Screening for Sexually Transmitted Infections (STIs) and High-Intensity Behavioral Counseling (HIBC) to prevent STIs

The National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) in the Centers for Disease Control and Prevention (CDC) has a strong interest in the Centers for Medicare and Medicaid’s (CMS) proposed coverage determination outlining coverage of screening for sexually transmitted infections (STIs) and high-intensity behavioral counseling (HIBC) to prevent STIs, including HIV, for Medicare beneficiaries.

Our interest in the content and application of this coverage decision stems from a number of considerations. Many older persons are sexually active but may not be practicing safer sex to reduce their risk for STIs, including HIV infection (1). Compared to those who are younger, some older persons may be less knowledgeable about STIs and HIV/AIDS and thus less likely to protect themselves. Others simply do not perceive themselves to be at risk for STIs or HIV, and so they may not use condoms or get tested (2). Continued gains in the life expectancy of persons living with HIV mean that a growing number of these individuals will be covered under Medicare (either by qualifying for Social Security Disability Insurance [SSDI] or by attaining age 65), and all HIV-infected individuals, regardless of age, should be screened for STIs and offered HIBC. Furthermore, Medicare covers approximately 8 million people under the age of 65, many of whom may be sexually active and at risk for acquiring an STI and some of whom are HIV-infected.

Although preventive service recommendations concerning the provision of STI screening and HIBC are available from a number of sources, including the U.S. Preventive Services Task Force (USPSTF) and the recently released Health Resource and Services Administration (HRSA) Women’s Preventive Services Guidelines, this proposed decision memo represents the first time that HIBC has been defined in a way that links a specific delivery method to reimbursement. Such guidance has long been awaited by our partners in the field, and will likely have broad impact on the services provided by them.

Given the importance of these issues, we urge CMS to consider carefully the following NCHHSTP recommendations related to the coverage of STI screening and HIBC for the prevention of STIs:

• Extend coverage to STI screening and HIBC services by non-primary care providers, such as those who specialize in, or possess expertise related to, STI and/or HIV care, as well as in appropriate clinical settings, including STD, HIV and family planning clinics, as consistent with each USPSTF recommendation.
• Extend HIBC services to adolescents at risk of engaging in sexual activity in the near future.
• Explicitly add people living with HIV to the list of at-risk adults eligible for services.
• Work with CDC to develop a definition of “community risk” that indicates to providers when STI screening and HIBC efforts are most relevant and would be reimbursable.
• Do not list STI screening and HIBC services in the Medicare Summary Notice delivered quarterly to clients in order to prevent the inadvertent disclosure of the receipt of these services to individuals other than the client.

Our concerns are detailed below.

Coverage of and Referral for STI Screening and HIBC in Specialty Care Settings

NCHHSTP urges CMS to extend coverage to STI screening and HIBC services by non-primary care providers, such as those who specialize in, or possess expertise related to, STI and/or HIV care, as well as in appropriate clinical settings, including STD, HIV and family planning clinics, as consistent with each USPSTF recommendation.

Limitations in the Proposed Memo

As written, the proposed decision memo limits the provision of STI screening services to those “ordered by the primary care provider, and performed by an eligible Medicare provider for these services.”

The memo tracks existing statutory definitions of a “primary care provider” as “a physician…who is identified in the available data as a general practitioner, family practice practitioner, general internist, or obstetrician or gynecologist; has a primary specialty designation of family medicine, internal medicine, geriatric medicine, or pediatric medicine; or (II) is a nurse practitioner, clinical nurse specialist, or physician assistant.” The proposed decision memo intends to cover HIBC services only “if referred for this service by a primary care provider and provided by a Medicare eligible primary care provider in a primary care setting.”

It defines a primary care setting as:

“… the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. Emergency departments, inpatient hospital settings, outpatient hospital settings, ambulatory surgical centers, independent diagnostic testing facilities, skilled nursing facilities, inpatient rehabilitation facilities, clinics providing a limited focus of health care services, and hospice are examples of settings not considered primary care settings under this definition.”

These definitions appear to explicitly preclude reimbursement for:

• STI screening services ordered a non-primary care provider;
• Delivery of STI screening services by a non-primary care provider to whom a patient was referred by his/her primary care provider;
• HIBC services without referral from a primary care provider;
• HIBC services provided by a non-primary care provider; and,
• HIBC services provided by any provider outside a primary care setting.

USPSTF Recommendations Acknowledge the Need for Services From a Broader Set of Providers and in a Broader Range of Settings

NCHHSTP recognizes that the majority of STIs are diagnosed in the private sector, and that primary care providers are well situated to address the sexual health needs of many of their clients. However, providers practicing in STD, HIV, and reproductive health specialty clinics diagnose a sizeable proportion of STIs. For example, 32% of reported gonorrhea and 33% of reported primary and secondary syphilis cases among men are diagnosed and managed in STD clinics(3). Research indicates that some primary care physicians have limited confidence in their ability to provide STI counseling and to change their patients’ sexual risk behaviors. Likewise, they often face time constraints that limit their ability to provide STI/STD prevention services(4).

Often, even the most basic STI risk assessment is not performed by many primary care physicians(5). Research also indicates that only one-third of primary care physicians indicate that they would screen asymptomatic, sexually active teenage women for chlamydia during a routine gynecologic examination, as recommended by the USPSTF(6). Other data shows that sexual health – which includes routine comprehensive sexual risk assessment, risk- and recommendation-based STI screening, and HIBC if needed – is infrequently addressed despite high rates of previous STDs and low condom use(7). Follow-up and treatment may also be problematic for many primary care providers. For example, recommended treatments for syphilis and gonorrhea are injectable antimicrobials and are often not available or easily acquired in a primary care setting at the time a patient must be treated. Likewise, STI/STD specialists and/or HIV care providers may be better equipped to handle treatment for certain STIs, especially in individuals infected with HIV.

In the guidelines referenced by CMS’ decision memo, the USPSTF itself explicitly acknowledges the need for sufficient flexibility in implementation to allow patients to access STI screening and HIBC services from those providers who are best positioned and possess sufficient technical expertise, training, and capacity to provide them. For provision of HIBC, USPSTF recommendations and guidance allow the referral of clients to care by other providers or sectors within the health care system, as well as the provision of HIBC directly by community organizations. In the Clinical Considerations section of its Recommendation Statement for HIBC, USPSTF describes preferred implementation as follows:

High-intensity behavioral counseling may be delivered in primary care settings or in other sectors of the health system after referral from the primary care clinician or system. In addition, risk-reduction counseling may be offered by community organizations. Strong linkages between the primary care setting and the community may greatly improve the delivery of this service(8).

