Comments on Nondiscrimination in Health Programs and Activities

National Center for Health Research, November 9, 2015

U.S. Department of Health and Human Services
Office for Civil Rights
Hubert H. Humphrey Building, Room 509F
200 Independence Avenue, SW
Washington, D.C. 20201

Comments of the National Center for Health Research
on
“Notice of Proposed Rulemaking, Nondiscrimination in Health Programs and Activities”
RIN: 0945–AA02

The National Center for Health Research appreciates the opportunity to provide comments on proposed rule on Section 1557 of the Affordable Care Act (ACA Section 1557). We fully support the Administration’s efforts to “prohibit discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities.” We thank the Administration for issuing the proposed rule and believe it will contribute to the health equity of our communities, promote equal access to healthcare for all, and increase affordability and accessibility of coverage and care for all individuals. ACA Section 1557 is the first federal civil rights law that has prohibited sex discrimination in health care and we thank the Administration for taking this important step in ensuring access to quality health care for all by providing necessary clarity on this essential provision.

It is vital that the final rule clearly prohibit sex-based exclusions in health insurance plans and ensure that the provisions are enforced. Our comments will respond to Subpart C §92.207 of the proposed rule which outlines nondiscrimination provisions in health-related insurance and coverage. We provide concrete examples of violations of Section 1557 by health insurance policies that exclude coverage for a woman who seeks medical care to reduce serious harm caused by certain implanted medical devices, specifically breast implants.

It is estimated that more than 360,000 women each year in the United States undergo breast implant surgery, with more than 300,000 of those surgeries for cosmetic reasons. When the FDA approved breast implants, the agency acknowledged that many if not most women with breast implants will eventually need to have the implants removed. It is therefore a serious problem that many health insurance policies specifically exclude coverage for breast implant removal, even if medically necessary, for more than 80% of women with breast implants.

The most serious risk of breast implants is Anaplastic Large Cell Lymphoma (ALCL), a rare cancer of the immune system that the FDA has linked to saline-filled and silicone gel-filled breast implants. Researchers report a high cure rate for ALCL if the fluid around the implant is tested in a timely manner, and the implant and fluid are removed when ALCL is diagnosed.[1] [2] [3] Other risks of breast implants are associated with implant failure after long-term use: most notably rupture/leakage; chronic pain; and infections:

  • The FDA and implant manufacturers acknowledge that these devices “do not last a lifetime,” with one study by FDA scientists indicating close to a 100% failure rate after 15-20 years.[4] Research indicates that when silicone gel breast implants fail, the silicone can leak into the lymph nodes and from there to numerous essential organs.[5] Timely removal of the implant will prevent leaking silicone from migrating to the lungs, liver or other organs where it is impossible to remove safely. Moreover, leakage of silicone gel can cause granulomas, which can be mistaken for breast tumors, causing a need for biopsies and other diagnostic procedures.
  • Tightening of scar tissue around either saline or silicone implants, known as capsular contracture, can result in chronic, debilitating breast pain as well as hardness that interferes with a woman’s ability to undergo mammography. Capsular contracture can only be remedied by removal of the implant and scar capsule.
  • Bacteria can colonize around any implant, including breast implants. Moreover, the sterile saline in some breast implants is no longer sterile after remaining in the body for months or years, and it is not unusual for mold or fungus to grow inside or outside the implant. When this problem is extensive, treatment with antimicrobials is ineffective, and removal is necessary.

Violations of §92.207

The proposed rule “does not require plans to cover any particular benefit or service, but a covered entity cannot have a coverage policy that operates in discriminatory manner.” Since most patients with breast implants are women, the numerous instances when health insurance policies on health insurance exchanges specifically exclude coverage of breast implant removal should be considered sex discrimination, especially when these policies do not specifically exclude coverage for removal of testicular implants, calf implants, or chest implants, which are usually used by men.

