THE AMERICAN CONGRESS OF OBSTETRICIANS AND GYNECOLOGISTS • WOMEN’S HEALTH CARE PHYSICIANS

409 12TH STREET SW, WASHINGTON DC 20024-2188 Phone: 202/638-5577

Office of the President 

Richard N. Waldman, MD, FACOG 

770 James Street 

Syracuse, NY 13202-2117 

Office of Consumer Information and Insurance Oversight 

Department of Health and Human Services 

P.O. Box 8016 

Baltimore, Maryland 21244-1850 

Attention: OCIIO-9994-IFC, RIN 0991-AB69 

Office of Health Plan Standards and Compliance Assistance 

Employee Benefits Security Administration. Room N-5653 

U.S. Department of Labor 

200 Constitution Avenue NW 

Washington, DC 20210 

Attention: RIN1210-AB43 

Internal Revenue Service 

CC: PA: LPD: PR, Room 5025 

P.O. Box 7604 Ben Franklin Station 

Washington, DC 20044 

Attention: REG-120399-10 

RE: File Code OCIIO-9994-IFC, RIN 0991-AB69/ RIN 1210–AB43/REG–120399-10. Requirements for Group 

Health Plans and Insurance Issuers under the Patient Protection and Affordable Care Act Relating to PreExisting Condition Exclusions, Lifetime and Annual Limits, Rescission, and Patient Protections, Final Rule and 

Proposed Rule 

Dear Sirs and Madams, 

On behalf of the American Congress of Obstetricians and Gynecologists (ACOG), representing over 54,000 physicians 

and partners in women’s health, I am pleased to offer comments on the Interim Final Rule (IFR) of the Patient 

Protection and Affordable Care Act (ACA) on Preexisting Condition Exclusions, Lifetime and Annual Limits, 

Rescissions, and Patient Protections (“Patient Bill of Rights”). 

DIRECT ACCESS TO OB-GYNS 

We applaud this new national insurance standard. ACA will guarantee direct access protection to women who reside in 

states without a direct access law and to women everywhere who are insured under ERISA-protected plans. We have 

over a decade of experience in 43 states with direct access initiatives, having crafted legislative and regulatory 

language, as well as practical experience in guiding implementation and monitoring health insurer compliance. We 

urge you to adopt our specific recommendations in the final rule to ensure women have meaningful access and to avoid 

the kinds of insurer compliance problems we encountered in the states. 

APPLICABILITY 

ACOG applauds the Administration for applying the ob-gyn direct access standard broadly to group health plans 

defined as both insured and self-insured group plans. 

REQUESTED CHANGE:

o We seek clarification that this standard also applies to all individual market plans. The statute states that group 

health plans, or health insurance issuers offering group or individual health insurance coverage must 

comply with this provision, however only the regulations described in the Department of Health and Human 

Services section (page 37239) apply this provision to health insurance issuers offering individual health 
THE AMERICAN CONGRESS OF OBSTETRICIANS AND GYNECOLOGISTS • WOMEN’S HEALTH CARE PHYSICIANS

409 12TH STREET SW WASHINGTON DC 20024-2188 Phone: 202/638-5577 

insurance coverage. 

 

o We are troubled that the ob-gyn direct access standard does not apply to grandfathered plans and urge 

you to reconsider this in the final rule so that all women who had insurance coverage prior to the 

enactment of PPACA will have this same protection. By comparison, for example, the rules on 

rescissions and advance notice do apply to all grandfathered health plans. ACOG believes all women 

should have direct access to their ob-gyn. 

PATIENT PROTECTIONS 

To ensure that the national ob-gyn direct access insurance standard delivers meaningful access, we urge the 

following specific amendments (listed below) and provide language for your consideration from state direct 

access laws and regulations. Without this specificity, health insurers could define ob-gyn direct access on their 

own terms and very narrowly. This has been a concern in some states. The language we provide here has been 

tested and implemented in the states to prevent an erosion of the direct access insurance protections. 

• no age restriction, 

• no restriction on choice of provider, 

• no additional cost-sharing, 

• ensure adequate number of participating ob-gyns 

• no limit on directly accessed visits, also known as self-referrals, to an ob-gyn, and 

services for which direct access to ob-gyn providers is protected. 

