health care provider affect individuals' access to OTC preventive products? What other practices (for example, reasonable medical management techniques, network restrictions, or formulary restrictions) are employed by plans and issuers that restrict access to recommended preventive products that are available OTC?
* If the Departments were to require plans and issuers to cover OTC preventive products without cost sharing and without a prescription by a health care provider, what would be optimal ways to communicate these changes to help ensure that participants, beneficiaries, and enrollees are educated about any steps they need to take to access these products, including to get reimbursed for purchasing OTC preventive products without a prescription by a health care provider? Similarly, what would be optimal ways to communicate the changes to retailers?
B. Implementation Issues
* In the event that the Departments require plans and issuers to cover OTC preventive products without cost sharing and without requiring a prescription by a health care provider under section 2713 of the PHS Act, what operational challenges would plans and issuers face in implementing the requirement? What operational challenges would retailers (including pharmacies) face if the requirement is implemented (for example, location of transaction, privacy concerns, or workload at point of sale)? How would these challenges impact participants, beneficiaries, and enrollees? How would these challenges impact the goal of E.O. 14101 to increase access to affordable contraception? /38/ What operational challenges may be associated with the use of telepharmacies and mail orders both within and across states or localities for OTC preventive products?
FOOTNOTE 38 E.O. 14101. (2023). END FOOTNOTE
* If plans and issuers were required to cover OTC preventive products without cost sharing and without requiring a prescription by a health care provider, how could plans and issuers ensure that participants, beneficiaries, and enrollees who purchase OTC preventive products do not incur out-of-pocket costs at the point of sale, or are timely and correctly reimbursed, such as through post-purchase reimbursement by the plan or issuer or other mechanisms? Would utilization rates differ depending on whether the products were covered without cost to the individual at the point of sale or were reimbursed following purchase? Should plans and issuers be required to cover costs associated with shipping and/or taxes for OTC preventive products? What is the best way to eliminate out-of-pocket costs to participants, beneficiaries, and enrollees, while ensuring that they have different options to obtain such products (such as via direct mail and in person)? What other issues related to consumer reimbursement would arise if plans and issuers were required to cover OTC preventive products without cost sharing and without a prescription by a health care provider?
* What issues related to reimbursement to retailers and providers would arise if plans and issuers are required to cover OTC preventive products without cost sharing and without a prescription by a health care provider? How might contracts between plans or issuers and PBMs, network pharmacies, or other service providers need to be modified to cover OTC preventive products without cost sharing and without a prescription by a health care provider? How do plans and issuers anticipate accounting for any retail markups, discounts or coupons, or manufacturer rebates?
* How do pharmacies or other retailers currently submit claims to plans and issuers for OTC preventive products and are there barriers associated with doing so? If plans and issuers were required to cover OTC preventive products without cost sharing and without requiring a prescription by a health care provider, would pharmacies or other retailers be able to ensure that a consumer does not incur out-of-pocket costs at the point of sale? If not, what barriers prevent this, and would addressing those barriers require changes to claims systems or additional guidance?
* If plans and issuers were required to cover OTC preventive products without cost sharing and without requiring a prescription by a health care provider, what types of reasonable medical management techniques related to frequency, method, treatment, or setting would plans and issuers consider implementing with respect to these products, in instances where an applicable recommendation or guideline did not specify the frequency, method, treatment, or setting for the provision of the recommended preventive service? How would such techniques differ or compare to strategies used currently? What additional guidance would be necessary to help plans and issuers understand what types of medical management techniques are considered to be reasonable when applied to OTC preventive products?
* If plans and issuers were required to cover OTC preventive products without cost sharing and without requiring a prescription by a health care provider, what guardrails would plans and issuers consider implementing to mitigate fraud, waste, and abuse?
* What operational challenges arose while plans and issuers were required to provide OTC COVID-19 diagnostic tests without cost sharing and without a prescription or provider involvement during the COVID-19 PHE that were not addressed through guidance issued by the Departments? Were there particular operational challenges experienced by retailers? What lessons learned from those experiences could be applied to efforts to require coverage for OTC preventive products without cost sharing and without a prescription by a health care provider? Would plans' and issuers' provision of direct coverage for OTC COVID-19 diagnostic tests to participants, beneficiaries, and enrollees by providing payments to sellers directly (without requiring upfront payment by consumers and subsequent reimbursement by the plans and issuers) be a model that could be used to implement an OTC coverage requirement for preventive products? The Departments are particularly interested in the experience of consumers, plan sponsors, retailers, plans, issuers, PBMs, and other service providers related to techniques that were implemented during the COVID-19 PHE to prevent, detect, and respond to fraud, waste, and abuse related to the provision of OTC COVID-19 diagnostic tests.
* What other strategies could the Departments implement to increase utilization of OTC preventive products, other than, or in addition to, requiring plans and issuers to cover such products without cost sharing and without a prescription by a health care provider? Should the Departments look to any specific strategies implemented by states, localities, plans, issuers, or large employers to increase utilization of OTC preventive products? Are there any state laws or regulations currently in place, or expected to be proposed, that could hinder utilization and access to OTC preventive products? If so, what specific requirements in federal regulations could mitigate these barriers to access? Do workplace wellness programs provide access to OTC preventive products? If so, how do such programs manage frequency, method, treatment, and setting to ensure effectiveness, efficiency, and access for workers? Does access for workers differ based on their employer's size? If so, how?