Likewise, the USPSTF recommendation statements for chlamydia also reference the need to ensure access to screening in settings outside of the primary care setting, when necessary:

“Primary care clinicians and the health care systems in which they work are responsible for ensuring that asymptomatic women at risk for chlamydial infection are screened. In some communities, this may involve home- or school-based screening programs.” (9)

The USPSTF clearly understands that, while delivery of STI screening and HIBC in the primary care setting is important, not all primary care providers have the time, resources, or skills to effectively conduct these services, nor do all patients seek such services in a primary care setting. Accordingly, the USPSTF explicitly recognizes the need for primary care providers/settings to work with other sectors of the health care system to ensure their patients receive appropriate, high quality STI screening and HIBC services that align with individual and community needs. These settings will not always be primary care settings, and the providers best situated to offer services will not always be primary care providers. In fact, STI/STD and/or HIV care settings, staffed by providers with expertise in screening for, diagnosing, and treating STIs, including HIV, may be best equipped to provide high-quality STI screening and HIBC services.

Broadening the Scope of Providers and Settings will be Consistent with Prior Departmental Interpretations

Aligning the Medicare decision memo with the settings referenced under each specific USPSTF recommendation will also make the proposed decision memo consistent with prior Departmental interpretation of coverage requirements under the USPSTF.

In the interim final rule on the Affordable Care Act (ACA) provision mandating coverage, without cost-sharing, of USPSTF-recommended and other preventive services by non-grandfathered health plans (42 USCA § 300gg–13, SEC. 2713), the Departments of Health and Human Services, Treasury, and Labor do not apply a blanket “primary care setting” requirement. Rather, they require coverage of services in settings specified in USPSTF recommendations and clarify that insurer flexibility as to setting exists only to the extent the recommendations are silent:

Nothing prevents a plan or issuer from using reasonable medical management techniques to determine the frequency, method, treatment, or setting for an item or service described in paragraph (a)(1) of this section to the extent not specified in the recommendation or guideline.(10) [emphasis added]

The implication of this provision is that if the USPSTF recommendation does specify a setting or settings in which a service can be offered, an insurer may not restrict coverage to a narrower range of settings.

To reflect the task force’s recommendations and ensure consistency with the above referenced Departmental interpretation, NCHHSTP asks that CMS amend the proposed decision to cover these Medicare services in primary care settings and other appropriate clinical settings, including STD, HIV and family planning clinics, and to allow referrals to providers who specialize or possess expertise in STI and/or HIV care, as allowed for by each service's respective USPSTF recommendation statement.

Beneficiary Eligibility for Services

Adolescents

NCHHSTP recommends that CMS extend HIBC services to adolescents at risk of engaging in sexual activity in the near future.

NCHHSTP appreciates the reinforcement of the USPSTF guidelines for assessing eligibility for STI screening as outlined in the decision memo, including screening sexually active women 24 years of age or younger for chlamydia and gonorrhea. Because an adolescent who is engaged in petting or similar activity is likely to engage in sex in the near future(11), all adolescents in such situations or participating in such activities would benefit from and should receive HIBC from the providers and in the settings recommended by USPSTF . Therefore, NCHHSTP urges CMS to determine that adolescents evaluated by their provider to be “at-risk” of initiating sexual activity in the near future be eligible for coverage of HIBC services. If the adolescent is not yet sexually active, STI screening is not needed.

HIV-Infected Individuals

NCHHSTP recommends that people living with HIV be explicitly added to the list of at-risk adults in the proposed decision memo.

NCHHSTP strongly supports CMS’ proposal to cover STI screening and HIBC services for individuals who, based on a comprehensive sexual history evaluation, are determined by their health care provider to be at increased risk for acquiring an STI. In the context of chronic STIs such as HIV, STI screening and HIBC services assume a dual function: not only do they help persons living with HIV avoid acquisition of a new STI (in the case of HIBC) or recognize a current infection (in the case of screening), but they also support HIV-infected persons’ efforts to reduce their risk of transmitting HIV to others (e.g., by supporting behavior changes or diagnosis and timely treatment of STIs that promote HIV transmission). Based on a recent review of the available literature, NCHHSTP believes that all persons with a diagnosis of HIV infection should regularly be asked about their current and past sexual practices and should receive counseling or prevention messages that provide tailored and up-to-date information on behaviors and prevention methods that best protect their health and the health of their partners. For HIV-diagnosed persons who engage in behaviors that put themselves at risk for STIs and their partners at risk for HIV infection and other STIs, HIBC is needed. In addition, all sexually active persons with HIV infection should be screened at least annually for syphilis, gonorrhea, and chlamydia (12).

Recently published studies conducted in clinic settings have demonstrated the effectiveness of screening HIV-diagnosed patients for HIV/STI risk behaviors during their HIV care visits and/or using STI screening as a risk marker and then using that information to guide individual prevention counseling. Findings from these studies show significant reduction in unprotected anal and vaginal sex with any partner (13), and some evidence suggests that the interventions might be effective in reducing unprotected acts with HIV-negative or serostatus unknown partners (14). Other published controlled trials (15) also demonstrate the efficacy of brief provider-delivered interventions during routine HIV care visits.

Medicare covers approximately one-fifth of people living with HIV who are receiving care in the United States, and represents nearly 40% of federal spending on HIV care (16). It is therefore crucial that Medicare beneficiaries living with HIV have ready, routine access to STI screening and HIBC services. To ensure such access, NCHHSTP strongly recommends that, in its final national coverage determination, CMS add HIV-infected Medicare beneficiaries to the list of at-risk adults. Although arguably the current category of those who “have had an STI within the past year” would include people with HIV, we believe explicit inclusion is necessary to avoid any ambiguity.

Community Risk

NCHHSTP recommends that CMS work with CDC to develop a definition of “community risk” which indicates to providers when STI screening and HIBC efforts are relevant and needed and would be reimbursable.

NCHHSTP commends CMS for noting that “…community social factors such as high prevalence of STIs in the community populations should be considered in determining high/increased risk for chlamydia, gonorrhea, syphilis and for recommending HIBC.” Through active, strengthened collaborations, NCHHSTP, CMS and state and local STD and HIV programs can ensure that providers understand and have the support they need to act in response to community risk. Public health surveillance data routinely collected by health departments are a good source for identifying communities and areas that are disproportionately affected by HIV, STIs, and related diseases and conditions. Using such data to drive evidence-based coverage decisions is crucial to ensuring that the accessibility and availability of essential prevention services are aligned with local need. Therefore, NCHHSTP is eager to work collaboratively with CMS to develop a definition of community risk which clearly indicates to community providers when heightened STI screening and HIBC efforts are needed, as well as to develop implementation and practice guidance for use by providers.