1. Specify No Age Restriction. 

The final rule should stipulate that the direct access protections extend to women of all ages, including 

dependents covered by the participant, beneficiary or enrollee. 

State Example:

New York’s Health Department guidelines on ob-gyn direct access state, “an enrollee shall include patients of 

any age requiring ob/gyn services.” 

REQUESTED CHANGE:

o On pages 37226 and 37232 amend “in the case of a female participant or beneficiary” to say “in the 

case of a female participant or beneficiary, or covered female dependent, of any age” 

o On page 37239 amend “in the case of a female participant, beneficiary, or enrollee” to say “in the 

case of a female participant, beneficiary, enrollee or covered female dependent, of any age” 

2. Allow Choice of Provider. 

ACOG recommends that the final rule explicitly permit woman to choose their ob-gyn who participates 

in their plan. This should be the woman’s decision, not a provider assigned by the health plan. 

State Examples:

New York’s direct access law states “A female enrollee shall have unrestricted access to primary and 

preventive obstetric and gynecologic services from a qualified provider of such services of her choice.” 

Montana's law states “Each health benefit plan must allow a covered person to select any participating 

obstetrician or gynecologist of the covered person's choice...must permit self-referral to any

participating obstetrician or gynecologist...” 

Texas’ law states “This subsection does not affect the right of the woman to select the physician who 

provides that care.” 
THE AMERICAN CONGRESS OF OBSTETRICIANS AND GYNECOLOGISTS • WOMEN’S HEALTH CARE PHYSICIANS

409 12TH STREET SW WASHINGTON DC 20024-2188 Phone: 202/638-5577 

REQUESTED CHANGE:

o On pages 37226, 37232, and 37239, amend the sentence “...who seeks coverage for obstetrical or 

gynecological care provided by a participating health care professional who specializes in obstetrics 

or gynecology.” to “...who seeks coverage for obstetrical or gynecological care provided by a 

participating health care professional of her choice who specializes in obstetrics or gynecology. 

The plan may not deny a request for direct access solely because the primary care provider is able 

and qualified to provide the same care.” 

3. Prohibit Additional Cost-Sharing.

The final rule should prohibit additional cost-sharing on women who self-refer to (directly access) their 

ob-gyn. Any cost-sharing must not be more restrictive than that for other services and providers in the 

health insurance plan. Women should not be forced to pay more for self-referring to their ob-gyn. 

State Examples: 

The prohibition on additional cost-sharing is a protection in most state direct access laws, including 

Colorado, Delaware, Louisiana, Massachusetts, Missouri, Montana, New Mexico, Ohio, Texas, Utah, 

Washington, West Virginia, and Wisconsin. 

REQUESTED CHANGE:

o Add language in relevant sections, stating “No plan or insurer shall impose cost-sharing, such as 

copayments, coinsurance, surcharges or deductibles, for directly accessed obstetric or 

gynecologic services that are not required for access to health care practitioners acting as primary 

care providers or for other types of health care services not delineated in this section.” 

4. Ensure Adequate Number of Participating Ob-Gyns. 

In order to ensure that women have meaningful direct access to ob-gyn care, ACOG recommends the 

final rule should include a requirement on health insurance plans to contract with sufficient numbers of 

obstetric and gynecologic providers. Without this requirement, a health plan could contract with a 

single ob-gyn to serve one or all of its networks, and satisfy the direct access standard. This has been a 

problem in some states. 

State Examples:

This provider contracting requirement is included in the ob-gyn direct access laws in several states 

including Delaware, Kentucky, Missouri, Montana, New Jersey, New Mexico, Texas, and Washington. 

Texas’ law states “The plan shall include in the classification of persons authorized to provide medical 

services under the plan a number of properly credentialed obstetricians and gynecologists sufficient to 

ensure access to the services that fall within the scope of that credential.” 

