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Medicare Department of Health andHuman Services (DHHS)

Carriers Manual HEALTH CARE FINANCINGADMINISTRATION (HCFA)

Part 3 - Claims ProcessTransmittal 1704 Date: MAY 25, 2001

These manual sections incorporate instructions previously issued in a memorandum to HCFAAssociate Regional Administrators in August of 1996 on Medicare Coverage of and Processingof Claims for Investigational Devices. This action is merely a manualization of theseinstructions. Coverage of certain investigational devices became effective on November 1,1995.

HEADER SECTION NUMBERS PAGES TO INSERT PAGES TO DELETE

Table of Contents - Chapter II 2-3 - 2-6 (4 pp.) 2-3 - 2-6 (4 pp.)2301.1 ---- 2-109.2 - 2-109.3 (2 pp.)2484 2-153 - 2-158 ----Table of Contents - Chapter III 3-1.2 - 3-2 (2 pp.) 3-1.2 - 3-2 (2 pp.)3313 - 3319 3-85 - 3-85.2 (3 pp.) 3-85 - 3-86 (2 pp.)Table of Contents - Chapter IV 4-1 - 4-2 (2 pp.) 4-1 - 4-2 (2 pp.)4121.3 - 4130 4-38.1 - 4.38.3 (3 pp.) 4-38.1 (1 p.)

MANUALIZATION--EFFECTIVE DATE: Not Applicable IMPLEMENTATION DATE: Not Applicable

Section 2303.1, Devices Not Approved by FDA, has been deleted.

Section 2484, Coverage Of Medical Devices Under Medicare, outlines coverage of medical devicesunder Medicare coverage of certain FDA-approved investigational device exemption (IDE) devicesand the services related to these devices. It describes the conditions and limits of coverage andpayment for specified devices with an FDA approved IDE.

Section 3317, Appeals Process for IDE Categorization Decisions, specifies the procedure that asponsor (typically, the manufacturer) must follow if the sponsor does not agree with the FDAcategorization of its device.

Section 4122, Certain Devices with a Food and Drug Administration (FDA) Investigational DeviceExemption (IDE), explains payment and billing procedures and defines devices in HCFA's MasterInvestigational Device file.

Section 4122.1, Certain Devices with an FDA Investigational Device Exemption, describes theprocedures to be used for processing payment of claims for investigational devices.

Section 4122.2, Payment of Certain Investigational Devices, explains the new benefit provided asa result of the revised coverage policy for investigational devices.

HCFA-Pub. 14-3

2

Section 4122.3, HCFA's Master File of Investigational Devices, describes what is contained in themaster file of investigational devices and what contractors should verify from the master file beforeprocessing a claim.

Section 4122.4, Adjudicating the Claim, describes how to process a claim for an investigationaldevice.

Section 4122.5, EOMB Messages, identifies messages specific to the benefit to be placed on EOMBsfor investigational devices.

DISCLAIMER: The revision date and transmittal number only apply to the redlinedmaterial. All other material was previously published in the manual andis only being reprinted.

These instructions should be implemented within your current operating budget.

CHAPTER IICOVERAGE AND LIMITATIONS

Section

Reimbursable Physical Therapy. ................................................................................ 2210 Restorative Therapy. ............................................................................................. 2210.1 Maintenance Programs.......................................................................................... 2210.2 Application of Guidelines. .................................................................................... 2210.3Services Furnished by a Physical or Occupational Therapist in Independent Practice................................................................................................ 2215Covered Speech Pathology . ....................................................................................... 2216Covered Occupational Therapy. ................................................................................. 2217Physical Therapy/Occupational Therapy Provided By Physicians and Physician Employees ............................................................................................... 2218

Comprehensive Outpatient RehabilitationFacility (CORF) Services

Coverage of Physicians' Services Provided in Comprehensive Outpatient Rehabilitation Facility.................................................. 2220

End Stage Renal Disease (ESRD)

Treatment of End Stage Renal Disease....................................................................... 2230 Definition of Terms............................................................................................... 2230.1 Approved Dialysis Settings................................................................................... 2230.2 Physicians' Services - General. ............................................................................. 2230.3 Physicians' Services to an Inpatient. ..................................................................... 2230.4 Physicians' Services - Outpatient Maintenance Dialysis . .................................... 2230.5 Physician Services During Self-Dialysis Training ............................................... 2230.6Continuous Ambulatory Peritoneal Dialysis .............................................................. 2231 Certification of Facilities Furnishing CAPD Services.......................................... 2231.1 Institutional Dialysis Services Furnished to CAPD Patients. ............................... 2231.2 Support Services and Supplies Furnished to Home CAPD Patients. ................... 2231.3 Physician Services. ............................................................................................... 2231.4Coverage of Home Dialysis Under Target Rate Reimbursement. .............................. 2234

Chiropractic Services

Chiropractic Services--General................................................................................... 2250Coverage of Chiropractic Services. ............................................................................ 2251 Manual Manipulation............................................................................................ 2251.1 Utilization Guidelines. .......................................................................................... 2251.2 Necessity for Treatment........................................................................................ 2251.3 Location of Subluxation........................................................................................ 2251.4 Treatment Guidelines............................................................................................ 2251.5

Payment for Ancillary Services

Medical and Other Health Services Furnished to Inpatients of Hospitals and Skilled Nursing Facilities.................................................................................. 2255

Rev. 1704 2-3


Section

Payment for Rural Health Clinic Services

Rural Health Clinic Services - General......................................................................... 2260 Rural Health Clinic Services................................................................................... 2260.1 Services Furnished by Rural Health Clinics Which Are Not Rural Health Clinic Services.......................................................................................... 2260.2 Payment Under Part B for Non-RHC Services Furnished by Independent Rural Health Clinics........................................................................ 2260.3

Ambulatory Surgical Center Services

Ambulatory Surgical Center Services........................................................................... 2265 Definition of Ambulatory Surgical Center. ............................................................ 2265.1 Ambulatory Surgical Center Services..................................................................... 2265.2 Services Furnished in ASCs Which Are Not ASC Facility Services................................................................................................... 2265.3 Coverage of Services in ASCs Which Are Not ASC Services. ............................................................................................................... 2265.4List of Covered Ambulatory Surgical Center Procedures. ........................................... 2266 Nature and Applicability of ASC List. ................................................................... 2266.1 Nomenclature and Organization of the List............................................................ 2266.2 Rebundling of CPT Codes. ..................................................................................... 2266.3

