Date: Commenter’s Name: Address: City, State & Zip Code: Comments on Medicaid Draft Proposal 1A-22 Request for Rejection of 1A-22 The North Carolina Medicaid Program provides payment for a variety of procedures, products and services for categorically needy and medically needy residents of the State. The requestor is requesting clinical policy consideration for : Medically Necessary Circumcision Clinical Coverage Policy No: 1A-22 All procedures, products and services must be medically necessary and may not be considered solely cosmetic, experimental or part of a clinical trial. Please provide the following information to expedite review of the request for flexible coverage. Indicate N/A if an item does not apply. 1. Name of procedure, product or service (provide a brief description) for which coverage is being requested or where change or flexibility is being requested. MAINTAIN ROUTINE INFANT CIRCUMCISION AS UNCOVERED PROCEDURE 2. Does this request replace an existing coverage, change or add flexibility (PA waiver, telehealth, etc.) to an existing coverage? Explain in detail what replacement or flexibilities are being requested. 3. Has the request been mandated through federal or state legislation? 4. Does this request appear to have a potential cost savings to the Medicaid program? If yes, explain. 5. Please provide details around the types of providers and beneficiaries whose quality of care will be enhanced due to this request. Infant circumcision is not medically necessary as per every international medical association that has issued such a policy. Please refer to : Joint policy statement by 20 international medical groups on circumcision https://intaction.org/circumcision-health-benefits/ 11/05/2020 Danish Medical Association: https://buff.ly/2IuCGe4 “The Danish Medical Association does not believe that it has been documented that circumcision has a health benefit for boys. The medical association believes that medical interventions that involve pain or discomfort for minors should be limited to situations where the intervention is a clear health benefit for the person. The medical association does not believe that such an advantage has been documented….. circumcision of boys without a medical indication is ethically unacceptable. Circumcision of boys without medical indication should cease.” Additional medical association policy statements in opposition to infant circumcision: https://www.cps.ca/en/media/canadian-paediatricians-revisit-newborn-male-circumcision-recommendations https://jme.bmj.com/content/30/3/259 https://www.independent.co.uk/news/world/europe/denmark-considering-banning-circumcision-for-children-under-18s-a7459291.html https://www.knmg.nl/web/file?uuid=4f46a948-1a37-4ee4-95be-976b541ec6ee&owner=5c945405-d6ca-4deb-aa16-7af2088aa173&contentid=286 https://www.racp.edu.au/docs/default-source/advocacy-library/circumcision-brochure.pdf Excerpts from medical association policy statements: The Canadian Paediatric Society stated, “medical necessity is not established, …interventions should be deferred until the individual concerned is able to make their own choices.” The Royal Dutch Medical Association said “there is no convincing evidence that circumcision is useful or necessary in terms of prevention or hygiene.” The Royal Australasian College of Physicians said that it is ethically questionable whether parents ought to be able to make such a decision for a child. The British Medical Association said it is “unethical and inappropriate” to circumcise for therapeutic reasons when effective and less invasive alternatives exist. The German Association of Pediatricians said “there is no reason from a medical point of view to remove an intact foreskin from …boys unable to give their consent.” In addition, organizations from Belgium, Finland, Norway, Slovenia, South Africa, Denmark, and Sweden have all come out in opposition to non-therapeutic circumcision. 6. Indications, limitations and restrictions for use. * Diagnostic indication(s) [ICD-10 CM code(s)]. * Proposed advantages of the new product, procedures or service. * Duration and frequency of use. * Gender restrictions. * Age restrictions. ________________ Page 2 7. Procedure (CPT or HCPCS) or revenue codes to be used or impacted by the request 8. Recommended place of service. 9. FDA approval status (attach copy of approval letter/documents to the email). 10. Supporting data from research studies, peer review journals etc. (attach copy of approval letter/documents to the email) 11. Extent to which the requested coverage/flexibility request is currently in use in North Carolina. 13. Is coverage/flexibility supported by other state Medicaid programs (List states or entity, if known, and a contact person with telephone number or email address.) 14. My Comments on Proposal 1A-22 The proposed changes to “Clinical Coverage Policies” with regards to circumcision are very concerning to me. The changes seem to be based on claims of unproven, overstated circumcision benefits with a disregard for circumcision risks, complications and loss of important erogenous tissue. Proposal 1A-22 seems to position hospitals, clinics, and doctors to increase medical income at the expense of baby boys from low income households. Routine infant circumcision fails to meet the threshold of “medical necessity,” a required criteria for Medicaid. North Carolina Medicaid has not provided any documentation or studies that showed babies or young adults in the state have higher rates of HIV, STD’s, UTI’s, or penile cancer during the years since North Carolina discontinued coverage. Yet N.C. Medicaid is moving ahead with this proposal despite lack of such evidence to justify the proposal. No Cost Benefit Analysis Done: The State has not performed a cost analysis for the reintroduction of coverage for circumcision. The State has not reviewed any data on circumcision complications, malpractice, or revision surgery when evaluating the cost/benefit of Proposal 1A-22. The complete costs are vital to know in an era of our overburden