Thursday, December 5, 2019

CPT CODE 99217, 99218, 99219, 99220 - Observation codes

CPT Code Description
99217 Observation care discharge day management (This code is to be utilized to report all services provided to a patient on discharge from outpatient hospital "observation status" if the discharge is on other than the initial date of "observation status." To report services to a patient designated as "observation status" or "inpatient status" and discharged on the same date, use the codes for Observation or Inpatient Care Services [including Admission and Discharge Services, 99234-99236 as appropriate.])

99218 Initial observation care, per day, for the evaluation and management of a patient which requires these 3 key components: A detailed or comprehensive history; A detailed or comprehensive examination; and Medical decision making that is straightforward or of low complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the problem(s) requiring admission to outpatient hospital "observation status" are of low severity. Typically, 30 minutes are spent at the bedside and on the patient's hospital floor or unit.

99219 Initial observation care, per day, for the evaluation and management of a patient, which requires these 3 key components: A comprehensive history; A comprehensive examination; and Medical decision making of moderate complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the problem(s) requiring admission to outpatient hospital "observation status" are of moderate severity. Typically, 50 minutes are spent at the bedside and on the patient's hospital floor or unit.

99220 Initial observation care, per day, for the evaluation and management of a patient, which requires these 3 key components: A comprehensive history; A comprehensive examination; and Medical decision making of high complexity. Counseling and/or coordination of care with other physicians, other qualified healthcare professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the problem(s) requiring admission to "observation status" are of high severity. Typically 70 minutes are spent at the bedside and on the patient's hospital floor or unit.


OBSERVATION SERVICES CPT CODES: 99218-99220, 99224 – 99226


Background Observation care is a well-defined set of specific, clinically appropriate services,

which include:

• Ongoing short term treatment,
• Assessment,
• Reassessment

These are furnished while a decision is being 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.

In only rare and exceptional cases do reasonable and necessary outpatient observation services span more than 48 hours.

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.


Who May Bill

• Contractors pay for initial observation care billed by only the physician/non physician practitioner who have hospital admitting privileges, who ordered hospital outpatient observation services, and who was responsible for the patient during his/her observation care. A physician who does not have inpatient admitting privileges but who is authorized to furnish hospital outpatient observation services may bill these codes.

• For a physician to bill observation care codes, there must be a medical observation record for the patient which contains dated and timed physician’s orders regarding the observation services the patient is to receive, nursing notes, and progress notes prepared by the physician while the patient received observation services.

This record must be in addition to any record prepared as a result of an emergency department or outpatient clinic encounter.

• Payment for an initial observation care code is for all the care rendered by the ordering physician on the date the patient’s observation services began. All other physicians who furnish consultations or additional evaluations or services while the patient is receiving hospital outpatient observation services must bill the appropriate outpatient service codes.

- For example, if an internist orders observation services and asks another physician to additionally evaluate the patient, only the internist may bill the initial and subsequent observation care codes. The other physician who evaluates the patient must bill the new or established office or other outpatient visit codes as appropriate.

Significance of Time as a Factor

The inclusion of time as an explicit factor beginning in CPT 1992 is done to assist in selecting the most appropriate level of E/M services. Please note that the specific times expressed in the CPT visitcode descriptors are averages and , therefore, represent a range of times that may be higher or lower depending on actual clinical circumstances.

• Intraservice times are defined as face-to-face time for office and other outpatients visits and as unit/floor time for hospital and other inpatient visits

- Unit/Floor time includes the time present on the patient’s hospital unit and at the bedside rendering services for that patient; includes time to establish and/or review patient’s chart, examine the patient, write notes, and communicate with other professionals and the patient’s family.

» Pre and Post-visit time is not included in the time component described in these codes (pre and post include time spent off the patient’s floor performing such tasks as reviewing pathology/radiology findings in another part of the hospital).


Initial Observation Care (CPT code range 99218-99220)

• Included in Initial Observation Care:
- Initiation of observation status
- Supervision of the care plan for observation
- Performance of periodic reassessments
• When a patient receives observation care for less than 8 hours on the same calendar date, the Initial Observation Care, from CPT code range 99218 – 99220, shall be reported by the physician.
• When a patient is admitted for observation care and then is discharged on a different calendar date, the physician shall report Initial Observation Care, from CPT code range 99218 – 99220, and CPT observation care discharge CPT code 99217.
• To report services provided to patient who is admitted to the hospital after receiving hospital observation care services on the same date, see initial hospital care notes in the American Medical Association (AMA) Current Procedural Terminology (CPT) Publication.
• To report hospital admission on a date subsequent to the date of observation status, use appropriate initial hospital care codes (CPT 99221 – 99223)
• Observation status that is initiated in the course of an encounter in another site of service (eg. hospital emergency department, office, nursing facility) all E/M services provided by the supervising physician or other qualified health care professional in conjunction with initiating “observation status” are  considered part of the initial observation care when performed on the same date.
- The level of service reported should include the services related to initiating “observation status” provided in the other sites of service as well as in the observation setting
• On the rare occasion when a patient remains in observation care for 3 days, the physician shall report an initial observation care code (99218-99220) for the first day of observation care, a subsequent observation care code (99224-99226) for the second day of observation care, and an observation care discharge CPT code 99217 for the observation care on the discharge date.
• Admitted and discharges from observation or inpatient status on the same date report CPT codes 99234-99236 as appropriate; do NOT report observation discharge in conjunction with a hospital admission.
• These codes may NOT be utilized for post-operative recovery if the procedure is considered part of the surgical “package.” Subsequent Observation Care (CPT code range 99224 – 99226)

• All levels of subsequent observation care include:
- Reviewing the medical record
- Reviewing the results of diagnostic studies
- Changes in the patient’s status (ie, changes in history physical condition, and response to management) since the last assessment.

• When observation care continues beyond three days, report subsequent observation care for each day between the first day of observation care and the discharge date When a patient receives observation care for a minimum of 8 hours, but less than 24 hours, and is discharged on the same calendar date, observation or inpatient care services (including admission and discharge services) CPT code range.

Discharge Observation Care (CPT code 99217)

• Included in CPT code 99217
- Final Examination of the patient
- Discussion of the hospital stay
- Instructions for continuing care
- Preparation of discharge records

• For observation or inpatient hospital care including the admission and discharge of the patient on the same date see CPT codes 99234 - 99236.


OVERVIEW FROM oxford insurance

Initial Observation Care CPT® codes 99218-99220 and subsequent Observation Care CPT codes 99224-99226 are used to report evaluation and management (E/M) services provided to new or established patients designated as "observation status" in a hospital. Observation service (including admission and discharge) CPT codes 99234-99236 are used to report E/M services provided to patients admitted and discharged on the same date of service.


For the purpose of this policy, the Same Specialty Physician or Other Qualified Health Care Professional is defined as a physician and/or health care professional of the same group and same specialty reporting the same Federal Tax Identification number.

REIMBURSEMENT GUIDELINES

Initial Observation Car
e

The physician supervising the care of the patient designated as "observation status" is the only physician who can report an initial Observation Care CPT code (99218-99220). It is not necessary that the patient be located in an observation area designated by the hospital, although in order to report the Observation Care codes the physician must:

** Indicate in the patient's medical record that the patient is designated or admitted as observation status;
** Clearly document the reason for the patient to be admitted to observation status; and
** Initiate the observations status, assess, establish and supervise the care plan for observation and perform periodic reassessments.

The CPT codebook states that "When "observation status" is initiated in the course of an encounter in another site of service (e.g., hospital emergency department, office, nursing facility) all evaluation and management services provided by the supervising physician or other qualified health care professional in conjunction with initiating "observation status" are considered part of the initial Observation Care when performed on the same date. The Observation Care level of service reported by the supervising physician should include the services related to initiating "observation status" provided in the other sites of services as well as in the observation setting."

Oxford follows the Centers for Medicare and Medicaid Services' (CMS) Claims Processing Manual which provides the instructions, "for a physician to bill the initial Observation Care codes [99218-99220], there must be a medical observation record for the patient which contains dated and timed physician's admitting orders regarding the care the patient is to receive while in observation, nursing notes, and progress notes prepared by the physician while the patient was in observation status. This record must be in addition to any record prepared as a result of an emergency department or outpatient clinic encounter."

Consistent with CMS guidelines, Oxford requires that an Initial Observation Care CPT code (99218-99220) should be reported for a patient admitted to Observation Care for less than 8 hours on the same calendar date.

QUESTIONS AND ANSWERS

Q: Can Observation Care codes 99217 and codes 99218-99220 be reported on the same date of service?

A: No. CPT codes 99234-99236 should be reported for patients who are admitted to and discharged from observation status on the same calendar date for a minimum of 8 hours but less than 24. An initial Observation Care code (99218-99220) should be reported for patients admitted and discharged from observation status for less than 8 hours on the same calendar date. CPT code 99217 can only be reported for a patient discharged on a different calendar date.

