Federal Register / Vol. 64, No. 7 / Tuesday, January 12, 1999 / Notices 1813

IV. Key to the OPO Codes • The accuracy of our estimate of the DEPARTMENT OF HEALTH AND The key to the acronyms used in the information collection burden. HUMAN SERVICES listings to identify OPOs and their • The quality, utility, and clarity of Office of Inspector General addresses is as follows: the information to be collected. DCTC—Washington Regional • Recommendations to minimize the Publication of OIG Special Fraud Alert Transplant Consortium, 8110 Gateway information collection burden on the on Physician Liability for Certifications Road, Suite 101 W, Falls Church, VA affected public, including automated in the Provision of Medical Equipment 22042 collection techniques. and Supplies and Home Health MAOB—New England Organ Bank, One Services Gateway Center, Newton, MA 02158 Therefore, we are soliciting public MIOP—Organ Procurement Agency of comment on the information collection AGENCY: Office of Inspector General Michigan, 2203 Platt Road, Ann requirements for the issue described (OIG), HHS. Arbor, MI 48104 below. ACTION: Notice MNOP—Lifesource, Upper Midwest Designation of one OPO for each SUMMARY: This Federal Register notice Organ Procurement Organization Inc., service area: 2550 University Avenue West, Suite sets forth a recently issued OIG Special 315 South, St. Paul, MN 55114–1904 Section 486.316(e) states the Fraud Alert concerning physician MSOP—Mississippi Organ Recovery requirements for a Medicare or liability for certifications in the Agency, Inc., 12 River Bend Place, Medicaid participating hospital to provision of medical equipment and Suite B, Jackson, MS 39208 request a waiver permitting the hospital supplies and home health services. For NYAP—OPO of Albany Medical to have an agreement with a designated the most part, OIG Special Fraud Alerts College, 47 Scotland Avenue, AP8, OPO other than the OPO designated for address national trends in health care Albany, NY 12208 the service area in which the hospital is fraud, including potential violations of NYFL—Finger Lakes Donor Recovery located. However, the burden associated the Medicare anti-kickback statute. This Network, Corporate Woods of with these requirements is currently Special Fraud Alert, issued to the health Brighton, Building 120, Suite 180, approved under OMB 0938–0688, care provider community and now Rochester, NY 14623 HCFA–R–13, Conditions of Coverage for being reprinted in this issue of the NYWN—Upstate New York Transplant Organ Procurement Organizations, with Federal Register, specifically highlights Services, Inc., 165 Genesee Street, physicians’ responsibilities in making Suite 103, Buffalo, NY 14209 an expiration date of November 30, 1999. certifications for home health services OHLC—Life Connection of Ohio, 1545 and durable medical equipment, and the Holland Road, Suite C, Maumee, OH If you comment on any of these legal significance of the certifications. 43537 information collection and record FOR FURTHER INFORMATION CONTACT: Joel OHLP—Lifeline of Ohio, 770 Kinnear keeping requirements, please mail J. Schaer, Office of Counsel to the Road, Suite 200, Columbus, OH 43212 copies directly to the following: TNMS—Mid-South Transplant Inspector General, (202) 619–0089. Foundation, 956 Court Avenue, Health Care Financing Administration, SUPPLEMENTARY INFORMATION: Memphis, TN 38163 Office of Information Services, I. Background VAOP—Virginia Organ Procurement Security and Standards Groups, Agency, 1527 Huguenot Road, Division of HCFA Enterprise The Office of Inspector General (OIG) Midlothian, VA 23113 Standards, Attention: Louis Blank, issues Special Fraud Alerts based on WISE—Wisconsin Donor Network, HCFA–1062–NC, Room N2–14–26, information it obtains concerning particular fraudulent or abusive Froedtert Memorial Lutheran Hospital 7500 Security Boulevard, Baltimore, practices within the health care 9200 West Wisconsin Avenue, MD 21244–1850, and Milwaukee, WI 53226 industry. WIUW—University of Wisconsin OPO, Office of Information and Regulatory Special Fraud Alerts are intended for University of Wisconsin Hospital and Affairs, Office of Management and widespread dissemination to the health Clinics, 600 Highland Avenue, Budget, Attention: Allison Eydt, care provider community, as well as Madison, WI 53792 HCFA Desk Officer, Room 10235, those charged with administering the New Executive Office Building, Medicare and Medicaid programs. To V. Collection of Information Washington, DC 20503. date, the OIG has published in the Requirements Federal Register the texts of 9 Authority: Section 1138 of the Social 1 Under the Paperwork Reduction Act Security Act (42 U.S.C. 1320b–8). previously-issued Special Fraud Alerts. of 1995, we are required to provide 60­ It is the OIG’s intention to publish (Catalog of Federal Domestic Assistance day notice in the Federal Register and future Special Fraud Alerts in this same Program No. 93.773, Medicare—Hospital solicit public comment before a manner as a regular part of our Insurance; Program No. 93.774 Medicare— collection of information requirement is dissemination of such information.2 Supplementary Medical Insurance, and submitted to the Office of Management In an effort to promote voluntary Program No. 93.778, Medical Assistance compliance in the health care industry and Budget (OMB) for review and Program) approval. In order to fairly evaluate and assist providers in their compliance whether an information collection Dated: January 5, 1999. efforts, the OIG has developed a Special requirement should be approved by Robert A. Berenson, Fraud Alert, set forth below, that OMB, section 3506(c)(2)(A) of the Director, Center for Health Plans and addresses potential problem areas with Paperwork Reduction Act of 1995 Providers, Health Care Financing requires that we solicit comment on the Administration. 