medical system and state budgets already impacted by COVID-19 costs. Yet the 1A-22 Proposal did not seem to consider these things at all. No analysis was done on the issue of correcting or surgically revising circumcision related complications in infants and children in-state and what this will cost the State Medicaid program. Such revisions typically include removing skin adhesions, repairing clamp damage, correcting meatal stenosis, buried penis syndrome, infections, post circumcision NICU costs, microsurgery reconstruction, or addressing parental post-circumcision cosmetic complaints. Controversial and Negligible Medical “Benefits” NC Medicaid offers a litany of oft claimed medical benefits for infant circumcision, yet these claims fall apart under objective evaluation. The claim that circumcision offers, “decreased risk of sexually transmitted infections (STIs) later in life including HIV” fails to consider that infants are not at risk for STI’s or sexually transmitted HIV infection. The HIV claim is unsubstantiated since no studies or clinical trials have been performed in western countries that showed any benefit. These claims were based on highly criticized sub-Saharan African research. Furthermore, HIV can be better prevented in adults with Pre-Exposure Prophylaxis (or PrEP) , which is widely available now. Furthermore, HIV may be a curable disease by the time a baby born today reaches sexual debut. In fact pharma companies like AGT are now conducting clinical trials on a HIV cure. Because of these new medical developments, a permanent surgical intervention like circumcision is not medically necessary and actually unethical. “Primum non nocere” - FIRST DO NO HARM! It is undisputed that circumcision does not provide any protection against the most common STD’s such as chlamydia and gonorrhea. Other claims made by North Carolina Medicaid are in conflict with the American Academy of Pediatrics, which stated the following in their 2012 Technical Report: Penile Cancer: Penile cancer is rare.....The clinical value of the modest risk reduction from circumcision for a rare cancer is difficult to measure against the potential for complications from the procedure. One study showed there would be 324 circumcision complications to prevent one penile cancer event. Penile cancer typically involves HPV which is addressed below. Cervical Cancer/HPV: The contribution of male circumcision to prevention of cervical cancer is likely to be small. The cancer causing subtypes of HPV are now preventable with the HPV vaccine. The vaccine is highly successful while surgical circumcision is highly questionable as prophylaxis. Urinary Tract Infections (UTI’s). The differences in UTI rates between circumcised and intact baby boys are negligible and UTI’s easily treated with antibiotics in any case. Incidentally infant girls contract UTI’s are three times the rate of boys, yet surgery is not proposed for them. Parents: It is improper to thrust parents into the role of deciding whether or not to circumcise when they are typically not qualified to evaluate such statistically insignificant and nuanced risks and benefits. Furthermore parental desire for a cosmetic procedure does not create medical necessity. Black and Brown Babies Disproportionately Harmed: Babies of color are disproportionately impacted by circumcision malpractice. They have higher rates of botches, complications, and even deaths. There have been several instances of doctors and clinics attempting to cover up the damage by telling these parents “there is nothing to worry about.” In one case the severed baby’s penis was put in a refrigerator for several days. It’s been shown that doctors downplay or brush off parental concerts after the circumcision is done, especially when a potential malpractice claim is looming. Here is one such story close to home. https://intaction.org/botched-circumcision-baby-loses-penis-malpractice/ These human tragedies don’t seem to be considered by policy makers because of the myopic obsession with infant circumcision. Hospital Revenues Are Not Medical Necessity The issue is not about establishing parity or “health equity” between private insurance and Medicaid. Proposal 1A-22 is seemingly about increasing insurance reimbursement rates from Medicaid patients relative to private insurance patients. Ethics and Human Rights: There are a host of ethical issues on forcing a permanent body modification on infant boys, many of whom experience significant and permanent disfigurements, sexual dysfunction, and psychological harm from circumcision. There are millions of American men that resent having been circumcised, even men that have had “normal” circumcisions. They find themselves forced into a situation that they cannot now change. The World Health Organization has stated that “satisfying sexual function is an important quality-of-life issue and a human right” Defining Sexual Health: Report of A Technical Consultation on Sexual Health. Geneva: WHO; 2006. Proposal 1A-22 will potentially interfere with an individual's human rights. In summary, benefits of routine infant male circumcision are unproven. The procedure forces radical surgical intervention in a situation where it is unneeded, on an individual that cannot consent. It can permanently affect a man throughout his life. From the perspective I have offered, the 1A-22 policy change can be seen as something designed to boost hospital reimbursements at the expense of the low-income families and their newborn sons. Many of the proponents of the change have ties to the healthcare industry. Seen from this light, it then becomes a case of exploitation under the guise of health equity. Please submit the information requested above within this document to the following inbox: medicaid.coverage.request@dhhs.nc.gov Or you can fax it to 919-715-0051 The request form can be mailed to: Clinical Policy and Programs NC Medicaid 2501 Mail Service Center Raleigh, NC 27699-2501 NC MEDICAID NC DEPARTMENT OF HEALTH AND HUMAN SERVICES • DIVISION OF HEALTH BENEFITS