Privacy and Health Equity Concerns

The proposed decision memo outlines in detail the importance of STI screening and HIBC services for prevention of disease transmission and complications. The ability of patients to access healthcare confidentially is of crucial importance. The stigmatizing nature of many of the services critical to our programs (e.g., HIV screening and STD treatment) means that many individuals prefer to have options for accessing these services from providers other than their primary or family physician. Coverage of these needed services must reflect actual patient patterns and preferences for seeking care, and we should not simply assume that individuals will readily seek HIV, STD, or other services at their primary source of care. Likewise, other population characteristics may introduce difficulties in interfacing with the health care system and require specialized care; , such challenges have been experienced by men who have sex with men (MSM), patients of color, adolescents, or foreign-born US residents. Research indicates that a perceived lack of access to confidential care is a significant barrier to receipt of health services by adolescents (17) as well as adults (18). The fact that many high-risk individuals lack access to primary care providers, and, for reasons of privacy and stigma, seek both HIV and STI testing and treatment from providers other than their primary care provider, adds further justification to the need to extend coverage to STI screening and HIBC services by non-primary care providers, such as those who specialize in, or possess expertise related to, STI and/or HIV care, as well as in appropriate clinical settings, including STD, HIV and family planning clinics, as consistent with each USPSTF recommendation.

For the same reasons, NCHHSTP strongly recommends that STI screening and HIBC services not be listed in the Medicare Summary Notice delivered quarterly to clients in order to prevent the inadvertent disclosure of the receipt of these services to individuals other than the client.

Conclusion

CMS’ final decisions about when Medicare beneficiaries are eligible for STI screening and HIBC services and who (provider types and settings) will be eligible to provide those covered services have the potential to dramatically improve not only the health of Medicare beneficiaries, but also that of their current and future sexual partners. However, in order to reduce confusion and to fully realize these individual and public health benefits, NCHHSTP urges CMS to align its coverage determination with the previously issued interim final rule as well as USPSTF recommendations for coverage in multiple settings. Doing so will allow beneficiaries to receive needed STI screening and HIBC services in those settings where the quality and impact of the covered services will be greatest. Likewise, CMS must clearly articulate the application of its coverage determination to certain key groups of beneficiaries, such as youth at risk of becoming sexually active and persons living with HIV/AIDS. Accordingly, we urge you to carefully consider the suggestions contained herein.

Thank you for the opportunity to provide comments as you prepare a final national coverage determination regarding STI screening and HIBC. NCHHSTP is very interested in collaborating with CMS on these issues moving forward, including the implementation of these recommendations and their translation into clinical practice. We look forward to working with you more in the future.

Sincerely,

Kevin Fenton, MD, PhD, FFPH
Director
National Center for HIV/AIDS, Viral Hepatitis STD and TB Prevention
Centers for Disease Control and Prevention

1. Lindau ST et al. A study of sexuality and health among older adults in the United States. N Engl J Med 2007;357:762–74.
2. Lindau ST et al. Older women’s attitudes, behavior, and communication about sex and HIV: a community-based study. J Womens Health 2006;6:747–53. Henderson SJ et al. Older women and HIV: how much do they know and where are they getting their information? J Am Geriatr Soc 2004;52:1549–53.
3. Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2009. Atlanta: U.S. Department of Health and Human Services; 2010.
4. Ashton MR., et. Al. “Primary Care Physician Attitudes Regarding Sexually Transmitted Diseases.” Sexually Transmitted Diseases. 2002;29(4):246-51.
5. Haley N, Maheau B, et al, “Sexual Health Risk Assessment and Counseling in Primary Care: How Involved Are General Practitioners and Obstetrician-Gynecologists? American Journal of Public Health. 1999;89(6):899-902
6. Cook RL, Wiesenfeld SC. Barriers to screening sexually active adolescent women for chlamydia: a survey of primary care physicians. Journal of Adolescent Health. 2001;28(3):204-210
7. Nurutdinova, D, Rao, S, et al, “STD/HIV Risk Among Adults in the Primary Car Setting: Are We Adequately Addressing Our Patient’s Needs?” Sexual Transmitted Diseases 2011;38(1):30-32
8. http://www.uspreventiveservicestaskforce.org/uspstf08/sti/stirs.htm
9. http://www.uspreventiveservicestaskforce.org/uspstf07/chlamydia/chlamydiars.htm
10. http://www.gpo.gov/fdsys/pkg/CFR-2010-title45-vol1/xml/CFR-2010-title45-vol1-sec147-130.xml
11. O'Sullivan LF, Cheng MM, Brooks-Gunn J. "I wanna hold your hand: the progression of social, romantic and sexual events in adolescent relationship. " Perspect Sex Reprod Health. 2007 Jun;39(2):100-7.
12. CDC. Incorporating HIV prevention into the medical care of persons living with HIV: recommendations of CDC, the Health Resources and Services Administration, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of American. MMWR 2003;52(No. RR-120).
13.Truong HM, Kellogg T, Klausner JD, et al. Increases in sexually transmitted infections and sexual risk behaviour without a concurrent increase in HIV incidence among men who have sex with men in San Francisco: a suggestion of HIV serosorting? Sex Transm Infect 2006;82:461-6.
14.Warner L, Klausner JD, Rietmeijer CA, et al. Effect of a brief video intervention on incident infection among patients attending sexually transmitted disease clinics. PLoS Med 2008;5:e135.
15. Richardson JL, Milam J, McCutchan A, et al. Effect of brief safer-sex counseling by medical providers to HIV-1 seropositive patients: a multi-clinic assessment. AIDS 2004;18:1179-86. Crepaz N, Lyles CM, Wolitski RJ, et al. Do prevention interventions reduce HIV risk behaviours among people living with HIV? A meta-analytic review of controlled trials. AIDS 2006;20:143-57.
16.“Fact Sheet: Medicare and HIV/AIDS,” Kaiser Family Foundation, publication #7171-04, April, 2009.
17.Ford C, English A, Sigman G. “Confidential Health Care for Adolescents: Positions Paper for the Society of Adolescent Medicine.” Journal of Adolescent Heath, 2004; 35:160
18.Cunningham SD, Kerrigan DL, Jennings JM, Ellen JM. (2009). Relationships between perceived STD-related stigma, STD-related shame and STD screening among a household sample of adolescents. Perspectives on Sexual & Reproductive Health. 2009;41(4):225-30. Lichtenstein, B. Stigma as a barrier to treatment of sexually transmitted infection in the American deep south: issues of race, gender and poverty. Social Science & Medicine. 2003;57(12):2435-2445. Lichtenstein B. & Bachmann L. Staff affirmations and client criticisms: staff and client perceptions of quality of care at sexually transmitted disease clinics. Sexually Transmitted Diseases, 2005;32(5):281-285.

