Medicare and Medicaid Coverage: Therapies and Supplies for Inflammatory Bowel Disease
Published: 2005-12-15T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Inflammatory bowel disease (IBD) affects an estimated one million Americans. IBD patients often have difficulty digesting food. As a result, they may require parenteral nutrition (intravenous feeding) or enteral nutrition (tube feeding), medically necessary food products to supplement their diets, and medications. In addition, some IBD patients must care for their ostomies--surgically created openings for the discharge of digested food. IBD advocates have recently expressed concerns regarding the ability of IBD patients to obtain the health care they need. The Research Review Act of 2004 directed GAO to study the Medicare and Medicaid coverage standards for individuals with IBD, in both home health and outpatient delivery settings. GAO (1) identified the Medicare and Medicaid coverage standards for five key therapies used for the treatment of IBD and (2) determined what specific supplies used in these therapies Medicare and Medicaid programs will pay for. In this work, GAO examined Medicare's national and local coverage policies and conducted a survey of Medicaid programs in the 50 states and the District of Columbia.
section_title: What GAO Found
paragraphs: Medicare generally provides coverage for parenteral and enteral nutrition and ostomy supplies in both home health and outpatient delivery settings. However, specific standards regarding medical conditions and appropriate documentation must be met for parenteral and enteral nutrition to be covered. Medicare has one coverage standard governing the provision of ostomy supplies--that beneficiaries receiving these items have had an ostomy. Medicare does not cover medically necessary food products and generally does not cover self-administered drugs, which include most drugs taken by IBD patients. However, medically necessary drugs, including those that are self-administered, will be covered by Medicare's voluntary prescription drug benefit, which becomes effective in January 2006. State Medicaid programs reported covering, at least partially, each of the five therapies. The survey indicated that most states' Medicaid coverage standards are generally comparable to Medicare's coverage for parenteral and enteral nutrition and ostomy care. Once Medicare coverage standards are met, the program will generally cover all medically necessary supplies associated with parenteral and enteral nutrition and ostomy care. The survey of state Medicaid programs showed variation in the specific supplies that states will provide. While many states pay for most supplies associated with parenteral and enteral nutrition, the specific ostomy supplies states cover vary. Most states--46--reported covering at least some medically necessary food products. GAO also found that states generally cover the drugs listed in the survey. CMS said that GAO correctly described its Medicare coverage policies and suggested that we clarify our description of Medicare's coverage policy for prescription drugs that are not self-administered. It also said that it will continue to consider access issues for Medicare and Medicaid IBD patients.

section_title: Letter
paragraphs: Inflammatory bowel disease (IBD) refers to two chronic autoimmune  diseases of the intestinal tract—Crohn’s disease and ulcerative colitis.  These diseases may result in abdominal pain, weight loss, fever, rectal  bleeding, and diarrhea, and are associated with a decreased quality of life.  IBD generally involves periods of active inflammation alternating with  periods of remission.
The estimated one million Americans with IBD—10 percent of whom are  children—have difficulty digesting food and may require different  treatments, depending on the specific nature of their condition. As a  result, some IBD patients may periodically require parenteral nutrition— the provision of nutrients intravenously. Others may receive enteral  nutrition, which is delivered through a feeding tube inserted into their  noses or stomachs. Some IBD patients may require nutrition in the form of  medically necessary food products, such as formulas that are more easily  digested than normal foods. IBD patients may also require medication,  and some may have ostomies—surgically created openings in their  abdominal wall for the discharge of digested food—and therefore depend  on a pouching system to collect, contain, and manage disposal of solid  body waste.
A number of IBD patients depend on Medicare and Medicaid, the nation’s  largest health insurance programs, for coverage of their treatment.  Medicare serves approximately 41 million elderly and certain disabled  beneficiaries and is administered by the Centers for Medicare & Medicaid  Services (CMS), an agency within the Department of Health and Human  Services (HHS). Based on the Social Security Act, CMS, and the claims  administration contractors that assist it in administering the Medicare  program, determine whether specific medical procedures, devices, and  services should be covered. Medicaid is a federal-state program that  finances health care coverage for approximately 54 million low income  individuals, about half of whom are children. Under CMS’s oversight, each  state administers its own Medicaid program. Within broad coverage  requirements set by law and CMS, states have discretion to develop  specific coverage policies for their Medicaid programs. In fiscal year 2004,  Medicare paid about $298 billion for services and supplies provided to  beneficiaries while Medicaid programs paid close to $272 billion.
Over the past few years, IBD advocates have tried to raise awareness  about IBD and the challenges IBD patients face, including concerns about  obtaining the health care that they need to manage their disease. The  Research Review Act of 2004 contains several provisions related to IBD,  including a mandate that we conduct a study on the Medicare and  Medicaid coverage standards for IBD patients. The act required us to  focus on five specific therapies—in both home health and outpatient  delivery settings—parenteral nutrition, enteral nutrition formula, ostomy  care, medically necessary food products, and drugs approved by the Food  and Drug Administration (FDA) for Crohn’s disease and ulcerative colitis.  In this report, we (1) identify the Medicare and Medicaid coverage  standards for these five therapies, and (2) determine which specific  supplies used in these therapies Medicare and Medicaid programs will pay  for in home health and outpatient delivery settings.
To determine Medicare’s coverage standards for the five therapies, we  obtained and reviewed relevant Medicare laws, regulations, national  coverage policies, and manuals to identify pertinent material. We also  interviewed CMS officials and the medical directors of the Durable  Medical Equipment Regional Carriers (DMERC)—the four claims  administration contractors involved in making local coverage decisions for  applicable therapies in our study. In addition, we discussed and obtained  documentation regarding specific supplies used in the five therapies that  Medicare would pay for in both home health and outpatient delivery  settings.
To obtain information on Medicaid’s coverage of the five therapies, we  developed a survey that we sent to Medicaid offices in all 50 states and the  District of Columbia and asked them to identify applicable coverage  standards. The survey asked state officials to identify specific supplies  their Medicaid program would pay for. It also asked them to note any  distinctions between supplies covered in home health and outpatient  delivery settings, and to indicate whether they had different coverage  policies for adults and children. Our survey was generally based on  relevant Medicare coverage standards and provided states with the  opportunity to describe how their coverage policies varied from  Medicare’s policies and to report other pertinent standards they may have  established. In addition, our survey included a list of drugs to treat IBD  that was developed in consultation with the FDA. Specifically, the survey  listed nine brand name drugs and two generic drugs that the FDA told us it  had approved to treat Crohn’s disease and ulcerative colitis.
