OPAT and CoPAT: It’s all about getting paid for a good practice

Secondary insurance still the only means for Medicare patients at home

"We’ve been able to take outpatient antibiotic therapy [OPAT] and community-based parenteral anti-infective therapy [CoPAT] to the point where we have as many people on intravenous therapy outside the hospital as we do inside the hospital," says Alan D. Tice, MD, a 20-year veteran in the war against infectious diseases. His Tacoma, WA-based practice, Infections Limited, is an outpatient infectious disease unit providing community services for people with serious infections, treating them at home rather than just hospitalizing them.

The practice of administering parenteral anti-infective therapy in the home and in other community settings has grown rapidly over the past 20 years. In the United States, CoPAT is a multibillion-dollar-a-year industry. It is estimated that more than 250,000 Americans are treated with CoPAT each year, and the growth rate for this practice is estimated to exceed 10% a year.1 But receiving reimbursement for OPAT and CoPAT — especially from Medicare — can be difficult.

"Medicare regulations were developed in the mid-1960s, before people had any concept we could be treated with IV antibiotic therapy on an outpatient basis," says Tice. "Medicare has been very inflexible, claiming that this was a home care benefit and was never intended to be covered in the ’60s, so we won’t pay for it at all."

Outdated policies

IV antibiotics administered in the home, with the exception of those that require durable medical equipment, are not currently covered by Medicare. And the huge potential Medicare savings associated with a new ambulatory IV benefit underscores the present outdated Medicare coverage policies for outpatient antibiotic therapy.

The program pays for inpatient care but excludes equally effective, less costly outpatient alternatives. This situation not only ignores the wide acceptance of outpatient IV therapy by the medical community and private health plans, but also illustrates the need for a change in Medicare’s benefit structure, which fails to take advantage of cost-effective medical advances. Medicare’s blanket prohibition of outpatient self-administered drugs is also inconsistent with recent congressional efforts to provide more care options to Medicare beneficiaries and slow the increase in Medicare expenditures.2

Fees add up

Ironically, the benefit for OPAT and CoPAT is provided if the therapy is applied in doctors’ offices. "If you have a drug you can give once a day and it’s fairly convenient for a person to go to a doctor’s office, get an intravenous drug, go home, and go back the next day, then you’re OK," says Tice. "We’re able to bill for it. The reimbursement is not good, and there are many practices in which doctors feel they can’t afford to provide these benefits to Medicare patients. But we have a sufficient volume, and I’m able to do so by charging the cost of the drug in addition to charging for the room fee and the physician visit."

However, travelling to a doctor’s office on a daily basis is just not feasible for some patients, especially those who require two or more infusions per day. For Medicare patients, having supplemental insurance is currently their only key to obtaining reimbursement.

Kathy Pinson, one of Tice’s Medicare patients, says, "If I had to rely totally upon Medicare paying my bills, without having a secondary insurance, I would have to drive an hour to an hour and a half every single day to the clinic here to get treatment."

Monitoring the care of patients receiving CoPAT includes attention to venous access, monitoring by means of specific laboratory tests, and emphasizing the importance of administering the first dose in a supervised setting. Anti-infective selection and administration issues involving CoPAT include observations that once-daily drug administration is convenient.2 Medicare requires a physician be present to oversee the therapy.

"It’s a fairly big hurdle, but we just hate to see people confined to the hospital because of monetary and regulatory issues," Tice says. "It’s not easy; and the way things are going with Medicare, it may be increasingly difficult. Hopefully, some of the focus on health care by the potential presidential candidates will loosen things up a little bit and the government will provide more services to Medicare patients rather than having them confined to a hospital or going to a nursing home to get their medications instead of being treated at home."

As far as his non-Medicare patients are concerned, Tice says there has been a general appreciation of the cost savings of OPAT and CoPAT therapy by most private payers.

"The individual states vary on individual welfare payments," he says. "Sometimes, you just can’t afford to provide that through your office or home care company. As far as private insurers are concerned, they will usually try to get people out of the hospital as soon as possible because of the cost savings. A usual day in the hospital is about $1,000 for an insurance company. A home care agency will get $150 to $250 per day for the same treatment in an otherwise healthy person."

Outpatients rule

Private payers, not satisfied with avoiding the higher costs of hospitalization, have begun ratcheting down the benefits for outpatient therapy, which Tice sees as a real threat to the quality of outpatient care — especially given the inherent problems of measuring outcomes and quality assurance in the nonhospital setting.