General Exclusions From Coverage

General Exclusions. ...................................................................................................... 2300 Services Related to and Required as a Result of Services Which Are Not Covered Under Medicare............................................. 2300.1Services Not Reasonable and Necessary. ..................................................................... 2303No Legal Obligation to Pay For or Provide Services. .................................................. 2306Items and Services Furnished, Paid for, or Authorized by Governmental Entities--Federal, State, or Local Governments......................................................... 2309 Items and Services Furnished by a Federal Provider of Services or Federal Agency. ...................................................................................................... 2309.1 Items and Services Which a Non-Federal Provider, Physician or Supplier Is Obligated to Furnish at Public Expense Pursuant to an Authorization Issued by a Federal Agency. ................................................................................. 2309.2 Indian Health Service (IHS) Entitlement................................................................ 2309.3 Items or Services Which Have Been Paid for by a Governmental Entity. ............. 2309.4

2-4 Rev. 1704

CHAPTER II COVERAGE AND LIMITATIONS

Section

Services Received by Medicare Beneficiaries Outside United States ................................................................................................................... 2312 Physician and Ambulance Services Furnished in Connection With Covered Foreign Inpatient Hospital Services ........................................................... 2312.2 Carriers Designated to Process Foreign Claims........................................................... 2312.3 Source of Part B Claims............................................................................................... 2312.4 Medicare-Approved Charges for Services Rendered in Canada or Mexico..................................................................................................... 2312.5 Appeals of Denied Charges for Physicians and Ambulance Services in Connection With Foreign Hospitalization .......................................................................................................... 2312.6 Claims for Services Furnished in Canada and Mexico to Qualified Railroad Retirement Beneficiaries........................................................ 2312.7Services Resulting From War ............................................................................................ 2315Personal Comfort Items ..................................................................................................... 2318Routine Services and Appliances....................................................................................... 2320Foot Care and Supportive Devices for Feet....................................................................... 2323Custodial Care.................................................................................................................... 2326Cosmetic Surgery............................................................................................................... 2329Charges Imposed by Immediate Relatives of Patient or Members of Household .............................................................................................. 2332Dental Services and Exclusion .......................................................................................... 2336Services Reimbursable Under Automobile, No Fault Or Any Liability Insurance .................................................................................................. 2340

Workers' Compensation

General............................................................................................................................... 2370 Definitions ................................................................................................................... 2370.1 Effect of Payments Under Workers' Compensation Plan ............................................ 2370.2 Workers' Compensation Cases Involving Liability Claims......................................... 2370.3 Possible Coverage of Work Related Services Under Automobile Medical or No Fault Insurance or Employer Group Health Plan ......... 2370.4 Workers' Compensation Pays Only for Services of Certain Physicians. ................................................................................................2370.5 Contested Workers' Compensation Claims2370.6 Lump Sum Compromise Settlement.............................................................................2370.7 Lump Sum - Commutation of Future Benefits. ............................................................2370.8 Right of Recovery. ........................................................................................................2370.9 Private Right of Action. ................................................................................................2370.10 Conflicting Claims by Medicare and Medicaid. ...........................................................2370.11 Authorities for Agreeing to Compromise or Waive Medicare's Claim. ......................................................................................................2370.12

Rev. 1704 2-5


Section

Inpatient Services Not Directly Delivered or Arranged for by the Hospital 2390

Deductible, Coinsurance,Psychiatric, and Physical Therapy Limitation

Annual Cash Deductible. ................................................................................................... 2450 Special Carryover Rule for Expenses Incurred Prior to 1981 ...................................................................................................................... 2450.1 Health Care Prepayment Plans and Health Maintenance Organizations ............................................................................................................ 2450.2Medical Insurance Blood Deductible................................................................................. 2455Coinsurance........................................................................................................................ 2460Exceptions to Annual Deductible and Coinsurance........................................................... 2462Outpatient Mental Health Treatment Limitation ............................................................... 2470Application of Limitation .................................................................................................. 2472 Status of Patient ........................................................................................................... 2472.1 Disorders Subject to Limitation ................................................................................... 2472.2 Services Subject to Limitation..................................................................................... 2472.3 Services Not Subject to Limitation .............................................................................. 2472.4 Computation of Limitation .......................................................................................... 2472.5Expenses Incurred Before 1990......................................................................................... 2474Limitation on Payment for Services Furnished by Physical or Occupational Therapist in Independent Practice....................................................................................................... 2480Coverage of Medical Devices............................................................................................ 2484

2-6 Rev. 1704

05-01 COVERAGE AND LIMITATIONS 2484

2484. COVERAGE OF MEDICAL DEVICES

Devices that may be covered under Medicare include the following categories:

? Devices approved by the FDA through the Pre-Market Approval (PMA) process.

? Devices cleared by the FDA through the 510(k) process.

? FDA-approved IDE Category B devices.

? Hospital Institutional Review Board (IRB) approved IDE devices.

A. FDA Approval IDEs.--The FDA assigns a special identifier number that corresponds to eachdevice granted an investigational device exemption (IDE). Under the Food, Drug and Cosmetic Act,devices are categorized into three classes. Class I devices are the least regulated. These are devicesthat the FDA has determined need to be subject only to general controls, such as good manufacturingpractice regulations. Class II devices are those which, in addition to general controls, require specialcontrols such as performance standards or post-market surveillance, to assure safety andeffectiveness. class III devices are those which cannot be classified into class I or class II becauseinsufficient information exists to determine that either special or general controls would providereasonable assurance of safety and effectiveness. Class III devices require pre-market approval.

For purposes of assisting HCFA in determining Medicare coverage, the FDA will place all approvedIDEs in one of two categories:

1. Category A.--Experimental--Innovative devices believed to be in class III for whichabsolute risk of the device type has not been established (i.e., initial questions of safety andeffectiveness have not been resolved and the FDA is unsure whether the device type is safe andeffective).

2. Category B.--Non-Experimental/Investigational Devices believed to be in classes I or IIor devices believed to be in Class III where the incremental risk is the primary risk in question (i.e.,underlying questions of safety and effectiveness of that device type have been resolved), or it isknown that the device type can be safe and effective because, for example, other manufacturers haveobtained FDA approval for that device type.

B. Coverage of FDA-Approved IDEs.--Category A devices are not covered under Medicarebecause they do not satisfy the statutory requirement that Medicare pay for devices determined tobe reasonable and necessary.