We received responses from all of the states and reviewed these data for  obvious inconsistency errors and completeness. For responses that were  unclear or incomplete, we contacted survey respondents to obtain  clarification before conducting our analyses. When necessary, we  compared our electronic data files of survey responses to the actual  surveys that we obtained from states. Based on these efforts, we  determined that the data were sufficiently reliable for the purposes of this  report. To obtain detailed background on the specific supplies that are  associated with each of the therapies, we also contacted representatives  from eight organizations representing patients with IBD, and medical  experts. (See app. I for additional information on our scope and  methodology.) We conducted our work from December 2004 through  November 2005, in accordance with generally accepted government  auditing standards.
subsections: section_title: Background
paragraphs: IBD refers to Crohn’s disease and ulcerative colitis. Crohn’s disease can  involve any area of the gastrointestinal tract but most commonly affects  the small intestine, which is responsible for the body’s absorption of most  needed nutrients, and the beginning of the large intestine, or colon. This  inflammation can result in excessive diarrhea, severe rectal bleeding,  anemia, fever, and abdominal pain. In addition, malnutrition or nutritional  deficiencies are also common among Crohn’s disease patients, particularly  if the disease is extensive and of long duration. Two-thirds to three- quarters of patients with Crohn’s disease will require surgery—in most  cases, to remove the diseased segment of the bowel and any associated  abscess. In some cases, an ostomy to remove the colon also may be  required. However, surgery is not considered a cure for Crohn’s disease  patients because the disease frequently recurs. Ulcerative colitis only  affects the colon. This condition causes diarrhea and bleeding, and can  ultimately lead to colon cancer. In one-quarter to one-third of patients with  ulcerative colitis, medical therapy is not completely successful or  complications arise. Under these circumstances, an ostomy operation may  be performed. Because inflammation in ulcerative colitis is confined to the  colon, the disease is curable by this operation.
IBD may occur at any age, but it most commonly develops between the  ages of 10 and 30. One-third of IBD patients develop symptoms before  adolescence. In such cases, the disease poses special problems because it  can impair children’s bodies’ ability to absorb nutrients and thus adversely  affects their growth and development.
IBD patients, depending on each individual’s unique circumstances, may  rely on one or more of the following key therapies in either home health or  outpatient delivery settings to manage their disease:    Parenteral nutrition is the intravenous administration of nutrients through  a catheter that carries liquid nutrients directly into the bloodstream, where  they are absorbed by the body, entirely bypassing the gastrointestinal  tract. It is typically used to treat patients with severe cases of IBD. In such  instances, patients’ gastrointestinal tracts cannot tolerate nutrition by  mouth or a feeding tube. The provision of parenteral nutrition allows the  intestines to rest and heal, and may relieve acute attacks and delay or  avoid the need for surgery. Supplies used in parenteral nutrition include  parenteral nutrition solutions and various products necessary to  administer the solutions to the patient, such as infusion pumps and  intravenous poles. Parenteral nutrition supply kits include supplies  necessary to transfer the solution to the infusion pump, such as tubes, and  sterilization pads. Parenteral nutrition administration kits include supplies  necessary to transfer the solution from the pump to the patient, such as  intravenous catheters, dressings, tapes, antiseptics, and sterile gloves.
Enteral nutrition is indicated for patients with a functioning  gastrointestinal tract but whose oral nutrient intake is insufficient to meet  their nutritional needs. Enteral nutrition employs a feeding tube to deliver  a liquid nutritional formula to the stomach or small intestine—it is  administered either through the nose or directly through the abdominal  wall into the gastrointestinal tract. For IBD patients, and particularly for  Crohn’s disease patients whose inflamed small intestine may not allow  them to absorb enough nutrients, this method—either used alone, or in  combination with food or liquids taken orally—may restore good nutrition  to patients weakened by severe diarrhea and poor nutrition. In addition,  according to gastrointestinal disease experts, enteral nutrition may have  therapeutic effects as well, by inducing remission. Supplies used in enteral  nutrition include enteral formulas and supplies necessary to administer  this therapy, such as enteral nutrition infusion pumps, intravenous poles,  catheters, and tubes. Enteral feeding supply kits include supplies  necessary to administer the formula to the patient, such as syringes, tubing  to transfer the formula to the catheter, tube connectors, and sterile  gloves. Tubing that goes inside the patient’s body to administer the  nutrients—i.e., nasogastric tubing that delivers the formula to the patient’s  gastrointestinal system through the nose, or gastrostomy tubing that  delivers the formula through a surgically created opening in the stomach— is also necessary. Other supplies needed may include additives, such as  fiber, to thicken enteral formulas.
Medically necessary food products are products that can be taken orally.
They include food supplements, such as the formulas used in enteral  nutrition, and prescription strength vitamins. For example, because  Crohn’s disease and surgical procedures that remove parts of the small  intestine can inhibit absorption of vitamins, fats, and other important  nutrients, taking certain supplements, such as fish oil, antioxidants, and  mineral supplements, may be beneficial for patients with Crohn’s disease.
Medications are often required to treat Crohn’s disease and ulcerative  colitis. The FDA has approved both brand name drugs and generic drugs  to treat IBD. These drugs are typically self-administered and taken to  reduce inflammation in the intestinal wall. In addition, there are other  medications approved by the FDA—but not specifically to treat IBD—that  may be effective in treating the disease.
IBD patients who have had an ostomy operation need to use specific  supplies for their ostomy care. An ostomy surgery creates an opening in  the abdomen. This opening, called a stoma, permits digested food to exit  the body. In most cases, this type of surgery results in a permanent  opening. Subsequent to the operation, ostomy patients need certain  supplies to manage the abdominal opening and the waste. For example,  the patient wears a pouch over the opening to collect the waste and then  empties the pouch as needed. Other necessary supplies include skin  barriers to protect the skin and irrigation and fluid discharge supplies.
Medicare pays for beneficiaries’ medically necessary health care needs as  long as they fit into one of the broadly-defined categories of benefits  established in the Social Security Act. Among other things, these  categories include commonly used medical services and supplies such as  physician visits, inpatient hospital stays, diagnostic tests, durable medical  equipment, and prosthetic devices. While the act provides for broad  coverage of many medical and health care services, it does not provide an  exhaustive list of all services covered. Similarly, the act generally does  not specify which medical devices, surgical procedures, or diagnostic  services the program covers. In addition, the act states that the program  cannot pay for any supplies or services that are not “reasonable and  necessary” for the diagnosis and treatment of an illness or injury. With  the Social Security Act serving as the primary authority for all coverage  provisions, CMS has established coverage policies that specify the  procedures, devices, and services that are covered in the broad benefit  categories established in the act. In addition, CMS has established the  criteria used to determine whether these supplies are reasonable and  necessary for a beneficiary’s treatment. CMS’s national coverage  determinations (NCDs) describe the circumstances for Medicare coverage  for a specific medical service, procedure, or device and they outline the  conditions for coverage. CMS interpretive manuals further define when  and under what circumstances items or services may be covered.