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September 9, 2011

Louis Jacques, MD
Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memo for Screening for Sexually Transmitted Infections (STIs) and High-Intensity Behavioral Counseling (HIBC) to prevent STIs (CAG-00426N)

Dear Dr. Jacques:

Thank you for the opportunity to comment on the Proposed Decision Memo for Screening for Sexually Transmitted Infections (STIs) and High-Intensity Behavioral Counseling (HIBC) to prevent STIs (CAG-00426N). The National Family Planning and Reproductive Health Association (NFPRHA) represents the nation’s publicly funded family planning providers – nurses, nurse practitioners, administrators and other key health care professionals. NFPRHA’s more than 400 organizational members operate or fund a network of more than 3,700 health centers and service sites that provide family planning services to millions of low-income and uninsured or underinsured individuals in 48 states and the District of Columbia.

NFPRHA applauds the Centers for Medicare & Medicaid Services (CMS) for highlighting the need for STI screening and counseling. However, NFPRHA is concerned that the proposed decision memo overlooks the importance of the nation’s publicly funded family planning providers – which include state, county and local health departments; non-profit organizations; community health care centers; and hospitals – in the provision of STI screening and counseling. NFPRHA therefore suggests the memo be modified to include family planning providers and settings, regardless of whether the services are ordered by a primary care provider.

Coverage of and Referral for STI Screening and Counseling by Family Planning Providers in Family Planning Settings

Reimbursement for STI screening and counseling is an important means to ensuring greater access to such services, and NFPRHA supports CMS’ move to cover them. However, the proposed decision memo limits this reimbursement to primary care physicians providing these services in primary care settings, when ordered by a primary care provider, which does not take into account the needs of individuals seeking STI screening and counseling, the means in which they often obtain these services, or the settings in which they are most likely to both seek these services and receive expert care.

In 1997, the Institute of Medicine called STIs “a hidden epidemic,” in part because of the prevalence of STIs and in part because many are asymptomatic and therefore go undiagnosed. Women are not only biologically more susceptible than men to some STIs, but also may suffer more serious consequences – untreated STIs in women can lead to pelvic inflammatory disease (PID), ectopic pregnancy, and infertility. Of women with PID, approximately 1 in 5 will become infertile, almost 1 in 5 will suffer from chronic pelvic pain, and nearly 1 in 10 will have an ectopic (tubal) pregnancy. A woman infected with Chlamydia has up to a five-fold increased risk of acquiring HIV infection. Chlamydia may also result in adverse outcomes for infants, including neonatal conjunctivitis and pneumonia.

Publicly funded family planning providers routinely screen and counsel for STIs, which disproportionately affect women, racial and ethnic minorities, and teenagers—populations that tend to rely heavily on family planning clinics for their reproductive health care. In 2009, health centers that receive funds through the federal Title X family planning program performed 5.9 million STD tests and nearly 1 million confidential HIV tests. Each year, family planning clinics serve one in three women of reproductive age who obtain testing or treatment for STIs and one in four who obtain an HIV test.

The Unique and Sensitive Nature of STI Screening and Counseling

Publicly funded family planning providers have the specialized knowledge and skills needed to diagnose, treat, and provide appropriate follow-up care for STIs. Because women are less likely than men to have STI symptoms, they are far more likely to have their infections detected in the context of a contraceptive or prenatal visit. According to the Guttmacher Institute, women receiving contraceptive or other related services at family planning centers are one-third more likely to report that they obtained an STI service than women who saw private physicians.

More and more private health care providers are providing STI testing; however, studies have shown that many primary care physicians have limited confidence in their ability to change their patients’ sexual risk behaviors, do not feel responsible for delivering STI prevention services and face time constraints that severely limit their ability to provide STI prevention services. Often, even the most basic STI risk assessment is not performed by many primary care physicians. Research conducted in 2000 found that only one-third of surveyed physicians stated that they would screen asymptomatic, sexually active adolescent women for Chlamydia during a routine gynecologic examination, which is the recommended screening practice for teenage women.

As the US Department of Health and Human Services’ (HHS) Healthy People 2020 report notes, “For many women, a family planning clinic is their entry point into the health care system and is considered to be their usual source of care. This is especially true for women with incomes below 100 percent of the poverty level, women who are uninsured, Hispanic women, and black women.” Even with the expansion of and emphasis on primary care settings in the Affordable Care Act (ACA), many of the patients who currently seek sexual health services at the nation’s publicly funded family planning centers will continue to seek services at these centers, with or without a referral from a primary care physician.

A key issue in the provision of sexual health services is that the services provided, and even the provider visit itself, be kept confidential. This is particularly important when minors are concerned, to ensure that the minor receives sexual health care free from governmental and/or parental intrusion which could prevent the minor from seeking such services. Research confirms that a perceived lack of access to confidential care is a significant barrier to the receipt of health services for adolescents.

The same need for confidentiality applies to adults, who have a legal right to keep their sexual health care private from spouses and/or partners. The sensitive nature of STI screening and counseling, coupled with the expertise that publicly funded family planning providers have in providing confidential, high-quality sexual health services, highlights the need to include these providers and settings for the purposes of Medicare reimbursement. Publicly funded family planning centers and providers have a long history of commitment to confidentiality and patient privacy, and it is critical that patients have choices beyond primary care providers when it comes to accessing sexual health services such as STI screening and counseling.

For the foregoing reasons, we urge CMS to modify the proposed decision memo to include family planning providers and settings, regardless of whether the services are ordered by a primary care provider.

* * *

We appreciate the opportunity to comment on the proposed decision memo. If you require additional information about the issues raised in these comments, please contact Robin Summers at 202-293-3114.

Sincerely,
Clare Coleman
President & CEO
National Family Planning & Reproductive Health Association (NFPRHA)

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September 9, 2011

Jonathan Blum
Deputy Administrator and Director, Center for Medicare
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Mr. Blum:

On behalf of the members of the American Academy of Pediatrics (AAP) and the Society for Adolescent Health and Medicine (SAHM), organizations committed to the attainment of optimal physical, mental, and social health and well-being for adolescents and young adults, we write to offer comments to the Centers for Medicare & Medicaid Services (CMS) on proposed Medicare coverage of sexually transmitted infection (STI) screening and counseling services (administrative file: CAG-00426N).