C. Health Equity
* Under current standards and requirements, do certain populations face additional or disproportionately burdensome challenges to accessing OTC preventive products? Do the current standards that require coverage of only prescribed OTC preventive products without cost sharing pose a substantial burden (for example, excess demand for appointments) on health care providers working in, or disproportionately serving, underserved communities? If plans and issuers were required to cover OTC preventive products without cost sharing and without requiring a prescription by a health care provider, how would such a requirement improve access for these populations? For example, is there evidence that coverage of OTC contraceptive medications or devices without a prescription by a health care provider would significantly impact access in "contraceptive deserts" (areas with low access to family planning resources)? /39/ Could a requirement to cover OTC preventive products without cost sharing and without a prescription by a health care provider potentially increase the retail prices of such products for individuals who purchase them without insurance? If so, what are options for addressing such retail price increases?
FOOTNOTE 39 Kreitzer, R.J.,
* Research suggests that provider bias may play a role in limiting access to certain recommended preventive services, including, for example, contraceptives and other family planning services, tobacco cessation pharmacotherapy, and medication to reduce the risk of acquiring HIV. /40/ Has permitting plans and issuers to require a prescription to obtain coverage for OTC preventive services led to lower utilization rates for certain recommended preventive services among particular populations with respect to different provider types or settings?
FOOTNOTE 40 See Mann, E., Chen, A., and Johnson, C. (2022). Doctor Knows Best? Provider Bias In the Context of Contraceptive Counseling in
D. Economic Impacts
* What are the current annual utilization costs and annual operational costs to plans and issuers related to coverage of OTC preventive products when such products are prescribed by a health care provider? Do the costs to plans, issuers, and third-party administrators vary for small versus large entities? If so, what are the costs for small entities as compared to large entities?
* How would a requirement to cover OTC preventive products without cost sharing and without a prescription by a health care provider affect utilization costs and operational costs to plans, issuers, plan sponsors, third-party administrators, PBMs, and retailers? What would be the resulting premium impacts, in the short- and long-term? Would utilization of OTC preventive products significantly replace utilization of non-OTC preventive products among participants, beneficiaries, and enrollees? Would there be an impact on the cost of non-OTC preventive products? What are the estimated initial and ongoing time and cost burdens on (or savings for) plans, issuers, plan sponsors, third-party administrators, PBMs, and retailers if plans and issuers were required to cover OTC preventive products without cost sharing and without a prescription by a health care provider?
* How would a requirement for plans and issuers to cover OTC preventive products without cost sharing and without a prescription by a health care provider affect price negotiations, pricing decisions, market power, discount or rebate programs, and marketing practices for these products? Would the costs to plans, issuers, third-party administrators, PBMs, and providers vary for small versus large entities? If so, what are the impacts for small entities as compared to large entities? What would the net impact of these changes be on prices for and the availability of OTC preventive products?
* To what degree would any potential increases in costs or premiums associated with a requirement for plans and issuers to cover OTC preventive products without cost sharing and without a prescription by a health care provider be offset by greater access to OTC preventive products (for example, due to improved health outcomes from greater uptake of recommended preventive products, or fewer office visits as a result of participants, beneficiaries, and enrollees no longer requiring an office visit to obtain a prescription for OTC preventive products)?
* Identify and provide estimates related to the potential societal and economic impacts (for example, benefits, costs, and transfers) on individuals and families, as well as on health care providers, if OTC preventive products were required to be covered without cost sharing and without a prescription by a health care provider. Would these impacts vary based on region, state, socioeconomic status, race, sex, age, insured status, or other factors? For example, would there be potential reductions in unintended pregnancies or maternal deaths due to participants, beneficiaries, and enrollees no longer requiring a prescription for OTC oral contraceptives? As another example, would there be increases in the length of time that children are breastfed if OTC preventive products such as breastfeeding supplies were required to be covered without cost sharing and without a prescription by a health care provider? Would smoking cessation rates improve with increased access to OTC tobacco cessation products?
* Identify and provide any information regarding the potential impact on health outcomes and quality of life of participants, beneficiaries, and enrollees if plans and issuers were required to cover OTC preventive products without cost sharing and without a prescription by a health care provider.
* Identify and provide estimates related to the potential economic impacts (short- and long-term) on health care providers, retailers, and pharmacists if OTC preventive products were required to be covered without cost sharing and without a prescription by a health care provider. How would the claim processing burden for health care providers, retailers, and pharmacists change? How would the number of visits to health care providers, retailers, and pharmacists change?
III. Collection of Information Requirements
This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. However, section II of this document does contain a general solicitation of comments in the form of an
Signed at
Associate Chief Counsel,(Employee Benefits, Exempt Organizations, and Employment Taxes),
Signed at
Benefits Tax Counsel,
Signed at
Assistant Secretary,
Secretary,
[FR Doc. 2023-21969 Filed 10-3-23;
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