Claims administration contractors are required to follow CMS’s national  coverage policies. However, if an NCD does not specifically exclude or  limit coverage for an item or service, or if the item or service is not  mentioned at all in an NCD or CMS manual, it is up to the contractors to  determine whether they will cover a particular item or service within their  geographic area. This is often done through a local coverage determination  (LCD). LCDs specify under what circumstances the item or service is  considered to be reasonable and necessary, in accordance with the Social  Security Act, and are supplemented by additional instructions from the  contractors. LCDs related to durable medical equipment, prosthetic  devices, orthotics, and a number of other supplies are made by the  DMERCs—the four CMS claims administration contractors that process  claims exclusively for these supplies. The DMERCs are required by CMS to  coordinate their coverage development process with one another and they  publish identical LCDs.
Medicaid coverage policies vary by state. While all state Medicaid  programs must pay for certain services, such as inpatient and outpatient  hospital services, and early and periodic screening, diagnostic, and  treatment services for individuals under the age of 21, states have broad  discretion in setting up their Medicaid programs. They may set different  eligibility standards, scope of services, and payments, and can elect to  cover a range of optional populations and benefits.
section_title: Coverage of IBD Therapies Is Subject to Medicare and Medicaid Standards
paragraphs: Medicare generally covers parenteral and enteral nutrition and ostomy  care in home health and outpatient delivery settings for beneficiaries who  meet certain medical standards. These three IBD therapies are included in  specific benefit categories established by the Social Security Act— primarily the prosthetic devices benefit category, and in the case of  ostomy care provided in a home health care delivery setting, the home  health benefit category. Medicare does not cover medically necessary food  products or most drugs approved by the FDA that are used to treat IBD.  However, in January 2006, Medicare will begin to cover medically  necessary drugs when the program’s new prescription drug benefit  becomes effective. None of the five therapies we examined for this report  are mandatory services under Medicaid. However, our survey of Medicaid  programs indicates that most of these programs provided eligible  individuals some coverage for all five therapies. We also found that  coverage standards that Medicaid recipients must meet to receive these  therapies varied by state. Table 1 summarizes the number of states  covering each of the five therapies. (See app. II for specific information on  each state Medicaid program’s coverage of these therapies.)
subsections: section_title: Medicare and Medicaid Coverage Standards for Parenteral Nutrition
paragraphs: Our analysis showed that Medicare and state Medicaid programs will  generally cover parenteral nutrition as follows:  Medicare: Medicare generally covers parenteral nutrition, as CMS has  determined that it falls under the prosthetic devices benefit category,  established in the Social Security Act. CMS’s coverage standards for  parenteral nutrition therapy are outlined in both an NCD and in local  coverage policy. Coverage is provided in both home health and outpatient  delivery settings. The NCD requires the patient to have a severe pathology  of the alimentary tract that does not allow absorption of sufficient  nutrients to maintain weight and strength commensurate with the patient’s  general condition. A period of hospitalization is required to initiate  coverage for parenteral nutrition and to train the patient in how to  prepare, manage, and administer the formula and equipment. The NCD  also requires a physician’s written order or prescription and sufficient  medical documentation to show that the prosthetic device coverage  requirements are met and that parenteral nutrition therapy is medically  necessary. In addition, before approving coverage, the carrier must agree  that a particular condition qualifies for parenteral nutrition therapy.  Medicare will approve coverage of parenteral nutrition at periodic  intervals of no more than three months. In addition, Medicare will pay for  no more than one month’s supply of nutrients at a time.
Building upon the coverage standards in the NCD, the DMERCs’ local  coverage policy on parenteral nutrition provides significantly more  detailed requirements. The policy consists of specific clinical criteria for  showing that parenteral nutrition is considered reasonable and necessary.  Like the NCD, the local policy specifies that a patient must either have a  condition involving the small intestine that significantly impairs the  absorption of nutrients, or a disease of the stomach or intestine that  impairs the ability of nutrients to be transported through the  gastrointestinal system. The local coverage policy also requires that the  patient’s inability to maintain proper weight and strength necessitates  intravenous nutrition, and that the patient is unable to be treated through  either diet modification or with drugs. It also describes specific clinical  conditions that meet these criteria. For patients who do not meet the  standards for these clinical conditions, coverage for parenteral nutrition  will be considered on an individual basis if detailed documentation is  submitted. However, some patients with moderate abnormalities may not  be covered unless they have experienced an unsuccessful trial of enteral  nutrition.
Medicaid: Our survey responses indicated that all states provide some  parenteral nutrition coverage for children and all but one—Georgia— provide such coverage for adults. However, Georgia reported that it would  consider coverage for adults under an appeal process to its medical  director. Our results showed variation among states in the standards used  to determine coverage for parenteral nutrition. Seven states used all six of  the coverage standards listed in our survey to determine whether Medicaid  would cover parenteral nutrition therapy for adults and children. The  remaining 44 states used a variety of the six coverage standards. For  example, Arkansas, California, Kentucky, North Carolina, and Oregon  require individuals to meet three of the six standards, including pathology  and documentation. Forty-five states indicated that before covering  parenteral nutrition therapy for individuals, they would require some form  of documentation, such as proof of a medical condition. Forty-one of these  same states also required individuals to have a severe pathology of the  gastrointestinal tract that would not allow absorption of sufficient  nutrients to maintain weight and strength. Only one state—Minnesota— provided coverage for parenteral nutrition therapy without listing any  specific conditions that individuals must meet to receive therapy. For  details on specific coverage standards for parenteral nutrition therapy by  state, see app. III.
section_title: Medicare and Medicaid Coverage Standards for Enteral Nutrition
paragraphs: Our analysis showed that Medicare and most state Medicaid programs will  generally cover enteral nutrition as follows:  Medicare: Medicare covers enteral nutrition under the prosthetic devices  benefit category. The NCD coverage standards for enteral nutrition are  very similar to those for parenteral nutrition, with the primary difference  being the requirements involving the patient’s clinical condition. As with  parenteral nutrition, coverage for enteral nutrition is provided in both  home health and outpatient delivery settings. However, for enteral  nutrition, the patient may have a functioning gastrointestinal tract but  must be unable to maintain appropriate weight and strength due to  pathology to, or the nonfunction of, the structures that normally permit  food to reach the digestive tract. The only other differing requirement in  the NCD between the two therapies is that there is no hospitalization  requirement for a patient seeking Medicare coverage for enteral nutrition.  The NCD also requires a physician’s written order or prescription and  sufficient medical documentation to show that the prosthetic device  coverage requirements are met and that enteral nutrition therapy is  medically necessary.