We applaud CMS for proposing to cover U.S. Preventive Services Task Force (USPSTF)-recommended STI screening and counseling under the Medicare program and for including community STI prevalence as a factor for determining increased risk. Adolescents are at high risk for STIs and research has demonstrated that screening and counseling are effective clinical tools for the prevention and early identification of reproductive health problems.

Research shows that adolescents often seek confidential reproductive and sexual health services in settings such as HIV clinics, family planning clinics, school-based health centers and STI clinics. The proposal excludes reimbursement for screening and counseling services provided in these types of clinics. While we encourage the provision of adolescent health care within a primary care medical home, we recognize that primary care services for adolescents are often provided elsewhere. Therefore, this proposal may restrict some adolescents from receiving these sexual health services. We ask that CMS revise the proposal to allow reimbursement to providers who practice in STD and reproductive health specialty clinics, school-based health centers and HIV care facilities.

The proposal provides coverage for STI counseling for those engaged in “high/increased risk individual sexual behaviors,” which includes consideration of age and specific high-risk behaviors. Counseling should also be available for adolescents who may soon engage in sexual activity. The proposal would provide STI screening for men and women “at increased risk for STIs annually.” This should be modified to clarify that age and behavior-based risk factors can be considered.

We recommend that HIV-infected individuals be added to the list of beneficiaries at high/increased risk. Based on a recent review of the available literature, the Centers for Disease Control and Prevention (CDC) recommends that all HIV-infected persons should regularly receive counseling or prevention messages that provide tailored and up-to-date information on behaviors and prevention methods that best protect their health and the health of their partners.

If you have questions about these comments, please contact Mark Del Monte at (202) 347-8600. Thank for your dedication to the health and well-being of adolescents.

Sincerely,

O. Marion Burton, MD, FAAP
President
American Academy of Pediatrics

Leslie R. Walker, MD, FSAHM
President
Society for Adolescent Health and Medicine

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The National Association of County and City Health Officials (NACCHO) commends CMS for recommending that Medicare begin covering screening for chlamydia, gonorrhea, syphilis and hepatitis B and high intensity behavioral counseling (HIBC) to prevent STIs for eligible beneficiaries. NACCHO is the national organization representing the nation's 2,800 local governmental health departments. These city, county, metropolitan, district, and tribal departments work every day to protect and promote health and well-being for all people in their communities.

Our interpretation of the proposed rule suggests that some entities that provide a significant proportion of STI screening and counseling services are not eligible for payment under the definition of “primary provider.” This is of significant concern. Local health departments (LHDs) and their affiliated specialty clinics provide STI prevention and treatment services for many of the highest-risk clients and occupy an important component of the primary care delivery system in many areas. LHDs are important providers of sexual health care and should be eligible for reimbursement for the services defined in this rule.

Again, NACCHO commends CMS for considering adding these important services to the Medicare benefits package and hope that this action establishes a precedent that other third-party payers will follow.

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September 9, 2011

Louis B. Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

Dear Dr. Jacques:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services' (CMS's) proposed coverage decision memo for Screening for Sexually Transmitted Infections (STIs) and High-Intensity Behavioral Counseling (HIBC) to prevent (STIs) (CAG-00426N). America's Health Insurance Plans (AHIP) is the national association for the health insurance industry. Our members provide coverage to more than 200 million Americans, offering a broad range of health insurance products in the commercial market and demonstrating a strong commitment to participation in public programs.

General Comments

AHIP and our member plans support CMS's efforts to ensure that Medicare beneficiaries receive access to safe and effective preventive health services, procedures, and treatments that can improve health outcomes, as determined by current and robust clinical evidence. Health insurance plans have a long-standing commitment to preventive services and provide coverage for services recommended by the U.S. Preventive Services Task Force (USPSTF). Health plans are currently implementing the four USPSTF recommendations this proposed coverage decision memo addresses: behavioral counseling to prevent STIs; screening for chlamydia and gonorrhea in pregnant women; screening for syphilis in pregnant women; and screening for hepatitis B in pregnant women.

Our members support covering up to two individual 20 to 30 minute, face-to-face counseling sessions annually for Medicare beneficiaries for HIBC to prevent STIs for all sexually active adolescents and for adults at increased risk for STIs, if referred for this service by a primary care provider and provided by a Medicare eligible primary care provider in a primary care setting. We recommend that CMS develop distinct codes to separate these two sessions, and make tracking utilization of this benefit more manageable.

We also support the definition of HIBC as intending to promote sexual risk reduction or risk avoidance, allowing flexibility for appropriate patient-focused elements including education, skills training, and guidance on how to change sexual behavior.

Thank you for the opportunity to comment on this important issue.

Sincerely,

/s/
Carmella Bocchino
Executive Vice President
Clinical Affairs and Strategic Planning

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Dear Dr. Jacques:

Thank you for the opportunity to provide public comments on the Proposed Decision Memo for the Screening for Sexually Transmitted Infections and High-Intensity Behavioral Counseling to prevent STIs. The National Coalition of STD Directors (NCSD), which represents the state STD programs in every state, territory, and seven large cities funded by the Centers for Disease Control and Prevention (CDC), applauds the Centers for Medicare and Medicaid Services (CMS) for outlining the need for STD screening and counseling. However, NCSD would like to highlight the importance of state and local health departments in the prevention and detection of STDs. We suggest a change to this memo to include state and local health departments and all of their affiliated health centers, such as STD clinics, as eligible entities under the Proposed Decision Memo.

The Role of Public Health Partners, Including State and Local Health Departments

Reimbursement for STI services by primary care physicians is a sensible move and we support it. While we appreciate the drive to ensure these services are provided within the context of a comprehensive prevention plan, the sole eligibility of primary care physicians providing these services in primary care settings does not take into account the reality of those in need of STD screening and counseling. The National Coalition of STD Directors would like to suggest that state and local health departments, including all of their affiliated health centers (e.g., STD clinics), also qualify to receive Medicare reimbursement for providing STI screening and counseling.

State and local health departments have long served an important role in protecting population and individual health within communities. For STD treatment and prevention, health departments serve as a hub of excellence, employing staff possessing specialized knowledge needed to diagnose, treat, and provide appropriate follow-up for such infections (e.g., syphilis and gonorrhea case management). For example, recommended treatments for syphilis and gonorrhea are injectable antimicrobials and are often not available or easily acquired in a primary care setting when a patient needs treatment. Moreover, health department staff is often best situated to be able to respond quickly and to effectively provide outreach to the partner(s) of an infected individual or others who may have been potentially exposed to infection. For many communities, the health department is the only place where STD expertise and experience exist. Allowing for these additional, qualified health professionals to receive reimbursement for STD services ensures that patients have high quality choices in their sexual health care.