Q: Does the patient need to be in an observation unit in order to report the Observation Care codes?
A: It is not necessary that the patient be located in an observation area designated by the hospital as long as the medical record indicates that the patient was admitted as observation status and the reason for Observation Care is documented.


Observation Services billing guidelines


Hospital observation services (procedure codes 1-99217, 1-99218, 1-99219, and 1-99220) is for professional services for a period of more than 6 hours, but fewer than 24 hours, regardless of the hour of the initial contact, whether or not the client remains under physician care beyond midnight.

Observation may take place in any patient care area of the hospital or outpatient setting.

Observation care discharge day management may be billed to report services provided to a client upon discharge from observation status if the discharge date is other than the initial date of admission. Procedure codes 1-99211, 1-99212, 1-99213, 1-99214, 1-99215, 1-99218, 1-99219, and 1-99220 will be denied if billed on the same day as procedure codes 1-99217, 1-99234, 1-99235, and 1-99236 by the same provider. Evaluation and management services provided in any place of service other than the inpatient hospital, billed on the same day as a physician observation visit, by the same provider, will be denied.

If a physician observation visit (procedure codes 1-99217, 1-99218, 1-99219, 1-99220, 1-99234, 1-99235, and 1-99236) is billed on the same day as prolonged services (procedure codes 1-99354 and 1-99355) by the same provider, the prolonged services will be denied as part of another procedure on the same day.

If dialysis treatment and physician observation visits are billed the same day, by the same provider, same specialty, other than Nephrology and Internal Medicine specialists, the dialysis treatment will be paid and the physician observation visit will be denied.

Prolonged Physician Services Prolonged services may be provided in the office, outpatient, or inpatient setting and involve direct (face-toface) client contact that is beyond the usual service and exceeds the time threshold of the following evaluation and management codes being billed on that day.


Tuesday, September 24, 2019

CPT H1000, H1001, H1004 - Prenatal and postpartum services

HCPCS code and Description

H1000 Prenatal care, at-risk assessment
H1001 Prenatal Care, At Risk Enhances Service;
H1004 Prenatal Care, At-Risk Enhanced; Follow Up Home Visit

FPC–Frequency of prenatal care

Prenatal standalone visits CPT codes:  99500, 0500F, 0501F, 0502F    
HCPCS Code : H1000-H1004   and H1005

The percentage of expected prenatal visits based on weeks of gestation at delivery and months of pregnancy when patient enrolled in Medicaid:

• Every four weeks for the first 28 weeks of pregnancy
• Every two-three weeks for the next seven weeks
• Weekly thereafter until delivery


Prenatal and Postpartum Care (PPC)

The percentage of deliveries of live births on or between November 6 of the year prior to the measurement year and November 5 of the measurement year. For these women, the measure assesses the following facets of prenatal and postpartum care.

• Timeliness of Prenatal Care. The percentage of deliveries that received a prenatal care visit as a member of the organization in the first trimester, on the enrollment start date or within 42 days of enrollment in the organization.

• Postpartum Care. The percentage of deliveries that had a postpartum visit on or between 21 and 56 days after delivery.


UHC Florida Guidelines
** Prenatal care must be billed separately from the delivery and postpartum care.
** FL providers are to submit prenatal codes H1001 and/or H1000.
** Up to 14visits are allowed for prenatal care& up to 18 visits are allowed for high risk prenatal care.
** Up to 3postpartum visits are allowed within 90 days following delivery, per recipient.
** Delivery of two or more infants from a single pregnancy, by different delivery method, separately.  Same delivery method is non-covered.

Per Florida State Requirements, Birthing Centers (POS 25) are reimbursed the facility fee with procedure code 59409 and Provider delivery services in a birthing center with code 59410


Prenatal and Postnatal Home Visits   - Medicaid insurance billing

Home visits can be included in the management plan of pregnant members when there is a need to assess the home environment and its implications for the management of prenatal and postnatal care; to provide direct care; to encourage regular visits for prenatal care; to provide emotional
support; and to determine educational needs.

Visits may be provided by one of the following Utah licensed qualified providers:
**  Registered Nurse
**  Certified Nurse-Midwife   
**  Certified Nurse Practitioner
**  Social Service Worker
**  Certified Social Worker
**  Licensed Practical Nurse, who works under the supervision of a registered nurse and has additional training and experience to be a perinatal care coordinator
**  Health Educator must have either a Bachelor’s degree in health education with a minimum of three years’ experience, at least one of which must be in a medical setting, a Master’s degree with a minimum of one year of experience working in a medical setting or with pregnant women, or a Bachelor’s degree and a certificate showing completion of a certification examination in health education.

The service is reported using HCPCS H1004 Prenatal Care, At-Risk Enhanced; Follow Up Home Visit.  Limited to six visits during a 12-month period.


Risk Assessment  


Risk assessment is the systematic review of relevant member data to identify potential problems and determine a plan for care.  Early identification of high risk pregnancies with appropriate consultation and intervention contributes significantly to an improved perinatal outcome and lowering of maternal and infant morbidity and mortality.   A care plan for high risk members, in addition to standard care, includes referral to or consultation with an appropriate specialist, individualized counseling and services designed to address the risk factor(s) involved.  A care plan for low risk members includes primary care services and additional services specific to the needs of the individual. 

Risk Assessments may be provided by one of the following licensed Medicaid providers:

**  Physician
**  Certified Nurse Practitioner
**  Certified Nurse-Midwife

The service is reported using HCPCS H1000 Prenatal Care, At Risk Assessment for a low risk assessment or HCPCS H1001 Prenatal Care, At Risk Enhances Service; Antepartum Management for high risk assessment.  Limited to two (2) assessments during any 10-month period.


Friday, July 19, 2019

Medicare inpatient only services

Medicare inpatient-only or hospital only Procedure

The medicare hospital-only list refers to CPT and services that CMS usually only paid in the hospital environment and thus does not pay for under OPPS. Most of the hospital-only CPTs are operating processes that can be complicated, difficult and/or involve hospital care and co-ordinated care. Surgeons must be conscious of the processes listed because of the potential effect on reimbursement and hospital interactions.

"Inpatient only" services are generally, but not always, surgical services that require inpatient care because of the nature of the procedure, the typical underlying physical condition of patients who require the service, or the need for at least 24 hours of postoperative recovery time or monitoring before the patient can be safely discharged.

No payment is made for an “inpatient-only” procedure submitted on the outpatient hospital type of bill, 13X. No payment is made for other services rendered on the same day as the “inpatient only” procedure.

An example of an “inpatient only” service is CPT code 33513, “Coronary artery bypass, vein only; four coronary venous grafts.”

Changes to the Inpatient-Only List (IPO) for CY 2019


The Medicare Inpatient-Only (IPO) list includes procedures that are typically only provided in the inpatient setting and therefore are not paid under the OPPS. For CY 2019, CMS is removing four procedures from the IPO list. CMS is also adding one procedure to the IPO list.

Example changes in the list during 2019

2019 Bariatric Surgery: Is the Surgery Medicare Inpatient Only or not?


43644 Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and Roux-en-Y gastroenterostomy (roux limb 150 cm or less) 43659 Unlisted laparoscopy procedure, stomach
43645 Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and small intestine reconstruction to limit absorption
43775 Laparoscopy, surgical, gastric restrictive procedure; longitudinal gastrectomy (ie, sleeve gastrectomy)
43843 Gastric restrictive procedure, without gastric bypass, for morbid obesity; other than verticalbanded gastroplasty
43845 Gastric restrictive procedure with partial gastrectomy, pylorus-preserving duodenoileostomy and ileoileostomy (50 to 100 cm common channel) to limit absorption (biliopancreatic diversion with duodenal switch)
43846 Gastric restrictive procedure, with gastric bypass for morbid obesity; with short limb (150 cm or less) Roux-en-Y gastroenterostomy
43847 Gastric restrictive procedure, with gastric bypass for morbid obesity; with small intestine reconstruction to limit absorptio
43848 Revision, open, of gastric restrictive procedure for morbid obesity, other than adjustable gastric restrictive device (separate procedure)

Inpatient-only procedure performed in outpatient setting within payment window

If an "inpatient-only" procedure is performed in the outpatient setting, and the patient is subsequently admitted as an inpatient, the "inpatient-only procedure" can be reported on the inpatient claim when the services are:

* Provided on the date of inpatient admission
* Provided within 3 days of inpatient admission
* Deemed related to inpatient admission per the payment window policy


Inpatient-only Services


CMS to define the services for which payment under the OPPS is appropriate and the Secretary has determined that the services designated to be “inpatient only” services are not appropriate to be furnished in a hospital outpatient department.  “Inpatient only” services are generally, but not always, surgical services that require inpatient care because of the nature of the procedure, the typical underlying physical condition of patients who require the service, or the need for at least 24 hours of postoperative recovery time or monitoring before the patient can be safely discharged.  An example of an “inpatient only” service is CPT code 33513, “Coronary artery bypass, vein only; four coronary venous grafts.” 

