evekhm/cms_iom_500 huggingface dataset:
(Medicare Benefit Policy Manual)
For therapeutic services furnished during CY 2011 and following, whether in the hospital or CAH or in an on- campus or off -campus outpatient department of the hospital or CAH as defined at 42 CFR 413.65, direct supervision means that the physician or nonphysician practitioner must be immediately available to furnish assistance and direction throughout the performance of the procedure.  As discussed below, the physician is not required to be present in the room where the procedure is performed or within any other physical boundary as long as he or she is immediately available.  Immediate availability requires the immediate physical presence of the supervisory physician or nonphysician practitioner.  CMS has not specifically defined the word immediate in terms of time or distance; however, an example of a lack of immediate avail ability would be situations where the supervisory physician or nonphysician practitioner is performing another procedure or service that he or she could not interrupt.  Also, for services furnished on- campus, the supervisory physician or nonphysician pract itioner may not be so physically distant on- campus from the location where hospital/CAH outpatient services are being furnished that he or she could not intervene right away.  The hospital or supervisory practitioner must judge the supervisory practitioner s relative location to ensure that he or she is immediately available.   For services furnished in CY 2011 and following, a supervisory practitioner may furnish direct supervision from a physician office or other nonhospital space that is not officially part of the hospital or CAH campus where the services are being furnished a s long as he or she remains immediately available.  Similarly, as of CY 2011, an allowed practitioner can furnish direct supervision from any location in or near an off -campus hospital or CAH building that houses multiple hospital provider -based department s where the services are being furnished as long as the supervisory practitioner is immediately available.
(Medicare Benefit Policy Manual)
The supervisory physician or nonphysician practitioner must have, within his or her State scope of practice and hospital -granted privileges, the knowledge, skills, ability, and privileges to perform the service or procedure.  Specially trained ancillary st aff and technicians are the primary operators of some specialized therapeutic equipment, and while in such cases CMS does not expect the supervisory physician or nonphysician practitioner to operate this equipment instead of technician, CMS does expect the  physician or nonphysician practitioner to be knowledgeable about the therapeutic service and clinically able to furnish the service.   The supervisory responsibility is more than the capacity to respond to an emergency, and includes the ability to take over performance of a procedure or provide additional orders.  CMS would not expect that the supervisory physician or nonphysician practitioner would make all decisions unilaterally without informing or consulting the patients treating physician or nonphysician practitioner.  In summary, the supervisory physician or nonphysician practitioner must be clinically able to supervise the service or procedure.  20.5.3 - Coverage of Outpatient Therapeutic Services Incident to a Physicians Service Furnished on or After January 1, 2020  Changes to Supervision Requirements  (Rev. 10541; Issued: 12-31- 20; Effective: 01 -01-21; Implementation: 01-04-21)
(Medicare Benefit Policy Manual)
Starting January 1, 2020, CMS requires, as the minimum level of supervision, general supervision by an appropriate physician or non-physician practitioner in the provision of all therapeutic services to hospital outpatients, including CAH outpatients.  General supervision means the definition specified at 42 CFR 410.32(b)(3)(i), that is, the procedure or service is furnished under the physician's overall direction and control, but the physician's presence is not required during the performance of the procedure. CMS may assign certain hospital outpatient therapeutic services either direct supervision or personal supervision.  When such assignment is made, direct supervision means the definition specified at 42 CFR 410.32(b)(3)(ii), that is, the physician must be immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician or must be present in the room when the procedure is performed.  Personal supervision means the definition specified at 42 CFR 410.32(b)(3)(iii), that is, the physician must be in attendance in the room during the performance of the service or procedure.   The list of services starting January 1, 2020 and ending December 31, 2020 that are defined as non-surgical extended duration therapeutic services where the initiation of the service must be performed under direct supervision is available on the OPPS Websi te at http://www.cms.gov/Medicare/Medicare- Fee-for-Service-Payment/HospitalOutpatientPPS/index.html. Starting January 1, 2021, the minimum level of supervision for non- surgical extended duration therapeutic services will be general supervision for the entire service including for the initiation of the service.  20.5.4 - Coverage of Outpatient Therapeutic Services Incident to a Physicians Service Furnished on or After January 1, 2024  Changes to Direct Supervision Requirements for Pulmonary, Cardiac and Intensive Cardiac Rehabilitation  (Rev. 12421; Issued: 12-21- 23; Effective: 01 -01-24: Implementation: 01-02-24)