The Proposed Decision Memo outlines in good detail the importance of STD counseling and increased screening for the prevention of disease. Safety net providers, such as state and local public health departments, are a primary source of care for vulnerable and marginalized populations. As such, they possess unique insights into, and familiarity with, the needs and challenges faced by these populations. Only half of those who have ever had an STD went to a private practice for treatment¹, which means over 50 percent of those who have been diagnosed with an STD received their care in other health care settings, including STD clinics and other clinics run by local and state health departments. Patients at STD clinics are young, minority, and poor² —populations that are bearing a much higher burden of STD disease, as outlined in the Proposed Decision Memo. These populations are less likely to have primary care physicians and that should be taken into account when determining what entities are eligible for STD reimbursement under Medicare.

The Unique and Sensitive Nature of STD Testing and Counseling

STD clinics and other health centers run by health departments have long filled the void left by STD services not provided by primary care facilities. More and more private health care providers are providing STD testing; however, studies have shown that many primary care physicians have limited confidence in their ability to change their patients’ sexual risk behaviors, do not feel responsible for delivering STD prevention services and face time constraints that severely limit their ability to provide STD prevention services³. Often, even the most basic STD risk assessment is not performed by many primary care physicians⁴. Research conducted in 2000 found that only one-third of surveyed physicians stated that they would screen asymptomatic, sexually active teenage women for chlamydia during a routine gynecologic examination, the recommended screening practices for teenage women⁵. Data also shows that sexual health is infrequently addressed by physicians despite high rates of previous STDs and low condom use in populations⁶. While lack of coverage and reimbursement may add to preventative services not being performed in primary care settings, current evidence does not support the idea that primary care has the sole or unique ability, time, or interest in providing these services once they are more universally covered.

NCSD values the increased access that Medicare coverage of STD services in primary care settings will provide; however, the general ability of patients to access health care confidentially is of primary importance to us as well. The stigmatizing nature of STD screening and testing means that many individuals prefer several options for accessing these services from providers other than their primary or family physician. Reimbursement for these needed services must reflect actual patient patterns and preferences regarding where they seek care, as well as the existing expertise of providers. CMS cannot simply assume that patients will readily seek STD services at their primary source of other care. In addition, the expansion of private insurance coverage with the full implementation of the Affordable Care Act will not supplant the need for public health clinics. Clients at STD clinics often possess primary care coverage, but choose public clinics for their STD services because of the availability of same-day appointments, concerns about confidentiality with other medical settings and the quality of STD care in non-STD clinic sites⁷. Even with unlimited future choice, two thirds of clients at STD clinics indicate they still prefer to be treated at STD clinics⁸.

As an additional consideration, service provision in state and local health departments is subject to severe financial constraints and is often curtailed as state budgets are taxed by other concerns. If state and local health departments are not able to receive outside reimbursement for STD counseling and testing, they likely will no longer be able to offer such services. In fact, several already have curtailed or eliminated their STD programs (e.g., Massachusetts, Maryland, New Hampshire, Rhode Island, South Carolina, Washington); the impact of this dilution of expertise and experience on patient care and disease outcomes has yet to be measured. In addition, the expansion of private insurance coverage with the full implementation of the Affordable Care Act will not supplant the need for public health clinics. Recognition of state and local health departments as important partners in the prevention and early detection of STIs is in the best interest of health at the population, community, and individual levels. Such recognition increases the likelihood that access to currently available critical communicable disease services, especially for the most vulnerable populations, is not compromised.

Additional Privacy and Health Equity Concerns

Privacy is of particular concern in adolescents’ STD treatment, a population that the Proposed Decision Memo itself highlights as having high incidence rates of gonorrhea. The CDC also reports that chlamydia has the highest prevalence in persons under the age of 25⁹. Fewer than half of all adolescents access comprehensive health care, including important preventative health services, such as STI screenings¹⁰. Research confirms that a perceived lack of access to confidential care is a significant barrier to receipt of health services by adolescents¹¹. Requirements for parental notification and consent, along with the disclosure of information through items such as the explanation of benefits (EOB) forms sent to policyholders after care is provided are two major obstacles to adolescents’ access to confidential care¹². The Proposed Decision Memo proposes to cover screening for STDs for women at an increased risk for chlamydia and gonorrhea, which is defined partially as those younger than 25, which will include a large number of adolescents. As a result, it is important that these patients have choices for their STD screening and counseling care, not just primary care providers.

Likewise, other population characteristics may introduce difficulties in interfacing with the health care system and require specialized care, such as those experienced by men who have sex with men (MSM), patients of color, or adolescents. The majority of black youth and the near majority of Hispanic youth, who bear a higher burden of gonorrhea and syphilis rates, receive most of their medical care from community health clinics and hospitals unlike white youth who mostly receive medical care from a private doctor¹³. Only 40 and 39 percent of Black and Hispanic youth receive care from a private doctor, respectively¹⁴. Unfortunately, there is a history of the U.S. health care and research settings having discriminatory practices with regard to ethnic and racial minorities, which affects where these at-risk groups seek care. Given that many high-risk individuals lack access to primary care providers, and, for reasons of privacy and stigma, seek both HIV and STD testing and treatment in STD clinics, we strongly recommend that STD screening and HIBC services be covered in these settings as well.

In sum, NCSD believes that state and local health departments and all of their affiliated health centers, such as STD clinics, should be considered eligible entities under Medicare to provide screening for STIs and high-intensity behavioral counseling to prevent STIs. We believe this due to the expertise of state and local health department staff, the unique and sensitive nature of STI services, and for concerns for adolescents and communities of color, and MSM.

Again, thank you for the ability to comment on these proposed coverage changes and for your consideration of these comments.