The designation of services to be “inpatient-only” is open to public comment each year as part of the annual rulemaking process.  Procedures removed from the “inpatient only” list may be appropriately furnished in either the inpatient or outpatient settings and such procedures continue to be payable when furnished in the inpatient setting.


There is no payment under the OPPS for services that CMS designates to be “inpatient-only” services.  These services have an OPPS status indicator of “C” in the OPPS Addendum B and are listed together in Addendum E of each year’s OPPS/ASC final rule. For the most current Addendum B and for Addendum E published with the OPPS notices and regulations, see http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html. Excluding the handful of exceptions discussed below, CMS does not pay for an “inpatient-only” service furnished to a person who is registered in the hospital as an outpatient and reports the service on the outpatient hospital bill type (TOB 13X).  CMS also does not pay for all other services on the same day as the “inpatient only” procedure.

There are two exceptions to the policy of not paying for outpatient services furnished on the same day with an “inpatient-only” service that would be paid under the OPPS if the inpatient service had not been furnished:

Exception 1:  If the “inpatient-only” service is defined in CPT to be a “separate procedure” and the other services billed with the “inpatient-only” service contain a procedure that can be paid under the OPPS and that has an OPPS SI=T on the same date as the “inpatient-only” procedure or OPPS SI = J1 on the same claim as the “inpatient-only” procedure, then the “inpatient-only” service is denied but CMS makes payment for the separate procedure and any remaining payable OPPS services.  The list of “separate procedures” is available with the Integrated Outpatient Code Editor (I/OCE) documentation.  See http://www.cms.gov/Medicare/Coding/OutpatientCodeEdit/.

Exception 2:  If an “inpatient-only” service is furnished but the patient expires before inpatient admission or transfer to another hospital and the hospital reports the “inpatient only” service with modifier “CA”, then CMS makes a single payment for all services reported on the claim, including the “inpatient only” procedure, through one unit of APC 5881, (Ancillary outpatient services when the patient dies.)  Hospitals should report modifier CA on only one procedure

Saturday, March 9, 2019

cpt 43843, 43845, 43846 - 43888 - Bariatric surgery

CPT code and Descriptions


 43843 Gastric restrictive procedure, without gastric bypass, for morbid obesity; other than vertical-banded gastroplasty
43845 Gastric restrictive procedure with partial gastrectomy, pylorus-preserving duodenoileostomy and ileoileostomy (50 to 100 cm common channel) to limit absorption (biliopancreatic diversion with duodenal switch)
43846 Gastric restrictive procedure, with gastric bypass for morbid obesity; with short limb (150 cm or less) Roux-en-Y gastroenterostomy
43847 Gastric restrictive procedure, with gastric bypass for morbid obesity; with small intestine reconstruction to limit absorption
43848 Revision, open, of gastric restrictive procedure for morbid obesity, other than adjustable gastric restrictive device (separate procedure)
43886 Gastric restrictive procedure, open; revision of subcutaneous port component only
43887 Gastric restrictive procedure, open; removal of subcutaneous port component only
43888 Gastric restrictive procedure, open; removal and replacement of subcutaneous port component only


Bariatric Surgery

Introduction


Bariatrics is the branch of medicine dealing with the causes and treatment of obesity. Clinically severe obesity (also known as morbid obesity) is when a person is excessively overweight. Obesity itself is a health hazard as it impacts the heart, lungs, muscles, and bones of the body. In addition, obesity is a known risk factor to develop type 2 diabetes, heart disease and high blood pressure. Many individuals are able to lose weight by changing their diet and increasing their exercise. The challenge for most people is keeping off the weight they have lost. For some people surgery may be needed. Bariatric surgery is often referred to as weight loss surgery or obesity surgery. Surgical approaches to support long-term weight loss have been developed over the past 20 years. For some individuals the surgery works very well, although even after surgery people may need to significantly change their eating habits. Surgery is not without risk, however. There are several different types of weight loss surgery that are done on the stomach, intestine or both. They generally fall into two main categories: surgeries that restrict the amount of food that may be eaten, and surgeries that restrict the body’s ability to absorb calories and nutrients. Not all plans cover obesity surgery. When plans have a benefit for obesity surgery, then this policy describes what information is needed by the health plan to determine if the surgery may be covered.


Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended fo providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. Policy Coverage Criteria Indication Coverage Criteria  Contract limitations Some health plan contracts do not have benefits to cover surgical treatment of morbid obesity, complications, or after effects associated with weight loss surgery. Refer to member contract language for benefit determination on weight loss surgery.

Patient selection criteria for adults (Must meet all 3 criteria) Bariatric (weight loss) surgery in an adult may be considered medically necessary when ALL of the following criteria are met:

* A body mass index (BMI) greater than 40 kg/m2 OR
* A BMI greater than 35 kg/m2 with at least ONE of the following conditions:
o Established Coronary Heart Disease, such as:
* History of angina pectoris (stable or unstable)
* History of angioplasty
* History of coronary artery surgery
* History of myocardial infarction
o Other Atherosclerotic Disease, such as:
* Abdominal aortic aneurysm
* Hypertension that is uncontrolled or resistant to treatment (medically refractory) with a blood pressure (BP) greater than 140/90 despite optimal medical management. Attempted medical management must have included at least 2 medications of different classes
* Peripheral arterial disease
* Symptomatic carotid artery disease
o Type 2 Diabetes uncontrolled by pharmacotherapy
o Obstructive sleep apnea as documented by a sleep study


Indication Coverage Criteria (polysomnography) (see Related Policies). AND

* Participation in a physician administered weight reductionprogram lasting at least six continuous months within the two year period before surgery is considered. o Evidence of active participation documented in the medical record includes:

* Weight

* Current dietary program (MediFast, OptiFast)

* Physical activity (eg, exercise/work-out program) OR

* Documentation of participation in a structured weight reduction program such as as Weight Watchers or Jenny Craig is an acceptable alternative if done in conjuction with physician supervision AND

* Psychological evaluation and clearance by a licensed mental health provider to rule out psychological disorders, inability to provide informed consent, or inability to comply with pre- and post-surgical requirements

Note: A physician’s summary letter alone is not sufficient documentation. Patient selection criteria for adolescents less than 18 years of age

Bariatric (weight loss) surgery in adolescents may be considered medically necessary when ALL of the following criteria are met:

* The health plan contract allows bariatric surgery for those younger than 18 years of age AND

* The adolescent meets the same patient selection criteria as an adult AND

* The facility has experienced staff to support adolescents including psychosocial and informed consent issues for bariatric surgery

Indication Coverage Criteria

Refer to member contract language for benefit determination on treatment of obesity for adolescents. Covered bariatric (weight loss) surgeries

The following bariatric (weight loss) surgery procedures may be considered medically necessary when criteria are met:
* Adjustable gastric banding–laparoscopic
* Biliopancreatic bypass (ie, the Scopinaro procedure) with duodenal switch–open or laparoscopic
* Gastric bypass using a Roux-en-Y anastomosis–open or laparoscopic
* Sleeve gastrectomy Surgeon and facility requirements
Bariatric (weight loss) surgery should be performed:
* By a surgeon with specialized training and experience in the bariatric surgery procedure used AND
* In an institution (facility or hospital) that includes a comprehensive bariatric surgery program AND
* Any device used for bariatric surgery must be FDA approved for that purpose and used according to the labeled indications Revision bariatric surgery to correct complications

Revision bariatric (weight loss) surgery (such as replacement and/or removal of an adjustable gastric band, surgical repair or reversal, or conversion to another covered bariatric surgical procedure) may be considered medically necessary to correct complications from the primary bariatric procedure including, but not limited to:
* Band erosion, slippage, leakage, herniation or intractable nausea/vomiting that cannot be corrected with manipulation or adjustment
* Hypoglycemia or malnutrition related to non-absorption
* Obstruction
* Staple-line failure (eg, Gastrogastric fistula)
* Stricture
* Ulceration
* Weight loss of 20% or more below ideal body weight
* Coverage for bariatric surgery is available under the individual’s


Indication Coverage Criteria current health benefit plan Reoperation bariatric  surgery for inadequateweight loss

In the absence of a technical failure or major complication, individuals with weight loss failure (not described above) must meet the initial medical necessity criteria for bariatric surgery Cholecystectomy Routine cholecystectomy (gallbladder removal) may be considered medically necessary when performed with bariatric surgery.