Category B devices may be considered reasonable and necessary and, therefore, may be covered ifall other applicable Medicare coverage requirements are met.

Refer to §2300.1--Services Related to and Required as a Result of Services Which Are Not CoveredUnder Medicare.

C. Providers Seeking Reimbursement for Investigational Devices.--It is the responsibility of theprovider participating in the clinical trial to furnish all necessary information concerning the device,the clinical trial and participating Medicare beneficiaries that the contractor deems necessary for acoverage determination and claims processing. (See samples 1 and 2 of FDA approval/clearanceletters you may receive from the provider seeking Medicare reimbursement).See §4122 for complete claims processing information.

Rev. 1704 2-153

2484 (Cont.) COVERAGE AND LIMITATIONS 05-01

D. Coverage Requirements.--Medicare contractors are responsible for making the coveragedeterminations on all FDA-approved Category B devices. Coverage decisions should be made forFDA-approved investigational device exemptions (IDEs), as they currently are made for FDA-approved devices, i.e., apply Medicare's long-standing criteria and procedures for making coveragedecisions. The following criteria must also be applied when making coverage determinations onFDA-approved IDE Category B devices:

? The device must be used within the context of the FDA-approved clinical trial.

? The device must be used according to the clinical trial's approved patient protocols.

? Established national policy as contained in existing manual instructions, e.g., CoverageIssues Manual instructions, etc.

? In the absence of national policy, local policy for similar FDA-approved devices.

? Policy/Position papers or recommendations made by pertinent national and/or local specialtysocieties.

Contractors should also consider, among other factors, whether the device is:

1. Medically necessary for the particular patient and whether the amount, duration andfrequency of use or application of the service are medically appropriate and,

2. Furnished in a setting appropriate to the patient's medical needs and condition.

This policy does not provide coverage for any devices that would otherwise not be covered byMedicare; e.g., statutorily excluded devices or items and services excluded from coverage throughregulation or current manual instructions.

E. Hospital Institutional Review Board (IRB) Approved IDE Devices.--Clinical trials for non-significant risk devices (devices which do not require an FDA-approved IDE are the responsibilityof the hospital's IRB. While these devices do not require an FDA-approved IDE, many of the FDA-approved IDE requirements apply to these nonsignificant risk devices (e.g., they may not be legallymarketed). Medicare contractors are responsible for making the coverage determinations onnonsignificant devices that are the responsibility of the hospital's IRB. Contractors should apply thesame coverage criteria, where appropriate to these devices as is applied to FDA-approved IDECategory B devices.

F. Payment for IDE Category B Devices.--Payment for a Category B IDE device or an IRBapproved device (provided to a nonhospital patient) and related services is limited to or less thanwhat Medicare would have paid for a comparable approved device or services.

G. Services Related to and Required as a Result of Services Which are Not Covered UnderMedicare.--This policy does not affect Medicare's coverage of services related to a noncovereddevice. That is, services related the use of a noncovered device are not covered under Medicare.

H. FDA Withdrawal of IDE Approval.--Potential Medicare coverage of Category B IDE devicesis predicated, in part, upon their status with the FDA. In the event a sponsor (e.g., a manufacturer)loses its Category B status, or violates relevant IDE requirements necessitating FDA's withdrawalof IDE approval, all payment of the device should cease. Carriers should inform the providercommunity that billing for the IDE means that the provider attests that the study was approved atthe time the service was rendered. The HCFA master file will be updated to reflect withdrawals ofFDA IDE approvals.

2-154 Rev. 1704

05-01 COVERAGE AND LIMITATIONS 2484 (Cont.)

I. Confidentiality of IDE Information.--You may not release claims information or informationreceived from the provider that is proprietary in nature, i.e.., information contained in the FDA IDEapproval letter (and conditional approval letter) to the sponsor (e.g, a manufacturer). Since the IDEnumber as well as other information will be necessary to process claims, you must take appropriateaction to ensure that the confidentiality of the information is protected. Because this informationis proprietary in nature, you may not release it under the Freedom of Information Act.

SAMPLE APPROVAL LETTER

Mr. John DoeVice PresidentMaintara Medical1 Main StreetAny Town, USA 11101

RE: IDE Number: G_____Maintara Medical DeviceIndications for Use: Treat Medical ConditionsDate: January 1, 1999Received: January 1, 1999HCFA Reimbursement Category: B2

Dear Mr. Doe:

The Food and Drug Administration (FDA) has received your investigational device exemption (IDE)application. Your application is approved, and you may begin your investigation at an institutionin accordance with the investigational site waiver granted below. Your investigation is limited to3 institutions and 100 subjects.

The FDA will waive those requirements regarding submission and prior FDA approval of asupplemental application and receipt of certification of institutional review board (IRB) approvalfor the addition of investigational sites (21 CFR 812.35(a)) provided:

1. The total number of investigational sites does not exceed 3, and the total number of patientsdoes not exceed 100; and

2. You maintain current records on:

? The names and addresses of all investigational sites.? The names and addresses of all investigators, identifying those who are currently

participating.? The names, addresses and chairpersons of all IRBs.? The dates of first shipment or first use of investigational devices for all participating

institutions.? The dates of first shipment or first use of investigational devices for all participating

institutions.

Section 812.150(b)(4) will contain the information specified in 2 above.

3. Within 5 days of reaching the investigational site limit, you must submit to the FDA a currentlist containing the information specified in 2 above.

Rev. 1704 2-155


4. The current investigator list is to be submitted to the FDA at 6-month intervals (2) CFR5.You must submit to the FDA, within 2 days of receipt of a request by the FDA, a current listcontaining the information specified in 2 above.

5. The reviewing IRB does not require significant changes in the investigational plan or in theinformed consent. That is, require any change which may increase the risks to subjects or affect thescientific soundness of the study. (Please note: if a significant change is requested, this change mustbe submitted to the FDA for review and approval prior to initiating the study at that investigationalsite). Minor changes requested by the IRB may be made without prior FDA approval. If you agreeto these conditions, you may begin an investigation at a new investigational site after the IRB hasapproved the investigation. No documentation should be submitted for any institution within theapproved limit until the investigational site limit is reached or the 6-month current investigator listis due. The FDA assumes that you have agreed to the conditions of this waiver unless youspecifically notify us in writing of your disagreement. Please note, however that you must submita supplemental IDE application, and receive FDA approval, prior to extending the investigationbeyond the limit specified above. Additionally, if you do not agree to these conditions, you mustcomply with the full requirements for the submissions to the FDA of a supplemental IDE applicationfor new investigational sites not already specifically approved for participating in your study. (See21 CFR 812.45(b)).