Sincerely,

William A. Smith
Executive Director
National Coalition of STD Directors
1029 Vermont Avenue, NW
Suite 500
Washington, DC 20005

Bibliography

Brackbill, R., Sternberg, M., Fishbein, M. “Where Do People Go for Treatment of Sexually Transmitted Diseases?” Family Planning Perspectives. 1999 January/February. Volume 31, Number 1.
Celum, C., Bolan, G., et al. “Patients Attending STD Clinics in an Evolving Health Care Environment: Demographics, Insurance Coverage, Preferences for STD Services and STD Morbidity.” Sexually Transmitted Diseases. 1997 November. Volume 24, Number10, pp. 599-605.
Ashton, Michael R., et al. “Primary Care Physician Attitudes Regarding Sexually Transmitted Diseases.” Sexually Transmitted Diseases. 2002 April Vol 29 No. 4. pp.246-51.
Haley, N., Maheau, B., et al. “Sexual Health Risk Assessment and Counseling in Primary Care: How Involved Are General Practitioners and Obstetrician-Gynecologists? American Journal of Public Health. 1999 June. Volume 89, No. 6. pp. 899-902
Cook, L., Wiesenfeld, H., et al. “Barriers to Screening Sexually Active Adolsecent Women for Chlamydia: A Survey of Primary Care Physicians.” Journal of Adolescent Health. Volume 28, Issue 3, March 2001, Pages 204-210
Nurutdinova, D, Rao, S, et al, “STD/HIV Risk Among Adults in the Primary Car Setting: Are We Adequately Addressing Our Patient’s Needs?” Sexual Transmitted Diseases. 2011 January. Volume 38, Issue 1, pp. 30-32
CDC. Sexually Transmitted Disease Surveillance, 2008. Atlanta, GA: US Department of Health and Human Services, CDC; 2009. http://www.thehealthplan.com/ghpcommon/qualitycare/HEDIS_Graphs.pdf
Ford C., English A., Signman G. “Confidential Health Care for Adolescents: Positions Paper for the Society of Adolescent Medicine.” Journal of Adolescent Heath. 2004; 35:160
National Institutes for Health Care Management Foundation Issue Brief: “Protecting Confidential Health Services for Adolescents &Young Adults: Strategies & Considerations for Health Plans.”
Black Youth Project: “Fact Sheet: Health” http://www.blackyouthproject.com/wp-content/uploads/2009/07/fact_sheet_health.pdf. Accessed August 26, 2011.

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1 Brackbill, R., Sternberg, M., Fishbein, M. “Where Do People Go for Treatment of Sexually Transmitted Diseases?” Family Planning Perspectives. 1999 January/February. Volume 31, Number 1.
2 Celum, C., Bolan, G., et al. “Patients Attending STD Clinics in an Evolving Health Care Environment: Demographics, Insurance Coverage, Preferences for STD Services and STD Morbidity.” Sexually Transmitted Diseases. 1997 November. Volume 24, Number10, pp. 599-605.
3 Ashton, Michael R., et al. “Primary Care Physician Attitudes Regarding Sexually Transmitted Diseases.” Sexually Transmitted Diseases. 2002 April Vol 29 No. 4. pp.246-51.
4 Haley, N., Maheau, B., et al. “Sexual Health Risk Assessment and Counseling in Primary Care: How Involved Are General Practitioners and Obstetrician-Gynecologists? American Journal of Public Health. 1999 June. Volume 89, No. 6. pp. 899-902
5 Cook, L., Wiesenfeld, H., et al. “Barriers to Screening Sexually Active Adolsecent Women for Chlamydia: A Survey of Primary Care Physicians.” Journal of Adolescent Health. Volume 28, Issue 3, March 2001, Pages 204-210
6 Nurutdinova, D, Rao, S, et al, “STD/HIV Risk Among Adults in the Primary Car Setting: Are We Adequately Addressing Our Patient’s Needs?” Sexual Transmitted Diseases. 2011 January. Volume 38, Issue 1, pp. 30-32
7 Celum, C., Bolan, G., et al. “Patients Attending STD Clinics in an Evolving Health Care Environment: Demographics, Insurance Coverage, Preferences for STD Services and STD Morbidity.” Sexually Transmitted Diseases. 1997 November. Volume 24, Number10, pp. 599-605.
8 Ibid.
9 CDC. Sexually Transmitted Disease Surveillance, 2008. Atlanta, GA: US Department of Health and Human Services, CDC; 2009.
10 http://www.thehealthplan.com/ghpcommon/qualitycare/HEDIS_Graphs.pdf
11 Ford C., English A., Signman G. “Confidential Health Care for Adolescents: Positions Paper for the Society of Adolescent Medicine.” Journal of Adolescent Heath. 2004; 35:160
12 National Institutes for Health Care Management Foundation Issue Brief: “Protecting Confidential Health Services for Adolescents &Young Adults: Strategies & Considerations for Health Plans.”
13 Black Youth Project: “Fact Sheet: Health” http://www.blackyouthproject.com/wpcontent/ uploads/2009/07/fact_sheet_health.pdf. Accessed August 26, 2011.
14 Ibid.

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Partnership for Prevention (Partnership) commends the Centers for Medicare & Medicaid Services (CMS) for considering coverage for the U.S. Preventive Service Task Force (USPSTF) recommended services for screening and counseling for sexually transmitted infections (STIs) and high intensity behavioral counseling to prevent STIs. In addition, we were pleased to see that community prevalence of STIs was included as a factor for determining high or increased risk.

In Section 1 under “Screening for chlamydia and gonorrhea,” Partnership suggests either adding an age clarification for screening of non-pregnant women, or referring readers to the section on high/increased risk, in which age as a risk factor for chlamydia and gonorrhea is explicitly defined. The current language in that section may be unclear to some readers.

Partnership welcomes the definition of high intensity behavioral counseling included in the Proposed Decision Memo. To obtain the potential health benefits from this service, it will be essential to work with relevant entities to ensure that coding and billing for behavioral counseling services are developed.
In the Decision Summary, we noted that pediatricians are absent from the “primary care physician” listing although appear later in the full document. Given the high prevalence of STIs among younger, sexually active young persons, it seems likely many readers with an interest in adolescent health may incorrectly assume pediatric providers are not included.

For clarity, we recommend mentioning that other sexual health related preventive services are already covered by Medicare, including for example, HIV screening and counseling for high risk persons and Pap smears for women.

Multiple USPSTF STI screening and counseling recommendations acknowledge that STI screening and counseling services are sometimes delivered in community-based settings, which might include school-based screening initiatives or specialty STD or HIV/AIDS clinics, for example. Yet the Proposed Decision Memo explicitly excludes coverage for these services in “clinics providing a limited focus of health care services.” We fully support and endorse the central role of primary care providers in managing all of a patient’s health care needs; however, we recognize that for multiple reasons—including stigma, provider training and capacity—these sensitive services are sometimes sought outside of primary care settings. Because of the important public health implications of STI screening and counseling, we urge you to be more inclusive of the settings in which recommended STI services can be accessed as a covered service.

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Dear Centers for Medicare and Medicaid Services (CMS) Colleagues:

Thank you for the opportunity to comment on the above-referenced proposed coverage determination to include screening for sexually transmitted infections (STIs) and high-intensity behavioral counseling (HIBC) to prevent STIs as a Medicare covered Part B benefit. We write on behalf of the Infectious Diseases Society of America (IDSA) and HIV Medicine Association (HIVMA), representing more than 9,300 physicians, scientists and other health care professionals who specialize in infectious diseases.