Hiatal hernia repair Repair of a hiatal hernia during bariatric surgery may be considered medically necessary for a preoperative diagnosis of hiatal hernia with clinical indications for surgical repair. Repair of a hiatal hernia performed at the time of bariatric surgery in the absence of preoperative clinical indications for surgical repairis considered not medically necessary Routine liver biopsy Routine liver biopsy during obesity surgery is considered not medically necessary in the absence of preoperative signs or symptoms of liver disease.(eg, elevated liver enzymes, enlarged liver)

Bariatric surgery for a BMI less than 35 kg/m2

Bariatric (weight loss) surgery is considered not medically necessary for patients with a BMI less than 35 kg/m2.

Bariatric surgery to treat conditions other than morbid obesity

Bariatric surgery is considered investigational for the treatment of any condition other than morbid obesity, including, but not limited to diabetes, gastroesophageal reflux disease (GERD), or gastroparesis

Non-covered bariatric surgeries/procedures

Vertical banded gastroplasty (stomach stapling) is considered not medically necessary as a treatment for obesity due to too many long-term complications.

The following weight loss (bariatric) surgery procedures are considered investigational for the treatment of morbid obesity:
* Biliopancreatic bypass without duodenal switch
* Gastric bypass using a Billroth II type of anastomosis (minigastric bypass)
* Laparoscopic gastric plication

Indication Coverage Criteria

* Long-limb gastric bypass procedure (ie, >150 cm)
* Single anastomosis duodenoileal bypass with sleeve gastrectomy
* Two-stage bariatric surgery procedures (eg, sleeve gastrectomy as initial procedure followed by biliopancreatic diversion at a later time)
* Vagus nerve blocking (eg, the VBLOC device or Maestro®) (See related medical policy 7.01.150)
* Endoscopic procedures as a primary bariatric procedure or as a revision procedure including but not limited to:
o Insertion of the StomaphyX™ device
o Insertion of a gastric balloon (eg, Orbera®)
o Endoscopic gastroplasty
o Use of an endoscopically placed duodenal-jejunal sleeve
o Aspiration therapy device (eg, AspireAssist®)

Documentation Requirements
The medical records submitted for review should document that medical necessity criteria are met. The record should include clinical documentation of ALL THREE (3) criteria:

1. A body mass index (BMI) greater than 40 kg/m2, or BMI greater than 35 kg/m2 with at least ONE (1) of the following conditions:
o Established coronary heart disease
o Other atherosclerotic disease
o Type 2 diabetes uncontrolled by medications
o Obstructive sleep apnea as documented by a sleep study
2. Completion of a physician administered weight-loss program that:
o Lasted for at least six (6) months in a row
o Took place within two (2) years before the proposed weight loss surgery
o Demonstrates in the medical record that the member actively took part in the program, as well as include member’s weight, the current dietary program (MediFast, OptiFast) and banded gastroplasty



Body Mass Index Calculation Morbid obesity, also known as clinically severe obesity, is measured using the body mass index (BMI). Severe obesity is weight-based and is defined as a BMI greater than 40 kg/m2 or a BMI greater than 35 kg/m2 with obesity-associated health conditions. BMI is calculated by dividing a patient’s weight (in kilograms) by height (in meters) squared.
* To convert pounds to kilograms, multiply pounds by 0.45
* To convert inches to meters multiply inches by 0.0254
* Click here for BMI calculation.

Evidence Review Description

Bariatric surgery is a treatment for morbid obesity in patients who fail to lose weight with conservative measures. There are numerous surgical techniques available. While these techniques have different mechanisms of action,the result is a smaller gastric pouch that leads to restricted eating. However, these surgeries may lead to malabsorption of nutrients or eventually to metabolic changes .

Background

Bariatric surgery is performed to treat morbid (clinically severe) obesity. Morbid obesity is defined as a body mass index (BMI) greater than 40 kg/m2 or a BMI greater than 35 kg/m2 with associated complications including, but not limited to, diabetes, hypertension, or obstructive sleep apnea. Morbid obesity results in a very high risk for weight-related complications, such as diabetes, hypertension, obstructive sleep apnea, and various types of cancers (for men: colon, rectal, prostate; for women: breast, uterine, ovarian), and a shortened life span. A morbidly obese man at age 20 can expect to live 13 fewer years than his counterpart with a normal BMI, which equates to a 22% reduction in life expectancy.

The first treatment of morbid obesity is dietary and lifestyle changes. Although this strategy may be effective in some patients, only a few morbidly obese individuals can reduce and control weight through diet and exercise. Most patients find it difficult to comply with these lifestyle modifications on a long-term basis.

When conservative measures fail, some patients may consider surgical approaches. A 1991 National Institutes of Health Consensus Conference defined surgical candidates as “those patients with a BMI of greater than 40 kg/m2, or greater than 35 kg/m2 in conjunction with severe comorbidities such as cardiopulmonary complications or severe diabetes.”1 Resolution (cure) or improvement of type 2 diabetes (T2D) after bariatric surgery and observations that glycemic control may improve immediately after surgery, before a significant amount of weight is lost, have promoted interest in a surgical approach to the treatment of T2D.

The various surgical procedures have different effects, and gastrointestinal rearrangement seems to confer additional antidiabetic benefits independent of weight loss and caloric restriction. The precise mechanisms are not clear, and multiple mechanisms may be involved. Gastrointestinal peptides, eg, glucagon-like peptide-1 (1GLP-1), glucose-dependent insulinotropic peptide (GIP), and peptide YY (PYY), are secreted in response to contact with unabsorbed nutrients and by vagally mediated parasympathetic neural mechanisms. GLP-1 is secreted by the L cells of the distal ileum in response to ingested nutrients and acts on pancreatic islets to augment glucose-dependent insulin secretion. It also slows gastric emptying, which delays digestion, blunts postprandial glycemia, and acts on the central nervous system to induce satiety and decrease food intake. Other effects may improve insulin sensitivity. GIP acts on pancreatic beta cells to increase insulin secretion through the same mechanisms as GLP-1, although it is less potent. PYY is also secreted by the L cells of the distal intestine and increases satiety and delays gastric emptying.

Types of Bariatric Surgery Procedures

The following summarizes the most common types of bariatric surgery procedures.

Open Gastric Bypass

The original gastric bypass surgeries were based on the observation that postgastrectomy patients tended to lose weight. The current procedure involves both a restrictive and a malabsorptive component, with horizontal or vertical partition of the stomach performed in association with a Roux-en-Y procedure (ie, a gastrojejunal anastomosis). Thus, the flow of food bypasses the duodenum and proximal small bowel. The procedure may also be associated with an unpleasant “dumping syndrome,” in which a large osmotic load delivered directly to the jejunum from the stomach produces abdominal pain and/or vomiting. The dumping syndrome may further reduce intake, particularly in “sweets eaters.” Surgical complications include leakage and operative margin ulceration at the anastomotic site. Because the normal flow of food is disrupted, there are more metabolic complications than with other gastric restrictive procedures, including iron deficiency anemia, vitamin B12 deficiency, and hypocalcemia, all of which can be corrected by oral supplementation. Another concern is the ability to evaluate the “blind” bypassed portion of the stomach. Gastric bypass may be performed with either an open or laparoscopic technique.


Note: In 2005, the CPT code 43846 was revised to indicate that the short limb must be 150 cm or less, compared with the previous 100 cm. This change reflects the common practice in which the alimentary (ie, jejunal limb) of a gastric bypass has been lengthened to 150 cm. This length also serves to distinguish a standard gastric bypass with a very long, or very, very long gastric bypass, as discussed further here.

Laparoscopic Gastric Bypass

CPT code 43644 was introduced in 2005 and described the same procedure as open gastric bypass (CPT code 43846), but performed laparoscopically.

Adjustable Gastric Banding


Adjustable gastric banding (CPT code 43770) involves placing a gastric band around the exterior of the stomach. The band is attached to a reservoir implanted subcutaneously in the rectus sheath. Injecting the reservoir with saline will alter the diameter of the gastric band; therefore, the rate-limiting stoma in the stomach can be progressively narrowed to induce greater weight loss, or expanded if complications develop. Because the stomach is not entered, the surgery and any revisions, if necessary, are relatively simple.

Complications include slippage of the external band or band erosion through the gastric wall. Adjustable gastric banding has been widely used in Europe. Two banding devices are approved by the Food and Drug Administration (FDA) for marketing in the United States. The first to receive FDA approval was the LAP-BAND (original applicant, Allergan, BioEnterics, Carpinteria, CA; now Apollo Endosurgery, Austin, TX). The labeled indications for this device are as follows:

"The LAP-BAND® system is indicated for use in weight reduction for severely obese patients with a body mass index (BMI) of at least 40 or a BMI of at least 35 with one or more severe comorbid conditions, or those who are 100 lb or more over their estimated ideal weight according to the 1983 Metropolitan Life Insurance Tables (use the midpoint for medium frame).

