HHS Seeks Comments on Medicare and State Health Care Programs
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A Proposed Rule by the Health and
Publication Date:
Agencies:
Dates: To ensure consideration, comments must be delivered to the
Entry Type: Proposed Rule
Action: Proposed rule.
Document Citation: 79 FR 59717
Page: 59717 -59733 (17 pages)
CFR: 42 CFR 1001
42 CFR 1003
RIN: 0936-AA06
Document Number: 2014-23182
Shorter URL: https://federalregister.gov/a/2014-23182
Action
Proposed Rule.
Summary
This proposed rule would amend the safe harbors to the anti-kickback statute and the civil monetary penalty (CMP) rules under the authority of the
DATES:
To ensure consideration, comments must be delivered to the address provided below by no later than
ADDRESSES:
In commenting, please reference file code
1. Electronically. You may submit electronically through the Federal eRulemaking Portal at http://www.regulations.gov. (Attachments should be in Microsoft Word, if possible.)
2. By regular, express, or overnight mail. You may mail your printed or written submissions to the following address:
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3. By hand or courier. You may deliver, by hand or courier, before the close of the comment period, your printed or written comments to:
Patrice Drew,Because access to the interior of the
Inspection of Public Comments: All comments received before the end of the comment period will be posted on http://www.regulations.gov for public viewing. Hard copies will also be available for public inspection at the
FOR FURTHER INFORMATION CONTACT:
Executive Summary
A. Need For Regulatory Action
MMA and ACA include exceptions to the anti-kickback statute, and BBA of 1997 and ACA include exceptions to the definition of "remuneration" under the civil monetary penalties law.
B. Summary of Major Provisions
1. Anti-Kickback Statute and Safe Harbors
We propose to amend 42 CFR 1001.952 by modifying certain existing safe harbors to the anti-kickback statute and by adding safe harbors that provide new protections or codify certain existing statutory protections. These changes include:
A technical correction to the existing safe harbor for referral services;
protection for certain cost-sharing waivers, including:
Pharmacy waivers of cost-sharing for financially needy
waivers of cost-sharing for emergency ambulance services furnished by State- or municipality-owned ambulance services;
protection for certain remuneration between
protection for discounts by manufacturers on drugs furnished to beneficiaries under the Medicare Coverage Gap Discount Program; and
protection for free or discounted local transportation services that meet specified criteria.
2. Civil Monetary Penalty Authorities
We propose to amend the definition of "remuneration" in the CMP regulations at 42 CFR 1003 by adding certain statutory exceptions for:
Copayment reductions for certain hospital outpatient department services;
certain remuneration that poses a low risk of harm and promotes access to care;
coupons, rebates, or other retailer reward programs that meet specified requirements;
certain remuneration to financially needy individuals; and
copayment waivers for the first fill of generic drugs.
We also propose to codify the gainsharing CMP set forth in section 1128A(b) of the Social Security Act (the Act) (42 U.S.C. 1320a-7a(b)).
C. Costs and Benefits
There are no significant costs associated with the proposed regulatory revisions that would impose any mandates on State, local, or tribal governments or on the private sector.
SUPPLEMENTARY INFORMATION:
This notice of proposed rulemaking is part of a rulemaking that was identified in the Unified Agenda by the title "
I. Background
A. Anti-Kickback Statute and Safe Harbors
Section 1128B(b) of the Act (42 U.S.C. 1320a-7b(b), the anti-kickback statute) provides criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit, or receive remuneration in order to induce or reward the referral of business reimbursable under Federal health care programs, as defined in section 1128B(f) of the Act. The offense is classified as a felony and is punishable by fines of up to
The types of remuneration covered specifically include, without limitation, kickbacks, bribes, and rebates, whether made directly or indirectly, overtly or covertly, in cash or in kind. In addition, prohibited conduct includes not only the payment of remuneration intended to induce or reward referrals of patients, but also the payment of remuneration intended to induce or reward the purchasing, leasing, or ordering of, or arranging for or recommending the purchasing, leasing, or ordering of, any good, facility, service, or item reimbursable by any Federal health care program.