REQUESTED CHANGE:

o Add language, in all relevant sections, stating “Plans shall contract with sufficient numbers of 

obstetric and gynecologic providers to ensure that female enrollees can exercise their right of direct 

access without unreasonable delay.” Or, “A plan may limit the number of obstetric and gynecologic 

providers only if there is a sufficient number of obstetric and gynecologic providers available to 

serve a defined population or geographic service area, so that female enrollees will have direct and 

timely access to obstetric and gynecological services." 

5. No Limit on Self-referral Visits to an Ob-Gyn. 

We request that the final rule specify that health insurance plans may not limit the number of allowable 

visits to a participating ob-gyn. Without this requirement, a health plan could limit direct access to one 

visit annually or one well-woman care visit, and satisfy the direct access standard. This is not the result 

women want. Women should not have to pay twice the fees and make twice the visits for ob-gyn care. 

This has been a particular problem with gynecologic care and care for an acute gyn condition. To 
THE AMERICAN CONGRESS OF OBSTETRICIANS AND GYNECOLOGISTS • WOMEN’S HEALTH CARE PHYSICIANS

409 12TH STREET SW WASHINGTON DC 20024-2188 Phone: 202/638-5577 

prevent this, the final rule, in addition to specifying no limits on self-referral, should specify the covered 

services that women may self-refer for. 

State Example:

Ohio’s direct access law includes this requirement, “No insurer may limit the number of allowable visits 

to a participating obstetrician or gynecologist.” 

REQUESTED CHANGE:

o Add language, in all relevant sections, stating “No insurer may limit the number of allowable visits 

to a participating obstetrician or gynecologist for medically necessary primary and preventive 

obstetric and gynecologic services from a qualified provider of such services of her choice. 

6. Services for which Direct Access to Ob-Gyn Providers is Protected 

In addition to concerns about possible insurer restrictions on the number of visits, ACOG is concerned 

that the interim final rule does not define the circumstances under which a woman may self-refer to her 

ob-gyn provider. While we understand that benefit coverage varies from plan to plan and that the rule 

does not mandate certain benefits, the rule should ensure that so long as the benefit is covered by a plan, 

a woman may elect to directly access her ob-gyn to receive that care, without prior authorization from 

the insurance plan, or referral from another provider. At minimum, the protected instances for which 

women may directly access their ob-gyn provider should include: acute gynecological care; abnormal 

pap smear treatment; follow-up care for problems discovered and treated during the ob-gyn visit; 

infertility care; family planning services, annual well-woman visits; and any care related to pregnancy. 

Spelling this out will ensure that insurance plans do not arbitrarily limit a women’s direct access right to 

only e.g. one annual well-woman visit, while barring women from directly accessing follow-up care 

based on a condition found during such an annual visit. 

State Examples:

California's direct access law specifies that utilization protocols imposed by the insurer may not be more 

restrictive for ob-gyn services than for other services. 

 New York’s law and Department of Health Guidelines state “The HMO shall not limit direct access to 

the enrollee’s chosen qualified provider for primary and preventive ob-gyn services required as a result 

of such annual examinations or as a result of an acute gynecological condition. If additional treatment is 

required for ob-gyn conditions during one or both of the two annual examinations, the follow-up visits 

would not count as primary/preventive visit. Once a diagnosis is made and follow-up treatment for that 

diagnosis is necessary, direct access to the qualified provider of ob/gyn services is allowed.” 

REQUESTED CHANGE:

o Add language, in all relevant sections, stating “Direct access to health care services provided by obgyn providers includes, but is not limited to: annual well-woman examinations; care related to 

pregnancy; family planning services; care for all active gynecologic conditions; and diagnosis, 

treatment and referral for any disease or condition within the scope of the professional practice of a 

properly credentialed ob-gyn provider.” 

NOTIFICATION REQUIREMENTS 

Our experience in the states has shown us that women’s knowledge of their right of direct access is critical to 

successful implementation of this patient protection. 