It is indicated for use only in severely obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives."


In 2011, FDA-labelled indications for the LAP-BAND were expanded to include patients with a BMI from 30 to 34 kg/m2 with at least 1 obesity-related comorbid condition. The second adjustable gastric banding device approved by FDA through the premarket approval process is the REALIZE® model (Ethicon Endo-Surgery, Cincinnati, OH). Labeled indications for this device are:

“Th[e REALIZE] device is indicated for weight reduction for morbidly obese patients and is indicated for individuals with a Body Mass Index of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with one or more comorbid conditions. The Band is indicated for use only in morbidly obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavior modification programs.”

Sleeve Gastrectomy

A sleeve gastrectomy (CPT code 43775) is an alternative approach to gastrectomy that can be performed on its own or in combination with malabsorptive procedures (most commonly biliopancreatic diversion [BPD] with duodenal switch). In this procedure, the greater curvature of the stomach is resected from the angle of His to the distal antrum, resulting in a stomach remnant shaped like a tube or sleeve. The pyloric sphincter is preserved, resulting in a more physiologic transit of food from the stomach to the duodenum and avoiding the dumping syndrome (overly rapid transport of food through the stomach into intestines) seen with distal gastrectomy. This procedure is relatively simple to perform and can be done as an open or laparoscopic procedure. Some surgeons have proposed the sleeve gastrectomy as the first in a 2-stage procedure for very high risk patients. Weight loss following sleeve gastrectomy may improve a patient’s overall medical status and, thus, reduce the risk of a subsequent more extensive malabsorptive procedure (eg, BPD).

Biliopancreatic Bypass Diversion

The BPD procedure (also known as the Scopinaro procedure; CPT code 43847) developed and used extensively in Italy, was designed to address drawbacks of the original intestinal bypass procedures that have been abandoned due to unacceptable metabolic complications. Many complications were thought to be related to bacterial overgrowth and toxin production in the blind, bypassed segment. In contrast, BPD consists of a subtotal gastrectomy and diversion of the biliopancreatic juices into the distal ileum by a long Roux-en-Y procedure. The procedure consists of the following components:

a. A distal gastrectomy induces a temporary early satiety and/or the dumping syndrome in the early postoperative period, both of which limit food intake.
b. A 200-cm long “alimentary tract” consists of 200 cm of ileum connecting the stomach to a common distal segment.
c. A 300- to 400-cm “biliary tract” connects the duodenum, jejunum, and remaining ileum to the common distal segment.
d. A 50- to 100-cm “common tract” is where food from the alimentary tract mixes with biliopancreatic juices from the biliary tract. Food digestion and absorption, particularly of fats and starches, are therefore limited to this small segment of bowel, ie, creating selective malabsorption. The length of the common segment will influence the degree of malabsorption.
e. Because of the high incidence of cholelithiasis associated with the procedure, patients typically undergo an associated cholecystectomy.

Many potential metabolic complications are related to BPD, including, most prominently, iron deficiency anemia, protein malnutrition, hypocalcemia, and bone demineralization. Protein malnutrition may require treatment with total parenteral nutrition. In addition, several case reports have noted liver failure resulting in death or liver transplant.

BPD With Duodenal Switch

CPT code 43845, which specifically identifies the duodenal switch procedure, was introduced in 2005. The duodenal switch procedure is a variant of the BPD previously described. In this procedure, instead of performing a distal gastrectomy, a sleeve gastrectomy is performed along the vertical axis of the stomach. This approach preserves the pylorus and initial segment of the duodenum, which is then anastomosed to a segment of the ileum, similar to the BPD, to create the alimentary limb. Preservation of the pyloric sphincter is intended to ameliorate the dumping syndrome and decrease the incidence of ulcers at the duodenoileal anastomosis by providing a more physiologic transfer of stomach contents to the duodenum. The sleeve gastrectomy also decreases the volume of the stomach and decreases the parietal cell mass. However, the basic principle of the procedure is similar to that of the BPD, ie, producing selective malabsorption by limiting the food digestion and absorption to a short common ileal segment.

Vertical-Banded Gastroplasty


Vertical-banded gastroplasty (VBG; CPT code 43842) was formerly one of the most common gastric restrictive procedures performed in the United States, but has now been replaced by other restrictive procedures due to high rates of revisions and reoperations. In this procedure, the stomach is segmented along its vertical axis. In order to create a durable reinforced and rate-limiting stoma at the distal end of the pouch, a plug of the stomach is removed, and a propylene collar is placed through this hole and then stapled to itself. Because the normal flow of food is preserved, metabolic complications are uncommon. Complications include  esophageal reflux, dilation, or obstruction of the stoma, with the latter 2 requiring reoperation. Dilation of the stoma is a common reason for weight regain. VBG may be performed using an open or laparoscopic approach.

Long-Limb Gastric Bypass (ie, >150 cm)

Variations of gastric bypass procedures have been described, consisting primarily of long-limb Roux-en-Y procedures (CPT code 43847), which vary in the length of the alimentary and common limbs. For example, the stomach may be divided with a long segment of the jejunum (instead of ileum) anastomosed to the proximal gastric stump, creating the alimentary limb. The remaining pancreaticobiliary limb, consisting of stomach remnant, duodenum, and length of proximal jejunum, is then anastomosed to the ileum, creating a common limb of variable length in which the ingested food mixes with the pancreaticobiliary juices. While the long alimentary limb permits absorption of most nutrients, the short common limb primarily limits absorption of fats. The stomach may be bypassed in a variety of ways (eg, resection or stapling along the  horizontal or vertical axis). Unlike the traditional gastric bypass, which is a gastric restrictive procedure, these very long-limb Roux-en-Y gastric bypasses combine gastric restriction with some element of malabsorptive procedure, depending on the location of the anastomoses. Note that CPT code for gastric bypass (43846) explicitly describes a short limb (<150 and="" apply="" br="" bypass.="" cm="" gastric="" gastroenterostomy="" long-limb="" not="" roux-en-y="" thus="" to="" would="">


Laparoscopic Malabsorptive Procedure CPT code 43645 was introduced in 2005 to specifically describe a laparoscopic malabsorptive procedure. However, the code does not specifically describe any specific malabsorptive procedure.

Weight Loss Outcomes

There is no uniform standard for reporting results of weight loss or for describing a successful procedure. Common methods of reporting the amount of body weight loss are percent of ideal body weight achieved or percent of excess body weight (EBW) loss, with the latter most commonly reported. EBW is defined as actual weight minus “ideal weight” and “ideal weight” is based on 1983 Metropolitan Life Insurance height-weight tables for medium frame.

These 2 reporting methods are generally preferred over the absolute amount of weight loss, because they reflect the ultimate goal of surgery: to reduce weight to a range that minimizes obesity-related morbidity. Obviously, an increasing degree of obesity will require a greater amount of weight loss to achieve these target goals. There are different definitions of successful outcomes, but a successful procedure is often considered one in which at least 50% of EBW is lost, or when the patient returns to within 30% of ideal body weight. The results may also be expressed as the percentage of patients losing at least 50% of EBW. Table 1 summarizes the variations in reporting weight loss outcomes.


Durability of Weight Loss Weight change (ie, gain or loss) at yearly intervals is often reported. Weight loss at 1 year is considered the minimum length of time for evaluating these procedures; weight loss at 3 to 5 years is considered an intermediate time period for evaluating weight loss; and weight loss at 5 to 10 years or more is considered to represent long-term weight loss following bariatric surgery. Short-Term Complications (Operative and Perioperative Complications <30 br="" days="">
In general, the incidence of operative and perioperative complications is increased in obese patients, particularly in thromboembolism and wound healing. Other perioperative

complications include anastomotic leaks, bleeding, bowel obstruction, and cardiopulmonary
complications (eg, pneumonia, myocardial infarction).
Reoperation Rate
Reoperation may be required to either “take down” or revise the original procedure.
Reoperation may be particularly common in VBG due to pouch dilation.


Long-Term Complications (Metabolic Adverse Events, Nutritional Deficiencies)

Metabolic adverse events are of particular concern in malabsorptive procedures. Other longterm complications include anastomotic ulcers, esophagitis, and procedure-specific complications such as band erosion or migration for gastric-banding surgeries. Improved Health Outcomes in Terms of Weight-Related Comorbidities Aside from psychosocial concerns, which may be considerable, one motivation for bariatric surgery is to decrease the incidence of complications of obesity, such as diabetes, cardiovascular risk factors (ie, increased cholesterol, hypertension), obstructive sleep apnea, or arthritis. Unfortunately, these final health outcomes are not consistently reported.