The local coverage policy on enteral nutrition is simpler than the local  policy for parenteral nutrition. It provides coverage for enteral nutrition so  long as adequate nutrition is not possible by either dietary adjustment or  oral supplements. Tube feedings of enteral nutrition must be required to  provide sufficient nutrients to maintain weight and strength  commensurate with the patient’s overall health status due to either one of  two conditions: (1) a permanent non-function or disease of the structures  that normally permit food to reach the small bowel, or (2) a disease of the  small bowel which impairs digestion and absorption of an oral diet.  However, coverage is possible for patients with partial impairments, such  as a Crohn’s disease patient who requires prolonged infusion of enteral  nutrients to overcome a problem with absorption. Enteral nutrition  products administered orally are not covered.
Medicaid: Forty-nine states reported that they provided some coverage for  enteral nutrition therapy for both adults and children. One state— Oklahoma—indicated that it provided coverage for children, but not for  adults. West Virginia responded that it did not cover this therapy at all.  Analysis of survey results also indicated that there was some variation in  coverage standards used among the 49 states that covered enteral  nutrition therapy for adults and children. Six states reported that they  cover enteral nutrition therapy for patients who meet all six coverage  standards listed in our survey. The remaining states used a variety of the  six coverage standards. For example, Arizona, Colorado, Michigan, New  Mexico, and Wisconsin indicated that they use five of the six standards— these states did not require the patient to have a permanent condition in  order to be covered for this therapy. Washington reported that, in addition  to subjecting individuals to most of the criteria listed in our survey, it also  requires prior approval of enteral nutrition therapy based on  documentation showing that the therapy is medically necessary and  outlining why traditional food is not appropriate. We also found that for  both adults and children, 45 of the 49 states that cover enteral nutrition  therapy require individuals to have specific documentation in their  medical records before the states would render coverage. We also found  that 12 states had less restrictive coverage standards for children. See app.  IV for more details on enteral nutrition therapy and supplies coverage  standards for each state.
section_title: Medicare and Medicaid Coverage Standards for Ostomy Care
paragraphs: Medicare and Medicaid provide at least some coverage of ostomy care. In  outpatient delivery settings, Medicare covers ostomy care for IBD patients  under its benefit category of prosthetic devices—similar to parenteral and  enteral nutrition. In home health care delivery settings, Medicare covers  this therapy as a home health benefit. While there is no NCD for ostomy  care, the four DMERCs have established a local coverage policy for these  supplies. According to the policy, the only Medicare coverage standard is  that the patient must have had an ostomy. Similarly, all state Medicaid  offices, according to our survey responses, provide coverage of ostomy  care for adults and children who have had ostomies.
section_title: Medicare and Medicaid Coverage Standards for Medically Necessary Food Products
paragraphs: Medicare does not cover medically necessary food products because such  supplies are not included in any of the benefit categories contained in the  Social Security Act. On the other hand, according to our survey results,  Medicaid provides at least some coverage of medically necessary food  products to its recipients in 46 of the states. Nevada, North Carolina, Ohio,  Utah, and West Virginia were the five states that did not provide any  coverage for medically necessary food products. Of those states reporting  that they provided coverage, 14 also noted that they had a requirement  that the individuals receive a certain percentage of their nutrition from  oral supplements in order for these supplements to be covered. In some  instances, this percentage was as high as 75 to 100 percent. For example,  Florida, Georgia, Mississippi, Rhode Island, and South Dakota required  some individuals to meet 100 percent of their nutritional requirements  from oral supplements; however these individuals did not have to meet all  of the other conditions listed in our survey. On the other hand, while North  Dakota reported that individuals must receive at least 51 percent of their  nutrition from oral supplements, it had the most stringent standards  overall because it required that individuals meet all three conditions for  coverage listed in our survey. For more information on states’ coverage  standards for medically necessary food products, see app. V.
section_title: Medicare and Medicaid Coverage Standards for Drugs to Treat IBD
paragraphs: Medicare does not generally cover medications that are self-administered,  including drugs approved by the FDA to treat IBD. Coverage is not  provided because such self-administered medications are not included in  any of the benefit categories contained in the Social Security Act.  However, in 2003, the Social Security Act was amended, establishing a  new voluntary prescription drug benefit for Medicare beneficiaries that  will become effective in January 2006. At that time, Medicare will begin to  cover self-administered drugs approved by the FDA to treat IBD.
States generally provide some coverage of drugs approved by the FDA to  treat IBD. Generally, before covering a drug, states require that: (1) a  physician or licensed practitioner writes the prescription; (2) a licensed  pharmacist or licensed authorized practitioner dispenses the prescription;  and (3) the drug is dispensed on a written prescription that is recorded  and maintained in the pharmacist’s or practitioner’s records. Our survey  did not ask state Medicaid programs about the standards used to  determine coverage of drugs to treat IBD because state Medicaid programs  are not required to cover prescription drugs.
Our survey also asked state officials whether their Medicaid programs  cover the off-label use of drugs to treat IBD. Responses to this question  varied. Nineteen states responded that they had no policy for the use of  off-label drugs or that their state did not cover off-label use. Many of these  respondents wrote that they only covered drugs approved by the FDA to  treat IBD. Twenty-four states indicated that they cover off-label drug use.  However, 20 of these 24 states responded that they would only cover the  drug under certain conditions. Many of these states reported that  individuals obtaining such prescriptions must receive prior approval or  documentation justifying medical necessity. Michigan has the most  detailed off-label coverage policy of all the states; it indicated that off-label  drugs must receive prior authorization as well as documentation outlining  the (1) diagnosis, (2) medical reason why the individual cannot use  another covered drug; (3) results of therapeutic alternative medication  tried, and (4) medical literature citations supporting the off-label usage.  The remaining eight states did not respond to this question.