1. Notice to Patients of Their Right to Direct Access. 

ACOG greatly appreciates the IFR’s requirement on the health plan to issue a notice to beneficiaries, 

enrollees, and participants, informing them of their right to directly access an ob-gyn provider. We 

believe the below suggested edits will serve to strengthen the proposed language. 
THE AMERICAN CONGRESS OF OBSTETRICIANS AND GYNECOLOGISTS • WOMEN’S HEALTH CARE PHYSICIANS

409 12TH STREET SW WASHINGTON DC 20024-2188 Phone: 202/638-5577 

REQUESTED CHANGE:

o Amend the rule language with the items in bold: 

 “You do not need prior authorization from [name of group health plan or issuer] or a referral from 

any other person (including a primary care provider) in order to obtain access to obstetrical or 

gynecological care from a health care professional in our network who specializes in obstetrics or 

gynecology, regardless of whether or not your primary care provider can provide that care. 

The health care professional, however, may be required to comply with certain procedures, 

including obtaining prior authorization for certain services, following a pre-approved treatment 

plan, or procedures for making referrals. You cannot be charged any additional amounts for 

choosing to directly access care from an ob-gyn provider, beyond what you would be required 

to pay for care received by your primary care provider. For a list of participating health care 

professionals who specialize in obstetrics or gynecology, contact the [plan administrator or issuer] 

at [insert contact information].” 

2. Reporting Requirements on the Ob-Gyn Provider. 

ACOG understands that in order to promote coordination of care, health insurance issuers and group 

health plans may require the directly accessed ob-gyn provider to forward information concerning 

medical care of the patient to the primary care provider or the plan or issuer, after a directly accessed 

ob-gyn visit. Any such requirement however should include protections for the ob-gyn provider and the 

patient against financial penalties or reimbursement denials, provided that the ob-gyn provider made a 

good-faith effort to report such information. 

State Examples:

Texas’ ob-gyn direct access law protects both the patient and the ob-gyn from any penalty, provided a 

good-faith effort was made to forward information to the primary care physician. 

New York’s Health Department guidelines on ob-gyn direct access protect both the patient and primary 

care provider from financial or other penalties being imposed because of failure to report by the ob-gyn 

provider. Additionally, New York’s guidelines specify “if an enrollee directly accesses her qualified 

provider of ob/gyn services for what the enrollee perceives as symptoms resembling an acute ob-gyn 

condition, then the qualified provider of ob/gyn services should document those presenting symptoms so 

that the direct access visit can be reasonably explained to the HMO and reimbursed, even if the actual 

diagnosis turns out to be non-gynecologic. Appropriateness of the direct referral is based on symptoms, 

not the actual diagnosis.” 

REQUESTED CHANGE:

o Add language in all relevant sections, stating “Failure to provide this information may not result in 

any penalty, financial or otherwise, being imposed upon the ob-gyn provider or the patient by the 

health plan, if the ob-gyn provider has made a reasonable and good-faith effort to provide 

information to the primary care provider and the health plan or issuer. If a woman directly accesses 

her qualified provider of ob/gyn services for what she perceives as symptoms resembling an acute 

ob-gyn condition, the plan may require that the provider document those presenting symptoms so 

that the direct access visit can be reasonably explained and reimbursed, even if the actual diagnosis 

turns out to be non-gynecologic. Appropriateness of the direct referral is based on symptoms, not 

the actual diagnosis.” 

ENFORCEMENT 

The lack of federal enforcement on insurance market abuses is a major reason why the Patient Bill of 

Rights regulations are so badly needed. The IFR however does not address enforcement mechanisms 

for failure to adhere to the new national direct access insurance standard. We urge the final rule to 

authorize enforcement and oversight, specifying the oversight and enforcement agency, as well as 

clarifying federal and state responsibilities. The state experience with ob-gyn direct access and other 

patient protections clearly favors strong oversight and enforcement. 
THE AMERICAN CONGRESS OF OBSTETRICIANS AND GYNECOLOGISTS • WOMEN’S HEALTH CARE PHYSICIANS

409 12TH STREET SW WASHINGTON DC 20024-2188 Phone: 202/638-5577 

State Examples: 

Colorado, Montana, New Mexico, New York, and Washington are among states that have implemented 

strong oversight and enforcement mechanisms. 

