Medicaid Guideline for EVIDENCED-BASED PRACTICE (EBP) and CARE COORDINATION:

EVIDENCED-BASED PRACTICE (EBP): 

Services that have specific fidelity measures for proven effectiveness. CCBHCs and DCOs must provide EBP services that meet criteria as best practices and approaches for the purpose of the CCBHC program. The following required EBPs are meant to meet the needs of the broader focus of recipients served throughout their lifespan and set the minimum standard of practice in the application of EBPs. The CCBHC may select more population-specific EBPs listed in the SAMHSAs Evidenced-Based Practices Guide to reflect the unique needs of their communities.

1. Crisis Behavioral Health Services

a. Collaborative Management and Assessment of Suicidality

b. Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA/CIWAAr)

c. Clinical Opiate Withdrawal Scale (COWS)

d. Targeted Case Management (TCM)

e. Solution-Focused, Brief Psychotherapy (SFBT)

f. Wellness Recovery Action Plans (WRAP)

2. Screening, Assessment and Diagnostic Services

a. Achenbach Children’s Behavioral Checklists

b. Ages and Stages Questionnaire-Social Emotional

c. CRAFIT Screening Test

d. Patient Health Questionnaire-9 (PHQ-9)

e. DSM-5 Level 1 and 2 Cross-Cutting Symptom

f. Child and Adolescent Needs and Strengths (CANS)

g. Children’s Uniform Mental Health Assessment (CUMHA)

h. Child and Adolescent Services Intensity Instrument (CASII)

i. Level of Care Utilization System (LOCUS)

j. American Society of Addiction Medicine – Patient Placement Criteria (ASAM)

k. World Health Organization Disability Assessment Scale Version 2 (WHODAS 2.0)

3. Outpatient Mental Health and Substance Use Treatment

a. Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

b. Cognitive Behavioral Therapies (CBT) including Dialectical Behavior

Therapy (DBT) and Acceptance and Commitment Therapy (ACT)

c. Family Check-Up and Everyday Parenting

d. Motivational Interviewing

e. Integrated Dual Diagnosis Treatment; Life Skills Training

f. Illness Management and Recovery (IMR)

g. Medication Management

h. Body Mass Index

i. Metabolic Monitoring with Atypical Antipsychotics

4. Psychiatric Rehabilitation Services

a. Basic Skills Training and Psychosocial Rehabilitation

b. Life Skills Curriculum

c. Assertive Community Treatment

5. Behavior Change and Counseling Risk Factors

a. Screening, Brief Intervention and Referral to Treatment (SBIRT)

b. Nursing Quit-Line

c. Chronic Disease Management

6. Peer Support, Counselor Services and Family Supports

a. Peer Support Services

FAMILY-CENTERED: An approach to the planning, delivery and evaluation of care based on active participation and input from a recipient’s family and the CCBHC. Family centered care recognizes families as the ultimate decision-makers for their child, with the child encouraged to gradually take on more and more of the decision-making. Services are culturally, linguistically and developmentally appropriate and youth-guided and not only meet the behavioral, mental, emotional, developmental, physical and social needs of the child, but also support the family’s relationship with the child’s health care providers.

CARE COORDINATION:

 Deliberately organizing, facilitating and managing a CCBHC recipient’s care. This includes coordinating all behavioral/mental and physical health activities regardless if the care is provided directly by the CCBHC and it’s DCO or through referral or other affiliation outside of the CCBHC delivery model. Care coordination

includes:

1. Ensuring access to high-quality physical health care (both acute and chronic) and behavioral health care, as well as social services, housing, educational systems and employment opportunities as necessary to facilitate wellness and recovery of the whole person. This may include the use of telehealth services. 

2. Having policies and procedures in place that comply with Health Insurance Portability and Accountability Act (HIPAA) and 42 CFR Part 2 requirements specific to adults and children, and other privacy and confidentiality requirements of state or federal law to facilitate care coordination.

3. Having policies and procedures in place to encourage participation by family members and others important to the recipient to achieve effective care coordination, subject to privacy and confidentiality requirements and recipient consent.

4. Having policies and procedures in place to assist recipients and families of children and adolescents in obtaining appointments and keeping the appointments when there is a referral to a provider outside the CCBHC delivery model, subject to privacy and confidentiality requirements and consistent with the recipient’s and heir family’s preference and need.

