(36) For coverage of contraceptive items or services provided pursuant to Insurance Law section 3216(i)(17), 4303(j) or 4303(cc), an insurer shall allow coverage for the dispensing of an initial three-month supply of a contraceptive to an insured. For subsequent dispensing of the same contraceptive covered under the same policy or renewal thereof, an insurer shall allow coverage for the dispensing of the entire prescribed supply, up to 12 months, of the contraceptive to the insured at the same time.

(37) For coverage of in-network contraceptive items or services provided pursuant to Insurance Law section 3216(i)(17) or 4303(j), an insurer shall cover at least one form of contraception within each of the methods of contraception that the federal food and drug administration has identified for women without annual deductibles or coinsurance, including co-payments. Additionally, where a form of contraception is covered pursuant to this paragraph without annual deductibles or coinsurance, including co-payments, an insurer shall cover services for insertion or implantation and services related to follow-up and management of side effects, counseling for continued adherence, and device removal, without annual deductibles or coinsurance, including co-payments. If a woman’s attending health care provider recommends a particular contraceptive item or service approved by the federal food and drug administration, based on a determination of medical necessity, that is subject to cost-sharing, then the insurer shall cover that item or service without annual deductibles or coinsurance, including co-payments. The insurer shall defer to the attending health care provider’s determination of medical necessity.

Section 52.18(a)(11) and (12) are added as follows:

(11) For coverage of contraceptive items or services provided pursuant to Insurance Law section 3221(l)(8), 3221(l)(16), 4303(j) or 4303(cc), an insurer shall allow coverage for the dispensing of an initial three-month supply of a contraceptive to an insured. For subsequent dispensing of the same contraceptive covered under the same policy or renewal thereof, an insurer shall allow coverage for the dispensing of the entire prescribed supply, up to 12 months, of the contraceptive to the insured at the same time.

(12) For coverage of in-network contraceptive items or services provided pursuant to Insurance Law section 3221(l)(8) or 4303(j), an insurer shall cover at least one form of contraception within each of the methods of contraception that the federal food and drug administration has identified for women without annual deductibles or coinsurance, including co- payments. Additionally, where a form of contraception is covered pursuant to this paragraph without annual deductibles or coinsurance, including co-payments, an insurer shall cover services for insertion or implantation and services related to follow-up and management of side effects, counseling for continued adherence, and device removal, without annual deductibles or coinsurance, including co-payments. If a woman’s attending health care provider recommends a particular contraceptive item or service approved by the federal food and drug administration, based on a determination of medical necessity, that is subject to cost-sharing, then the insurer shall cover that item or service without annual deductibles or coinsurance, including co-payments. The insurer shall defer to the attending health care provider’s determination of medical necessity.

1. Statutory authority: Financial Services Law (“FSL”) sections 202 and 302 and Insurance Law (“IL”) sections 301, 3216(i)(17) and (33), 3217, 3221(l), (8), (16), and (19), and 4303(j), (cc), and (qq).

FSL section 202 establishes the office of the Superintendent of Financial Services (“Superintendent”). FSL section 302 and IL section 301, in pertinent part, authorize the Superintendent to prescribe regulations interpreting the IL and to effectuate any power granted to the Superintendent in the IL, FSL, or any other law.

IL sections 3216(i)(17), 3221(l)(8), and 4303(j) require every policy or contract delivered or issued for delivery in New York that provides hospital, surgical, or medical care coverage, except for a grandfathered health plan, to provide coverage for certain preventive care and screenings, including contraceptives at no cost-sharing.

IL Section 3217 authorizes the Superintendent to issue regulations to establish minimum standards, including standards for full and fair disclosure, for the form, content and sale of accident and health insurance policies and subscriber contracts of corporations organized under IL Article 32 and Article 43, and Public Health Law Article 44.

IL sections 3221(l)(16) and 4303(cc) require policies and contracts delivered or issued for delivery in New York that provide prescription drug coverage to provide coverage for all contraceptive drugs and devices approved by the Food and Drug Administration (“FDA”) or generic equivalents when prescribed by a health care provider legally authorized to prescribe under Education Law Title VIII.

IL sections 3216(i)(33), 3221(l)(19), and 4303(qq) provide that whenever in those sections an insurer or corporation must provide benefits with no coinsurance or deductible, the requirement only applies with respect to participating providers in the insurer’s or corporation’s network, or with respect to non-participating providers, if the insurer or corporation does not have a participating provider in the in-network benefits portion of its network with the appropriate training and experience to meet the particular health care needs of the covered person pursuant to IL section 3217-d(d) or 4306-c(d), or as applicable, pursuant to Public Health Law section 4403(6)(a).