We would like to point out that the FDA approval of your IDE application does not imply that thisinvestigation will develop sufficient safety and effectiveness data to assure FDA approval of a pre-market approval (PMA) application for this device. You may obtain the guideline for thepreparation of a PMA application, entitled Pre-market Approval (PMA) Manual from the divisionof small manufactures assistance at its toll-free number.

Future correspondence concerning this application should be identified as an IDE supplementreferencing the IDE number above and must be submitted in triplicate to: __________

We have enclosed the guidance document entitled, Sponsor's Responsibilities for a Significant RiskDevice Investigation to help you understand the functions and duties of a manufacturer. Alsoenclosed is the guidance document entitled Investigators Responsibilities for a Significant RiskDevice Investigation which you should provide to participating investigators.

If you have any questions, please contact_______________.

Sincerely yours,

SAMPLE OF CONDITIONAL LETTER

Ms. Penelope BrownManagerADE Medical Corporation222 2nd StreetAny City, Any State, USA 11111

RE: IDE Number: G_____Bladder ControllerIndications for Use: Bladder ControlDated: January 1, 1999Received: January 8, 1999HCFA Reimbursement Category: B4

2-156 Rev. 1704

05-01 COVERAGE AND LIMITATIONS 2484 (Cont.)

Dear Ms. Brown:

The Food and Drug Administration (FDA) has received your investigational device exemption (IDE)application. Your application is conditionally approved, and you may begin your investigation,using a revised informed consent document which corrects deficiency numbers one and two inaccordance with the investigational site waiver granted below. Your investigation is limited to afeasibility study at three of the institutions listed in your submission and ten subjects.

This approval is being granted on the condition that, within 45 days from the date of this letter, youmust submit information correcting the following deficiencies:

1. Per 21 CFR 812.5(b), this manufacturer of the IDE shall not represent that the device iseffective for the purpose for which is being investigated. Please revise the informed consent formin conformance with the following:

? Remove the statement that the device is in use in over 10,000 patients.

? Remove paragraph two under purpose of the study.

? Remove the statement regarding pregnant women.

? Remove the statement under anticipated benefits of the study that says, From theexperiences of patients who have received it in other countries.

This information should be identified as an IDE supplement referencing the IDE number above andmust be submitted in triplicate to______.

If you do not provide this information within 45 days from the date of this letter, we may take stepsto propose withdrawal of approval of your IDE application. The FDA will waive those requirementsregarding the submission and prior FDA approval of a supplemental application and receipt ofcertification of institutional review board (IRB) approval for the addition of investigational sites (21CFR 812.45(b) provided:

1. The total number of investigational sites does not exceed three.

2. You maintain current records on:

? The names and addresses of all investigational sites:

? The names and addresses of all investigators, identifying those that are currentlyparticipating:

? The names, addresses and chairpersons of all IRBs;

? The dates of the IRB approvals; and,

? The dates of first shipment or first use of investigational devices for all participatinginstitutions.

If you agree to these conditions, you may begin an investigation at a new investigational site afterthe IRB has approved the investigation. No documentation should be submitted for any institutionwithin the approval limit until the investigational site limit is reached or the 6-month currentinvestigator list is due. The FDA assumes that you have agreed to the conditions of this waiverunless you specifically notify us in writing of your disagreement.

Rev. 1704 2-157


Please note, however, that you must submit a letter to expand the investigation beyond the limitspecified above. Additionally, if you do not agree to these conditions, you must comply with thefull requirements for the submission to the FDA of a supplemental IDE application for newinvestigational sites not already specifically approved for participating in your study (21 CFR 812.35(b)).

We would like to point out that the FDA approval of your IDE application does not imply that thisinvestigation will develop sufficient safety and effectiveness data to assure FDA approval of a pre-market approval (PMA) application for this device. You may obtain the guideline for thepreparation of a PMA application, entitled Pre-market Approval (PMA) Manual, from the Divisionof Small Manufactures Assistance at its toll free number.

We have enclosed the guidance document entitled, Sponsor's Responsibilities for a Significant RiskDevice Investigation to help you understand the functions and duties of a manufacturer. Alsoenclosed is the guidance document entitled Investigators Responsibilities for a Significant RiskDevice Investigation which you should provide to participating investigators.

If you have any questions, please contact .

Sincerely yours,

2-158 Rev. 1704

CHAPTER IIICLAIMS, FILING, JURISDICTION

AND DEVELOPMENT PROCEDURES

Section

Jurisdiction of Claims

Jurisdiction of Requests For Payment................................................................................ 3100Area Carrier - Physicians' Services.................................................................................... 3101Area Carrier - Supplier's Services...................................................................................... 3102Railroad Retirement Beneficiary Carrier ........................................................................... 3103Welfare Carriers................................................................................................................. 3104United Mine Workers of America (UMWA)..................................................................... 3105Title XIX Beneficiaries Residing in California ................................................................. 3106Transferring Requests for Medicare Payment ................................................................... 3110 Transfer of Claims Material Between Carrier and Intermediary................................. 3110.1 Signature Requirements ............................................................................................... 3110.2Payments Under Part B for Services Furnished by Suppliers of Service to Patients of a Provider ..................................................................................................... 3115

Parenteral and Enteral Nutrition

Parenteral and Enteral Nutrition (PEN) Claims Jurisdiction ............................................. 3116

Claim Number

Health Insurance Card........................................................................................................ 3200Health Insurance Claim Numbers (HICN) ........................................................................ 3203Health Insurance Claim Numbers Assigned by the Railroad Retirement Board............... 3204Changes in Health Insurance Claim Numbers ................................................................... 3205Procedures for Obtaining Missing or Incorrect Claim Numbers ....................................... 3208Guidelines for Use of Carrier Alphabetic State File (CASF) - General ............................ 3215 Confidentiality ............................................................................................................. 3215.1 Receipt and Disposition Procedures ............................................................................ 3215.2 Explanation of CASF Data .......................................................................................... 3215.3 Using the CASF ........................................................................................................... 3215.4 Guidelines for Beneficiary Identification .................................................................... 3215.5 Tolerances for Use With the Guidelines...................................................................... 3215.6 Special Conditions in the CASF .................................................................................. 3215.7Guidelines for Use of the Health Insurance Beneficiary State Tape (BEST) - General.... 3216 Confidentiality ............................................................................................................. 3216.1 Receipt and Disposition Procedures ............................................................................ 3216.2 Description of BEST.................................................................................................... 3216.3 Special Conditions in the BEST .................................................................................. 3216.4 Using the BEST ........................................................................................................... 3216.5

