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)

2 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 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.

3 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

4 - 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 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)

5 - Requirements for Medicare Coverage for EPO - Medicare Coverage of Epoetin Alfa (Procrit) for Preoperative Use - Oral Anti-Cancer Drugs - Oral Anti-Nausea (Anti-Emetic) 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)

6 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)

7 - Background - Authority - Definition - Conditions for Coverage - Frequency Standards - Beneficiaries Who May be Covered - Noncovered BMMs - Claims Processing - National Coverage Determinations (NCDs) - 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.

8 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) Services 220 - Coverage of Outpatient Rehabilitation Therapy Services (Physical Therapy, Occupational Therapy, and Speech-Language Pathology Services)

9 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.

10 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) - 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)