(Medicare Benefit Policy Manual)
Beginning January 1, 2024, the required direct supervision of pulmonary rehabilitation services, as specified at 42 CFR 410.47, and cardiac rehabilitation and intensive cardiac rehabilitation services, as specified at 42 CFR 410.49, may be furnished by a doctor of medicine, a doctor of osteopathy, a physician assistant, a nurse practitioner, or a clinical nurse specialist.  20.6 - Outpatient Observation Services  (Rev.  215, Issued, 12-18-15, Effective, 01-01-16, Implementation: 01 -04-16)
(Medicare Benefit Policy Manual)
A.  Outpatient Observation Services Defined   Observation care is a well -defined set of specific, clinically appropriate services, which include ongoing short term treatment, assessment, and reassessment before a decision can be made regarding whether patients will require further treatment as hospital inpatients or if they are able to be discharged from the hospital.  Observation services are commonly ordered for patients who present to the emergency department and who then require a significant period of treatment or monitoring in order to make a decision concerning their admission or discharge.  Observation services are covered only when provided by the order of a physician or another individual authorized by state licensure law and hospital staff bylaws to admit patients to the hospital or to order outpatient tests.  In the majority of cases, the decision whether to discharge a patient from the hospital following resolution of the reason for the observation care or to admit the patient as an inpatient can be made in less than 48 hours, usually in less than 24 hours.  In only rare and exceptional c ases do reasonable and necessary outpatient observation services span more than 48 hours.  Hospitals may bill for patients who are directly referred to the hospital for outpatient observation services.  A direct referral occurs when a physician in the community refers a patient to the hospital for outpatient observation, bypassing the clinic or emergency department (ED) visit.  Effective for services furnished on or after January 1, 2003, hospitals may bill for patients directly referred for observation services.  See, Pub. 100-04, Medicare Claims Processing Manual, chapter 4, section 290, at http://www.cms.hhs.gov/manuals/downloads/clm104c04.pdf for billing and payment instructions for outpatient observation services.  Future updates will be issued in a Recurring Update Notification.  B.  Coverage of Outpatient Observation Services   When a physician orders that a patient receive observation care, the patients status is that of an outpatient.  The purpose of observation is to determine the need for further treatment or for inpatient admission.  Thus, a patient receiving observation se rvices may improve and be released, or be admitted as an inpatient (see Pub. 100- 02, Medicare Benefit Policy Manual, Chapter 1, Section 10 Covered Inpatient Hospital Services Covered Under Part A at https://www.cms.gov/Regulations- and-Guidance/Guidance/Manuals/Downloads/bp102c01.pdf ).  For more information on
(Medicare Benefit Policy Manual)
10 Covered Inpatient Hospital Services Covered Under Part A at https://www.cms.gov/Regulations- and-Guidance/Guidance/Manuals/Downloads/bp102c01.pdf ).  For more information on correct reporting of observation services, see Pub. 100- 04, Medicare Claims Processing Manual, chapter 4, section 290.2.2.)
(Medicare Benefit Policy Manual)
All hospital observation services, regardless of the duration of the observation care, that are medically reasonable and necessary are covered by Medicare.  Observation services are reported using HCPCS code G0378 (Hospital observation service, per hour).  As of January 1, 2008, HCPCS code G0378 for hourly observation services is assigned status indicator N, signifying that its payment is always packaged.  No separate payment is made for observation services reported with HCPCS code G0378.  In most circumst ances, observation services are supportive and ancillary to the other separately payable services provided to a patient.  Beginning January 1, 2016, in certain circumstances when observation care is billed in conjunction with a clinic visit, Type A emergen cy department visit (Level 1 through 5), Type B emergency department visit (Level 1 through 5), critical care services, or direct referral for observation services as an integral part of a patients extended encounter of care, comprehensive payment may be made for all services on the claim including, the entire extended care encounter when certain criteria are met.  