Claims Development Procedures and Situations

Claim Review - General..................................................................................................... 3300Beneficiary Identification .................................................................................................. 3301Informing Claimant of Incorrect or Incomplete Identification .......................................... 3302Dating of Request for Payment Forms............................................................................... 3304Obtaining Copies of Medical Records from Providers...................................................... 3307

Rev. 1704 3-1.2

CHAPTER IIICHAPTER, FILING, JURISDICTION

AND DEVELOPMENT PROCEDURES

Section

Contacts With Physicians, Suppliers, or Beneficiaries for Additional Information .......... 3311Evidence of Medical Necessity for Durable Medical Equipment ..................................... 3312Physician or Supplier Refusal to Furnish an Itemized Bill to the Patient.......................... 3313Physician or Supplier Refuses to Submit Medicare Claims .............................................. 3314Physical Examinations of Beneficiaries by Carriers.......................................................... 3316Appeals Process for Investigational Device Exemptions (IDE) Categorization Decisions ................................................................................................ 3317Disposition of Claims Where Supporting Evidence Is Needed ......................................... 3319Physician’s or Supplier’s Charges for Completing or Submitting a Medicare Claim or For Furnishing an Itemized Bill........................................................ 3321Charges by Relative or Member of Immediate Household ............................................... 3322Duplicate and/or Overlapping Bills With Discrepant Charges.......................................... 3323Evidence of Medical Necessity for Parenteral and Enteral Nutrition (PEN) Therapy................................................................................................................ 3324Medicare Secondary Payer (MSP) General Provisions ..................................................... 3328 Beneficiary's Responsibility With Respect to TPPs That Are Primary to Medicare... 3328.1 TPP Pays Charges in Full ............................................................................................ 3328.2 TPP Pays Portion of Charges....................................................................................... 3328.3 TPP Denies Payment.................................................................................................... 3328.4 Notification When Claims for Primary Medicare Benefits Are Denied...................... 3328.5 Carrier Action When There Is Indication That Medicare May Be Secondary Payer .. 3328.6 Physician, Supplier, or Beneficiary Bills Medicare for Primary Benefits................... 3328.7 TPP Does Not Pay Because of Deductible or Coinsurance Provision......................... 3328.8 TPP Gives Medicare Beneficiary Choice of Using Preferred Provider....................... 3328.9 Multiple Insurers.......................................................................................................... 3328.10 Recovery of MSP Mistaken Payments ........................................................................ 3328.11 Claimant's Right to Take Legal Action Against TPP .................................................. 3328.12 Allowance for Procurement Costs ............................................................................... 3328.13 Primary Payer Is Bankrupt or Insolvent....................................................................... 3328.14 Advice to Providers, Physicians, and Beneficiaries..................................................... 3328.15 TPP Pays Primary Benefits When Not Required......................................................... 3328.16 Federal Government's Right to Sue and Collect Double Damages ............................. 3328.17 When Medicare Secondary Benefits Are Payable ....................................................... 3328.18 When Medicare Secondary Benefits Are Not Payable ................................................ 3328.19 Calculating Medicare Secondary Payments for Services Reimbursed on Reasonable Charge or Other Basis Under Part B ..................................................... 3328.20 Effect of Failure to File Proper Claim ......................................................................... 3328.21 Effect of Primary Payments on Deductibles and Coinsurance .................................... 3328.22 Medicare Secondary Payment for Managed Care Organizations' (MCO) Copayments............................................................................................................... 3328.23 Right of Physician or Supplier to Charge Beneficiary................................................. 3328.24 Charging Expenses Against Annual Limit on Incurred Expenses for Services of Independently Practicing Physical Therapists.................................. 3328.25MSP - General Provisions Applicable to Individuals Covered by Group Health Plans (GHP) and Large Group Health Plans (LGHP)......................................... 3329 General......................................................................................................................... 3329.1 Definitions ................................................................................................................... 3329.2 Current Employment Status......................................................................................... 3329.3 Employer Sponsored Prepaid Health Care Plan .......................................................... 3329.4 Prohibition Against Financial and Other Incentives.................................................... 3329.5 Nondiscrimination ....................................................................................................... 3329.6 Tax Imposed on Contributors to Nonconforming GHPs ............................................. 3329.7 Referral to Internal Revenue Service (IRS) ................................................................. 3329.8

3-2 Rev. 1704

05-01 CLAIMS REVIEW AND ADJUDICATION PROCEDURES 3313

3313. PHYSICIAN OR SUPPLIER REFUSAL TO FURNISH AN ITEMIZED BILL TO THEPATIENT

An enrollee's statement or an SSO's report that a physician or supplier refuses to furnish the patientwith an itemized bill until it is paid. Contact the physician or supplier or, when necessary, the localmedical society or supplier association, in an effort to resolve the problem. If appropriate, suggestthat the enrollee make direct contact with the society. You may find it helpful to enlist the assistanceof a State or local consumer protection agency or suggest that the enrollee do so.

Once it is clear that such efforts will not induce the physician or supplier to furnish itemization (orother information necessary to evaluate the services or charges on his bill) which should materiallyaffect your coverage and/or payment determination, try to obtain the information from availablemedical sources (e.g., the records of the hospital or other facility at which the enrollee receivedtreatment, or the statement of another physician involved in the case). The statement of the enrolleefully describing the services received may also be used.

In dealing with these "itemization refusal" cases, commensurate your efforts with the amount of theSMI benefits at issue. Thus, a trip by a carrier representative to a hospital would probably bewarranted only if at least $50 in benefits were at stake. Where necessary information can be obtainedby a phone call or letter, a smaller benefit amount justifies the effort and expense.

In some situations (e.g., where a new or unusual procedure is involved), obtain the opinion of yourmedical staff or the local medical society, if it is important for handling of future claims regardlessof the amount involved.

Evaluate the information given by the enrollee (or a relative or other person in a position to know).The information should describe the enrollees condition and give details about the services received.Other evidence to be used in determining the nature and reasonable charge for services furnishedshould also be provided.