We believe that the following examples convey a few of the many violations of section 1557 and its prohibition against sex discrimination in any health insurance Exchange:

  • The North Carolina Blue Cross Blue Shield medical policy specifically excludes coverage for the removal of breast implants, even when the proposed removal of the implant is considered medically necessary. There is no similar and specific exclusion for coverage for the removal of testicular implants or other implants used as cosmetic devices.
  • The Texas Blue Cross Blue Shield medical policy excludes coverage for removal of implants if they were initially implanted for cosmetic purposes (a non-covered benefit), under the following circumstances: mammographic evidence of silicone gel-filled implant rupture with extrusion of contents into the subcutaneous tissue; Baker Class IV contracture (the most severe in terms of pain and hardness); recurrent breast infection related only to contracture from or rupture of breast implant; chronic breast pain related only to recurrent breast infection, contracture from or rupture of breast implant. There is no similar exclusion for coverage for the removal of testicular implants or other male implants that were implanted as a cosmetic device.

These policies fail to recognize the medical necessity of removing implants under certain high-risk circumstances, especially when they can cause ALCL, mask breast cancer, cause infection or severe pain, prevent mammography, extrude through the skin, or leak silicone gel into the lymphatic system.

We do not find a logical, non-discriminatory reason for any carrier to selectively exclude coverage for the medically necessary removal of cosmetic breast implants while not excluding coverage for the medically necessary removal of cosmetic testicular implants. In the first instance women are left to suffer the consequences of a debilitating and chronic condition and in the second instance men are promptly treated. Given the similarities between the breast and testicular implants, which are made of silicone elastomer and filled with either silicone gel or saline, and can cause pain, infections, necrosis, and other serious medical problems, we believe that the carriers’ sharply divergent medical policies regarding coverage exclusions for the medically necessary removal of the cosmetic implants represents sex discrimination in health insurance coverage and should be unacceptable in all plans sold on the Exchange.

The Need for Enforcement

We support the Administration’s proposal for enforcing the provisions under section 1557 and agree that insurers must “keep records and submit compliance reports to OCR” as well as conduct “compliance reviews and complaint investigations.” Additionally, we agree that “a private right of action and damages for violations of Section 1557 are available” is an appropriate course of action for violators.

We recommend that the Administration require insurers who are in violation of Section 1557 remove the discriminatory exclusions from their medical policies. Additionally, we recommend the establishment of a robust record keeping system that will track insurers’ denials of coverage as well as consumers’ reports of complaints that their requested services were not covered.

Conclusions

We commend HHS for taking the important step of issuing this proposed rule on ACA Section 1557. It is critical that HHS ensure that all plans do not include discriminatory exclusions and enforce the provisions outlined in the proposed rule. This is essential to ensure that ACA Section 1557 can truly ensure health equity and nondiscrimination in health care for all communities.

The National Center for Health Research

All NCHR articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff. 

  1. Miranda RN, et al. Breast Implant–Associated Anaplastic Large-Cell Lymphoma: Long-Term Follow-Up of 60 Patients. Journal Of Clinical Oncology, 2014; 32 (2): 114-120. doi:10.1200/JCO.2013.52.7911.
  2. Mazzucco AE. Next Steps for Breast Implant–Associated Anaplastic Large-Cell Lymphoma. Journal of Clinical Oncology, 2014; 32(21): 2275-2276. doi:10.1200/JCO.2014.55.2778
  3. Miranda RN. Reply to A.E. Mazzucco. Journal Of Clinical Oncology, 2014: 32(21): 2276-2277. doi:10.1200/JCO.2014.55.8205
  4. Brown SL, Middleton MS, Berg WA, et al. Prevalence of rupture of silicone gel breast implants revealed on MR imaging in a population of women in Birmingham, Alabama, American Journal of Roentgenology. 2000; 175: 1057-1064.
  5. Katzin WE, Centeno JA, Feng LJ. Pathology of lymph nodes from patients with breast implants: A histologic and spectroscopic evaluation. Modern Pathology, 2002; 15: 246A.