United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2001_register executive 2010-09-24 article Part II Rules and Regulations D09002ee1c81e87ba D09002ee1c81e8885 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Health Care Financing Administration originator org United States Government Agency or Subagency This final rule with 90-day comment period (Phase I of this rulemaking) incorporates into regulations the provisions in paragraphs (a), (b), and (h) of section 1877 of the Social Security Act (the Act). Under section 1877, if a physician or a member of a physician's immediate family has a financial relationship with a health care entity, the physician may not make referrals to that entity for the furnishing of designated health services (DHS) under the Medicare program, unless an exception applies. The following services are DHS: clinical laboratory services; physical therapy services; occupational therapy services; radiology services, including magnetic resonance imaging, computerized axial tomography scans, and ultrasound services; radiation therapy services and supplies; durable medical equipment and supplies; parenteral and enteral nutrients, equipment, and supplies; prosthetics, orthotics, and prosthetic devices and supplies; home health services; outpatient prescription drugs; and inpatient and outpatient hospital services. In addition, section 1877 of the Act provides that an entity may not present or cause to be presented a Medicare claim or bill to any individual, third party payer, or other entity for DHS furnished under a prohibited referral, nor may we make payment for a designated health service furnished under a prohibited referral. Paragraph (a) of section 1877 of the Act includes the general prohibition. Paragraph (b) of the Act includes exceptions that pertain to both ownership and compensation relationships, including an in- office ancillary services exception. Paragraph (h) includes definitions that are used throughout section 1877 of the Act, including the group practice definition and the definitions for each of the DHS. We intend to publish a second final rule with comment period (Phase II of this rulemaking) shortly addressing, to the extent necessary, the remaining sections of the Act. Phase II of this rulemaking will address comments concerning the ownership and investment exceptions in paragraphs (c) and (d) and the compensation exceptions in paragraph (e) of section 1877 of the Act. Phase II of this rulemaking will also address comments concerning the reporting requirements and sanctions provided by paragraphs (f) and (g) of the Act, respectively, and include further consideration of the general exception to the referral prohibition related to both ownership/investment and compensation for services furnished in an ambulatory surgical center (ASC), end-stage renal dialysis facility, or by a hospice in Sec. 411.355(d) of the regulations (this exception presently is in force and effect as to clinical laboratory services). In addition, Phase II of this rulemaking will address section 1903(s) of the Act, which extends aspects of the referral prohibition to the Medicaid Program. Phase II will also address comments received in response to this rulemaking, as appropriate, and certain proposals for new exceptions to section 1877 of the Act not included in the 1998 proposed rulemaking, but suggested in the public comments. 66 FR 856 https://www.govinfo.gov/app/details/FR-2001-01-04/01-4 01-4 fr04ja01-16 RIN 0938-AG80 4120-03-P HCFA-1809-FC https://www.govinfo.gov/app/details/FR-2001-01-04/01-4 https://www.govinfo.gov/content/pkg/FR-2001-01-04/html/01-4.htm https://www.govinfo.gov/content/pkg/FR-2001-01-04/pdf/01-4.pdf Kidney Diseases Medicare Physician Referral Reporting and Recordkeeping Requirements Emergency Medical Services Health Facilities Health Professions 110 p. 856 965 66 FR 856 Title 42 Part 411 42 CFR Part 411 Title 42 Part 424 42 CFR Part 424 RIN 0938-AG80 Medicare and Medicaid Programs; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships; Federal Register Vol. 66, Issue RULE 01-4 II DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Care Financing Administration 2002-01-04 HCFA-1809-FC 4120-03-P 01-4 Final rule with comment period.

This final rule with 90-day comment period (Phase I of this rulemaking) incorporates into regulations the provisions in paragraphs (a), (b), and (h) of section 1877 of the Social Security Act (the Act). Under section 1877, if a physician or a member of a physician's immediate family has a financial relationship with a health care entity, the physician may not make referrals to that entity for the furnishing of designated health services (DHS) under the Medicare program, unless an exception applies. The following services are DHS: clinical laboratory services; physical therapy services; occupational therapy services; radiology services, including magnetic resonance imaging, computerized axial tomography scans, and ultrasound services; radiation therapy services and supplies; durable medical equipment and supplies; parenteral and enteral nutrients, equipment, and supplies; prosthetics, orthotics, and prosthetic devices and supplies; home health services; outpatient prescription drugs; and inpatient and outpatient hospital services. In addition, section 1877 of the Act provides that an entity may not present or cause to be presented a Medicare claim or bill to any individual, third party payer, or other entity for DHS furnished under a prohibited referral, nor may we make payment for a designated health service furnished under a prohibited referral. Paragraph (a) of section 1877 of the Act includes the general prohibition. Paragraph (b) of the Act includes exceptions that pertain to both ownership and compensation relationships, including an in- office ancillary services exception. Paragraph (h) includes definitions that are used throughout section 1877 of the Act, including the group practice definition and the definitions for each of the DHS. We intend to publish a second final rule with comment period (Phase II of this rulemaking) shortly addressing, to the extent necessary, the remaining sections of the Act. Phase II of this rulemaking will address comments concerning the ownership and investment exceptions in paragraphs (c) and (d) and the compensation exceptions in paragraph (e) of section 1877 of the Act. Phase II of this rulemaking will also address comments concerning the reporting requirements and sanctions provided by paragraphs (f) and (g) of the Act, respectively, and include further consideration of the general exception to the referral prohibition related to both ownership/investment and compensation for services furnished in an ambulatory surgical center (ASC), end-stage renal dialysis facility, or by a hospice in Sec. 411.355(d) of the regulations (this exception presently is in force and effect as to clinical laboratory services). In addition, Phase II of this rulemaking will address section 1903(s) of the Act, which extends aspects of the referral prohibition to the Medicaid Program. Phase II will also address comments received in response to this rulemaking, as appropriate, and certain proposals for new exceptions to section 1877 of the Act not included in the 1998 proposed rulemaking, but suggested in the public comments.

Effective date: The regulations delineated in Phase I of this rulemaking are effective on January 4, 2002 except for Sec. 424.22(d), which is effective on February 5, 2001. Joanne Sinsheimer, (410) 786-4620. Kidney Diseases Medicare Physician Referral Reporting and Recordkeeping Requirements Emergency Medical Services Health Facilities Health Professions Medicare and Medicaid: Physicians referrals to health care entities with which they have financial relationships, http://www.access.gpo.gov/nara_docs/ http://www.dhhs.oig/gov http://www.hcfa.gov http://www.hcfa.gov/pubforms/progman.htm http://www.hcfa.gov/regs/regsnotices.htm swais.access.gpo.gov www.hcfa.gov/stats/pufiles.htm Vol. 66, no. 3 Office of the Federal Register, National Archives and Records Administration 2001-01-04 continuing daily deposited born digital 316 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2001-01-04 P0b002ee180a08afd 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr04ja01 https://www.govinfo.gov/app/details/FR-2001-01-04 https://www.govinfo.gov/content/pkg/FR-2001-01-04/pdf/FR-2001-01-04.pdf https://www.govinfo.gov/content/pkg/FR-2001-01-04/xml/FR-2001-01-04.xml fdlp 705 1011 DGPO 2010-09-24 2024-06-08 FR-2001-01-04 machine generated eng FR FR-2001-01-04 66 3