Where all reasonable efforts to obtain a reliable list of the services fail, and it becomes necessaryeither to disallow or substantially reduce benefits, advise the enrollee to consider consulting anattorney, a legal aid society, or a consumer protection society or appropriate state agency.Determine whether an obligation exists under State law to pay a physician's or supplier's bill onwhich itemization has been refused.

If necessary, consult appropriate state authorities to ascertain whether the refusal is in violation ofany state laws.

If the service in question was furnished on or after September 1, 1990, send a letter to the physicianor supplier requesting that he/she complete and submit a claim for the case in question, under theauthority of 1848(g)(4). If a claim is not filed within one year of the date of service, develop aviolation and, if appropriate, refer the case to OIG for monetary penalty and sanction consideration.

Rev. 1704 3-85

3314 CLAIMS REVIEW AND ADJUDICATION PROCEDURES 05-01

3314. PHYSICIAN OR SUPPLIER REFUSES TO SUBMIT MEDICARE CLAIMS

Section 1848(g)(4) of the Social Security Act requires all physicians and suppliers to submit PartB claims processed by Medicare carriers for covered services furnished to program beneficiaries onor after September 1, 1990. Those physicians and suppliers who knowingly, willfully and repeatedlyfail to submit a claim are subject to sanctions, including civil monetary penalties of up to $2000 perviolation and exclusion from the Medicare program. OIG is responsible for assessing sanctions.

A beneficiary complaint to you, SSA, or HCFA may occur where a physician or supplier fails toadhere to the claim submission requirement. This may happen, for example, when a beneficiarysubmits a HCFA-1490S claim and your EOMB notice indicates that the physician or supplier shouldhave filed the claim. The beneficiary may indicate that the physician or supplier refused to comply.

Develop such complaints received and make physician or supplier educational contacts, asappropriate. If physician or supplier noncompliance is not corrected (i.e., your monitoring programconsistently identifies a service provider as having 11 or more potential violations per month andeducational contacts do not resolve the problem), establish controls to develop and refer cases toOIG after the 12 month filing limit is exceeded. (See §7560.)

33l6. PHYSICAL EXAMINATIONS OF BENEFICIARIES BY CARRIERS

You have the authority to obtain an independent medical examination of a beneficiary where yourmedical personnel conclude that such an examination will assist in properly and effectivelycomplying with your responsibilities. Expenses incurred in connection with obtaining suchindependent medical examinations are payable administrative costs. It is expected, however, thatcarrier-initiated examinations will be utilized only after other methods of resolving the issue havebeen explored and found to be insufficient, and then, only with the express permission of thebeneficiary. (Information which may be derived from hospital records and contacts with thebeneficiary's attending physician and evaluations of such data by your medical personnel, as wellas the appropriate committees of local medical societies, are among the more usual methodsavailable to resolve questionable claims before initiating an examination of the beneficiary.) Theonly use to make of the medical information derived from an independent examination is to assistyou in the claims review process.

3317. APPEALS PROCESS FOR INVESTIGATIONAL DEVICE EXEMPTION (IDE) CATEGORIZATION DECISIONS

The Food and Drug Administration (FDA) assigns an IDE number that corresponds to each IDEapplication received. Through an interagency agreement HCFA and the FDA have developed aprocess to categorize all FDA-approved IDEs for Medicare coverage and payment purposes. Thiscategorization process differentiates between novel, first-of-a-kind devices for which absolute riskof the device has not been established (Category A), and those devices which are of a device typefor which the underlying questions of safety and effectiveness have been resolved (Category B).(See §2484).

Any manufacturer that does not agree with the FDA decision that categorizes its device as CategoryA-experimental may submit a written request asking the FDA to reevaluate its categorizationdecision. The sponsor (e.g., a manufacturer) may send a written request to the FDA at any timeasking for a reevaluation of its original categorization decision, submitting any additional evidenceand information which it believes supports a recategorization. The FDA notifies both HCFA andthe sponsor (manufacturer) of its re-evaluation decision.

3-85.1 Rev. 1704


If the FDA reconfirms its original decision on the categorization of the device, the sponsor (e.g., amanufacturer) may seek a review by the HCFA Central Office. The device sponsor (e.g., amanufacturer) must submit its request in writing, and must include all materials submitted with itsreevaluation request to the FDA. Review requests must be addressed to:

IDE Categorization Review, Office of Clinical Standards and Quality Coverage and Analysis Group

Health Care Financing AdministrationRoom S3-25-257500 Security Blvd.Baltimore, MD 21244-1850

HCFA staff will then review this information to determine whether to change the categorization ofthe device. HCFA will then issue a written decision notifying both the device sponsor (e.g., amanufacturer) and the FDA of its decision. In evaluating a manufacturer's request forrecategorization, HCFA will review only that information submitted to the FDA. Information notsubmitted to the FDA for its consideration will not be reviewed by HCFA.

To the extent that HCFA relies on confidential commercial or trade secret information in its review,the Agency will maintain confidentiality of the information in accordance with Federal law.

No reviews of a categorization decision other than those described above are available to a sponsor(e.g., a manufacturer). Neither the FDA original categorization decision or reevaluation nor HCFA'sreview constitutes an initial determination for purposes of the Medicare appeals processes under part405, subpart G or subpart H or parts 417, 473 or 498 of title 42 of the Code of Federal Regulations.

3319. DISPOSITION OF CLAIMS WHERE SUPPORTING EVIDENCE IS NEEDED

Make one request for necessary supporting information as soon as possible after the claim isreceived. When possible, obtain or request the information by telephone. Follow-up telephonerequests in writing within 5 days.

Include in both the written request and the follow-up to the beneficiary/provider that the claim willbe adjudicated on the basis of the evidence on hand if the requested information is not receivedwithin 45 days from the date of the written request and that this might result in a reduction in thepayment allowed or a denial. Do not include in written requests, bills or forms that contain adiagnosis. (See §3311.)

