Department of Health and Human Services - GPO

1 Vol. 79 Friday, No. 85 May 2, 2014 Part V Department of Health and Human Services Centers for Medicare & Medicaid Services 42 CFR Parts 405, 410, et al. Medicare Program; Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics; and Changes to Clinical Laboratory Improvement Amendments of 1988 Enforcement Actions for Proficiency Testing Referral; Final Rule VerDate Mar<15>2010 20:24 May 01, 2014 Jkt 232001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\ 02 MYR3mstockstill on DSK4 VPTVN1 PROD with RULES325436 Federal Register/ Vol.

2 79, No. 85 / Friday, May 2, 2014 / Rules and Regulations Department OF Health AND Human Services Centers for Medicare & Medicaid Services 42 CFR Parts 405, 410, 491, and 493 [CMS 1443 FC] RIN 0938 AR62 Medicare Program; Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics; and Changes to Clinical Laboratory Improvement Amendments of 1988 Enforcement Actions for Proficiency Testing Referral AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule with comment period. SUMMARY: This final rule with comment period implements methodology and payment rates for a prospective payment system (PPS) for federally qualified Health center (FQHC) Services under Medicare Part B beginning on October 1, 2014, in compliance with the statutory requirement of the Affordable Care Act.

3 In addition, it establishes a policy which allows rural Health clinics (RHCs) to contract with nonphysician practitioners when statutory requirements for employment of nurse practitioners and physician assistants are met, and makes other technical and conforming changes to the RHC and FQHC regulations. Finally, this final rule with comment period implements changes to the Clinical Laboratory Improvement Amendments (CLIA) regulations regarding enforcement actions for proficiency testing (PT) referrals. DATES: Effective Dates: The provisions of this final rule with comment period are effective on October 1, 2014, except for amendments to (b)(1), (a)(3), , , , and which are effective July 1, 2014.

4 Comment Period: We will consider comments on the subjects indicated in sections , and of this final rule with comment period received at one of the addresses provided below, no later than 5 on July 1, 2014. ADDRESSES: In commenting, please refer to file code CMS 1443 FC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation to Follow the Submit a comment instructions. 2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services , Department of Health and Human Services , Attention: CMS 1443 FC, Box 8013, Baltimore, MD 21244 1850.

5 Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services , Department of Health and Human Services , Attention: CMS 1443 FC, Mail Stop C4 26 05, 7500 Security Boulevard, Baltimore, MD 21244 1850. 4. By hand or courier. Alternatively, you may deliver (by hand or courier) your written comments ONLY to the following addresses prior to the close of the comment period: a. For delivery in Washington, DC Centers for Medicare & Medicaid Services , Department of Health and Human Services , Room 445 G, Hubert H.

6 Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201. (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) b. For delivery in Baltimore, MD Centers for Medicare & Medicaid Services , Department of Health and Human Services , 7500 Security Boulevard, Baltimore, MD 21244 1850. If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786 7195 in advance to schedule your arrival with one of our staff members.

7 Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Corinne Axelrod, (410) 786 5620 for FQHCs and RHCs. Melissa Singer, (410) 786 0365 for CLIA Enforcement Actions for Proficiency Testing Referral. Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: Follow the search instructions on that Web site to view public comments.

8 Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services , 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 to 4 To schedule an appointment to view public comments, phone 1 800 743 3951. SUPPLEMENTARY INFORMATION: Acronyms ACS American Community Survey AI/AN American Indian/Alaskan Native AIR All-Inclusive Rate APCP Advanced Primary Care Practice BLS Bureau of Labor Statistics CCM Chronic Care Management CCN CMS Certification Number CCR Cost-To-Charge Ratio CFR Code of Federal Regulations CLIA Clinical Laboratory Improvement Amendments of 1988 CMP Civil Monetary Penalty CMS Centers for Medicare & Medicaid Services CNM Certified Nurse Midwife CP Clinical Psychologist CR Change Request CSW Clinical Social Worker CY Calendar Year DSMT Diabetes Self-Management Training EHR Electronic Health Record E/M Evaluation and Management

9 FQHC Federally Qualified Health Center FSHCAA Federally Supported Health Centers Assistance Act FTCA Federal Tort Claims Act GAF Geographic Adjustment Factor GAO Government Accountability Office GPCI Geographic Practice Cost Index HCPCS Healthcare Common Procedure Coding System HCRIS Healthcare Cost Report Information System HBV Hepatitis B Vaccines HRSA Health Resources and Services Administration IDR Integrated Data Repository IPPE Initial Preventive Physical Exam MA Medicare Advantage MAC Medicare Administrative Contractor VerDate Mar<15>2010 20:24 May 01, 2014 Jkt 232001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\ 02 MYR3mstockstill on DSK4 VPTVN1 PROD with RULES325437 Federal Register/ Vol.

10 79, No. 85 / Friday, May 2, 2014 / Rules and Regulations MCO Managed Care Organization MEI Medicare Economic Index MIPPA Medicare Improvements for Patients and Providers Act MNT Medical Nutrition Therapy MSA Metropolitan Statistical Area NP Nurse Practitioner OBRA Omnibus Budget Reconciliation Act PA Physician Assistant PHS Public Health Service PFS Physician Fee Schedule PPS Prospective Payment System PT Proficiency testing RIA Regulatory Impact Analysis RHC Rural Health Clinic SNF Skilled Nursing Facility UDS Uniform Data System UPL Upper Payment Limit Table of Contents I. Executive Summary and Background A. Executive Summary 1.