Monday, February 11, 2019

CPT 0075T, 0076T - Endovascular Therapies for Extracranial Vertebral Artery Disease

Coding Code Description CPT

0075T Transcatheter placement of extracranial vertebral artery stent(s), including radiologic supervision and interpretation, open or percutaneous; initial vessel

0076T Transcatheter placement of extracranial vertebral artery stent(s), including radiologic supervision and interpretation, open or percutaneous; each additional vessel (List separately in addition to code for primary procedure)


Endovascular Therapies for Extracranial Vertebral Artery Disease


Introduction


The vertebral arteries travel along the spine, up the back of the neck, and enter the brain. When one of these arteries is narrowed, blocked, or there is a bulge before it enters the brain, it’s known as extracranial vertebral artery disease. (Extracranial means outside the skull.) Treatment usually involves medication or surgery. Other techniques that are done inside the blood vessels are being studied. These techniques are known as endovascular therapies. An example of an endovascular therapy is placing a tiny tube inside a blocked artery to allow blood to flow through it. Endovascular therapy for extracranial vertebral artery disease is investigational. These techniques are still being studied to see if they are as effective as standard treatments.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. Policy Coverage Criteria

Service Investigational


Endovascular therapy Endovascular therapy, including percutaneous transluminal angioplasty with or without stenting, is considered investigational for the management of extracranial vertebral artery disease.

Note: The extracranial vertebral artery is considered to be segments V1-V3 of the vertebral artery from its origin at the subclavian artery until it crosses the dura mater.



Related Information N/A

Evidence Review

Description

Vertebral artery diseases, including atherosclerotic stenosis, dissections, and aneurysms, can lead to ischemia of the posterior cerebral circulation. Conventional management of extracranial vertebral artery diseases may include medical therapy (eg, antiplatelet or anticoagulant medications), medications to reduce atherosclerotic disease risk (eg, statins), and/or surgical revascularization. Endovascular therapies have been investigated as an alternative to conventional management.

Background

Vertebrobasilar Circulation Ischemia


Ischemia of the vertebrobasilar or posterior circulation accounts for about 20% of all strokes. Posterior circulation strokes may arise from occlusion of the innominate and subclavian arteries, the extracranial vertebral arteries, or the intracranial vertebral, basilar, or posterior cerebral arteries. Compared with carotid artery disease, relatively little is known about the true prevalence of specific causes of posterior circulation strokes, particularly the prevalence of vertebral artery disease. A report from a stroke registry, Gulli et al (2013), estimated that in 9% of cases posterior circulation strokes are due to stenosis of the proximal vertebral artery.1 Patients who experience strokes or transient ischemic attacks of the vertebrobasilar circulation face a 25% to 35% risk of stroke within the subsequent 5 years. In particular, the presence of vertebral artery stenosis increases the 90-day risk of recurrent stroke by about 4-fold.

Relevant Clinical Anatomy and Pathophysiology

Large artery disease of the posterior circulation may be due to atherosclerosis (stenosis), embolism, dissection, or aneurysms. In about a third of cases, posterior circulation strokes are due to stenosis of the extracranial vertebral arteries or the intracranial vertebral, basilar, and posterior cerebral arteries. The proximal portion of the vertebral artery in the neck is the most common location of atherosclerotic stenosis in the posterior circulation. Dissection of the extracranial or intracranial vertebral arteries may also cause posterior circulation ischemia. By contrast, posterior cerebral artery ischemic events are more likely to be secondary to embolism from more proximal vessels.

The vertebral artery is divided into 4 segments, V1-V4, of which segments V1-V3 are extracranial. V1 originates at the subclavian artery and extends to the C5 or C6 vertebrae; V2


crosses the bony canal of the transverse foramina from C2 to C5; V3 starts as the artery exits the transverse foramina at C2 and ends as the vessel crosses the dura matter and becomes an intracranial vessel. The most proximal segment (V1) is the most common location for atherosclerotic occlusive disease to occur, while arterial dissections are most likely to involve the extracranial vertebral artery just before the vessel crosses the dura mater. Compared with the carotid circulation, the vertebral artery system is more likely to be associated with anatomic variants, including a unilateral artery.

Atherosclerotic disease of the vertebral artery is associated with conventional risk factors for cerebrovascular disease. However, risk factors and the underlying pathophysiology of vertebral artery dissection and aneurysms differ. Extracranial vertebral artery aneurysms and dissections are most often secondary to trauma, particularly those with excessive rotation, distraction, or flexion/extension, or iatrogenic injury, such as during cervical spine surgeries. Spontaneous vertebral artery dissections are rare, and in many cases are associated with connective tissue disorders including Ehlers-Danlos syndrome type IV, Marfan syndrome, autosomal-dominant polycystic kidney disease, and osteogenesis imperfecta type I.2

Management of Extracranial Vertebral Artery Disease
The optimal management of occlusive extracranial vertebral artery disease is not well defined. Medical treatment with antiplatelet or anticoagulant medications is a mainstay of therapy to reduce stroke risk. Medical therapy also typically involves risk reduction for classical cardiovascular risk factors. However, no randomized trials have compared specific antiplatelet or anticoagulant regimens.

Surgical revascularization may be used for vertebral artery atherosclerotic disease, but open surgical repair is considered technically challenging due to poor access to the vessel origin.

Surgical repair may involve vertebral endarterectomy, bypass grafting, or transposition of the vertebral artery, usually to the common or internal carotid artery. Moderately sized single-center case series of surgical vertebral artery repair from 2012 and 2013 have reported overall survival rates of 91% and 77% at 3 and 6 years postoperatively, respectively, and arterial patency rates of 80% after 1 year of follow-up.3,4 Surgical revascularization may be used when symptomatic vertebral artery stenosis is not responsive to medical therapy, particularly when bilateral vertebral artery stenosis is present or when unilateral stenosis is present in the presence of an occluded or hypoplastic contralateral vertebral artery. Surgical revascularization may also be considered in patients with concomitant symptomatic carotid and vertebral disease who do not have relief of vertebrobasilar ischemia after carotid revascularization.


The management of extracranial vertebral artery aneurysms or dissections is controversial due to uncertainty about the risk of thromboembolic events associated with aneurysms and dissections. Antiplatelet therapy is typically used; surgical repair, which may include vertebral bypass, external carotid autograft, and vertebral artery transposition to the internal carotid artery, or endovascular treatment with stent placement or coil embolization, may also be used. Given the technical difficulties related to surgically accessing the extracranial vertebral artery, endovascular therapies have been investigated for extracranial vertebral artery disease. Endovascular therapy may consist of percutaneous transluminal angioplasty, with or without stent implantation.

Friday, January 4, 2019

CPT 33361, 33362, 33363- 33369 - Transcatheter Aortic Valve Implantation for Aortic Stenosis

Coding Code Description CPT

33361 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach

33362 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open femoral artery approach

33363 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open axillary artery approach

33364 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open iliac artery approach

33365 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transaortic approach (eg, median sternotomy, mediastinotomy)

33366 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transapical exposure (eg, left thoracotomy)

33367 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with percutaneous peripheral arterial and venous cannulation (eg, femoral vessels) (List separately in addition to code for primary procedure)

33368 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with open peripheral arterial and venous cannulation (eg, femoral, iliac, axillary vessels) (List separately in addition to code for primary procedure)

33369 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with central arterial and venous cannulation (eg, aorta, right atrium, pulmonary artery) (List separately in addition to code for primary procedure)


Transcatheter Aortic Valve Implantation for Aortic Stenosis

Introduction


The aortic valve is a valve that separates the main pumping chamber of the heart (the left ventricle) from the large artery that takes oxygen rich blood away from the heart and out to the body (the aorta). If the valve doesn’t completely open, it is called aortic stenosis. Aortic stenosis decreases the amount of oxygenated blood getting out to the body. Open surgery is one method of replacing a damaged aortic valve. A newer procedure — known as transcatheter aortic valve replacement or transcatheter aortic valve implantation — has been developed. It allows a replacement valve to be threaded through an artery and into the heart without open heart surgery. A catheter (a long thin, tube) is threaded through an artery, either in the leg or in the chest, and into the heart. The replacement valve is then lodged into the defective aortic valve. The new valve is then expanded, pushing aside parts of the old valve. This policy describes when transcatheter aortic valve replacement may be considered medically necessary. Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.


