Medicare Benefit Policy Manual

1 Medicare Benefit Policy Manual Chapter 15 Covered Medical and Other Health Services Table of Contents (Rev. 235, 07-11-17) Transmittals for Chapter 15 10 - Supplementary Medical Insurance (SMI) Provisions 20 - When Part B Expenses Are Incurred - Physician Expense for Surgery, Childbirth, and Treatment for Infertility - Physician Expense for Allergy Treatment - Artificial Limbs, Braces, and Other Custom Made Items Ordered But Not Furnished 30 - Physician Services - Provider-Based Physician Services - Teaching Physician Services - Interns and Residents - Optometrist s Services - Chiropractor s Services - Indian Health Service (IHS) Physician and Nonphysician Services - Payment for Medicare Part B Services Furnished by Certain IHS Hospitals and Clinics 40 - Effect of Beneficiary Agreements Not to Use Medicare Coverage - Private Contracts Between Beneficiaries and Physicians/Practitioners - General Rules of Private Contracts - Effective Date of the Opt-Out Provision - Definition of Physician/Practitioner - When a Physician or Practitioner Opts Out of Medicare - When Payment May be Made to a Beneficiary for Service of an Opt-Out Physician/Practitioner - Definition of a Private Contract - Requirements of a Private Contract - Requirements of the Opt-Out Affidavit - Failure to Properly Opt Out - Failure to Maintain Opt-Out - Actions to Take in Cases of Failure to Maintain Opt-Out - Physician/Practitioner Who Has Never Enrolled in Medicare - Nonparticipating

2 Physicians or Practitioners Who Opt Out of Medicare - Excluded Physicians and Practitioners - Relationship Between Opt-Out and Medicare Participation Agreements - Participating Physicians and Practitioners - Physicians or Practitioners Who Choose to Opt Out of Medicare - Opt-Out Relationship to Noncovered Services - Maintaining Information on Opt-Out Physicians - Informing Medicare Managed Care Plans of the Identity of the Opt-Out Physicians or Practitioners - Informing the National Supplier Clearinghouse (NSC) of the Identity of the Opt-Out Physicians or Practitioners - Organizations That Furnish Physician or Practitioner Services - The Difference Between Advance Beneficiary Notices (ABN) and Private Contracts - Private Contracting Rules When Medicare is the Secondary Payer - Registration and Identification of Physicians or Practitioners Who Opt Out - System Identification - Emergency and Urgent Care Situations - Definition of Emergency and Urgent Care Situations - Denial of Payment to Employers of Opt-Out Physicians and Practitioners - Denial of Payment to Beneficiaries and Others - Payment for Medically Necessary Services Ordered or Prescribed by an Opt-out physician or Practitioner - Mandatory Claims Submission - Cancellation of Opt-Out - Early Termination of Opt-Out - Appeals - Application to the Medicare Advantage Program - Claims Denial Notices to Opt-Out Physicians and Practitioners - Claims Denial Notices to Beneficiaries 50 - Drugs and Biologicals - Definition of Drug or Biological - Determining

3 Self-Administration of Drug or Biological - Incident-to Requirements - Reasonableness and Necessity - Approved Use of Drug - Unlabeled Use of Drug - Examples of Not Reasonable and Necessary - Payment for Antigens and Immunizations - Antigens - Immunizations - Off Lable Use of Anti-Cancer Drugs and Biologicals - Process for Amending the List of Compendia for Determination of Medically-Accepted Indications for Off-Label Uses of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen - Less Than Effective Drug - Denial of Medicare Payment for Compounded Drugs Produced in Violation of Federal Food, Drug, and Cosmetic Act - Process for Amending the List of Compendia for Determination of Medically-Accepted Indications for Off-Label Uses of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen - Self-Administered Drugs and Biologicals - Immunosuppressive Drugs - Erythropoietin (EPO) - Requirements for Medicare Coverage for EPO - Medicare Coverage of Epoetin Alfa (Procrit) for Preoperative Use - Oral Anti-Cancer Drugs - Oral Anti-Nausea (Anti-Emetic)