section_title: Variation in Medicare and Medicaid Programs’ Coverage of Specific Supplies Related to IBD Therapies
paragraphs: Once coverage standards are met, Medicare generally covers all medically  necessary supplies for the administration of parenteral and enteral  nutrition and ostomy care—the three therapies that this program covers.  On the other hand, our survey of Medicaid programs showed that although  most states provide eligible individuals at least some coverage of each of  the five therapies addressed in this report, the specific supplies that states  will pay for vary and may be subject to restrictions. According to our  survey results, most states will cover necessary supplies related to  parenteral and enteral nutrition with only slight variations for the specific  supplies supplied. We also found that, while all states provided some  coverage of ostomy care, the specific supplies that states cover varied. Our  survey also showed that, while most states will cover at least one of the  five medically necessary food products listed in our survey, no state  covers all of them for both adults and children. Finally, we found that most  Medicaid programs generally covered many of the brand name drugs and  equivalent generic drugs listed in our survey.
subsections: section_title: Parenteral Nutrition Supplies Covered by Medicare and Medicaid
paragraphs: Medicare will generally cover parenteral nutrition therapy supplies, such  as nutrients and administration supplies, for beneficiaries who have met  applicable coverage standards. Specifically, according to the applicable  local coverage policy, Medicare will cover necessary parenteral nutrition  solutions. In addition, when coverage requirements for parenteral  nutrition are met, Medicare will also pay for one supply kit and one  administration kit for each day that parenteral nutrition is administered, if  such kits are medically necessary and used. Medicare will also cover  infusion pumps—only one pump will be covered at any one time.
The local coverage policy also outlines several documentation  requirements for ensuring that the patient’s medical records—including  test reports and records from the physician’s office, home health agency,  hospital, nursing home, and other health care professionals—establish the  medical necessity for the care provided. These records must be made  available to the DMERC upon request. In addition, an order for each item  billed and a certificate of medical necessity must be signed and dated by  the treating physician, kept on file by the supplier, and be made available  to the DMERC. Besides the initial certification, there are also  documentation requirements if recertifications or revised certifications are  necessary.
States’ Medicaid coverage of the five most commonly used parenteral  nutrition therapy supplies shows some variation, depending on the item  and the delivery setting. As table 2 shows, parenteral nutrition therapy  supplies—such as the infusion pump—are covered by more states than the  parenteral nutrition solution. In addition, more states reported that they  cover parenteral nutrition therapy supplies in outpatient delivery settings  than in home health delivery settings. There was little difference in the  coverage of various supplies between adults and children.
Further analysis of survey results revealed that 28 states covered all  supplies in both home health and outpatient delivery settings for adults  and children. For more specific information on the parenteral nutrition  supplies covered by each state, see app. VI.
section_title: Enteral Nutrition Supplies Covered by Medicare and Medicaid
paragraphs: Medicare will generally cover supplies associated with enteral nutrition  therapy for beneficiaries who meet coverage standards. According to the  enteral nutrition local coverage policy, Medicare will cover all enteral  formulas for covered beneficiaries. In addition, Medicare will also cover  medically necessary equipment and supplies for this therapy, such as  feeding supply kits and pumps that are associated with the specific  method of administration used by the patient. However, a few limitations  apply. For example, claims for more than one type of kit delivered on the  same date will be denied as not medically necessary. Similarly, Medicare  will rarely consider the use of more than three nasogastric tubes or one  gastrostomy tube over a 3-month period as medically necessary.
The local coverage policy also outlines several documentation  requirements for coverage of enteral nutrition supplies. Similar to the  parenteral nutrition local policy, the enteral nutrition policy requires that  the patient’s medical record reflect the need for the care provided. It also  has requirements associated with the certification of enteral nutrition. For  example, if the physician orders enteral nutrition supplies for a longer  period of time than is indicated on the original certificate of medical  necessity, the enteral nutrition policy will require recertification. However,  the enteral nutrition policy generally has fewer documentation  requirements than that of parenteral nutrition.
Based on our survey, state Medicaid programs’ payment for seven of the  most commonly used enteral nutrition therapy supplies varies depending  on the type of product, delivery setting, and whether the patient is an adult  or a child. Table 3 shows that states reported that their Medicaid programs  pay for enteral feeding supply kits and tubing more than other therapy  supplies. In addition, more states pay for enteral supplies for children than  adults and more states pay for supplies in outpatient delivery settings than  in home health delivery settings.
Further analysis revealed that 15 states pay for all seven supplies listed in  our survey in both home health and outpatient delivery settings for adults  and children. Thirty states pay for five or more enteral nutrition supplies  for adults and children in these same settings. We also found that additives  for enteral formula, such as fiber, are the least covered product, with only  21 states covering it in both home health and outpatient delivery settings  for adults and children. For specific results of enteral nutrition supplies  provided by each state, see app. VII.
section_title: Ostomy Supplies Covered by Medicare and Medicaid
paragraphs: Medicare covers all of the types of ostomy supplies used by IBD patients  who require ostomy care. However, there are two restrictions regarding  the types of ostomy supplies covered. First, Medicare will only provide a  beneficiary with one type of liquid skin barrier if one is needed—either a  liquid or spray barrier, or individual wipes. Second, Medicare will only pay  for one type of drainage supply—a stoma cap, a stoma plug, or gauze  pads—on a given day. These restrictions are imposed by the DMERCs in a  local coverage policy, which also specifies the “usual maximum quantity”  of supplies that typically meet the needs of ostomy patients for a specific  time period (generally for either 1 or 6 months) for each of the most  commonly used ostomy supplies. However, according to the four DMERC  medical directors, these quantities only serve as guidelines. Because the  need for ostomy supplies can vary substantially among patients, DMERCs  may cover supplies that exceed the usual maximum quantities if the need  is justified.
Medicare’s coverage of ostomy supplies is different for IBD patients who  receive care under a home health plan of care than for those who receive  it in an outpatient delivery setting. If an IBD patient is being served by a  home health agency and is under a home health plan of care, all of the  patient’s medical supplies, including ostomy supplies, are considered part  of the Medicare home health services benefit. This is generally the case  even when the IBD is a pre-existing condition unrelated to the immediate  reason for home health care, such as hip replacement surgery. Medicare  pays a fixed amount determined under a prospective payment system to  the home health agency for the cost of all covered home health visits,  including ostomy supplies delivered during these visits. The home health  agency is obligated to provide the beneficiary with the necessary ostomy  supplies, which are bundled with all other necessary home health services.  The home health agency selects the type of ostomy products to be used  and if the patient wishes to use different products, the patient must do so  at his or her own expense. This practice can be contrasted to the  outpatient delivery setting, where the products are generally selected by  the patient, or the patient’s doctor.
