OPTN rules are non-binding?

That's what it says in a footnote, clearly written by a lawyer (or, like myself, a brilliant law student), of a 2008 GAO report.

"Under a 1986 addition to the Social Security Act, hospitals that participate in Medicare and Medicaid and perform organ transplants are required to be members of and abide by the rules of the OPTN. Pub. L. No. 99-509, § 9318, 100 Stat. 1874, 2009 (adding section 1138 to the Social Security Act) (codified as amended at 42 U.S.C. § 1320b-8). HHS interpreted this provision to require that to be considered a rule or requirement of the OPTN and therefore binding on participating hospitals, the rule or requirement must be formally approved by the Secretary. 54 Fed. Reg. 51802 (Dec. 18, 1989); see also 42 C.F.R. § 121.4(b)(2) and (c) (2007) (regulation providing framework for submission of OPTN policies to the Secretary for review and approval). As of February 2008, the Secretary had not approved any OPTN policies for this purpose. Although OPTN policies have not been formally approved by the Secretary, HRSA has indicated that certain data submitted to the OPTN are mandatory under 42 C.F.R. § 121.11(b)(2) and that failure to submit these data accurately and completely could be considered a violation of this section." (emphasis supplied).

U.S. GEN. ACCOUNTING OFFICE, Report to the Ranking Member, Committee on Finance, U.S. Senate, ORGAN TRANSPLANT PROGRAMS: Federal Agencies Have Acted to Improve Oversight, but Implementation Issues Remain, GAO-08-412, at 10 n.16 (2008).

Ultimately, the OPTN doesn't have much teeth itself.

"On its own, the OPTN can impose certain sanctions against noncompliant transplant programs, such as issuing a letter of warning or placing a program on probation. The OPTN can also request that the Secretary of Health and Human Services impose stronger enforcement actions, including terminating a program’s ability to receive organs or reimbursement under Medicare." Id. at 11.