1 See December 19, 1994 (59 FR 65372); August following issues: [FR Doc. 99–630 Filed 1–11–99; 8:45 am] 10, 1995 (60 FR 40847); June 17, 1996 (61 FR • 30623); and April 24, 1998 (63 FR 20415). The need for the information BILLING CODE 4120±01±P 2 All OIG Special Fraud Alerts are also available collection and its usefulness in carrying on the internet at the OIG web site at http:// out the proper functions of our agency. www.dhhs.gov/progorg/oig/frdalrt/index.htm. 1814 Federal Register / Vol. 64, No. 7 / Tuesday, January 12, 1999 / Notices regard to physician certification in the disregard as to the truth of the discharge their responsibility to assess provision of medical equipment and information being submitted. While a their patients’ conditions and need for supplies and home health services. physician’s signature on a false or home health care. Similarly, the OIG has Among other things, this newly-issued misleading certification made through found numerous examples of physicians Special Fraud Alert addresses: (1) the mistake, simple negligence, or who have ordered DME or signed CMNs importance of physician certification for inadvertence will not result in personal for DME without reviewing the medical Medicare; (2) how improper physician liability, the physician may unwittingly necessity for the item or even knowing certifications foster fraud; and (3) be facilitating the perpetration of fraud the patient. potential consequences for knowingly on Medicare by suppliers or providers. signing a false or misleading Accordingly, we urge all physicians to Physician Certification for Home Health certification, or signing with reckless review and familiarize themselves with Services disregard for the truth. A reprint of this the information in this Fraud Alert. If a Medicare will pay a Medicare­ Special Fraud Alert follows. physician has any questions as to the certified home health agency for home application of these requirements to health care provided under a II. Special Fraud Alert: Physician specific facts, the physician should physician’s plan of care to a patient Liability for Certifications in the contact the appropriate Medicare Fiscal confined to the home. Covered services Provision of Medical Equipment and Intermediary or Carrier. may include skilled nursing services, Supplies and Home Health Services home health aide services, physical and (January 1999) The Importance of Physician occupational therapy and speech Certification for Medicare The Office of Inspector General (OIG) language pathology, medical social was established at the Department of The Medicare program only pays for services, medical supplies (other than Health and Human Services by Congress health care services that are medically drugs and biologicals), and DME. in 1976 to identify and eliminate fraud, necessary. In determining what services As a condition for payment, Medicare waste, and abuse in the Department’s are medically necessary, Medicare requires a patient’s treating physician to programs and to promote efficiency and primarily relies on the professional certify initially and recertify at least economy in departmental operations. judgment of the beneficiary’s treating every 62 days (2 months) that: The OIG carries out this mission physician, since he or she knows the • The patient is confined to the home; through a nationwide program of audits, patient’s history and makes critical • The individual needs or needed (i) inspections, and investigations. decisions, such as admitting the patient intermittent skilled nursing care; (ii) To reduce fraud and abuse in the to the hospital; ordering tests, drugs, speech or physical therapy or speech­ Federal health care programs, including and treatments; and determining the language pathology services; or (iii) Medicare and Medicaid, the OIG length of treatment. In other words, the occupational therapy or a continued actively investigates fraudulent schemes physician has a key role in determining need for occupational therapy (payment that obtain money from these programs both the medical need for, and for occupational therapy will be made and, when appropriate, issues Special utilization of, many health care services, only upon an initial certification that Fraud Alerts that identify segments of including those furnished and billed by includes care under (i) or (ii) or a the health care industry that are other providers and suppliers. recertification where the initial particularly vulnerable to abuse. Copies Congress has conditioned payment for certification included care under (i) or of all OIG Special Fraud Alerts are many Medicare items and services on a (ii)); available on the internet at http:// certification signed by a physician • A plan of care has been established www.dhhs.gov/progorg/oig/frdalrt/ attesting that the item or service is and periodically reviewed by the index.htm. medically necessary. For example, physician; and We are issuing this Fraud Alert physicians are routinely required to • The services are (were) furnished because physicians may not appreciate certify to the medical necessity for any while the patient is (was) under the care the legal and programmatic significance service for which they submit bills to of a physician. of certifications they make in the Medicare program. The physician must order the home connection with the ordering of certain Physicians also are involved in health services, either orally or in items and services for their Medicare attesting to medical necessity when writing, prior to the services being patients. While the OIG believes that the ordering services or supplies that must furnished. The physician certification actual incidence of physicians’ be billed and provided by an must be obtained at the time the plan of intentionally submitting false or independent supplier or provider. treatment is established or as soon misleading certifications of medical Medicare requires physicians to certify thereafter as possible. The physician necessity for durable medical to the medical necessity for many of certification must be signed and dated equipment or home health care is these items and services through prior to the submission of the claim to relatively infrequent, physician laxity in prescriptions, orders, or, in certain Medicare. If a physician has any reviewing and completing these specific circumstances, Certificates of questions as to the application of these certifications contributes to fraudulent Medical Necessity (CMNs). These requirements to specific facts, the and abusive practices by unscrupulous documentation requirements physician should contact the suppliers and home health providers. substantiate that the physician has appropriate Medicare Fiscal We urge physicians and their staff to reviewed the patient’s condition and Intermediary or Carrier. report any suspicious activity in has determined that services or supplies connection with the solicitation or are medically necessary. Physician Orders and Certificates of completion of certifications to the OIG. Two areas where the documentation Medical Necessity for Durable Medical Physicians should also be aware that of medical necessity by physician Equipment, Prosthetics, Orthotics, and they are subject to substantial criminal, certification plays a key role are (i) Supplies for Home Use civil, and administrative penalties if home health services and (ii) durable DME is equipment that can withstand they sign a certification knowing that medical equipment (DME). Through repeated use, is primarily used for a the information relating to medical various OIG audits, we have discovered medical purpose, and is not generally necessity is false, or with reckless that physicians sometimes fail to used in the absence of illness or injury. Federal Register / Vol. 64, No. 7 / Tuesday, January 12, 1999 / Notices 1815

Examples include hospital beds, • Section C contains a description of investigations of fraud in the provision wheelchairs, and oxygen delivery the equipment and its cost. Section C is of home health services and medical systems. Medicare will cover medical completed by the supplier. equipment and supplies: supplies that are necessary for the • Section D is the treating physician’s A physician knowingly signs a effective use of DME, as well as surgical attestation and signature, which certifies number of forms provided by a home dressings, catheters, and ostomy bags. that the physician has reviewed sections health agency that falsely represent that However, Medicare will only cover A, B, and C of the CMN and that the skilled nursing services are medically DME and supplies that have been information in section B is true, necessary in order to qualify the patient ordered or prescribed by a physician. accurate, and complete. Section D must for home health services. The order or prescription must be be signed by the treating physician. A physician certifies that a patient is personally signed and dated by the Signature stamps and date stamps are confined to the home and qualifies for patient’s treating physician. not acceptable. home health services, even though the DME suppliers that submit bills to By signing the CMN, the physician patient tells the physician that her only Medicare are required to maintain the represents that: • restrictions are due to arthritis in her physician’s original written order or He or she is the patient’s treating hands, and she has no restrictions