Rev. 1704 3-85.2

CHAPTER IVCLAIMS REVIEW AND ADJUDICATION PROCEDURES

Section

Line Review - HCFA-l490S

Review of Form HCFA-l490S.................................................................................... 4010 Items 1-3 - Patient Identification ............................................................................. 4010.1 Item 4 - Nature of Illness or Injury and Employment Relationship .......................................................................................................... 4010.2 Item 5 - Information for Complementary Insurer .................................................... 4010.3 Item 6 - Signature of Patient .................................................................................... 4010.4Review of Physician's or Supplier's Statement ........................................................... 4011

Line Review - Health Insurance Claim Form

Review of the Health Insurance Claim Form - HCFA-1500 ...................................... 4020 Items 1-13 - Patient Identification Information ....................................................... 4020.1 Items 14-22 - Physician or Supplier Information .................................................... 4020.2 Item 23A - Diagnosis or Nature of Illness or Injury................................................ 4020.3 Item 23B................................................................................................................... 4020.4Simplified Billing Requirements for Independent Laboratory Claims ................................................................................................... 4021Review of Relevant Information................................................................................. 4022Time Limit for Filing Claims...................................................................................... 4025

Items and Services Having Special Review Considerations

Durable Medical Equipment, Prosthetic, and Orthotic Supplies ................................ 4105 Home Use of DME .................................................................................................. 4105.1 Evidence of Medical Necessity................................................................................ 4105.2 Incurred Expenses for DME, and Orthotic and Prosthetic Devices......................... 4105.3 Patient Equipment Payments Exceed Deductible and Coinsurance on Assigned Claims .................................................................. 4105.4 Evidence of Medical Necessity - Oxygen Claims .................................................... 4105.5Durable Medical Equipment ....................................................................................... 4106 Making the Rental/Purchase Decision Actions to be Completed Before Implementing Procedures to Make Reimbursement Based on Carrier Rental/Purchase Decision ...................................................................... 4106.1 Rental Equipment Being Paid When Carrier Rental/Purchase Decisions Go Into Effect......................................................... 4106.2 Processing DME Claims Involving Carrier Rental/Purchase Decision .................................................................................. 4106.3 Systems and Pricing Consultation in Making Rental/Purchase Decision .................................................................................. 4106.4 Beneficiary Alleges Hardship ............................................................................... 4106.5Durable Medical Equipment - Billing and Payment Considerations Under the Fee Schedule .................................................................. 4107 General Billing and Claims Processing Requirements .................................................................................. 4107.1 Rent/Purchase Decision ........................................................................................ 4107.2 Comparability and Inherent Reasonableness Limitations ........................................................................................................ 4107.3 15 Month Ceiling on Capped Rental Items........................................................... 4107.4 Transcutaneous Electrical Nerve Stimulator (TENS)........................................... 4107.5

Rev. 1704 4-1

CHAPTER IVCLAIMS REVIEW AND ADJUDICATION PROCEDURES

Section

Written Order Prior to Delivery............................................................................. 4107.6 Special Requirements for Oxygen Claims............................................................ 4107.7 EOMB Messages .................................................................................................. 4107.8 Oxygen HCPCS Codes Effective 1/1/89 .............................................................. 4107.9 Oxygen Equipment and Contents Billing Chart ................................................... 4107.10Laboratory Services - (Item 7C) ................................................................................. 4110 Services by Participating Hospital-Leased Laboratories ....................................................................................................... 4110.1 Laboratory Services by Physicians ....................................................................... 4110.2 Independent Laboratory Services ......................................................................... 4110.3 Laboratory Services to a Patient at Home or in Institution ........................................................................................................... 4110.4 Hospital Laboratory Services Furnished to Non-Hospital Patients ........................................................................................ 4110.5Billing for Physician Assistant (PA) and Nurse Practitioner (NP) Services........................................................................................ 4112Billings for SNF and NF Visits................................................................................... 4113Billing Procedures for Maxillofacial Services............................................................ 4114Ambulance Services.................................................................................................... 4115Chiropractic Services .................................................................................................. 4118Foot Care..................................................................................................................... 4120 Application of Foot Care Exclusions to Physicians Services .............................................................................................................. 4120.1 Application of "Reasonable and Necessary" Limitations to Foot Care Services..................................................................... 4120.2 Denial Messages ................................................................................................... 4121.3Certain Devices with a Food and Drug Administration (FDA) Investigational Device Exemption (IDE)................................................................. 4122 Payment for Certain Investigational Devices ....................................................... 4122.1 Billing Requirements for FDA-Approved Investigational Devices...................... 4122.2 HCFA's Master File of Investigational Devices ................................................... 4122.3 Adjudicating the Claim ........................................................................................ 4122.4 MSN/EOMB Messages......................................................................................... 4122.5Eye Refractions (Item 7C) .......................................................................................... 4125Portable X-Ray Services (Item 7C) ............................................................................ 4130Claims for Transportation in Connection With Furnishing Diagnostic Tests....................................................................................................... 4131Radiology and Pathology Services to Hospital Inpatients (Item 7C) ......................... 4135Anesthesiology Services (Item 7C) ............................................................................ 4137Blood or Packed Cells (Items 7C and 7E) .................................................................. 4140Patient-Initiated Second Opinions .............................................................................. 4141Consultations .............................................................................................................. 4142Preadmission Diagnostic Testing................................................................................ 4143Flat Fee or Package Charges....................................................................................... 4145Alzheimer's Disease or a Related Disorder and the Non- Inpatient Psychiatric Services Limitation ................................................................ 4146Services to Homebound Patients ................................................................................ 4147 Processing and Review of Claims - Homebound Patients .......................................................................................... 4147.1Surgery - Multiple Procedures Performed During the Same Operations ...................................................................................................... 4149Services Performed by More than One Physician for the Same Surgery........................................................................................................... 4151

4-2 Rev. 1704

05-01 CLAIMS REVIEW AND ADJUDICATION PROCEDURES 4121.34121.3 Denial Messages.--When you deny the claim, use the following messages:

A. MSN/EOMB.--

21.22/16.58 “Medicare does not pay for this service because it is consideredinvestigational and/or experimental in these circumstances.”

B. Remittance Advice.--American National Standard Institute (ANSI) X-12-835 claimadjustment reason code/message B22, “This claim/service is denied/reduced based on the diagnosis.”

4122 CERTAIN DEVICES WITH A FOOD AND DRUG ADMINISTRATION (FDA) INVESTIGATIONAL DEVICE EXEMPTION (IDE)

4122.1 Payment for Certain Investigational Devices.--For dates of service on or after November1, 1995, Medicare may cover certain FDA-approved and Institutional Review Board (IRB) approvedinvestigational devices and services incident to, provided the investigational device meets thefollowing conditions:

? Appears on the listing of devices eligible for coverage/payment on HCFA's master file ofIDE devices (See §4122.3)

? Is reasonable and necessary for the individual patient;

? The device or services associated with the use of a device were provided to the beneficiarywithin the start and end dates contained in the master file.

? There is no national coverage policy that would otherwise prohibit Medicare coverage.

