Whether the rulemaking requirements of 42 U.S.C. § 1395hh(a)(2) apply to a Medicare policy deeming all molecular diagnostic laboratory tests "investigational" and thus not covered by Medicare because it was issued by a Medicare Administrative Contractor ("MAC") as an LCD.

Whether Congress' delegation of policy-making authority to a MAC, a non-governmental entity, to establish LCDs is permissible because HHS adjudicators are not absolutely bound by LCDs even though they must give LCDs "substantial deference," as the final agency decision maker did in this case.

Whether the rulemaking requirements of 42 U.S.C. § 1395hh(a)(2) apply to a Medicare policy deeming all molecular diagnostic laboratory tests 'investigational' and thus not covered by Medicare because it was issued by a Medicare Administrative Contractor (MAC) as a Local Coverage Determination (LCD)