CPT code Venofer - J1756, J2916

 

 HCPCS Codes, Level II: Drug Code for Venofer

HCPCS codes are used to identify most drugs and biologics. Venofer® (iron sucrose) injection, USP has been assigned the following drug-specific HCPCS code (also known as a J-code):

J1756 Injection, Iron Sucrose, 1 mg - Drug code Venofer

J2916  Injection, Sodium Ferric Gluconate Complex in Sucrose Injection, 12.5 mg (Ferrlecit®

Each 1 mg of Venofer is equivalent to one (1) service unit. When billing for quantities greater than 1 mg, indicate the total amount used as a multiple of service units on the claim form. Service units are very important and must be included on every claim. Here are some Venofer examples:

• One (1) vial (2.5 mL) or 50 mg = 50 service units

• One (1) vial (5 mL) or 100 mg = 100 service units

• One (1) vial (10 mL) or 200 mg = 200 service units

Medicaid

Medicaid may also cover Venofer when it is used for its FDA-approved indications. Medicaid patient eligibility guidelines and coverage policies vary from state to state, and some states maintain mandatory review criteria for including a product as an approved drug or service. Medicaid programs may base their coverage guidelines on Medicare or commercial payers or have more restrictive coverage. Most Medicaid programs in 2020 require prior authorization for branded drugs like Venofer.

III. Coding

Proper coding of services is key to your success in terms of billing for Venofer® (iron sucrose) injection, USP given in your office or clinic. Why is coding so crucial? Codes are simply an abbreviated way of describing the appropriateness and medical necessity of treatments given in your facility. This is what codes describe, in a nutshell:

• ICD-10-CM/diagnosis codes

show medical necessity of Venofer in terms of the reason for giving it

• CPT (HCPCS Level I) codes

demonstrate how Venofer was given to the patient

• HCPCS Level II codes

provide evidence of the type of drug and how much of it was given or wasted

More details are documented below.

A. International Classification of Disease, 10th Edition, Clinical Modification (ICD-10-CM) Diagnosis Coding for Venofer

ICD-10-CM diagnosis codes identify the patient’s diagnosis and inform insurers of why a service was provided. It should be simple, but it can get difficult with Venofer. First of all, there is a coding guideline that states, “Certain conditions have both an underlying etiology and multiple body system manifestations due to the underlying etiology. For such conditions, the ICD-10-CM has a coding convention that requires the underlying condition be sequenced first, if applicable, followed by the manifestation.”5  On the Venofer package insert, the indication is for iron deficiency anemia in chronic kidney disease. So, per coding guidelines, the chronic kidney disease is the underlying condition (etiology), and the resulting condition (manifestation) is the iron deficiency anemia. Therefore, it is very important that 2 codes are billed—the one for CKD and the one for iron deficiency anemia.

Venofer is approved for the treatment of iron deficiency anemia in adult patients with CKD. In addition, it is also approved for maintenance therapy in pediatric (greater than 2 years of age) hemodialysis patients with IDA, whether or not they are on ESA therapy. Venofer is also approved for maintenance therapy in pediatric (greater than 2 years of age) non-dialysis and peritonealdialysis patients with IDA who are on ESA therapy. American Regent makes no representation that Venofer is safe and effective in other patients or that it is permissible or legal to use for other indications. 

General Guidelines

Understanding today’s complex world of healthcare reimbursement requires a good sense of direction. Even though Venofer® (iron sucrose) injection, USP has been in the marketplace since the year 2000 as a trusted iron product, the reimbursement landscape changes daily. Constant shifts in Medicare rules, payer policies, billing edits (eg, Medically Unlikely Edits), and medical coding are reasons to refer to this guide, whether you have billed for Venofer once or a hundred times.

Caring for patients with chronic kidney disease (CKD) requires that providers work closely with third-party payers to ensure that they are paid fully and fairly

for medically necessary healthcare items and services. American Regent, the manufacturer of Venofer, wants prescribing providers to better understand the complexities of reimbursement. The company has prepared this guide to assist you with common questions about Venofer and its reimbursement.

This guide provides general coverage, coding, and updated payment information about Venofer to help you better understand the policies of the Medicare program and other third-party payers. The guide should also help you avoid troublesome denials based on real-world data. The goal is to help you get paid fully and fairly for every claim.