(See §2484 of the Medicare Carriers Manual for additional coverage instructions for FDA-approvedinvestigational devices.)

4122.2 Billing Requirements for FDA-Approved Investigational Devices.--Providers bill usingthe appropriate HCPCS code. Instruct billers to identify claims for investigational devices and/orservices incident to the use of such devices with the "QA" modifier. Item 23 of the HCFA-1500 isused by billers to enter the investigational device exemption number assigned to the device. Forelectronic claims, the device number is entered in the DAO field of the national standard format field14. The ANSI 837 is position 180 Ref segment, REF 01 value of LX and REF 02 for theinvestigational device exemption number. (Providers must obtain the investigation deviceexemption number from the manufacturer supplying the device in the clinical trial.) Providers mayalso provide a copy of their approval letter (See §2030 C and I. Also see §4122.4B) to substantiatetheir claim for payment, though this is not mandatory.

4122.3 HCFA's Master File of Investigational Devices.--The devices in the master file are onlythose devices that may be covered if they meet the coverage criteria outlined in §2030 of theMedicare Carriers Manual. Carriers may access HCFA's master file of investigational devicesthrough the network data mover. The file will be updated as appropriate.

HCFA's master file of investigational devices contains the following fields:

? The investigational device exemption (IDE) number.? HCPCS code(s) (where available).? Narrative description of the device.? Start date.? End date.? Maintenance date.

Rev. 1704 4-38.1

4122.4 CLAIMS REVIEW AND ADJUDICATION PROCEDURES 05-01

Listed below is a brief description of the fields contained in the HCFA's master file of investigationaldevices.

Investigational Device Exemption Number - The investigational device exemption number is analphanumeric (one alpha and six numeric) character that is assigned by the FDA to an investigationaldevice and must be used when filing a claim.

HCPCS Codes - HCFA has identified (where possible) HCPCS code(s) that providers may use tobill for these investigational devices. In the master file of investigational devices some have noidentified HCPCS code associated with the claim; these may be billed using the appropriatemiscellaneous HCPCS code. Carriers are not to deny claims just because they may have HCPCScode(s) other than those in the master file.

HCFA's master file of investigational devices is to be used as a guide. The indications of use for thedevice shall be used to determine the appropriate HCPCS code. When you identify additionalHCPCS Code(s) for billing the investigational device, notify HCFA (See §4122.2).

Narrative Description - HCFA has provided a brief description of the investigational device, e.g.,intraocular lens. This information should assist you in identifying whether the provider is billingcorrectly.

Start Date - The start date field houses the beginning of the approval period for that investigationaldevice. Claims received with dates of service prior to this date should be denied (See§4122.4 B forthe appropriate EOMB message).

End Date - The end date field indicates the completion of the clinical trial for that device. Claimsreceived with dates of service after that date should be denied (See §4122.5 for the appropriateEOMB message).

Maintenance Date -- This is an optional field. It may indicate the date on which a field pertainingto an IDE record is changed.

4122.4 Adjudicating the Claim.--

A. FDA Approval.--Investigational devices are only covered when they are used in a clinicaltrial approval by the FDA. When billing a service with the investigational modifier, the provideris certifying FDA approval of a clinical trial for the device.

B. Editing the Claim Against the Master File of Investigational Devices.--Claims forinvestigational devices should be edited against the master file. Deny claims in instances where theinvestigation device exemption number is not found in the master file. When providers submitdocumentation that a device is a Category B device, carriers should confirm this information withHCFA (E-mail destination SHIPPLER or fax (410) 786-6730). Only after an updated master fileis received that contains the investigational device exemption number in question is the claim to beprocessed.

4122.5 MSN/EOMB Messages.--Providers must identify services for an investigational deviceand/or the services incident to such devices using a two-digit procedure code modifier as specifiedin §4122.2.

Deny claims for investigational devices that are Category A devices, using the following EOMBmessage when denying the assigned claim:

"Medicare does not pay for this investigational device(s)."

4-38.2 Rev. 1704


If the claim for an IDE is denied because the approval period has not begun or has expired, use theappropriate message:

"Medicare cannot pay for this investigational device because the approval period for theinvestigation device in the FDA clinical trial has not begun."

"Medicare cannot pay for this investigational device because the approval period for theinvestigational device in the FDA clinical trial has expired."

If an FDA-approved investigational device or service incident to such a device is denied because theimplantation, removal or replacement is determined to be not medically necessary or reasonable, usethe appropriate message:

Message 15.35, 15.28, 15.29 or 15.30.

Assigned or unassigned claims received containing the HCPCS code and the "QA" modifier butlacking the investigation device exemption number should be developed.

4125. EYE REFRACTIONS (ITEM 7C)

The carrier must exclude that part of the total charge made by the physician for services involvingeye care that relate to the procedures performed to determine the refractive state of the eyes. It willbe necessary for the carrier to undertake appropriate development, wherever necessary, to ascertainwhether refractive procedures were performed and to establish the reasonable charge for theseprocedures.

EXAMPLE: A beneficiary complaining of failing vision and watering of the eyes was examinedby an ophthalmologist. In the course of the diagnostic ophthalmological eyeexamination the physician performed procedures to determine the refractive state ofthe eyes. The physician's bill showed a single inclusive charge for the entirediagnostic examination. Apart from the refractive procedures, all of the otherservices furnished by the ophthalmologist to the beneficiary are covered. Since thephysician did not show separate charge for the refractive procedures, the carrier mustdetermine what portion of the physician's total charge represents the charge for theprocedure performed to determine the refractive state of the eyes.

In other situations, the physician may indicate the charge for procedures to determinethe refractive state of the eye by an itemization of the specific charge, or by astatement of a percentage or proportion of the total charge. These values, if stated,should be evaluated by the carrier under the guidelines stated in §52l7.

4130. PORTABLE X-RAY SERVICES (ITEM 7C)

A. Supplier Bills.--Whether a supplier of portable x-ray services completes an SSA-l490 orfurnishes an itemized bill, both the supplier and the physician who ordered the services must beshown. In addition, all bills for portable x-ray services involving the sheet must show the reason anx-ray was required. If any of the information is not submitted with the claim, the carrier shouldobtain it before making payment. Where it is found that the service is not within the scope of theportable x-ray benefit (see §2070.4) or was not ordered by a physician, no payment may be made.

Carriers should assure, before making payment, that services are not routine screening proceduresor tests in connection with routine physical examinations.

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Rev. 1704 4-38.3

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