All states responded that their Medicaid programs pay for ostomy supplies  for adults and children who have had ostomies; however the range of  supplies covered varied. Because of the relatively large number of supplies  commonly used by ostomy patients we grouped these supplies in nine  categories, based on input from a representative of the United Ostomy  Association. Table 4 shows the median percent of states covering ostomy  supplies in home health and outpatient delivery settings, after they have  been placed in these categories. For example, for the 14 supplies in the  drainable pouch with standard barrier supplies category—half of supplies  are covered by at least 84 percent of states in home health delivery  settings and 85 percent of states in outpatient delivery settings. In general,  states’ coverage of ostomy supplies was greater in outpatient, than in  home health delivery settings. For more details on the individual ostomy  supplies included in each category and the percent of states covering each  supply, see app. VIII.
Twenty-four states reported covering all of the ostomy supplies listed in  our survey in both delivery settings. Nine of the 24 states that covered all  supplies imposed no supply limits or dollar caps on individuals. The  remaining 15 states reported that they had supply limits or dollar caps;  however five of these states—Arizona, Hawaii, North Dakota, Rhode  Island, and Virginia—added that they often allowed individuals to exceed  these limits and caps for certain supplies. For example, one state reported  that while it has a supply limit of one box of 50 skin barrier wipes and  dollar cap of $9.36 per month, it will often allow individuals to exceed  limits and caps. See app. IX for more details on individual states’ coverage  of supplies, including supply limits and dollar caps, in both home health  and outpatient delivery settings.
section_title: Medically Necessary Food Products Covered by Medicaid
paragraphs: Unlike Medicare, which does not pay for any medically necessary food  products, most state Medicaid programs pay for some products. These  products include prescription strength vitamins, oral nutritional formulas,  food thickeners, baby foods, blended grocery products, and other supplies.  According to our survey, 46 states reported covering at least one of the  five products listed in our survey for either adults or children.
As table 5 shows, out of the five food products, state Medicaid programs  reported paying for oral nutritional formulas most often. Baby food and  other blenderized products were the least common products covered with  only four states—Missouri, New Jersey, Tennessee, and Texas—reporting  that they paid for these products. In addition, more states paid for  medically necessary food products for children than for adults.
For more details on states’ payment of medically necessary food products,  see app. X.
section_title: Drugs Covered by Medicaid to Treat IBD
paragraphs: All states reported that their Medicaid programs paid for at least one of the  nine brand name drugs or two of the generic drugs that were included in  our survey and which were approved by the FDA to treat IBD. Figure 1  shows the number of states covering each drug. The brand name drug  Remicade was the most commonly paid for drug, with all states reporting  payment. The generic drugs available for Azulfidine and Rowasa were  covered by 48 and 46 states respectively.
Further analysis revealed that six states—Colorado, Minnesota, Montana,  Nevada, Oklahoma, and Wisconsin—reported that individuals must use  generic drugs if they are available, before obtaining the equivalent, but  more expensive brand name drugs. Three states—California, Iowa, and  Ohio—indicated that they would not cover the brand name drug Remicade  without prior authorizations. See app. XI for a listing of each state’s  coverage of drugs listed in our survey to treat IBD for adults and children.
section_title: Agency Comments
paragraphs: We provided a draft of this report to CMS. In its written comments, CMS  said that it determined that we correctly described the Medicare coverage  policies for parenteral and enteral nutrition and ostomy supplies.  However, CMS suggested that we clarify our description of Medicare’s  coverage policy for prescription drugs that are not self-administered. We  revised our language to address this concern. It also said that, as it  proceeds with policy development, it will continue to give consideration to  access issues that affect Medicare beneficiaries and Medicaid recipients in  their treatment of IBD. We have reprinted CMS’s letter in app. XII.
We also provided FDA with excerpts of the draft concerning drugs it has  approved to treat Crohn’s disease and ulcerative colitis. FDA responded by  e-mail and provided a list that contained several additional drugs it said it  considered as valid, labeled, treatments for IBD. FDA’s revised list was  provided after our survey was administered and these drugs are not  discussed in this report. We modified our report to note this.
We are sending copies of this report to the Secretary of Health and Human  Services, the Administrator of CMS, the Commissioner of FDA, and other  interested parties. In addition, this report will be available at no charge on  GAO’s Web site at http://www.gao.gov. We will also make copies available  to others upon request.
If you or your staffs have any questions about this report, please contact  me at (312) 220-7600 or aronovitzl@gao.gov. Contact points for our Offices  of Congressional Relations and Public Affairs may be found on the last  page of this report. Key contributors to this report are listed in app. XIII.
section_title: Appendix I: Scope and Methodology
paragraphs: In this report, we (1) identify the Medicare and Medicaid coverage  standards for five therapies—parenteral nutrition, enteral nutrition  formula, ostomy care, medically necessary food products, and drugs  approved by the Food and Drug Administration (FDA) for inflammatory  bowel disease (IBD); and (2) determine what specific supplies used in  these therapies Medicare and state Medicaid programs pay for in home  health and outpatient delivery settings. In examining Medicare and  Medicaid coverage of these therapies and the related supplies, we  considered whether each program would cover these items in both home  health and outpatient settings. For purposes of this study, we defined  these settings as follows:    Home health care refers to the situation in which a medical supply is being  provided to the individual by a home health aide or others through an  arrangement made by a home health agency, in accordance with a plan for  furnishing the supply that a physician has established and periodically  reviews. The supply is provided through visits made to an individual’s  residence.
Outpatient care refers to any situation in which a patient receives a  medical supply but does not require an overnight hospital stay. This  includes a situation in which the supply is provided to the individual  during a visit with a physician in an office or hospital. It may include a  situation in which the individual obtains and self-administers the supply  outside of the office or hospital setting, without the assistance of a home  health aide or a home health agency.
subsections: section_title: Medicare and Medicaid’s Coverage Standards of IBD Therapies
paragraphs: To identify Medicare’s coverage standards for parenteral and enteral  nutrition, ostomy care, medically necessary food products, and drugs  approved by the FDA for the treatment of IBD in home health and  outpatient delivery settings, we reviewed the standards established by the  Centers for Medicare & Medicaid Services (CMS) in its national coverage  policies. Specifically, we examined CMS’s database of national coverage  determinations (NCD) as well as its interpretive manuals, which address  coverage policies. We also reviewed local coverage policies established by  CMS’s four Durable Medical Equipment Regional Carriers (DMERC). In  addition, we reviewed relevant Medicare laws and regulations. To clarify  our understanding of these materials, we interviewed CMS officials and  the medical directors of the four DMERCs. We also reviewed relevant  laws, and other CMS and DMERC documentation to determine if the  program covers these therapies in both the home health and outpatient  delivery settings.