If you need more help, American Regent’s VenAccess™ Reimbursement Hotline is available to provide assistance and to answer all of your payment questions.

This hotline can be reached by calling 877-4-IV-IRON (877-448-4766), Monday through Friday, between 9 am and 8 pm ET.

II. Coverage

For those of you who are newer to billing, coverage refers to 2 things. First, coverage is contingent upon whether the patient’s policy covers a particular aspect of care. For example, if a patient has major medical coverage without prescription coverage, self-administered (prescription) drugs probably will not be covered under that benefit. But non-self-administered (“buy-and-bill”) drugs, like Venofer® (iron sucrose) injection, USP, will be covered in a doctor’s office or hospital outpatient setting under the major medical benefit as long as certain parameters are met, as described in the next paragraph.

The second aspect of coverage is whether a particular payer, per their own policies, will cover a particular item or service. Generally, a drug is covered if it is FDA-approved, given for the diagnoses that the FDA approved it for, and administered per the package insert, which is an outline of what the FDA approved for that drug. Added to that, the drug must be necessary and appropriate for a specific patient, which means that the patient must have the correct diagnosis and be eligible, in terms of health status, to receive the product. Both public and private payers may modify or widen this coverage by issuing policies that specify how and when they will cover a product like Venofer.

Medicare Coverage

Medicare is likely to cover Venofer and its administration when used for its FDA- approved indication and when administered per its package insert. Venofer is approved for the treatment of iron deficiency anemia (IDA) in adult patients with CKD. Under Medicare Part B (the doctor’s office), it must be given incident to a provider’s service. In order to meet all the general requirements for coverage under the incident-to provision, an FDA-approved drug or biologic must be: a) of a form that is not usually self-administered; b) furnished by a physician practice; and c) administered by the physician or by auxiliary personnel employed by the physician and under the physician’s personal supervision.1

The charge, if any, for the drug or biologic must be included in the physician’s bill, and the cost of the drug or biologic must represent an expense to the physician. Drugs and biologics furnished by other health professionals (nurse practitioners, physician assistants, and clinical nurse specialists with Medicare billing capability) may also meet these requirements. (See sections 170, 180, 190, and 200 in Chapter 15 of the Medicare Benefit Policy Manual for specific instructions.)1

In addition, Venofer® (iron sucrose) injection, USP is approved for maintenance therapy in pediatric (greater than 2 years of age) hemodialysis patients with iron deficiency anemia, whether or not they are on erythropoietin-stimulating agent (ESA) therapy. Venofer is also approved for maintenance therapy in pediatric (greater than 2 years of age) non-dialysis and peritoneal-dialysis patients with iron deficiency anemia who are on ESA therapy. Patients on dialysis are covered by a separate benefit under Medicare Part A. Additionally, the Medicare rules for dialysis facilities include bundled payments. The bundled per-treatment payment includes drugs, laboratory services, supplies, and capital-related costs related to furnishing maintenance dialysis. So, Venofer may be covered but not paid for separately in dialysis facilities.2

Additionally, for dialysis patients, there is a National Coverage Determination by Medicare, which takes precedence over local intermediary decisions. The National Coverage Determination states, “Effective October 1, 2001, Medicare also covers iron sucrose injection as a first line treatment of iron deficiency anemia when furnished intravenously to patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.”3

For non-dialysis patients, Medicare Part B coverage may be determined by local carriers or Medicare Administrative Contractors (MACs), who are responsible for issuing local coverage determinations (LCDs) that detail coverage guidelines.4

 Additionally, carriers and MACs are responsible for processing Medicare claims. Prior authorization (PA) is not required under Part B. Also, Medicare coverage policies must be drafted and approved by a group of clinicians in your area called the Carrier Advisory Council (CAC). This body gives the public a voice in Medicare policy. Please see the CMS.gov website (link below) for more information.*

Commercial Payers and Medicare Advantage

Medicare Part C is called Medicare Advantage (MA) and currently covers approximately 36.5% of Medicare patients. MA plans are private plans that must cover the same breadth of services that traditional Medicare does. But, other than that, MA behaves like a commercial payer and not like Medicare in terms of coverage and payment. Almost all private payers these days, including MA, require prior authorization for branded drugs like Venofer® (iron sucrose) injection, USP. This will tell you definitively whether a commercial plan will cover Venofer for your patient.