2. Legislative objectives: Insurance Law sections 3221(l)(16) and 4303(cc) require policies and contracts that provide prescription drug coverage to provide coverage for all contraceptive drugs and devices approved by the FDA or generic equivalents when prescribed by a health care provider legally authorized to prescribe under Education Law Title VIII. Insurance Law sections 3216(i)(17), 3221(l)(8), and 4303(j) require all policies and contracts, except for grandfathered health plans as defined therein, to include coverage for certain preventive care and screenings, including contraceptives, at no cost-sharing.

This proposed amendment to 11 NYCRR 52 (Insurance Regulation 62) accords with the public policy objectives that the Legislature sought to advance in IL sections 3216(i)(17) and (33), 3217, 3221(l)(8), (16), and (19), and 4303(j), (cc), and (qq) by requiring an insurer to allow coverage for the dispensing of an initial three-month supply of a contraceptive to an insured. For subsequent dispensing of the same contraceptive covered under the same policy or contract or renewal thereof, an insurer must allow coverage for the dispensing of the entire prescribed supply, up to 12 months, of the contraceptive to the insured at the same time. In addition, for coverage of in-network contraceptive items or services, an insurer must cover at least one form of contraception within each of the methods of contraception that the FDA has identified for women without annual deductibles or coinsurance, including co-payments. If a woman’s attending health care provider recommends a particular contraceptive item or service approved by the FDA, based on a determination of medical necessity, that is subject to cost-sharing, then the insurer must cover that item or service without annual deductibles or coinsurance, including co-payments. The insurer must defer to the attending health care provider’s determination of medical necessity.

3. Needs and benefits: While the IL requires an insurer to provide coverage for contraceptives, whether an insurer will provide coverage for the dispensing of more than a one-month supply of contraceptives at one time varies by insurer. According to the Henry J. Kaiser Family Foundation (the “Foundation”), there is evidence that a greater supply of contraceptives dispensed at one time may lead to more consistent contraceptive use, and women who receive a 12-month supply have been found to be 30% less likely to have an unintended pregnancy compared to women receiving a one to three-month supply. A study cited by the Foundation indicates that there is evidence that a greater supply of contraceptives dispensed at one time is associated with fewer pregnancy tests, fewer pregnancies, and less cost per insured.

Accordingly, this amendment requires an insurer to allow, where the prescription so provides, for the dispensing of an initial three-month supply of a contraceptive to an insured, and up to a 12-month prescribed supply for any subsequent dispensing of the same contraceptive covered under the same policy or contract or renewal thereof.

4. Costs: Insurers may incur costs to file new policy and contract forms to provide coverage for a 12- month supply of contraceptives. However, any additional costs should be minimal and should be offset by potential administrative cost savings to insurers because contraceptives will be dispensed less frequently.

This amendment may impose compliance costs on the Department of Financial Services (“Department”) because the Department will need to review amended policy and contract forms. However, any additional costs incurred by the Department should be limited because the need to refile forms will be a one-time only circumstance. As such, the costs to the Department should be minimal and the Department expects to absorb the costs in its ordinary budget. The Department does not anticipate any need to have revised rate filings since the coverage is not changing; only the timing of the dispensing of the prescriptions.

This amendment will not impose compliance costs on state or local governments.

5. Local government mandates: This amendment does not impose a new mandate on any county, city, town, village, school district, fire district or other special district.

6. Paperwork: As noted, insurers may need to file new policy and contract forms with the Superintendent in order to provide coverage for a 12-month supply of contraceptives.

7. Duplication: This amendment, in part, duplicates current federal guidance but does not conflict with any existing state or federal rules or other legal requirements.

8. Alternatives: The Department considered requiring an insurer to allow coverage for the initial dispensing of up to a 12-month prescribed supply of contraceptives. However, the Department decided to require an insurer to allow coverage for an initial three-month supply and up to a 12-month prescribed supply subsequently because the Department was concerned that an initial dispensing of up to a 12-month prescribed supply could result in lost or wasted contraceptives.

9. Federal standards: The amendment does not exceed any minimum standards of the federal government for the same or similar subject areas.

10. Compliance schedule: The amendment will take effect 60 days after publication of the Notice of Adoption in the State Register.

The changes made to the regulation did not impact the Regulatory Flexibility Analysis for Small Businesses and Local Governments, Rural Area Flexibility Analysis and Job Impact Statement previously filed with the Notice of Proposed Rule Making.

As a rule that requires a RFA, RAFA or JIS, this rule will be initially reviewed in the calendar year 2020, which is no later than the 3rd year after the year in which this rule is being adopted.