on prescription in their files. The order or physician and the information regarding her routine activities, such as grocery prescription must include: the physician’s address and unique shopping. • The beneficiary’s name and full physician identification number (UPIN) At the prompting of a DME supplier, address; is correct; a physician signs a stack of blank CMNs • The physician’s signature; The entire CMN, including the • for transcutaneous electrical nerve The date the physician signed the sections filled out by the supplier, was stimulators (TENS) units. The CMNs are prescription or order; completed prior to the physician’s • later completed with false information A description of the items needed; signature; and in support of fraudulent claims for the • The start date of the order (if The information in section B relating equipment. The false information appropriate); and to medical necessity is true, accurate, purports to show that the physician the diagnosis (if required by Medicare and complete to the best of the ordered and certified to the medical program policies) and a realistic physician’s knowledge. estimate of the total length of time the necessity for the TENS units for which Improper Physician Certifications Foster equipment will be needed (in months or the supplier has submitted claims. Fraud years). A physician signs CMNs for For certain items or supplies, Unscrupulous suppliers and respiratory medical equipment falsely including supplies provided on a providers may steer physicians into representing that the equipment was periodic basis and drugs, additional signing or authorizing improper medically necessary. information may be required. For certifications of medical necessity. In A physician signs CMNs for supplies provided on a periodic basis, some instances, the certification forms wheelchairs and hospital beds without appropriate information on the quantity or statements are completed by DME seeing the patients, then falsifies his used, the frequency of change, and the suppliers or home health agencies and medical charts to indicate that he duration of need should be included. If presented to the physician, who then treated them. drugs are included in the order, the signs the forms without verifying the A physician accepts anywhere from dosage, frequency of administration, actual need for the items or services. In $50 to $400 from a DME supplier for and, if applicable, the duration of many cases, the physician may obtain each prescription he signs for oxygen infusion and concentration should be no personal benefit when signing these concentrators and nebulizers. included. unverified orders and is only Potential Consequences for Unlawful Medicare further requires claims for accommodating the supplier or Acts payment for certain kinds of DME to be provider. While a physician’s signature accompanied by a CMN signed by a on a false or misleading certification A physician is not personally liable treating physician (unless the DME is made through mistake, simple for erroneous claims due to mistakes, prescribed as part of a plan of care for negligence, or inadvertence will not inadvertence, or simple negligence. home health services). When a CMN is result in personal liability, the However, knowingly signing a false or required, the provider or supplier must physician may unwittingly be misleading certification or signing with keep the CMN containing the treating facilitating the perpetration of fraud on reckless disregard for the truth can lead physician’s original signature and date Medicare by suppliers or providers. to serious criminal, civil, and on file. When the physician knows the administrative penalties including: Generally, a CMN has four sections: information is false or acts with reckless Criminal prosecution; • Section A contains general disregard as to the truth of the Fines as high as $10,000 per false information on the patient, supplier, statement, such physician risks claim plus treble damages; or and physician. Section A may be criminal, civil, and administrative administrative sanctions including: completed by the supplier. penalties. exclusion from participation in Federal • Section B contains the medical Sometimes, a physician may receive health care programs, withholding or necessity justification for DME. This compensation in exchange for his or her recovery of payments, and loss of cannot be filled out by the supplier. signature. Compensation can take the license or disciplinary actions by state Section B must be completed by the form of cash payments, free goods, or regulatory agencies. physician, a non-physician clinician any other thing of value. Such cases Physicians may violate these laws involved in the care of the patient, or a may trigger additional criminal and civil when, for example: physician employee. If the physician penalties under the anti-kickback They sign a certification as a did not personally complete section B, statute. ‘‘courtesy’’ to a patient, service the name of the person who did The following are examples of provider, or DME supplier when they complete section B and his or her title inappropriate certifications uncovered have not first made a determination of and employer must be specified. by the OIG in the course of its medical necessity; 1816 Federal Register / Vol. 64, No. 7 / Tuesday, January 12, 1999 / Notices