Frequent benefit investigation (sometimes known as insurance verification) is necessary for commercial patients—particularly if they are Affordable Care Act (ACA) patients with premiums or are on employer-based insurance. If patients do not pay premiums or they change jobs, this can impact insurance coverage. Healthcare insurance policies also have various levels of coverage and may have “caps” for drugs. This needs to be ascertained for each policy. Additionally, commercial payers often publish policies regarding iron products like Venofer. You should check the payer policies for Venofer each time you infuse a patient and each time you initiate a new course of iron treatment with Venofer. You can also verify how a policy applies to your patient at the time of prior authorization.

National Drug Codes (NDCs)

National Drug Codes are becoming more prevalent in billing for drugs. Many plans now require NDCs on every claim. The most prominent payers to require NDCs are UnitedHealthcare and all Medicaid plans.

The NDC for Venofer (and all drugs) should be applied to the claim in a 5-4-2 format, meaning that there should be 5 digits, then 4 digits, then 2 digits on the claim, like this:

Venofer is preservative free and available as 50 mg/2.5 mL single-use vials, 100 mg/ 5 mL single-use vials, and 200 mg/10 mL single-use vials. The NDC numbers are:

Drug Payment in the Hospital Outpatient Department

Medicare

Under the Hospital Outpatient Prospective Payment System (HOPPS), drugs and biologics have different payments throughout their product life cycle. Older drugs, like Venofer, that are more than 2 to 3 years after launch, receive either packaged payment or separate payment through their own Ambulatory Payment Classification (APC). The APC is a payment grouping used for hospital outpatient claims as well as ambulatory surgical center (ASC) claims. Each APC group is assigned a preset payment amount, which is intended to cover the hospital’s costs related to the item or service provided. This method of payment ONLY applies to fee-for-service Medicare beneficiaries—not those enrolled in Medicare Advantage Plans.

Some drugs, like Venofer, are packaged based upon a daily predetermined per-encounter rate. That is, if the drug’s per-encounter cost is less than the predetermined threshold, the drug is packaged into the APC of the drug administration for that Venofer encounter.

Medicare groups CPT and HCPCS codes for Venofer® (iron sucrose) injection, USP administration into the corresponding APCs for payment and, thereby, does not pay separately for it. It becomes part of the APC payment for the administration.  The following CPT codes may be used to bill for the administration of Venofer and are assigned to each corresponding APC group for the calendar year 2020:

Denials

All provider-administered (“buy-and-bill”) drugs have complicated payment scenarios based on cost and various payer coverage policies. Moreover, for nonTraditional Medicare payers, prior authorization is needed for all branded drugs, like Venofer® (iron sucrose) injection, USP, to be paid. Thus, denials are common and create much follow-up for providers. Venofer is no exception; however, some of its denials are unique to its indication of iron deficiency anemia in chronic kidney disease. A Clearinghouse database* evidences the following top 5 denial codes for Venofer in 2019, an explanation as to why these may be happening, and how these may be prevented in the buy-and-bill setting

Claim Denial Code #50, Lack of Medical Necessity: This denial code seems to imply that payers are not covering Venofer because the reasons for the administration are not covered. However, in looking at the data, most claims denied under this denial code are not coded correctly in terms of their diagnosis. The top denied ICD-10-CM diagnosis code is D50.9, “unspecified anemia.” Unspecified codes for drugs are very often denied. It is important to use the most specific code that matches individual record documentation. Further, it is also vital to check all individual payer policies for coding guidance and, if they are not available, review the applicable ICD10-CM guidelines to choose the optimal code for payment of Venofer.

Claim Denial Code #11, The Procedure Code and Diagnosis Code Do Not Match: This denial means that the payer expects to see a different diagnosis with the Venofer® (iron sucrose) injection, USP HCPCS code. Again, unspecified codes are a problem, as they are codes that do not convey the diagnosis on the Venofer package insert. Further, there are some claims for diagnoses that are not indicated for Venofer. Please verify coverage and coding guidelines prior to administration of Venofer.

If you receive a Venofer denial and have questions about it, please call the VenAccess™ Reimbursement Hotline at 877-4-IV-IRON (877-448-4766), Monday through Friday, between 9 am and 8 pm ET.

