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Executive unless enacted in a veto override. 23 The past century of U.S.
federal law has seen an explosion of regulations, generally published in the
Federal Register (FR) and codified in the Code of Federal Regulations (CFR).
These regulations are promulgated by the Executive in theory to fill in the
gaps of the statutes and describe how the statute will be enforced. In practice
they take on a life of their own, which has increasingly come to be known as
the administrative state. 24 The multitude of these regulations were growing
at a pace and with dubious practices of due process and constitutional regard
that the Administrative Procedure Act25 (APA) was adopted in 1946 to give
shape and process to these executive actions. By and large, regulations
adopted by the Executive must comply with the APA unless there is a
statutory exception. The cheese of regulations is more Swiss than hard
cheddar as Congress has seen fit to punch numerous holes in the APA and
provide the Executive with work-arounds to adopt regulations. One of the
most aggressively used exceptions to the APA is in the Medicare program in
which Congress allows the Centers for Medicare and Medicaid Services to
adopt National Coverage Determinations (NCDs) in a bypass of the APA and
without any need of publication in the FR or codification in the CFR. 26 The
NCDs go through a notice and comment period in a nod to the conceptual
framework of the APA but have a short-circuit approach to becoming
something like a law. Going even further than the NCD process in the same
section of the Social Security Act, Congress has allowed private contractors
to adopt Local Coverage Determinations (LCDs) for local regulation of
Medicare policy. 27 Like the NCDs, the LCDs must also have a notice and
comment period, but unlike the NCDs that are promulgated by a government
agency responsible to the President, the LCDs are promulgated by private
corporations that have a contract with CMS to administer the Medicare
program. 28 In this instance Congress has not just delegated legislative
authority to the Executive, but Congress has approved the Executive
outsourcing lawmaking to a private company. Needless to say, the LCD
process (formerly known as Local Medical Review Policies) is not without
its critics. 29
23. U.S. Const. art. I, § 7.
24. See F. T. C. v. Ruberoid Co., 343 U.S. 470, 487 (1952) (Jackson, J., dissenting) (“The
rise of administrative bodies probably has been the most significant legal trend of the last
century. . . They have become a veritable fourth branch of the Government, which has
deranged our three-branch legal theories….”).
25. Administrative Procedure Act, 5 U.S. C. §§ 500-596 (2012).
26. 42 U.S. C. § 1395y(I) (2015).
27. 42 U.S. C. § 1395y(I)( 5) (2015).
28. 42 U.S. C. § 1395kk- 1 (2015).
29. See generally, Ryan Meade & Steven Ortquist, Is a Medicare Local Medical Review
Policy Law? Maybe, Maybe Not, J. HEALTHCARE COMPLIANCE (Dec. 2002).