Montana’s ob-gyn direct access law states: 

“If the commissioner determines that a health benefit plan does not comply with (sections 1through 8) 

or that a health carrier has not complied with (sections 1 through 8), the commissioner may: 

(1) recommend a correction plan that must be followed by the health carrier; 

(2) institute corrective action that must be followed by the health carrier; 

(3) suspend or revoke the certificate of authority or deny the health carrier’s application for a certificate 

of authority; or 

(4) use any of the commissioner’s enforcement powers to obtain the health carrier’s compliance with 

(sections 1 through 8) 

REQUESTED CHANGE:

o ACOG recommends adding language in all relevant sections, similar to the language on page 37208 

on enforcement of rescissions, as well as borrowing from the Montana law. Additionally, ACOG 

recommends the HHS Secretary use her power to not certify a plan for participation in the Health 

Insurance Exchanges, if it does not comply with direct access laws. 

OTHER 

o On page 37225, the regulation cites a “temporary expiration date June 21, 2013” ACOG requests 

clarification on this provision. Specifically, ACOG wants to ensure that there is not a gap of patient 

protections between the June 21, 2013 and the commencement of the remaining insurance market reforms 

on January 1, 2014. 

PATIENT DESIGNATION OF PRIMARY CARE PROVIDER 

ACOG fully supports this provision and a patient’s right to designate a participating primary care provider of their 

choosing, in cases where the group health plan, or a health insurance issuer offering group or individual health 

insurance coverage, requires or provides for designation of a participating primary care provider. 

REQUESTED CHANGE:

o We note however that the IFR does not provide a definition of who qualifies as a primary care provider. 

We urge you to recognize in the final rule that ob-gyns can be eligible primary care providers for women. 

For many women, especially women of reproductive age 18-44, the ob-gyn is their primary care provider. 

Currently 17 states require that insurance plans contract with ob-gyns as primary care providers, if the obgyn applies for such designation. In three additional states, health plans have the option to contract with 

ob-gyns as primary care providers. The final rule should apply this nationally to protect a woman’s right 

to elect her ob-gyn as a primary care provider and to allow any qualified ob-gyn to contract with a health 

plan as a primary care provider. 

PRE-EXISTING CONDITION EXCLUSIONS FOR CHILDREN/ADULTS 

We are pleased that the interim final rule clearly prohibits the denial of coverage based on health status and the 

exclusion of coverage of specific benefits associated with a pre-existing condition for children under 19 in plan years 

beginning on or after September 23, 2010 and for adults in plan years beginning on or after January 1, 2014. In order to 

strengthen the protections and to fulfill the promise of the ACA, we recommend the following improvements to the 

interim final rule: 
THE AMERICAN CONGRESS OF OBSTETRICIANS AND GYNECOLOGISTS • WOMEN’S HEALTH CARE PHYSICIANS

409 12TH STREET SW WASHINGTON DC 20024-2188 Phone: 202/638-5577 

REQUESTED CHANGES:

o The final rule should include excessive waiting periods in the definition of pre-existing condition 

exclusions. An excessive waiting period should be defined as any period longer than 90 days, in line with 

the ACA provision that will go into effect on January 1, 2014. Without such an inclusion, children with 

pre-existing conditions will continue to face delays in access to necessary coverage and care for their 

health conditions. 

o The final rule should explicitly allow the Secretary of Health and Human Services to use her/his 

regulatory authority under Section 2794 to prohibit unreasonable premium increases and/or excessive 

premiums for families with children with pre-existing conditions. Without such authority, insurers may 

charge newly covered children with pre-existing conditions excessively high premiums or significantly 

increase premiums for currently covered children based on their health status, making coverage 

unaffordable and unattainable for families. Allowing such high premiums and premium increases goes 

against the intention of this provision of the ACA, to expand health coverage to more children. 

o If states allow limited open enrollment periods for children, they should be required to have special 

enrollment periods in individual market policies as well as group policies. On July 28, the Administration 

issued new guidance regarding the sale of health plans to children with pre-existing conditions that 

permits open enrollment periods in the individual market, as allowed under state law. We appreciate this 

new guidance and request that for states without laws on the timing and duration of open enrollment 

periods, the final rule should, at a minimum, establish special enrollment period rules for the individual 

market, paralleling the rules of the group market. Special enrollment periods will provide families the 

opportunity to learn about and understand their coverage options and make educated decisions. Moreover, 

during the first year in which coverage is available to children without regard to pre-existing conditions, 

plans should not restrict enrollment periods or should allow liberal exemptions to any open enrollment 

periods, since it will take time for many families to learn about their new rights to coverage and seek 

enrollment. 