Because of the broad reach of the statute, concern was expressed that some relatively innocuous commercial arrangements were covered by the statute and, therefore, potentially subject to criminal prosecution. In response,
Section 205 of the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191, established section 1128D of the Act, which includes criteria for modifying and establishing safe harbors. Specifically, section 1128D(a)(2) of the Act provides that, in modifying and establishing safe harbors, the Secretary of
An increase or decrease in access to health care services;
an increase or decrease in the quality of health care services;
an increase or decrease in patient freedom of choice among health care providers;
an increase or decrease in competition among health care providers;
an increase or decrease in the ability of health care facilities to provide services in medically underserved areas or to medically underserved populations;
an increase or decrease in the cost to Federal health care programs;
an increase or decrease in the potential overutilization of health care services;
the existence or nonexistence of any potential financial benefit to a health care professional or provider, which benefit may vary depending on whether the health care professional or provider decides to order a health care item or service or arrange for a referral of health care items or services to a particular practitioner or provider;
any other factors the Secretary deems appropriate in the interest of preventing fraud and abuse in Federal health care programs.
Since
Health care providers and others may voluntarily seek to comply with safe harbors so that they have the assurance that their business practices will not be subject to enforcement action under the anti-kickback statute, the CMP provision for anti-kickback violations, or the program exclusion authority related to kickbacks. We note, however, that compliance with a safe harbor insulates an individual or entity from liability under the anti-kickback statute and the beneficiary inducements CMP [2] only; individuals and entities remain responsible for complying with all other laws, regulations, and guidance that apply to their businesses. In authorizing the
Section 101 of MMA added a new section 1860D to the Act, establishing the Part D prescription drug benefit in the
ACA also includes a number of provisions that could affect liability under the anti-kickback statute. Section 3301 of ACA establishes the Medicare Coverage Gap Discount Program, codified at new section 1860D-14A of the Act (42 U.S.C. 1395w-114A). Pursuant to this program, prescription drug manufacturers have entered into agreements with the Secretary to provide certain beneficiaries access to discounts on drugs at the point of sale. Section 3301(d) of ACA amends the anti-kickback statute to protect the discounts provided for under the Medicare Coverage Gap Discount Program.
We are proposing to incorporate into our regulations safe harbors for payment and business practices permitted under MMA and ACA, as well as proposing new safe harbors pursuant to our authority under section 14 of the
B. Civil Monetary Penalty Authorities
1. Overview of OIG Civil Monetary Penalty Authorities
In 1981,
2. The Definition of "Remuneration"
The BBA of 1997 and section 6402(d)(2)(B) of ACA amended the definition of "remuneration" for purposes of the beneficiary inducements CMP at section 1128A(a)(5) of the Act, as discussed below. We propose to incorporate these changes into the definition of "remuneration" under proposed section 1003.110 [3] (current section 1003.101).
3. The Gainsharing CMP
99, the Omnibus Budget Reconciliation Act (OBRA) of 1986, authorized the Secretary to impose CMPs for certain incentive payments made to physicians by hospitals, risk-sharing health maintenance organizations (HMOs), and competitive medical plans. Over time, this provision, section 1128A(b) of the Act (the Gainsharing CMP), has been amended to repeal the provisions relating to HMOs and other risk-sharing entities and to make various other changes in terminology. [4] See section 6003(g)(3) of 101, OBRA of 1989; section 4204(a)(3) and 4731(b) of 101, OBRA of 1990; and section 4201(c) of the BBA of 1997.
Section 1128A(b)(1) prohibits a hospital or a critical access hospital from knowingly making a payment, directly or indirectly, to a physician as an inducement to reduce or limit services provided to
[*Federal RegisterVJ 2014-10-03]
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