American Regent has established a toll-free hotline to help physicians and other providers understand payers’ coverage and reimbursement policies for Venofer® (iron sucrose) injection, USP, and when necessary, address reimbursement issues. Specifically, on a limited basis, hotline reimbursement specialists can assist with the following:

• Insurance verifications: Help callers verify payer coverage and reimbursement policies for Venofer. Reimbursement specialists will determine patient benefit levels and discuss potential billing options with patient consent

• Billing assistance: Assist callers with filing claims and understanding the reimbursement policies for Venofer

• Claims appeals: Support callers in appealing denied claims or inadequate reimbursement for Venofer

• Patient assistance: Screen individuals without health insurance who are ineligible for public assistance for enrollment in a product replacement program

Patient information will be kept strictly confidential at all times. Every attempt is made to provide accurate, up-to-date information. The Venofer Reimbursement Hotline cannot guarantee successful reimbursement. To speak with someone at American Regent’s Customer Service or Medical Affairs department, please call 800-645-1706.

Guidelines

Medicare covers Sodium Ferric Gluconate Complex in Sucrose Injection as a first line treatment of Iron Deficiency Anemia when furnished intravenously to patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.

Medicare also covers Iron Sucrose Injection as a first line treatment of Iron Deficiency Anemia when furnished intravenously to patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy.

Coverage also includes for parenteral iron in iron deficiency anemia:

• For patients with iron deficiency anemia who do not respond to oral iron supplementation due to malabsorption disorders or patients who have documented intolerance to oral iron supplementation.

• For anemia related to chronic kidney disease.

• Initial treatment of absolute iron deficiency in patients receiving myelosuppressive chemotherapy who have asymptomatic anemia and risk factors for the development of symptomatic anemia requiring transfusion.

For the pregnant beneficiary when iron stores are depleted such that the mother and/or the fetus are at risk of adverse outcomes and oral iron replenishment is either not tolerated or the anemia is of such severity as to require more immediate replenishment. Additionally, use in the peripartum period may be indicated when intra/post-partum hemorrhage is severe and by administering parenteral iron a transfusion may be avoided. This indication does not replace the strong consideration for transfusions when the hemorrhage is potentially life threatening.

APPLICABLE CODES

The following list(s) of codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this guideline does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws  that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.

HCPCS Code Description

J1756 Injection, Iron Sucrose, 1 mg (Venofer®)

J2916 Injection, Sodium Ferric Gluconate Complex in Sucrose Injection, 12.5 mg (Ferrlecit®)

USAGE OF PECOS System - Provider Enrollment, Chain, and Ownership System

The Medicare Provider Enrollment, Chain, and Ownership System (PECOS) is an online provider and supplier enrollment system used to:

** Submit Medicare enrollment applications
** View and print enrollment information
** Update enrollment information
** Complete the enrollment revalidation process
** Withdraw voluntarily from the Medicare Program
** Track Medicare enrollment applications

This booklet teaches Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers how to use PECOS. Go to the Medicare Provider-Supplier Enrollment National Educational Products listing for information about other provider types.

DMEPOS SUPPLIER STANDARDS, ACCREDITATION, AND SURETY BOND

To enroll or keep your Medicare billing privileges, all DMEPOS suppliers (except certain exempted professionals) must meet supplier and DMEPOS Quality Standards to become accredited. Certain DMEPOS suppliers must also submit a surety bond.

DMEPOS suppliers (except for those exempted eligible professionals and “other persons”) must be accredited prior to submitting a Medicare enrollment application to the National Supplier Clearinghouse (NSC). For more information on these conditions, go to the Centers for Medicare & Medicaid Services (CMS) DMEPOS Enrollment webpage or review the DMEPOS Accreditation fact sheet, which lists exempted eligible professionals.

ONE ACCOUNT, MULTIPLE SYSTEMS

CMS uses several provider enrollment systems. Organizational DMEPOS suppliers must use the Identity & Access Management (I&A) System to name an Authorized Official (AO) to work in CMS systems. The I&A System allows you to:

** Use the National Plan and Provider Enumeration System (NPPES) to apply for and manage National Provider Identifiers (NPIs)

** Use PECOS to complete Medicare enrollment or update or revalidate your current enrollment information

** Register to get Electronic Health Record (EHR) incentive payments for eligible professionals and hospitals who adopt, use and upgrade, or demonstrate meaningful EHR certified technology use Individual DMEPOS Suppliers (for example, sole proprietorships) Physicians and non-physician practitioners (NPPs) who are DMEPOS suppliers may use their I&A System user ID and password to access PECOS. If you do not already have an I&A System account, go to the I&A System User Registration page and enter the information to open an account. For help, go to the I&A System Quick Reference Guide and click the “How to Setup Your Account if you are a Sole Owner” link.