They knowingly or recklessly sign a or suppliers, physicians may be liable companies engaging in any of the false or misleading certification that for making false or misleading activities described above, contact any causes a false claim to be submitted to certifications. of the regional offices of the Office of a Federal health care program; or What To Do If You Have Information Investigations of the Office of Inspector They receive any financial benefit General, U.S. Department of Health and for signing the certification (including About Fraud and Abuse Against Medicare or Medicaid Programs Human Services, at the following free or reduced rent, patient referrals, locations: supplies, equipment, or free labor). If you have information about Even if they do not receive any physicians, home health agencies, or financial or other benefit from providers medical equipment and supply

Field offices States served Telephone

Boston ...... MA, VT, NH, 617±565±2664 ME, RI, CT New York ...... NY, NJ, PR, VI 212±264±1691 Philadelphia ...... PA, MD, DE, 215±861±4586 WV, VA, DC Atlanta ...... GA, KY, NC, 404±562±7603 SC, FL, TN, AL, MS Chicago ...... IL, MN, WI, MI, 312±353±2740 IN, OH, IA, MO Dallas ...... TX, NM, OK, 214±767±8406 AR, LA, CO, UT, WY, MT, ND, SD, NE, KS Los Angeles ...... AZ, NV, So. CA 714±246±8302 San Francisco ...... No. CA, AK, HI 415±437±7961 OR, ID, WA

To Report Suspected Fraud, Call or effectiveness of various approaches to the Panel’s mission. Individuals Write: 1–800-HHS-TIPS (1–800–447– teaching children how to read and desiring an opportunity to speak before 8477), Department of Health and Human report on the best ways to apply these the Panel should address their requests Services, Office of Inspector General, findings in classrooms and at home. Its to F. William Dommel, Jr., J.D., P.O. Box 23489, L’Enfant Plaza Station, members include prominent reading Executive Director, National Reading Washington, D.C. 20026–3489. researchers, teachers, child Panel, c/o Ms. Amy Andryszak and Dated: January 6, 1999. development experts, leaders in either mail them to the Widmeyer-Baker June Gibbs Brown, elementary and higher education, and Group, 1875 Connecticut Avenue, NW, Inspector General. parents. The Chair of the Panel is Dr. Suite 800, Washington, DC 20009, or e­ Donald N. Langenberg, Chancellor of the [FR Doc. 99–631 Filed 1–11–99; 8:45 am] mail them to [email protected], or fax University System of Maryland. BILLING CODE 4150±04±P them to 202–667–0902. Requests for The Panel will build on the recently addressing the Panel should be received announced findings presented by the by January 15, 1999. Panel business DEPARTMENT OF HEALTH AND National Research Council’s Committee permitting, each public speaker will be HUMAN SERVICES on the Prevention of Reading allowed five minutes to present his or Difficulties in Young Children. Based on her views. In the event of a large National Institutes of Health a review of the literature, the Panel will: number of public speakers, the Panel determine the readiness for application National Institute of Child Health and in the classroom of the results of these Chair retains the option to further limit Human Development; Meeting of the research studies; identify appropriate the presentation time allowed to each. National Reading Panel means to rapidly disseminate this Although the time permitted for oral information to facilitate effective presentations will be brief, the full text Notice is hereby given of the fifth of all written comments submitted to Washington area meeting of the reading instruction in the schools; and the Panel will be made available to the National Reading Panel. The meeting identify gaps in the knowledge base for Panel members for consideration. will be held on Thursday, January 21, reading instruction and the best ways to 1999, from 12:30 to 6:00 PM at the close these gaps. For further information contact Ms. Holiday Inn Georgetown, 2101 The agenda for this meeting will Amy Andryszak at 202–667–0901. Wisconsin Avenue, NW, Washington, include discussing the Individuals who plan to attend and DC 20007. The entire meeting will be recommendations made by the science need special assistance, such as sign open to the public. members of the National Reading Panel, language interpretation or other The National Reading Panel was who have been developing a proposed reasonable accommodations, should requested by Congress and created by methodology to select and evaluate contact Ms. Amy Andryszak by January the Director of the National Institute of research studies. A period of time will 15, 1999. Child Health and Human Development be set aside at approximately 4:00 PM in consultation with the Secretary of for members of the public to address the Education. The Panel will study the Panel and express their view regarding