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Revised by sections 10603 and 10604 of the Senate Manager’s Amendment. Effective July 1, 2010, requires physicians who order DME items or home health services be enrolled in the Medicare program. Authorizes the Secretary of HHS to extend this requirement to all other categories of Medicare items or services, including Part D–covered drugs.
Prior to January 2013, CMS first effectuated provisions relating to this section in an interim final rule with comment released in May 2010, followed by a final rule in the fall of that year (regarding additional DMEPOS safeguards). In the spring of 2012, this provision was addressed in the CY 2013 MA and Part D final rule relative to the potential application of the authority under section 6405 to require NPIs for Part D claims and prescription drug events (PDEs). CMS issued a final rule in the spring 2012 effectuating the interim final rule that was released in May 2010.
On January 6, 2014, CMS issued a proposed rule delineating Contract Year 2015 MA and Part D policy and technical changes. The rule proposes, among other things, to limit and redefine, based on new criteria, Part D’s protected drug classes to initially include anticonvulsants, antiretrovirals and antineoplastics — but not antidepressants and immunosuppressants – as “drug categories and classes of clinical concern” for the 2015 coverage year. The rule addresses each of these provisions of the ACA in some manner. A CMS fact sheet is available.
In February 2014, CMS released a MLN Matters article here that delineates certain revisions to its standing guidance pertaining to the full implementation of edits on the ordering/referring providers in Medicare Part B, durable medical equipment (DME), and Part A Home Health Agency (HHA) Claims pursuant to this provision of the ACA.
On March 10, 2014, the Administration informed top Congressional leaders that it will not finalize some of the key changes to Part D that it had proposed in a draft regulation issued January 10. The elements of the Proposed Rule that the Administration will not finalize include: (1) Changes to the Six Protected Classes, which would have excluded mental health and immunosuppressive drugs from these protections (such as a requirement that plans cover all drugs in these classes), among other revisions; (2) Reductions in the number of plans a Part D sponsor may offer; (3) Limitations on the use of preferred pharmacies; and (4) New interpretation of the non-interference provisions. The Administration notes it will gather additional input and effectively reserves the right to advance changes in these areas in future years. But no changes will be made for the CY15 plan year. It will move forward with other elements of the Rule, as discussed in the Administration’s letter to Congressional members. A copy of the letter is available externally here.
On May 19, CMS issued a final rule on MA and Part D contract year 2015 technical changes. While the final rule codifies a number of fraud and abuse-related proposals, as signaled in an earlier letter to Congress the final rule does not adopt controversial proposed modifications to Part D protected drug classes or limitations on offering more than two Part D plans in a given region. The rule addresses each of these provisions of the ACA in some manner. A fact sheet is available here.
On Dec. 3, CMS issued a final rule to implement new safeguards intended to reduce Medicare fraud through enhanced provider oversight and beneficiary protections.
On Jan. 29, 2015, CMC announced the extension of the ACA-imposed temporary moratoria on enrollment of new ambulance suppliers and HHAs in select metropolitan areas (announcement here).
SEC. 6405. PHYSICIANS WHO ORDER ITEMS OR SERVICES REQUIRED TO BE MEDICARE ENROLLED PHYSICIANS OR ELIGIBLE PROFESSIONALS. (a) DME.—Section 1834(a)(11)(B) of the Social Security Act (42 U.S.C. 1395m(a)(11)(B)) is amended by striking ‘‘physician’’ and inserting ‘‘physician enrolled under section 1866(j) or an eligible professional under section 1848(k)(3)(B) that is enrolled under section 1866(j)’’. (b) HOME HEALTH SERVICES.—øReplaced by section 10603¿ (1) PART A.—Section 1814(a)(2) of the Social Security Act (42 U.S.C. 1395(a)(2)) is amended in the matter preceding subparagraph (A) by inserting ‘‘, or, in the case of services described in subparagraph (C), a physician enrolled under section 1866(j),’’ after ‘‘in collaboration with a physician,’’. (2) PART B.—Section 1835(a)(2) of the Social Security Act (42 U.S.C. 1395n(a)(2)) is amended in the matter preceding subparagraph (A) by inserting ‘‘, or, in the case of services described in subparagraph (A), a physician enrolled under section 1866(j),’’ after ‘‘a physician’’. (c) APPLICATION TO OTHER ITEMS OR SERVICES.—The Secretary may extend the requirement applied by the amendments made by subsections (a) and (b) to durable medical equipment and home health services (relating to requiring certifications and written orders to be made by enrolled physicians and health professions) to all other categories of items or services under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.), including covered part D drugs as defined in section 1860D–2(e) of such Act (42 U.S.C. 1395w–102), that are ordered, prescribed, or referred by a physician enrolled under section 1866(j) of such Act (42 U.S.C. 1395cc(j)) or an eligible professional under section 1848(k)(3)(B) of such Act (42 U.S.C. 1395w–4(k)(3)(B)). (d) EFFECTIVE DATE.—The amendments made by this section shall apply to written orders and certifications made on or after July 1, 2010.
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