Once you have your DMEPOS ID and password, skip to Step 3. As an individual DMEPOS supplier, you do not need an AO or other delegated user.

Organizational DMEPOS Suppliers System Users

CMS allows various types of organizations and users to work in their systems. The type of user  depends on the individual’s relationship with you and the duties they perform in your practice. A  DMEPOS supplier organization must appoint an AO to act on behalf of the organization to manageconnections and staff, including appointing and approving other authorized PECOS users. The organization must identify the AO in the enrollment application. The AO must have ownership or managing control in the DMEPOS supplier organization.

NOTE: CMS recommends using the same I&A System-appointed AO and any Delegated Officials (DOs) in PECOS. The AO and DOs must have the right to legally bind the company, are responsible for approving the system staff, and are approved in the I&A System based on their PECOS status. For more information go to the CMS External User Services (EUS) answers to frequently asked questions webpage.

STEP 1: AUTHENTICATE AO CREDENTIALS

The organization must choose, invite, and authenticate you as their “Authorized Official” (AO) to work in PECOS for them. That individual must meet the AO regulatory definition. An AO is, for example, a chief executive officer, chief financial officer, general partner, chairman of the board, or direct owner to whom the organization gives the legal authority to enroll it in the Medicare Program.

Respond to your employer’s AO invitation or initiate the request yourself. When you are the confirmed AO, use PECOS for your organizational DMEPOS supplier. You may choose to give this responsibility to a DO, Staff End User (SEU), or surrogate. As an AO, you are responsible for approving system user requests to work in PECOS for the organizational DMEPOS supplier. Regularly check your email and take the requested actions. AOs may also appoint DOs to act for them. For more information on registering for an I&A System account or enrolling as an AO, go to the I&A System Quick Reference Guide and the I&A Frequently Asked Questions (FAQs) and click the “Create Your Account” link.



ENTER PECOS ENROLLMENT INFORMATION
After CMS approves your I&A System registration, submit your organizational DMEPOS supplier application. PECOS is a scenario-driven application—it presents a series of questions to recover only the information needed to process your specific enrollment scenario. Follow these instructions:

1. Log in to PECOS.

2. Continue with an existing enrollment or create a new application.

3. When PECOS determines your enrollment scenario and you confirm it is correct, it shows the topics for submitting your application. To complete each topic, enter the necessary information.

4. At the end of the data entry process, PECOS: Confirms you entered all necessary data Shows a list of the Medicare Administrative Contractor/National Supplier Clearinghouse (MAC/NSC) documents to submit for review (the NSC is the MAC responsible for processing all DMEPOS applications)


STEP 4: RESPOND TO MEDICARE CONTRACTORS’ REQUESTS FOR MORE INFORMATION
Respond to information requests within 30 days; otherwise, the MAC/NSC may reject your enrollment.

Your MAC/NSC will not complete processing your PECOS enrollment application without your electronic signature, application fee, and necessary supporting documentation. The effective application enrollment filing is the date the MAC/NSC gets your electronic signature.

You can check your PECOS enrollment application status in two ways:

1. Log in to PECOS and click the “View Enrollments” link. In the “Existing Enrollments” section, find the application. The system shows the application status.

2. To see your enrollment status, go to the PECOS homepage and click “Application Status” under “Helpful Links.” You do not need to log in to PECOS to use this application status feature.

STEP 5: KEEP YOUR PECOS ENROLLMENT INFORMATION UP TO DATE Report a Medicare enrollment change using PECOS. You must report a change of ownership or control, a change in practice location, and any final adverse legal actions (such as revocation or suspension of a Federal or State license) within 30 days of the reportable event (go to the PECOS FAQs for a definition). Submit all other changes within 90 days of the reportable event. For more information, go to the MLN Matters® Article, Timely Reporting of Provider Enrollment Information Changes.

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 Care

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.

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.

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

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.