4 Drugs - Hemophilia Clotting Factors - Coverage of Intravenous Immune Globulin for Treatment of Primary Immune Deficiency Diseases in the Home 60 - Services and Supplies - Incident To Physician s Professional Services - Services of Nonphysician Personnel Furnished Incident To Physician s Services - Incident To Physician sServices in Clinic - Services Incident to a Physician s Service to Homebound Patients Under General Physician Supervision - Definition of Homebound Patient Under the Medicare Home Health (HH) Benefit 70 - Sleep Disorder Clinics 80 - Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests - Clinical Laboratory Services - Certification Changes - A/B MAC (B) Contacts With Independent Clinical Laboratories - Independent Laboratory Service to a Patient in the Patient s Home or an Institution - Psychological and Neuropsychological Tests - Audiology Services - Definition of Qualified Audiologist - Coverage of Portable X-Ray Services Not Under the Direct Supervision of a Physician - Diagnostic X-Ray Tests - Applicability of Health and Safety Standards - Scope of Portable X-Ray Benefit - Exclusions From Coverage as Portable X-Ray Services - Electrocardiograms - Bone Mass Measurements (BMMs) - Background - Authority - Definition - Conditions for Coverage - Frequency Standards - Beneficiaries Who May be Covered - Noncovered BMMs - Claims Processing - National Coverage Determinations (NCDs)

5 - Requirements for Ordering and Following Orders for Diagnostic Tests - Definitions - Interpreting Physician Determines a Different Diagnostic Test is Appropriate - Rules for Testing Facility to Furnish Additional Tests - Rules for Testing Facility Interpreting Physician to Furnish Different or Additional Tests - Surgical/Cytopathology Exception 90 - X -Ray, Radium, and Radioactive Isotope Therapy 100 - Surgical Dressings, Splints, Casts, and Other Devices Used for Reductions of Fractures and Dislocations 110 - Durable Medical Equipment - General - Definition of Durable Medical Equipment - Repairs, Maintenance, Replacement, and Delivery - Coverage of Supplies and Accessories - Miscellaneous Issues Included in the Coverage of Equipment - Incurred Expense Dates for Durable Medical Equipment - Determining Months for Which Periodic Payments May Be Made for Equipment Used in an Institution - No Payment for Purchased Equipment Delivered Outside the United States or Before Beneficiary s Coverage Began 120 - Prosthetic Devices 130 - Leg, Arm, Back, and Neck Braces, Trusses, and Artificial Legs, Arms, and Eyes 140 - Therapeutic Shoes for Individuals with Diabetes 150 - Dental Services - Treatment of Temporomandibular Joint (TMJ) Syndrome 160 - Clinical Psychologist Services 170 - Clinical Social Worker (CSW) Services 180 - Nurse-Midwife (CNM) Services 190 - Physician Assistant (PA) Services 200 - Nurse Practitioner (NP) Services 210 - Clinical Nurse Specialist (CNS)

6 Services 220 - Coverage of Outpatient Rehabilitation Therapy Services (Physical Therapy, Occupational Therapy, and Speech-Language Pathology Services) Under Medical Insurance - Conditions of Coverage and Payment for Outpatient Physical Therapy, Occupational Therapy, or Speech-Language Pathology Services - Care of a Physician/Nonphysician Practitioner (NPP) - Plans of Care for Outpatient Physical Therapy, Occupational Therapy, or Speech-Language Pathology Services - Certification and Recertification of Need for Treatment and Therapy Plans of Care - Requirement That Services Be Furnished on an Outpatient Basis - Reasonable and Necessary Outpatient Rehabilitation Therapy Services - Documentation Requirements for Therapy Services - Functional Reporting 230 - Practice of Physical Therapy, Occupational Therapy, and Speech-Language Pathology - Practice of Physical Therapy - Practice of Occupational Therapy - Practice of Speech-Language Pathology - Services Furnished by a Therapist in Private Practice (TPP) - Physical Therapy, Occupational Therapy and Speech-Language Pathology Services Provided Incident to the Services of Physicians and Nonphysician Practitioners (NPP)