To identify the Medicaid program’s coverage standards in each state for  the five therapies addressed by our study in home health and outpatient  delivery settings, we sent a survey to Medicaid offices in the 50 states and  the District of Columbia. The survey addressed each state’s coverage  policies and medical criteria that an individual must meet to receive each  of the five therapies as a Medicaid benefit. Specifically, we asked states to  indicate whether their program provides coverage of each of the five  therapies and the criteria and conditions they have established, if  applicable. In general, we used Medicare’s coverage policies as a basis for  the survey’s coverage questions, and we provided states the opportunity to  describe how their policies varied from Medicare’s policies. We also  provided states with the option of describing other pertinent criteria they  may have established. The survey asked them to indicate whether they had  different coverage policies for adults and children for such therapies.  Because Medicare does not cover medically necessary food products and  self-administered prescription medications, we formulated our survey  questions on applicable coverage standards for these two items based on  discussions with medical experts and organizations that represent IBD  patients, and our review of pertinent literature. Regarding drugs used to  treat IBD, we consulted with the FDA, which provided us with a list of  nine brand name drugs and two generic drugs that it had approved to treat  Crohn’s disease and ulcerative colitis. We included these drugs in our  survey.
We pretested our survey with Medicaid officials in the District of  Columbia, Georgia, and Virginia. We selected the District of Columbia and  Georgia because of the contrasting sizes of these two Medicaid programs.  We selected Virginia to obtain additional input on the structure of our  questions related to prescription drug coverage. We received responses  from all of the states and reviewed these data for obvious inconsistency  errors and completeness. For responses that were unclear or incomplete,  we contacted survey respondents to obtain clarification before conducting  our analyses. We did not verify all the information we received in the  survey. When necessary, we compared our electronic data files of survey  responses with the actual surveys we obtained from states. We also did  several internal verification checks to ensure accuracy. Based on these  efforts, we determined that the data were sufficiently reliable for the  purposes of this report.
section_title: Specific Supplies Paid for by Medicare and State Medicaid Programs
paragraphs: To identify the specific supplies used in the covered therapies that  Medicare will pay for, we reviewed relevant NCDs, local coverage policies,  and CMS interpretive manuals. We interviewed CMS officials and the four  DMERC directors about the supplies that Medicare will pay for, and any  applicable limitations or restrictions. To improve our understanding of the  various supplies used in each therapy, we obtained information from the  two medical experts and representatives of organizations that participated  in our panel.
To determine the specific supplies that state Medicaid programs will pay  for, we provided in our survey a list of commonly used supplies for each of  the five therapies. To determine the supplies that are most commonly used  in the five therapies, we interviewed the directors of the four DMERCs,  representatives of some of the organizations that participated in our panel,  and the two medical experts, and reviewed relevant literature. States were  asked to report whether or not the specific supplies listed were covered  for adults and children, and whether their Medicaid program would cover  these supplies in both home health and outpatient delivery settings. In the  case of parenteral and enteral nutrition, and ostomy supplies, we listed  items by name and included their identifying codes as specified in the  Health Care Common Procedure Coding System (HCPCS). Because there  is no standard definition of what constitutes medically necessary food  products, we developed a list of items that members of our panel and the  physicians we spoke to generally considered commonly used. To  determine whether states covered medications to treat IBD, we asked  states to indicate whether they paid for the nine brand name drugs and  two generic drugs listed in our survey. With the exception of drugs, we  asked states to indicate whether they had established any restrictions,  including supply limits and monetary caps, on the provision of covered  products. We conducted our work from December 2004 through  November 2005, in accordance with generally accepted government  auditing standards.
section_title: Appendix II: Reported State Medicaid Program Coverage of Therapies Used by IBD Patients
paragraphs: Only total parenteral nutrition is covered.
section_title: Appendix III: Reported Parenteral Nutrition Therapy Coverage Standards by State Medicaid Program
paragraphs: Patient has to have a severe pathology of the gastrointestinal tract that does not allow absorption of  sufficient nutrients to maintain weight and strength.
For acute care adults receiving total parenteral nutrition, parenteral nutrition therapy must be the sole  source of nutrition.
Only total parenteral nutrition is covered. Individuals must document the reason enteral feeding  cannot be given.
The coverage standards related to pathology and clinical conditions are only applicable in home  health delivery settings.
The recipient must require total parenteral nutrition to sustain life. Adequate nutrition must not be  possible by dietary adjustment, oral supplements, or tube enteral nutrition.
section_title: Appendix IV: Reported Enteral Nutrition Therapy Coverage Standards by State Medicaid Program
paragraphs: Applie to oth lt nd children Ste doe not cover therpy Coverge ndrd or requirement doe not pply Patient has to have a severe pathology or non-function of the structures that normally permit food to  reach the small bowel (e.g., inability to swallow), which impairs the ability to maintain weight and  strength.
For acute care adult patients, enteral therapy must be the sole source of nutrition.
For adults, enteral nutrition is covered only if it is the sole source of nutrition.
For adults and children, enteral nutrition must provide 51 percent of more of caloric intake.
For adults, the tube feeding criterion is only applicable in home health delivery settings.
The state does not require documentation for adults. It did not respond to this question for children.
Enteral nutrition therapy must be the primary source of nutrition. The state may cover oral nutritional  products for children who have had an early and periodic screening, diagnostic, and treatment  screening which results in a diagnosed condition that impairs absorption of specific nutrients.
Documentation must indicate that there is a defined pathologic process for which nutritional support  is therapeutic.
section_title: Appendix V: Reported Medically Necessary Food Products Coverage Standards by State Medicaid Program
section_title: Appendix VI: Reported Parenteral Nutrition Supplies Covered by Medicaid in Home Health and Outpatient Delivery Settings
paragraphs: Parenteral nutrition solution includes all types of solutions.
Supplies are covered only when administered at home. They are not covered in other outpatient  delivery settings.
section_title: Appendix VII: Reported Enteral Nutrition Supplies Covered by Medicaid in Home Health and Outpatient Delivery Settings
paragraphs: Ste doe not cover supply Ste doe not cover therpy Enteral formula includes all types.
State’s coverage is limited to home health delivery settings.
The state does not cover enteral nutrition infusion pump – without alarm.
The state does not cover blenderized enteral formulas.
For adults, the state handles coverage for enteral supplies on a case-by-case basis.
