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Effective after January 1, 2010, with some exceptions, increases the amount of applicable civil monetary penalties (CMPs) for false statements or delaying inspections – up to $50,000 for each false record or statement and $15,000 for each day of failure. Delineates changes to MA and Part D plans to ensure timely inspections relating to contracts with MA organizations.
Prior to January 2013, it does not appear that CMS issued guidance pursuant to this provision.
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.
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 May 8, 2014, the OIG issued a proposed rule delineating revisions to the OIG’s exclusion authority that aim to expand the agency’s fraud and abuse oversight of Federal health care programs. In particular, the regulation codifies statutory changes made by the Affordable Care Act (ACA) – including those delineated at sections 6402 (enhanced Medicare and Medicaid program integrity), 6406 (provider documentation), and 6408 (enhanced penalties) – that expand the OIG’s fraud and abuse oversight authorities. Finally, the regulation updates exclusion-related language pursuant to changes made by the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA). Additional information is available HHS here. Comments are due by July 8. Also, following the May 8 regulation, the OIG on May 9 issued a proposed rule that would incorporate new CMP authorities and make clarifying updates to associated regulations that stem from provisions of the ACA and Medicare Prescription Drug, Improvement and Modernization Act. Comments are due by July 11.
2016
On Dec. 7, 2016, the HHS Office of Inspector General (OIG) published a final rule in the Federal Register incorporating the changes made by the ACA to the definition of “remuneration.”
2017
On Jan. 11, the 2017 HHS OIG published a final rule in the Federal Register that amended regulations relating to the OIG’s exclusion authorities. The rule included statutory changes made by the ACA and the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).
SEC. 6408. ENHANCED PENALTIES. (a) CIVIL MONETARY PENALTIES FOR FALSE STATEMENTS OR DE- LAYING INSPECTIONS.—Section 1128A(a) of the Social Security Act (42 U.S.C. 1320a–7a(a)), as amended by section 5002(d)(2)(A), is amended— (1) in paragraph (6), by striking ‘‘or’’ at the end; and (2) by inserting after paragraph (7) the following new paragraphs: ‘‘(8) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim for payment for items and services furnished under a Federal health care program; or ‘‘(9) fails to grant timely access, upon reasonable request (as defined by the Secretary in regulations), to the Inspector General of the Department of Health and Human Services, for the purpose of audits, investigations, evaluations, or other statutory functions of the Inspector General of the Department of Health and Human Services;’’; and (3) in the first sentence— (A) by striking ‘‘or in cases under paragraph (7)’’ and inserting ‘‘in cases under paragraph (7)’’; and (B) by striking ‘‘act)’’ and inserting ‘‘act, in cases under paragraph (8), $50,000 for each false record or statement, or in cases under paragraph (9), $15,000 for each day of the failure described in such paragraph)’’. (b) MEDICARE ADVANTAGE AND PART D PLANS.— (1) ENSURING TIMELY INSPECTIONS RELATING TO CONTRACTS WITH MA ORGANIZATIONS.—Section 1857(d)(2) of such Act (42 U.S.C. 1395w–27(d)(2)) is amended— (A) in subparagraph (A), by inserting ‘‘timely’’ before ‘‘inspect’’; and (B) in subparagraph (B), by inserting ‘‘timely’’ before ‘‘audit and inspect’’. (2) MARKETING VIOLATIONS.—Section 1857(g)(1) of the Social Security Act (42 U.S.C. 1395w–27(g)(1)) is amended— (A) in subparagraph (F), by striking ‘‘or’’ at the end; (B) by inserting after subparagraph (G) the following new subparagraphs: ‘‘(H) except as provided under subparagraph (C) or (D) of section 1860D–1(b)(1), enrolls an individual in any plan under this part without the prior consent of the individual or the designee of the individual; ‘‘(I) transfers an individual enrolled under this part from one plan to another without the prior consent of the individual or the designee of the individual or solely for the purpose of earning a commission; ‘‘(J) fails to comply with marketing restrictions described in subsections (h) and (j) of section 1851 or applicable implementing regulations or guidance; or ‘‘(K) employs or contracts with any individual or entity who engages in the conduct described in subparagraphs (A) through (J) of this paragraph;’’; and (C) by adding at the end the following new sentence: ‘‘The Secretary may provide, in addition to any other remedies authorized by law, for any of the remedies described in paragraph (2), if the Secretary determines that any employee or agent of such organization, or any provider or supplier who contracts with such organization, has engaged in any conduct described in subparagraphs (A) through (K) of this paragraph.’’. (3) PROVISION OF FALSE INFORMATION.—Section 1857(g)(2)(A) of the Social Security Act (42 U.S.C. 1395w– 27(g)(2)(A)) is amended by inserting ‘‘except with respect to a determination under subparagraph (E), an assessment of not more than the amount claimed by such plan or plan sponsor based upon the misrepresentation or falsified information involved,’’ after ‘‘for each such determination,’’. (c) OBSTRUCTION OF PROGRAM AUDITS.—Section 1128(b)(2) of the Social Security Act (42 U.S.C. 1320a–7(b)(2)) is amended— (1) in the heading, by inserting ‘‘OR AUDIT’’ after ‘‘INVESTIGATION’’; and (2) by striking ‘‘investigation into’’ and all that follows through the period and inserting ‘‘investigation or audit related to—’’ ‘‘(i) any offense described in paragraph (1) or in subsection (a); or ‘‘(ii) the use of funds received, directly or indirectly, from any Federal health care program (as defined in section 1128B(f)).’’. (d) EFFECTIVE DATE.— (1) IN GENERAL.—Except as provided in paragraph (2), the amendments made by this section shall apply to acts committed on or after January 1, 2010. (2) EXCEPTION.—The amendments made by subsection (b)(1) take effect on the date of enactment of this Act.
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