Medicare is an important source of health coverage for patients suffering from infections, including HIV. In fact, it is estimated to cover approximately one fifth of people with HIV who are receiving care in the United States.

We concur with your finding that the evidence supports coverage of screening for chlamydia, gonorrhea, syphilis and hepatitis B, consistent with the grade A and B recommendations by the U.S. Preventive Services Task Force (USPSTF). STIs screening is important for the prevention or early detection of more serious illness and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B.

In addition to these screenings, we are pleased that CMS is proposing to cover High Intensity Behavioral Counseling (HIBC) to prevent STIs for all sexually active adolescents and for adults at increased risk for STIs. Covering up to two individual 20 to 30 minute, face to face counseling sessions annually for this population will fill a critical gap in STI prevention by providing patients education, skills training, and guidance on how to change behavior to protect their health and that of their partners.

We also support CMS’s finding that beyond individual risk factors, in concurrence with the USPSTF recommendations, social factors such as high prevalence of STIs in the community populations should be considered in determining high/increased risk for chlamydia, gonorrhea, and syphilis and for recommending HIBC.

We do have some concerns that coverage for these services is limited to referrals by a primary care provider in a primary care setting and provided by a Medicare eligible primary care provider. The definition of a primary care setting explicitly excludes “clinics providing a limited focus of health care services” which we fear may rule out many essential safety net facilities that are front line providers of STIs and HIV preventive services and serving populations most at risk for STIs, including:

• Ryan White-funded HIV safety-net clinics
• Sexually Transmitted Diseases clinics

We urge CMS to carefully review and revise the language to ensure that the above entities are included among the clinical settings in which Medicare will cover STIs screening and behavioral counseling for eligible patient populations.

We applaud CMS’s work on this important clinical preventive services issue and encourage CMS to move quickly to finalize this national coverage decision. Please do not hesitate to contact us if we can be of assistance or provide further information. We can be reached through Robert Guidos (rguidos@idsociety.org) of IDSA staff or Andrea Weddle (aweddle@hivma.org), HIVMA Executive Director.

James M. Hughes, MD, FIDSA
IDSA President

Kathleen Squires, MD
Chair, HIV Medicine Association

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September 7, 2011

The Centers for Medicare and Medicaid Services in the Department of Health and Human Services seeks public comment on the “Screening for Sexually Transmitted Infections (STIs) and High-Intensity Behavioral Counseling (HIBC) to Prevent STIs” Proposed Decision Memo. Below, the Association of State and Territorial Health Officials (ASTHO) offers comments for consideration. ASTHO appreciates the opportunity to comment on this important topic.

ASTHO is the national nonprofit organization representing the public health agencies of the United States, the U.S. Territories, and the District of Columbia, as well as the 120,000 public health professionals these agencies employ. ASTHO members, the chief health officials of these jurisdictions, are dedicated to formulating and influencing sound public health policy and to assuring excellence in state-based public health practice. Our vision is healthy people thriving in a nation free of preventable illness and injury.

Addressing Sexually Transmitted Infections (STIs) is an important factor in reducing the incidence of preventable illness and death in the United States, and is therefore a key area of focus for ASTHO. Sexually active individuals with more than one partner should be screened for STIs at any age. In addition, ASTHO continues to work with its members to strengthen partnerships with healthcare and maximize the benefit of health reform on infectious disease prevention and control. ASTHO believes this proposed decision memo is important because it specifies that Medicare will cover certain prevention activities that will help reduce the incidence of STIs.

Screening Services

ASTHO encourages CMS and CDC to monitor and describe any changes in screening rates or case finding as a result of these activities. Any information documenting an increase in screening of Medicare patients due to the new coverage of services or an increase in screening in new populations will be useful information for state health agencies to know in their efforts to reduce disease transmission. Engagement of state and territorial public health agencies for case follow-up and surveillance is also strongly encouraged.

ASTHO recommends the memo clearly state whether Medicare Part D formularies include the required antibiotics consistent with the 2010 STD Treatment Guidelines. This information may help healthcare providers better serve their patients and reduce the incidence of non-treatment upon a positive test result. In addition, patients might be more likely to request screening if they know treatment will be covered.

ASTHO appreciates the encouragement of further research on STI intervention and racial and ethnic disparities. We support further discussion regarding how the specific proposed screening and counseling coverage may reduce these disparities, reduce the incidence of the included STIs among those populations, and have a positive impact on health equity.

High-Intensity Behavioral Counseling (HIBC)

ASTHO supports the inclusion of HIBC as part of CMS covered services. The coverage notes in the memo are helpful in that they give specific information regarding what type of counseling is covered, who may provide the counseling, and what the reimbursement structure will be for counseling given. It will be important for Medicare providers to refer their patients as appropriate to complementary or more intensive prevention services offered by public health, such as those recommended by the Community Guide.

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The American Congress of Obstetricians and Gynecologists (ACOG) appreciates the CMS effort to improve prevention of sexually transmitted infections. We strongly support the proposal to cover the cost of appropriate screening and counseling. However, we are very concerned that CMS is proposing to limit coverage of counseling to only two individual 20 to 30 minute sessions. This is completely inconsistent with the USPSTF recommendations. Only one study that the USPSTF reviewed concluded that such moderate intensity counseling was effective, while two studies found that such counseling was not effective. High intensity behavioral counseling (HIBC) is most often delivered in many sessions, all exceeding 30 minutes, with total face-to-face time of 3 to 9 hours. We recommend that the final CMS National Coverage Decision include coverage for all of the HIBC variations that the USPSTF report identified. These are the USPSTF findings:

"Among the studies reviewed, successful high-intensity interventions were delivered through multiple sessions, most often in groups, with total durations from 3 to 9 hours. Little evidence suggests that single-session interventions or interventions lasting less than 30 minutes were effective in reducing STIs. Although 2 studies of moderate-intensity interventions did not demonstrate effect, a third study demonstrated that two 20-minute counseling sessions before and after HIV testing resulted in a clinically and statistically significant reduction in STIs....

Five of 6 trials demonstrated statistically significant reductions in biologically confirmed STIs at 6 and 12 months after the interventions. The absolute risk reduction rate ranged from 2.6% to 11.1%, with generally higher rates of reduction among adolescents. As noted, the interventions in this group were considered “high-intensity”; they included a single 4-hour session, three 1-hour sessions over 3 consecutive weeks, four 4-hour sessions, and a 10-session intervention. "

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