For information about billing and payment methodology for observation services in years prior to CY 2008, see Pub. 100- 04, Medicare Claims Processing Manual, Chapter 4, 290.3- 290.4.  For information about payment for extended assessment and management under composite APCs and comprehensive APCs, see 290.5.   Payment for all reasonable and necessary observation services is packaged into the payments for other separately payable services provided to the patient in the same encounter.  Observation services packaged through assignment of status indicator N are covered OPPS services.  Since the payment for these services is included in the AP C payment for other separately payable services on the claim, hospitals must not bill Medicare beneficiaries directly for the packaged services.   C.  Services Not Covered by Medicare and Notification to the Beneficiary
(Medicare Benefit Policy Manual)
C.  Services Not Covered by Medicare and Notification to the Beneficiary   In making the determination whether an ABN can be used to shift liability to a beneficiary for the cost of non- covered items or services related to an encounter that includes observation care, the provider should follow a two step process.  First, the provider must decide whether the item or service meets either the definition of observation care or would be otherwise covered.  If the item or service does not meet the definitional requirements of any Medicare -covered benefit under Part B, then the item or service is not covered by Medicare and an ABN is not required to shift the liability to the beneficiary.  However, the provider may choose to provide voluntary notification for these items or services.   Second, if the item or service meets the definition of observation services or would be otherwise covered, then the provider must decide whether the item or service is reasonable and necessary for the beneficiary on the occasion in question, or if the it em or service exceeds any frequency limitation for the particular benefit or falls outside of a timeframe for receipt of a particular benefit. In these cases, the ABN would be used to shift the liability to the beneficiary (see Pub. 100- 04, Medicare Claims Processing Manual; Chapter 30, Financial Liability Protections, Section 20, at https://www.cms.gov/Regulations- and-Guidance/Guidance/Manuals/Downloads/clm104c30.pdf  for information regarding Limitation On Liability (LOL) Under 1879 Where Medicare Claims Are Disallowed).   If an ABN is not issued to the beneficiary, the provider may be held liable for the cost of the item or service unless the provider/supplier is able to demonstrate that they did not know and could not have reasonably been expected to know that Medicare would not pay for the item or service.      30 - Drugs and Biologicals  (Rev. 1, 10-01-03) A3-3112.4.B, HO-230.4.B
(Medicare Benefit Policy Manual)
30 - Drugs and Biologicals  (Rev. 1, 10-01-03) A3-3112.4.B, HO-230.4.B  See the Medicare Benefit Policy Manual, Chapter 15,Covered  Medical and Other Health Services, 50 for a description of conditions for coverage for drugs and biologicals.  Notwithstanding the instructions in the Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, drugs and biologicals furnished to hospital or SNF inpatients who have exhausted Part A benefits, or who are not eligible under Part A, are not covered under Part B except the following:   Hemophilia clotting factors (The limitation contained in 42 CFR 410.10(q) states that this applies to hemophilia patients competent to use these factors without supervision);   Immunosuppressive drugs;   Oral anti -cancer drugs;   Oral drug prescribed for use as an acute anti -emetic used as part of an anti -cancer chemotherapeutic regimen; or    Epoetin Alfa (EPO).   Specific coverage for each of the above drugs is found in Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, 50.  In addition pneumococcal pneumonia, influenza virus, and hepatitis B vaccines are covered under Part B.  See the Medicare Claims Processing Manual, Chapter 18, Preventive and Screening Services, and the Medicare Benefit Policy Manual, Chapter 15, for additional information concerning these vaccines.   40 - Other Covered Services and Items  (Rev. 1, 10- 01-03) A3-3112.4.C, HO -230.4.D   Covered services and items provided by the hospital in connection with a clinic visit or a physicians treatment of outpatients include the use of the following:    Hospital facilities, including the use of the emergency room;    Services of nurses, nonphysician anesthetists, psychologists, technicians, therapists, and other aides; and   Medical supplies such as gauze, oxygen, ointments, and other supplies used by physicians or hospital personnel in the treatment of outpatients.