The Department of Financial Services (“Department”) received comments from seventy three interested persons in response to its proposed amendment to Insurance Regulation 62 regarding coverage for contraceptive drugs and devices, some of which were incorporated into the final rulemaking, discussed below.

Comment:

The vast majority of commenters requested that the Department broaden the required coverage to include all Food and Drug Administration (“FDA”) approved methods and types of contraception. Over seventy commenters called for this expanded coverage. A large number of commenters also suggest that coverage be expanded to include male contraception.

Response:

The Department recognizes the importance of ensuring access to contraceptive drugs and devices. By providing women the tools and agency to determine whether and when to have children, contraception has been a catalyst for women’s equal participation in our political and educational institutions and the workforce. Indeed, the broad and positive impact of contraception was recognized by the Centers for Disease Control and Prevention as one of the ten great public health achievements of the 20th century. Also importantly, contraception provides essential health benefits that are both related and unrelated to managing fertility. Studies have demonstrated repeatedly that access to contraception leads to improved birth outcomes and child health, reductions in morbidity and mortality rates, and decreases in the risk of developing reproductive cancers.

As such the Department’s proposed amendment requires, in line with existing federal requirements, and consistent with the public policy adopted by the Legislature in passing the Women’s Health and Wellness Act (“WHWA”) in 2002, that every insurer provide coverage for at least one form of contraception within each of the methods that the FDA has identified for women without any cost sharing. Additionally, the proposed amendment requires that a method that would be subject to cost sharing be available without such cost sharing if the woman’s doctor determines the method is medically necessary.

The Department has similarly considered the addition of coverage for male contraception, but has not added such contraception to the regulation. In accordance with regulations issued pursuant to the Affordable Care Act (“ACA”), a male contraceptive coverage requirement would constitute a new mandate for which the State would be required to defray the cost in full for small group and individual plans. Additionally, unlike in the field of female contraception, where the Department’s amendment is consistent with public policy adopted by the Legislature in the WHWA and the existing Federal government’s rules under the ACA, there is no similar state or federal pronouncement of public policy for the coverage of male contraception. The Department’s decision with regard to this regulation is not intended to impact future decisions with regard to these matters.

Comment:

About seventy commenters called for the Department to eliminate the pre-requisites to obtaining a twelve month supply of contraception. Other commenters suggested that the term “same prescriber” needed further clarification to prevent confusion and the claimed unequal application of the regulation.

Response:

The Department has determined that the appropriate balance between access to contraception and protecting against unnecessary prescribing requires that the initial three month supply requirement be retained. The Department, however, agrees that the requirement that subsequent prescriptions be written by the same prescriber is not necessary, and has adopted commenters’ suggestion to remove that requirement. The Department is cognizant that many women are unable to have a consistent relationship with one medical provider, and that, for example, it is common for women to see providers within the same practice without seeing the same provider on each visit. Additionally, providers may move practices, practices’ contractual arrangements with insurers may change, and patients may relocate, none of which events should prevent a women from receiving a twelve month supply of contraception for which an initial three month supply was already obtained. The Department has determined that the same provider requirement would unnecessarily place a barrier to receiving a twelve month supply of contraception, directly contrary to the purpose of the amendment. The elimination of the requirement should also satisfy the need to provide further clarity as to the term “same prescriber” raised by other commenters.

Comment:

Insurer commenters suggest that a twelve month supply would lead to waste and abuse, which in turn would lead to increased costs and increased premiums. Particular concern was called to the potential need to change method or drug during the course of treatment, for example in response to side effects.

Response:

As discussed above, the Department appreciates the concern over unnecessary prescriptions and the potential effect of such practices on premium rates for health insurance in New York. The Department also believes that providing annual supplies ensures necessary access to contraceptives for women who need them for medical as well as fertility reasons. The Department has struck the correct balance between providing adequate access to contraceptives and the requirements to obtain a larger supply of contraceptives, such as the requirement that an initial three months’ supply be obtained before any greater supply is covered. The Department has determined that these requirements adequately protect the insurance markets against potential waste.

Comment:

Four commenters indicated opposition to the requirement that the insurer defer to the attending healthcare provider’s determination of medical necessity, saying it amounted to a “provider prevail” provision. Objections to this part of the proposed amendment ranged from the potential for waste and abuse to religious objection to covering all contraceptive methods.

Response:

The Department has rejected any suggested change to the requirement that insurers defer to the attending healthcare provider’s determination of medical necessity. The proposed amendment’s requirement applies the exact standard already required under federal law. As the relevant federal regulators have consistently explained in the context of providing no cost sharing coverage for contraceptives, “[t]he plan or issuer must defer to the determination of the attending provider.” See i.e., Dept. of Labor, et al., FAQS ABOUT AFFORDABLE CARE ACT IMPLEMENTATION (PART XXVI), May 11, 2016. Moreover, the amendment is entirely consistent with New York’s public policy of ensuring access to contraceptives including as in enacted in the WHWA, the Department has determined that no changes to the proposed amendment are warranted.