RESCISSIONS 

The regulation prohibits plans from rescinding coverage “unless the individual (or a person seeking coverage on behalf 

of the individual) performs an act, practice, or omission that constitutes fraud, or unless the individual makes an 

intentional misrepresentation of material fact, as prohibited by terms of the plan or coverage.” This addresses, and will 

hopefully end, the practice of insurers retroactively cancelling coverage based on mistakes or unintentional omissions 

on an enrollee’s application. We appreciate the clarification that more protective federal or state laws may apply 

without preemption and the admonition in the regulation’s preamble that the Department will be watching for 

“attempts in the marketplace to subvert these rules.” This watchfulness is necessary given insurers’ continued battle 

over rescission rules in the states. Additionally we recommend the following enhancements: 

REQUESTED CHANGE:

o Standards Regarding Health Questionnaires 

One way for insurers to collect health information on prospective plan enrollees is through a health 

questionnaire. Potential enrollees should be informed in writing that information collected on a health 

questionnaire by an insurer, or an employer on an insurer’s behalf, can potentially be cited as evidence of 

fraud or intentional misrepresentation at the time of application or at any time during the life of the policy. 

In addition, the regulation should set minimum standards for the content of health questionnaires. Without 

commonsense protections, a confusing, ambiguous, or misleading questionnaire may be set as a trap for 

consumers and allow insurers to violate the spirit of the rescission restrictions. At a minimum, questionnaires 

should use clear, unambiguous, lay-person language in discussing a prospective enrollee’s medical history. 

Questions should only elicit medical information that is reasonable and necessary for medical underwriting, 

and each question should clearly state the time frame covered. Also, questions should not require an applicant 

to guess what symptoms are significant to the health insurer or to understand the medical significance of 
symptoms or conditions. Applicants should also have the opportunity to indicate where they are unsure of an 

answer. 

o 30-Day Advance Notice of Rescission 

In the past, many consumers have faced rescission without the benefit of any advance notice, so a 30 calendarday window in which to begin the process of contesting the insurer’s decision or to find alternative coverage is 

a good start. The notice should be delivered by certified mail with return receipt requested, or by similar 

timely method that provides proof of delivery, to ensure the notice arrives in the hands of the enrollee. The 

30-day clock should begin when the enrollee receives the notification, not when it is sent. 

The regulation should also make clear what kind of information must be contained in the 30-day notice. At a 

minimum, the notice should include: 

 a detailed explanation of the reason for rescission, including the legal standard for rescission and the 

ways in which the insurer believes the consumer has committed fraud or intentional misrepresentation 

of a material fact; 

 a statement acknowledging that the insurer, not the beneficiary, bears the burden of proof; 

 an affirmation of the beneficiary’s right to obtain copies of any and all information used in making 

this determination and an explanation of how this documentation can be obtained; 

 a description of any federal or state consumer protections that exist, such as the right to an appeal; 

 a description of how an appeal can be initiated and of the levels of appeal available to the consumer; 

 a statement that tells the consumer about his/her right to fight the insurer’s decision to rescind in 

court; 

 a clear indication of the date the rescission decision takes effect and the date of the retroactive loss of 

coverage; and 

 an itemized accounting of pending or previously-reimbursed medical expenses that will be recouped 

by the insurer, with provider’s name and contact information. 

Again, thank you for the opportunity to comment on the Interim Final Patient Bill of Rights Rule. We hope you have 

found our comments helpful. Should you have any questions, please contact ACOG’s Government Affairs Manager, 

Nevena Minor at nminor@acog.org or 202-314-2322. 

Sincerely, 

Richard N. Waldman, MD, FACOG 

President 

THE AMERICAN CONGRESS OF OBSTETRICIANS AND GYNECOLOGISTS • WOMEN’S HEALTH CARE PHYSICIANS

409 12TH STREET SW WASHINGTON DC 20024-2188 Phone: 202/638-5577