Procedure Medical Necessity Transcatheter aortic valve replacement

Transcatheter aortic valve replacement with a U.S. Food and Drug Administration (FDA)*approved transcatheter heart valve system, when performed via an approach consistent with the device’s FDA-approved labeling, may be considered medically necessary as a treatment for native valve aortic stenosis when ALL of the following criteria are met:
* Severe aortic stenosis (see the Definition of Terms section) with a calcified aortic annulus is present AND
* New York Heart Association (NYHA) heart failure class II, III or IV symptoms AND
* Left ventricular ejection fraction greater than 20% AND
* Patient is not an operable candidate for open surgery, as judged by at least 2 cardiovascular specialists (cardiologist and/or cardiac surgeon); or patient is an operable candidate but is at high or intermediate risk for open surgery (see the

Definition of Terms section)

Transcatheter aortic valve replacement with an FDA approved transcatheter heart valve system for repair of a degenerated bioprosthetic valve may be considered medically necessary

when ALL of the following criteria are met:
* Failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve AND
* NYHA heart failure class II, III or IV symptoms AND
* Left ventricular ejection fraction greater than 20% AND
* Patient is not an operable candidate for open surgery, as judged by at least 2 cardiovascular specialists (cardiologist and/or cardiac surgeon); or patient is an operable candidate but is at high risk for open surgery (see the Definition of


Medical Necessity Terms section)

Transcatheter aortic valve replacement is considered investigational for all other indications and when criteria are not met.





Related Information Definition of Terms

Extreme risk or inoperable for open heart surgery: FDA definition of extreme risk or inoperable for open surgery:

* Predicted risk of operative mortality and/or serious irreversible morbidity 50% or higher for open surgery High Risk for open heart surgery: FDA definition of high risk for open surgery:
* Society of Thoracic Surgeons predicted operative risk score of 8% or higher; or
* Judged by a heart team, which includes an experienced cardiac surgeon and a cardiologist, to have an expected mortality risk of 15% or higher for open surgery Intermediate risk: FDA definition of intermediate risk is:
* Society of Thoracic Surgeons predicted operative risk score of 3% to 7%. Severe aortic stenosis: For the use of the Sapien or CoreValve devices, severe aortic stenosis is defined by the presence of one or more of the following criteria:
* An aortic valve area of less than or equal to 1 cm2
* An aortic valve area index of less than or equal to 0.6 cm2/m2
* A mean aortic valve gradient greater than or equal to 40 mm Hg
* A peak aortic-jet velocity greater than or equal to 4.0 m/s

Description

Transcatheter aortic valve implantation (TAVI; also known as transcatheter aortic valve replacement) is a potential treatment for patients with severe aortic stenosis. Many patients with aortic stenosis are elderly and/or have multiple medical comorbidities, thus indicating a high, often prohibitive, risk for surgery. This procedure is being evaluated as an alternative to open surgery, or surgical aortic valve replacement (SAVR), for high-risk patients with aortic stenosis and as an alternative to nonsurgical therapy for patients with a prohibitive risk for surgery.

Background

Aortic Stenosis


Aortic stenosis is defined as narrowing of the aortic valve opening, resulting in obstruction of blood flow from the left ventricle into the ascending aorta. Progressive calcification of the aortic valve is the most common etiology in North America and Europe, while rheumatic fever is the most common etiology in developing countries.1 Congenital abnormalities of the aortic valve, most commonly a bicuspid valve, increase the risk for aortic stenosis, but aortic stenosis can also occur in a normal aortic valve. Risk factors for calcification of a congenitally normal valve mirror those for atherosclerotic vascular disease, including advanced age, male gender, smoking, hypertension, and hyperlipidemia.1 Thus, the pathogenesis of calcific aortic stenosis is thought to be similar to that of atherosclerosis, ie, deposition of atherogenic lipids and infiltration of inflammatory cells, followed by progressive calcification.

The natural history of aortic stenosis involves a long asymptomatic period, with slowly progressive narrowing of the valve until the stenosis reaches the severe stage. At this time, symptoms of dyspnea, chest pain, and/or dizziness and syncope often occur and the disorder  progresses rapidly. Treatment of aortic stenosis is primarily surgical, involving replacement of the diseased valve with a bio-prosthetic or mechanical valve by open heart surgery.

Disease Burden Aortic stenosis is a relatively common disorder in elderly patients and is the most common acquired valve disorder in the UnitedStates. Approximately 2% to 4% of people older than 65 years of age have evidence of significant aortic stenosis,1 increasing up to 8% of people by age 85 years.2 In the Helsinki Aging Study (1993), a population-based study of 501 patients ages 75 to 86 years, the prevalence of severe aortic stenosis by echocardiography was estimated to be 2.9%.3 In the United States, more than 50,000 aortic valve replacements are performed annually due to severe aortic stenosis.

Aortic stenosis does not cause substantial morbidity or mortality when the disease is mild or moderate in severity. By the time it becomes severe, there is an untreated mortality rate of approximately 50% within 2 years.4 Open surgical repair is an effective treatment for reversing aortic stenosis, and artificial valves have demonstrated good durability for periods of up to 20 years.4 However, these benefits are accompanied by a perioperative mortality of approximately 3% to 4% and substantial morbidity,4 both of which increase with advancing age.

Unmet Needs
Many patients with severe, symptomatic aortic stenosis are poor operative candidates. Approximately 30% of patients presenting with severe aortic stenosis do not undergo open surgery due to factors such as advanced age, advanced left ventricular dysfunction, or multiple medical comorbidities.5 For patients who are not surgical candidates, medical therapy can partially alleviate the symptoms of aortic stenosis but does not affect the underlying disease progression. Percutaneous balloon valvuloplasty can be performed, but this procedure has less than optimal outcomes.6 Balloon valvuloplasty can improve symptoms and increase flow across the stenotic valve but is associated with high rates of complications such as stroke, myocardial infarction (MI), and aortic regurgitation. Also, restenosis can occur rapidly, and there is no improvement in mortality. As a result, there is a large unmet need for less invasive treatments for aortic stenosis in patients who are at increased risk for open surgery.

Treatment

Transcatheter aortic valve implantation (TAVI) has been developed in response to this unmet needand was originally intended as an alternative for patients for whom surgery was not an option due toprohibitive surgical risk or for patients at high risk for open surgery. The procedure is performed percutaneously, most often through the transfemoral artery approach. It can also  be done through the subclavian artery approach and transapically using mediastinoscopy. Balloon valvuloplasty is first performed to open up the stenotic area. This is followed by passageof a bioprosthetic artificial valve across the native aortic valve. The valve is initially compressed to allow passage across the native valve and is then expanded and secured to the underlying aortic valve annulus. The procedure is performed on the beating heart without the need for cardiopulmonary bypass.

Summary of Evidence
For individuals who have severe symptomatic aortic stenosis who are at prohibitive risk for open surgery who receive transcatheter aortic valve implantation (TAVI), the evidence includes a randomized controlled trial (RCT) comparing TAVI with medical management in individuals at prohibitive risk of surgery, a single-arm prospective trial, multiple case series, and multiple systematic reviews. Relevant outcomes are overall survival, symptoms, morbid events, and treatment-related mortality and morbidity. For patients who are not surgical candidates due to excessive surgical risk, the PARTNER B trial reported on results for patients treated with TAVI by the transfemoral approach compared with continued medical care with or without balloon valvuloplasty. There was a large decrease in mortality for the TAVI patients at 1 year compared with medical care. This trial also reported improvements in other relevant clinical outcomes for the TAVI group. There was an increased risk of stroke and vascular complications in the TAVI group. Despite these concerns, the overall balance of benefits and risks from this trial indicate that health outcomes are improved. For patients who are not surgical candidates, no randomized trials have compared the self-expandable valve with best medical therapy. However, results from the single-arm CoreValve Extreme Risk Pivotal Trial met trialists’ pre-specified objective performance goal. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have severe symptomatic aortic stenosis who are at high risk for open surgery who receive TAVI, the evidence includes 2 RCTs comparing TAVI with surgical repair in individuals at high risk for surgery, multiple nonrandomized comparative studies, and systematic reviews of these studies. Relevant outcomes are overall survival, symptoms, morbid events, and  treatment-related mortality and morbidity.