7 - Therapy Services Furnished Under Arrangements With Providers and Clinics 231 - Pulmonary Rehabilitation (PR) Program Services Furnished on or After January 1, 2010 232 - Cardiac Rehabilitation (CR) and Intensive Cardiac Rehabilitation (ICR) Services Furnished On or After January 1, 2010 240 - Chiropractic Services - General - Coverage of Chiropractic Services - Manual Manipulation - Subluxation May Be Demonstrated by X-Ray or Physician s Exam - Necessity for Treatment Location of Subluxation - Treatment Parameters 250 - Medical and Other Health Services Furnished to Inpatients of Hospitals and Skilled Nursing Facilities 260 - Ambulatory Surgical Center Services - Definition of Ambulatory Surgical Center (ASC) - Ambulatory Surgical Center Services - Services Furnished in ASCs Which are Not ASC Facility Services - Coverage of Services in ASCs, Which are Not ASC Services - List of Covered Ambulatory Surgical Center Procedures - Nature and Applicability of ASC List - Nomenclature and Organization of the List - Rebundling of CPT Codes 270 - Telehealth Services 280 Preventive and Screening Services Glaucoma Screening - Colorectal Cancer Screening - Covered Services and HCPCS Codes - Coverage Criteria - Determining Whether or Not the Beneficiary is at High Risk for Developing Colorectal Cancer - Determining Frequency Standards - Noncovered Services - Screening Mammography - Screening Pap Smears - Annual Wellness Visit (AWV) Providing Personalized Prevention Plan Services (PPPS) Advance Care Planning (ACP)

8 Furnished as an Optional Element with an Annual Wellness Visit (AWV) upon Agreement with the Patient 290 - Foot Care 300 - Diabetes Self-Management Training Services - Beneficiaries Eligible for Coverage and Definition of Diabetes - Certified Providers - Frequency of Training - Coverage Requirements for Individual Training Incident -To Provision - Payment for DSMT - Special Claims Processing Instructions A/B MACs (A) 310 Kidney Disease Patient Education Services - Beneficiaries Eligible for Coverage - Qualified Person - Limitations for Coverage - Standards for Content - Outcomes Assessment 10 - Supplementary Medical Insurance (SMI) Provisions (Rev. 37, Issued: 08-12-05; Effective/Implementation: 09-12-05) The supplementary medical insurance plan covers expenses incurred for the following medical and other health services under Part B of Medicare : Physician s services, including surgery, consultation, office and institutional calls, and services and supplies furnished incident to a physician s professional service; Outpatient hospital services furnished incident to physicians services; Outpatient diagnostic services furnished by a hospital; Outpatient physical therapy, outpatient occupational therapy, outpatient speech-language pathology services; Diagnostic x-ray tests, laboratory tests, and other diagnostic tests; X-ray, radium, and radioactive isotope therapy; Surgical dressings, and splints, casts, and other devices used for reduction of fractures and dislocations.

9 Rental or purchase of durable medical equipment for use in the patient s home; Ambulance service; Prosthetic devices, other than dental, which replace all or part of an internal body organ; Leg, arm, back and neck braces and artificial legs, arms, and eyes including adjustments, repairs, and replacements required because of breakage, wear, loss, or change in the patient s physical condition; Certain medical supplies used in connection with home dialysis delivery systems; Rural health clinic (RHC) services; Federally Qualified Health Center (FQHC) services; Ambulatory surgical center (ASC) services; Screening mammography services; Screening pap smears and pelvic exams; Screening glaucoma services; Influenza, pneumococcal pneumonia, and hepatitis B vaccines; Colorectal screening; Bone mass measurements; Diabetes self-management services; Prostate screening; and Home health visits after all covered Part A visits have been used.

10 See 250 for provisions regarding supplementary medical insurance coverage of certain of these services when furnished to hospital and SNF inpatients. Payment may not be made under Part B for services furnished an individual if the individual is entitled to have payment made for those services under Part A. An individual is considered entitled to have payment made under Part A if the expenses incurred were used to satisfy a Part A deductible or coinsurance amount, or if payment would be made under P