Comment:

One commenter suggested that there is an insufficient exemption provided for religious employers. The commenter suggests that the regulation must be changed to provide for the religious employer exemption contained in the WHWA.

Response:

The religious employer exemption contained in the WHWA is the law of this state. Nothing in the proposed amendment changes that exemption or the process by which the exemption is obtained. The Legislature has spoken on the appropriateness of the WHWA exemption, and the Court of Appeals has upheld the Legislature’s decision. Therefore, the Department has determined that no change to the proposed amendment is needed to address these concerns.

Comment:

One commenter requested clarification as to whether the initial three month supply was to be followed by a nine month supply or a twelve month supply.

Response:

At the discretion of the prescriber, a twelve month supply (or any shorter supply) could follow the initial three month supply. The Department has determined that no change to the proposed amendment is necessary to address this issue.

Comment:

One commenter requested clarification as to whether the phrase “same contraceptive” meant the same drug, same strength, and same manufacturer.

Response:

The Department intends by the use of the phrase “same contraceptive” to mean the same drug, at the same strength, made by the same manufacturer. The Department has balanced the interest in providing access to contraception with the need to prevent waste. As with the initial three month supply, the requirement that the twelve month supply be of the same contraceptive provides an important countervailing consideration to commenters who suggest that changes during the course of treatment, due, for instance, to side effects, will produce waste when a twelve month supply goes unused.

Comment:

One commenter suggested that the proposed amendment violates the anti-discrimination provisions in the insurance law and regulations. Treating contraceptive drugs differently than other types of drugs, the commenter reasons, would be in violation of the “spirit and intent” of state law, as there is “no rational basis to afford special treatment for women utilizing contraceptives.” The commenter, a law firm that is retained to lobby on behalf of insurers, suggests that the proposed amendment “suggests that women are unable to responsibly take charge of their reproductive health.”

Response:

The Department flatly rejects the positions taken by this commenter. To begin with, the Court of Appeals recognized over a decade ago that the state has a “substantial interest in fostering equality between the sexes, and in providing women with better health care.” In Catholic Charities v. Serio, 7 N.Y.3d 510, the Court recognized that in enacting the WHWA, “[t]he Legislature had extensive evidence before it that the absence of contraceptive coverage for many women was seriously interfering with both of these important goals.” Moreover, in line with the federal contraceptive mandate, while the subject of extensive litigation, has never been found to be in violation of any prohibition on discrimination.

Accordingly, the Department has proposed an amendment to its regulations to ensure coverage that the New York State Legislature, the U.S. Congress, federal regulators, doctors, and scholars have all uniformly agreed is beneficial not only for women individually but for society generally. Irrespective of whether any changes are made to the contraception coverage mandates in federal law, New York will continue to ensure that women will continue to be protected in their rights to health care access including by the existing prescription contraception coverage with no cost-sharing required by this amendment. The Department made no changes in response to this comment.

Comment:

One commenter suggested that the presence of legislation pending in the Legislature that is directed at coverage for contraceptive drugs should preclude the Department from taking action in that sphere, until the Legislature has acted. The commenter suggested that the proposed amendment is an attempt to preempt the role of the Legislature.

Response:

The Department’s authority to promulgate regulations is not impaired by the presence of a legislative proposal. The role of the Department is to regulate based on the law as it exists, and not what may, in the future, become law. The proposed amendment is entirely consistent with the policy adopted in the WHWA, the directly on point state statute, and other New York law, as well as existing federal law.

Comment:

The Department also received comments suggesting that the proposed amendment lacked clarity surrounding services related to coverage of contraception.

Response:

State and federal guidance on the matter is clear that services related to a covered contraceptive method are also to be covered at no cost sharing. To address the perceived lack of guidance, the Department has determined to incorporate the relevant existing rules into the proposed amendment. As such the Department has directly incorporated the relevant guidance into the final rulemaking.

Comment:

An insurer commenter requested that the Department delay the publication of the final regulation until November to align the effective date with the beginning of the calendar year. The commenter suggested this would allow plans time to operationalize the regulation’s requirements.

Response:

In response to this comment and consistent with the intent of the Department in proposing this amendment, the Department has provided clarifying language in the final amendment which further explains that the amendment does not impair contracts in force and applies to policies and contracts issued, renewed, modified or amended after the effective date of the amendment.