"I think the opportunities and needs are really there to keep people in the community, at home, [and] back at work if there is leadership on the part of nurses, physicians, [and] pharmacists, as well. What we find when we ask people after their course of therapy whether they would prefer to be hospitalized for another course of IV therapy or to be treated at home, 99% of them say they prefer to be treated as outpatients. And these are people who have been hospitalized and then treated as outpatients, so they know both sides of the fence. We’ve also found that about half the people who are employed can go back to work before they complete their courses of therapy. The majority of children are able to go back to school, too, and learn while they’re being treated," Tice says.

Tice and his fellow physicians have started a network to try and assure the quality of care for outpatient antibiotic therapy. They now have over 4,000 patients in their database from 20 different sites around the country. The goal is developing a useful standard to help people understand issues, such as what’s a safe complication rate and what’s not, and what are the outcomes of therapy.

According to Tice, the greatest needs for infection control and quality assurance are in the community, not the hospital.

"As medical care evolves, you’ll see more and more people who used to be required to be in the hospital for treatment being treated at home. Increasingly, we’re faced with the need for a support system for these people — for quality control and safety measures to be certain things go well with them. But it’s difficult to do. There’s a clear cost savings of $500 or more dollars per day for their insurance companies to get people out of the hospital, but there are risks there, as well," he says. "We have educational materials and are trying to evolve a network of centers that is going to be helpful in measuring the quality of care to create benchmarks. We’ve also been involved in writing guidelines for CoPAT."

Guidelines outlined

OPAT and CoPAT have proven to be clinically effective treatments. A series of studies from 1991-95 looked at 137 patients, most of whom were hospitalized for a short time and then received OPAT with ceftriaxone in combination with other antibiotics. The clinical success rates ranged from 88% to 100%. A statistical analysis of 30 patients involved revealed 380 hospital days were saved.

Tice says the Infectious Disease Society of America (IDSA; www.idsociety.org) has taken a leadership role in trying to outline the responsibilities of home care companies that are attending to patients in their homes and in developing standards for monitoring patients to be certain they don’t develop toxic problems or toxicity from the drugs they are receiving in order to assure a positive outcome.

The IDSA guidelines for patient selection says the following items should be observed in determining which patients should receive CoPAT:

The patient’s medical care needs do not require hospitalization and do not exceed resources available at the proposed site of care.

The patient or caregiver is capable of safely and effectively delivering parenteral anti-infectives and compliant with recommended treatment and, after discussion of the benefits, risks (including informed consent when appropriate), and economic considerations (such as insurance issues), willing and able to participate in the proposed therapy.

Lines of communication between the patient, caregiver, physician, and other health care personnel are sufficient for monitoring therapy.

The home/outpatient environment is safe and adequate to support care.1

The appropriateness of CoPAT for drug- or alcohol-using patients should be carefully evaluated before therapy is initiated. If a patient was actively abusing parenteral drugs immediately before the acute presentation, administration of IV antibiotics in a supervised setting is recommended. Tice cautions that plans for quality assurance and outcomes monitoring should be incorporated into CoPAT programs. He also believes that an experienced physician director or advisor for any CoPAT delivery organization is important for the success of the program. The venous access site and device generally need to be carefully examined every three to four days by a nurse or physician for evidence of local tenderness, phlebitis, infiltration, erythema, or other sign of local infection.

Traditionally, patients or their caregivers have infused anti-infective drugs by the gravity-infusion method. A variety of alternative methods, including elastomeric infusion devices, syringe pumps, programmable infusion devices or direct IV bolus injection techniques, have been used increasingly to circumvent several potential barriers to using CoPAT.1

New Medicare proposal

For appropriate candidates, ambulatory IV antibiotic therapy is safe, effective, and less expensive than inpatient hospital care, Tice says. Private insurers and Medicare HMOs have promoted home care for stable patients requiring IV antibiotic therapy, he adds. Also, he says, a proposed Medicare benefit for ambulatory IV antibiotic therapy can reduce Medicare expenditures while providing good clinical outcomes.

Hospitals would continue to benefit since under the Medicare diagnosis-related group system they receive a fixed amount per case, regardless of how long the patient is hospitalized, Tice says. Medicare fee-for-service coverage of ambulatory therapy could also result in substantial cost savings, he adds.

Furthermore, he muses, the new benefit would be fully self-financing. As Congress and the president continue to consider Medicare program changes that will reduce expenditures and expand beneficiaries’ care options, an ambulatory IV antibiotic benefit that meets both goals should receive serious consideration, Tice believes.2

References

1. Williams D, Rehm S, et al. Practice guidelines for community-based parenteral anti-infective therapy. Clin Infect Dis 1997; 25:787-801.

2. Tice A, Poretz D, et al. Medicare coverage of outpatient ambulatory intravenous antibiotic therapy: A program that pays for itself. Clin Infect Dis 1998; 27:1,415-1,421.