(Medicare Benefit Policy Manual)
 Medical supplies such as gauze, oxygen, ointments, and other supplies used by physicians or hospital personnel in the treatment of outpatients.  Additional examples of covered items are surgical dressings; splints, casts, and other devices used for reduction of fractures and dislocations; prosthetic devices; leg, arm, back, and neck braces, trusses, and artificial legs, arms, and eyes.   50 - Sleep Disorder Clinics  (Rev. 1, 10- 01-03) A3-3112.5   Sleep disorder clinics are facilities in which certain conditions are diagnosed through the study of sleep.  Such clinics are for diagnosis, therapy, and research.  Sleep disorder clinics may provide some diagnostic or therapeutic services that are covered under Medicare.  These clinics may be affiliated either with a hospital or a freestanding facility.  Whether a clinic is hospital -affiliated or freestanding, coverage for diagnostic services under some circumstances is covered under provisions of the law different from those for coverage of therapeutic services.   60 - Intermittent Peritoneal Dialysis Services  (Rev. 1, 10- 01-03) A3-3112.6   See the discussion of dialysis services in the Medicare Benefits Policy Manual, Chapter 11, End Stage Renal Disease.   70 - Outpatient Hospital Psychiatric Services  (Rev. 1, 10- 01-03) A3-3112.7, HO -230.5  70.1 - General  (Rev. 12425; Issued: 12-21- 23: Effective: 01 -01-24; Implementation: 01-02-24)     There is a wide range of services and programs that a hospital may provide to its outpatients who need psychiatric care, ranging from a few individual services to comprehensive, full -day programs; from intensive treatment programs to those that provide primarily supportive services .    In general, to be covered the services must be:     Incident to a physicians service (see 20.4); and     Reasonable and necessary for the diagnosis or treatment of the patients condition.    This means the services must be for the purpose of diagnostic study or the services must reasonably be expected to improve the patients condition.     A.  Coverage Criteria  The services must meet the following criteria:     1.  Individualized Treatment Plan
(Medicare Benefit Policy Manual)
This means the services must be for the purpose of diagnostic study or the services must reasonably be expected to improve the patients condition.     A.  Coverage Criteria  The services must meet the following criteria:     1.  Individualized Treatment Plan    Services must be prescribed by a physician and provided under an individualized written plan of treatment established by a physician after any needed consultation with appropriate staff members.  The plan must state the type, amount, frequency, and duration of the services to be furnished and indicate the diagnoses and anticipated goals.  (A plan is not required if only a few brief services are furnished.)     2.  Physician Supervision and Evaluation    Services must be supervised and periodically evaluated by a physician to determine the extent to which treatment goals are being realized.  The evaluation must be based on periodic consultation and conference with therapists and staff, review of medical records, and patient interviews.  Physician entries in medical records must support this involvement.  The physician must also provide supervision and direction to any therapist involved in the patient's treatment and see the patient periodically to evaluate the course of treatment and to determine the extent to which treatment goals are being realized and whether changes in direction or emphasis are needed.     3.  Reasonable Expectation of Improvement    Services must be for the purpose of diagnostic study or reasonably be expected to improve the patient's condition.  The treatment must, at a minimum, be designed to reduce or control the patient's psychiatric symptoms so as to prevent relapse or hospitaliz ation, and  improve or maintain the patient's level of functioning.    It is not necessary that a course of therapy have as its goal restoration of the patient to the level of functioning exhibited prior to the onset of the illness, although this may be appropriate for some patients.  For many other psychiatric patients, part icularly those with long-term, chronic conditions, control of symptoms and maintenance of a functional level to avoid further deterioration or hospitalization is an acceptable expectation of improvement.  "Improvement" in this context is measured by compar ing the effect of continuing treatment versus discontinuing it.  Where there is a reasonable expectation that if treatment services were withdrawn the patient's condition would deteriorate, relapse further, or require hospitalization, this criterion is met.
(Medicare Benefit Policy Manual)
Some patients may undergo a course of treatment that increases their level of functioning, but then reach a point where further significant increase is not expected. Such claims are not automatically considered noncovered because conditions have stabilized , or because treatment is now primarily for the purpose of maintaining present level of functioning.  Rather, coverage depends on whether the criteria discussed above are met.  Services are noncovered only where the evidence clearly establishes that the cr iteria are not met; for example, that stability can be maintained without further treatment or with less intensive treatment.     B. Partial Hospitalization and Intensive Outpatient Program    Partial hospitalization is a distinct and organized intensive treatment program for patients who would otherwise require inpatient psychiatric care.  See 70.3 for specific program requirements.     An intensive outpatient program is a distinct and organized ambulatory treatment program for patients who have an acute mental illness, including substance use disorder (SUD). Intensive outpatient services are not required to be provided in lieu of inpatient hospitalization. See 70.4 for specific program requirements.  C.  Application of Criteria    The following discussion illustrates the application of the above guidelines to the more common modalities and procedures used in the treatment of psychiatric patients and some factors that are considered in determining whether the coverage criteria are met.     1.  Covered Services    Services generally covered for the treatment of psychiatric patients (including patients with SUD) are:     Individual and group therapy with physicians, psychologists, or other mental health professionals (including SUD professionals)  authorized by the State.     Occupational therapy services are covered if they require the skills of a qualified occupational therapist and be performed by or under the supervision of a qualified occupational therapist or by an occupational therapy assistant.     Services of social workers, trained psychiatric nurses, and other staff trained to work with psychiatric patients (including patients with SUD) . These include principal illness navigation services provided by auxiliary staff, including peer support specialists.    Drugs and biologicals furnished to outpatients for therapeutic purposes, but only if they are of a type which cannot be self-administered.     Activity therapies but only those that are individualized and essential for the treatment of the patient's condition.  The treatment plan must clearly justify the need for each particular therapy utilized and explain how it fits into the patient's treatmen t.