For patients who are high risk for open surgery and are surgical candidates, the PARTNER A trial reported noninferiority for survival at 1 year for the balloon-expandable valve compared with open surgery. In this trial, TAVI patients also had higher risks for stroke and vascular complications. Nonrandomized comparative studies of TAVI versus open surgery in high-risk patients have reported no major differences in rates of mortality or stroke between the 2 procedures. Since publication of the PARTNER A trial, the CoreValve High Risk Trial demonstrated noninferiority for survival at 1 year and 2 years for the self-expanding prosthesis. This trial reported no significant differences in stroke rates between groups. In an RCT directly comparing the self-expandable with the balloon-expandable valve among surgically high-risk patients, the devices had similar 30-day mortality outcomes, although the self-expandable valve was associated with higher rates of residual aortic regurgitation and requirement for a new permanent pacemaker. Evidence from RCT and nonrandomized studies has suggested that TAVI with a self-expanding device is associated wit higher rates for permanent pacemakers postprocedure. However, survival rates appear to be similar between device types, and the evidence does not clearly support the superiority of one device over another in all patients. Two sex-specific studies were also identified in a literature search with the objective of observing mortality rates in women undergoing TAVI or SAVR. Results were varied, and further study is needed. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have severe symptomatic aortic stenosis who are at intermediate risk for open surgery who receive TAVI, the evidence includes 3 RCTs comparing TAVI with surgical repair including individuals at intermediate surgical risk, 2 RCTs only in patients with intermediate risk, and multiple systematic reviews and nonrandomized cohort studies. Relevant outcomes are overall survival, symptoms, morbid events, and treatment-related mortality and morbidity. Five RCTs have evaluated TAVI in patients with intermediate risk for open surgery. Three of them, which included over 4000 patients combined, reported noninferiority of TAVI vs SAVR for their composite outcome measures (generally including death and stroke). A subset analysis of patients (n=383) with low and intermediate surgical risk from a fourth trial reported higher rates of death at 2 years for TAVI vs SAVR. The final study (N=70) had an unclear hypothesis and reported 30-day mortality rates favoring SAVR (15% vs 2%, p=0.07) but used a transthoracic approach. The rates of adverse events differed between groups, with bleeding, cardiogenic shock, and acute kidney injury higher in patients randomized to open surgery and permanent pacemaker requirement higher in patients randomized to TAVI. Subgroup analyses of meta-analyses and the transthoracic arm of the Leon et al RCT has suggested that the benefit  of TAVI may be limited to patients who are candidates for transfemoral access. Although several RCTs have 2 years of follow-up postprocedure, it is uncertain how many individuals require reoperation. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have severe symptomatic aortic stenosis who are at low risk for open surgery who receive TAVI, the evidence includes 2 RCTs comparing TAVI with surgical repair in individuals selected without specific surgical risk criteria but including patients at low surgical risk, systematic reviews, and nonrandomized cohort studies. Relevant outcomes are overall survival, symptoms, morbid events, and treatment-related mortality and morbidity. Limited data are available comparing SAVR with TAVI in patients who had severe aortic stenosis with low risk for open surgery. A systematic review including the low surgical risk patients of these 2 RCTs, and 4 observational studies, with propensity score matching, reported that the 30-day and inhospital mortality rates were similar for TAVI (2.2%) and SAVR (2.6%). However, TAVI was associated with increased risk of mortality with longer follow-up (median, 2 years; 17.2% vs 12.7%). TAVI was associated with reduced risk for bleeding, renal failure and, an increase in vascular complications and pacemaker implantation compared with SAVR. The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals who have valve dysfunction and aortic stenosis or regurgitation after aortic valve repair who receive transcatheter aortic “valve-in-valve” implantation, the evidence includes case series (largest included 459 patients) and systematic reviews of case series. Relevant outcomes are overall survival, symptoms, morbid events, and treatment-related mortality and morbidity. These case series have reported high rates of technical success of valve implantation and improvement in heart-failure symptoms for most patients. However, they have also reported high rates of shortterm complications and high rates of mortality at 1 year postprocedure. There is a lack of evidence comparing valve-in-valve replacement with alternative treatment approaches. The evidence is insufficient to determine the effects of the technology on health outcomes.

Thursday, November 1, 2018

CPT 82310, 84590, 82725, 86353, 88348 - Calcium, Vitamin A procedurces


Code Description CPT

82310 Calcium; total
82725 Fatty acids, nonesterified
84590 Vitamin A
84591 Vitamin, not otherwise specified
84999 Unlisted chemistry procedure
86353 Lymphocyte transformation, mitogen (phytomitogen) or antigen induced blastogenesis
88348 Electron microscopy, diagnostic


Introduction
Micronutrients are essential vitamins and minerals. Getting enough of them is important for good health. It’s rare in the United States to have medical conditions caused by lack of nutrients like vitamins A, B1, B12, C, and D, and selenium. Most people get enough vitamins and minerals through their diet or over-the-counter vitamins. Blood samples are a proven way to measure the level of essential nutrients. Other tests have been created that look at nutrient levels inside cells.

These tests are unproven. There are no published medical studies showing whether the cell tests are more accurate or useful than standard blood tests at measuring levels of vitamins or minerals. There are also no randomized controlled trials — studies that randomly put people in different study groups — exploring whether the cell tests are effective to screen for or diagnose nutrient deficiencies.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.



When reviewing intracellular micronutrient panel testing, the entire panel is to be reviewed as a whole versus the individual elements of the panel.

Reference Laboratories (see Benefit Application)
IntraCellular Diagnostics
IntraCellular Diagnostics uses electron microscopy for which CPT code 88348 might be reported.

SpectraCell Laboratories

According to SpectraCell Laboratories, their total antioxidant function testing (SPECTROX®) is reported using CPT code 86353.

Benefit Application

This testing is currently only available through two reference laboratories: SpectraCell Laboratories (Houston, TX) and IntraCellular Diagnostics (Medford, OR).

Evidence Review Description

Commercial laboratories offer panels of tests evaluating intracellular levels of micronutrients (essential vitamins and minerals). Potential uses of these tests include screening for nutritional deficiencies in healthy people or those with chronic disease and aiding in the diagnosis of disease in patients with nonspecific symptoms.
Background

Vitamin Deficiencies

“Micronutrients” collectively refer to essential vitamins minerals necessary in trace amounts for health. Clinical deficiency states (states occurring after prolonged consumption of a diet lacking the nutrient and is treated by adding the nutrient to the diet) have been reported for vitamins A, B1, B12, C, and D, selenium, and other micronutrients. Classic nutritional deficiency diseases are uncommon in the United States; most people derive sufficient nutrition from their diets alone or in combination with over-the-counter multivitamins. Laboratory tests are available for individual micronutrients and are generally used to confirm suspected micronutrient deficiencies. Testing is performed by serum analysis using standardized

values for defining normal and deficient states. In addition, some commercial laboratories offer panels of vitamin and mineral testing that also use serum analysis.

Diagnostic Testing

This policy evaluates novel laboratory tests that measure the intracellular levels of micronutrients. This testing, also known as intracellular micronutrient analysis, micronutrient testing or functional intracellular analysis is claimed to be superior to serum testing because intracellular levels reflect more stable micronutrient levels over longer time periods than serum levels and because intracellular levels are not influenced by recent nutrition intake. However, the relation between serum and intracellular levels of micronutrients is complex. The balance of intra- and extracellular levels depends on a number of factors, including the physiology of cellular transport mechanisms and the individual cell type.

At least 2 commercial laboratories offer intracellular testing for micronutrients. Laboratories perform a panel of tests evaluating the intracellular level of a variety of micronutrients (eg, minerals, vitamins, amino acids, fatty acids). The test offered by IntraCellular Diagnostics evaluates epithelial cells from buccal swabs and assesses levels of intracellular mineral electrolyte (ie, magnesium, calcium, potassium, phosphorous, sodium, chloride). SpectraCell Laboratories offers a panel of tests that evaluates the intracellular status of micronutrients within lymphocytes in blood samples. The micronutrients measured by the test include:

* Vitamins: A, B1, B2, B3, B6, B12, C, D, K; biotin, folate, pantothenic acid
* Minerals: calcium, magnesium, zinc, copper
* Antioxidants: alpha lipoic acid, coenzyme Q10, cysteine, glutathione, selenium, vitamin E
* Amino acids: asparagine, glutamine, serine
* Carbohydrate metabolism: chromium, fructose sensitivity, glucose-insulin metabolism
* Fatty acids: oleic acid
* Metabolites: choline, inositol, carnitine

The SpectraCell micronutrient panel also includes an evaluation of total antioxidant function.

Summary of Evidence

For individuals who have chronic diseases or nonspecific generalized symptoms who receive intracellular micronutrient analysis, the evidence includes observational studies. Relevant  outcomes are test accuracy, symptoms, and change in disease status. No studies were identified that evaluated clinical validity or clinical utility of intracellular micronutrient testing compared with standard testing for vitamin or mineral levels. Limited data from observational studies are available on correlations between serum and intracellular micronutrient levels. No randomized controlled trials or other comparative studies were identified evaluating the direct health impact of intracellular micronutrient testing. Moreover, there are insufficient data to construct a chain of evidence that intracellular micronutrient testing would likely lead to identifying patients whose health outcomes would be improved compared with alternative approaches to patient management. The evidence is insufficient to determine the effects of the technology on health outcomes.

Ongoing snd Unpublished Clinical Trials

A search of ClinicalTrials.gov in January 2018 did not identify any ongoing or unpublished trials that would likely influence this review. Practice Guidelines and Position Statements No guidelines or statements were identified.

Medicare National Coverage

There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.

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