The state only covers specific enteral nutrition supplies. Nasogastric tubings with and without stylets  along with stomach tubes are only covered for children.
Pediatric enteral formula and blenderized enteral formula are only covered for children under the age  of 21.
The state does not cover all enteral formulas.
section_title: Appendix VIII: Reported Percent of States Covering Ostomy Supplies in Home Health and Outpatient Delivery Settings
subsections: section_title: Drainable pouch with extended wear barrier
paragraphs: Ostomy pouch, drainable, with extended wear barrier attached  Ostomy pouch, drainable, with extended wear barrier attached, with built-in convexity  Ostomy pouch, drainable with faceplate attached, plastic  Ostomy pouch, drainable with faceplate attached, rubber  Ostomy pouch, drainable, for use on faceplate, plastic  Ostomy pouch, drainable, for use on faceplate, rubber  Ostomy pouch, drainable, high output, for use on a barrier with flange (2 piece system),  with filter  Ostomy pouch, closed, for use on barrier with locking flange, with filter (2 pieces)
Ostomy pouch, drainable, with barrier attached, with filter (1 piece)
Ostomy pouch, drainable, for use on barrier with non-locking flange, with filter (2 pieces)
Ostomy pouch, drainable, for use on barrier with locking flange (2 pieces)
Ostomy pouch, drainable, for use on barrier with locking flange, with filter (2 pieces)
Ostomy pouch, drainable, without barrier attached (1 piece)
Ostomy pouch, drainable with barrier attached (1 piece)
Ostomy pouch, drainable, for use on barrier with flange (2 piece system)
Ostomy skin barrier, with flange, extended wear with built-in convexity, larger than 4x4  inches   Ostomy skin barrier, with flange, extended wear, without built-in convexity, 4x4 inches or  smaller  Ostomy skin barrier, with flange, extended wear, without built-in convexity, larger than 4x4  inches  Ostomy faceplate equivalent, silicone ring  Ostomy skin barrier, non-pectin based, paste  Adhesive or non-adhesive, disk or foam pad  Ostomy skin barrier, closed, with extended wear barrier attached, with built-in convexity  Ostomy pouch, closed, with barrier, with filter  Ostomy pouch, closed, with barrier attached, with built-in convexity  Ostomy pouch, closed, without barrier, with filter (1 piece)
Ostomy pouch, closed, fuse use on barrier with non-locking flange (2 pieces)
Ostomy pouch, closed, fuse use on barrier with locking flange (2 pieces)
Ostomy supplies were placed in related categories based on discussions with an official from the  United Ostomy Association.
section_title: Appendix IX: Reported Information on Medicaid Coverage of Ostomy Supplies and Related Limits
subsections: section_title: Number of supplies covered
paragraphs: Percent of  covered supplies  with dollar caps  and/or supply  Supplies are only covered if they are used at home. Dollar caps and supply limits only apply to  adults.
The state has supply limits and dollar caps that can never be exceeded for certain supplies; however  some of the limits and caps are very high. For example, for one item that can never be exceeded— the ostomy belt with peristomal hernia support—the state reported that it will pay for up to 999 belts  and $38,571.39 per month.
There are no supply limits or dollar caps for home health ostomy supplies.
Supply limits or dollar caps are only for home health.
Once the accumulated dollar value of all products reaches $300 or more in a year, the state looks at  the usage patterns and other information. The state reported that IBD patients often reach or exceed  the $300 limit but it often allows individuals to exceed the amount with written justification.
section_title: Appendix X: Reported Medically Necessary Food Products Covered by State Medicaid Program
paragraphs: For prescription strength vitamins, the state covers prenatal vitamins for pregnant women only.  Prescription fluoride vitamins are covered for children up to eight years of age.
The state only covers prenatal vitamins. Food thickeners are covered for any condition, as long as  they are medically necessary.
For prescription strength vitamins, the state limits coverage to prenatal vitamins, folic acid, pediatric  vitamins with fluoride for children less than 13 years of age, multivitamins for dialysis patients, and  iron supplements.
The state covers special metabolic formulas for oral administration for children under medically  necessary food products.
For prescription strength vitamins, multivitamins can be covered but they must have prior  authorization and meet the state’s criteria for medically necessary.
Coverage for prescription strength vitamins is based on documented vitamin deficiencies in the  patient’s medical record. Nutritional formulas taken orally must have prior authorization.
CMS standard exemptions related to legend vitamins are covered. Pediatric vitamin supplements  with fluoride are covered. Other pediatric legend vitamins may be covered with statement of medical  necessity.
The state requires a defined/specific pathologic condition for which nutritional support is therapeutic.  If the purpose of the supply is simply to provide food, then it is not considered medically necessary.
The state covers general nutritional supplements. Other disease specific products are not covered.
Appendix X: Reported Medically Necessary  Food Products Covered by State Medicaid  Program For prescription strength vitamins, the state limits coverage for children less than two years of age or  for prenatal use.
For prescription strength vitamins, the state covers prenatal vitamins for women.
The state does not cover nutritional shakes and vitamins.
section_title: Appendix XI: Summary of Drugs Listed in Our Survey to Treat IBD That Are Covered by Medicaid for Adults and Children
paragraphs: The state requires patients to use a generic equivalent drug, if available.
The state covers brand name drugs only after documentation of medical necessity is complete. The  documentation has to include a summary of benefit versus risk.
The state will cover brand name drugs with prior authorization when there are generic equivalent  drugs available.
The state does not cover Remicade, Colozal, and Entocort for children age 11 or under.
The state requires prior authorization for Remicade and Asacol.
The state did not indicate whether it covered the generic drug for Azulfidine for children.
The state will pay for brand name drugs after demonstrating failure of generic equivalent drugs.
The state will cover brand name drugs with prior authorization when there are generic equivalent  drugs available.
Appendix XI: Summary of Drugs Listed in Our  Survey to Treat IBD That Are Covered by  Medicaid for Adults and Children  The state requires prior authorization for Remicade.
The state requires patients to use a generic equivalent drug, if available.
The state may require prior authorization if generic equivalent drug or therapeutic alternatives exist.
The state requires prior authorization for brand name drugs when there is a generic equivalent drug  available.
The state will cover brand name drugs with prior authorization when there are generic equivalent  drugs available.
section_title: Appendix XII: Comments from the Centers for Medicare & Medicaid Services
section_title: Appendix XIII: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, Geraldine Redican-Bigott,  Assistant Director; Shaunessye Curry; Adrienne Griffin; Ba Lin; Janet  Rosenblad; and Pauline Seretakis made key contributions to this report.