I am attaching a coding alert article for your perusal. I hope this will clear the doubts.
Providers who mix more than one vial of antigen may now bill Medicare for the total number of doses in all vials, as long as that number does not exceed 10 per vial, according to a clarification by HCFA (now the Centers for Medicare and Medicaid Services, or CMS) in the Nov. 1, 2000, Federal Register. The clarification was necessary, the document states, to resolve "the ambiguity and confusion in the medical community surrounding this issue."
But uncertainty about how to bill Medicare for 95165 (professional services for the supervision and provision of antigens for allergen immunotherapy; single or multiple antigens [specify number of doses]) continues, in part because many Medicare carriers have yet to implement the new guidelines -- and also because other billing problems involving this service remain unresolved.
Code 95165 describes the preparation of antigens prior to administration. Doses of single or multiple antigens are prepared either in vials or "off the board" (i.e., individual doses are prepared for patients when they arrive for their shot). Prepared vials usually include multiple doses.
For example, the provider determines that a patient requires a series of 10 1-cc doses and prepares a 10-cc vial. During the same visit, he or she injects the first dose. Code 95115 (professional services for allergen immunotherapy not including provision of allergenic extracts; single injection) is billed for the injection and 95165 is also reported, with a "10" in the units box to indicate that 10 doses were prepared. For the remaining nine injections, only 95115 would be coded. For off-the-board antigen preparation, 95115 is billed along with one unit only of 95165.
Billing Multiple Doses Allowable
Some antigens cannot be mixed together in a single dose, which means the provider must prepare two or more separate doses. For example, if the patient requires immunotherapy for allergies to mold and pollen, separate vials need to be prepared and the patient will receive two injections.
The injections for the multiple doses are billed using 95117 (professional services for allergen immunotherapy not including provision of allergenic extracts; two or more injections). But billing 95165 for antigen preparation (in particular, determining the correct number of units) has been a major problem since May 1998, when HCFA modified its guidelines for allergen immunotherapy and, in doing so, defined a dose (95165) as "the total amount of antigen to be administered to a patient during one treatment session, whether mixed or in separate vials" [emphasis added].
The change had drastic payment implications for allergy providers: Regardless of the number of vials prepared or injections performed during a single session, only one dose could be billed. For example, the provider could bill only 10 units of 95165 even though 20 1-cc doses had been prepared in two separate vials.
The 1998 definition significantly reduced allergy treatment reimbursements for Medicare patients. This spurred the separate organizations representing otolaryngologists and general allergists to band together to convince HCFA to revert to its traditional definition, wherein the amount of allergen in each injection equals one dose.
The organizations argued that many patients on immunotherapy are allergic to several allergens and therefore require multiple vials and multiple shots. Furthermore, some allergens are not compatible with others (e.g., molds and pollens) and therefore need to be kept in separate vials.
In its November 2000 Final Rule, HCFA recognized that its 1998 definition was problematic and stated that as of Jan. 1, 2001, "physicians will be able to bill Medicare for each dose prepared in each multidose vial." Although this clarification should please allergy treatment providers, it is accompanied by three new guidelines that could complicate and diminish reimbursement for 95165:
1. HCFA clearly states that a maximum of 10 doses per vial should be billed, regardless of the size of the dose. For example, even if 20 0.5-cc doses are obtained from a 10-cc vial, only 10 doses should be billed.
2. HCFA categorically rejects additional billing for dilutions. According to the Final Rule, when a physician dilutes a multidose vial (for example, by taking a 1-cc aliquot from a multidose vial and mixing it with 9 cc of diluent in a new multidose vial), Medicare should not be billed an additional amount for these diluted doses. HCFA reasons, "The additional clinical staff and supply costs for preparing such a diluted vial are minimal, because allergens represent over 80 percent of the direct costs of preparing a multidose vial. In a diluted vial, there are no associated allergen costs, since they have already been billed in preparation of the initial vial."
Note: If fewer than 10 doses are prepared from a vial, the actual number should be billed. Otherwise, carriers may ask why the provider billed for 10 units of antigen but gave the patient fewer shots.
3. The clarification fixes a particular amount (1 cc) as a standard dose, stating that the practice expense inputs for 95165 "have been analyzed and adjusted so that they now correspond to the practice expense of preparing a 1-cc dose from a 10-cc (10-dose) vial," and concludes by stating that the Medicare Carriers Manual will be revised "to define a dose as a 1-cc aliquot from a single multidose vial."
This last requirement has been the most difficult component of the policy because allergy specialists frequently prepare 10 doses significantly smaller than 1 cc each. Many Medicare carriers have interpreted the clarification literally and will pay only for 1-cc doses as the billable unit, says Jami Lucas, executive director of the American Academy of Otolaryngic Allergy (AAOA). If the specialist prepares 10 0.5-cc doses, for example, Medicare will pay for five doses only.
Although the medical societies involved are working with HCFA to clarify this interpretation (and allow the provider to bill for 10 doses of 0.5 cc from a 5-cc vial, for example), the AAOA recommends allergy providers follow the guidelines laid out by their specific regional Medicare carrier.
The 1-cc definition of a dose has also complicated Medicare billing for providers who prepare doses off the board, says Teresa Thompson, CPC, an allergy coding and reimbursement specialist in Sequim, Wash. According to CPT, such services should be billed using codes 95120-95134, but -- because these codes are noncovered by Medicare -- most local carriers instruct providers to bill these services using 95165 and 95115 or 95117.
Because many off-the-board doses are less than 1 cc, uncertainty remains about whether 1 unit per dose of 95165 may be billed. In such situations, Thompson recommends billing for one unit only after 1 cc has been injected. For example, if the patient's dose is 0.5 cc, one unit of 95165 could be billed after two visits.
Slow and/or confused implementation of the HCFA guidelines outlined in the Final Rule further complicates this difficult issue. Although the clarification stated that HCFA planned "to issue new instructions to the carriers and update the carrier manual to ensure that appropriate payment is made as of Jan. 1, 2001," many carriers have yet to change their policies and still consider one dose to be whatever was injected into the patient during an immunotherapy session -- regardless of whether the patient received shots from one, two, or even three or more vials.
Many commercial carriers continue to pay for every dose administered to the patient if it is billed as a unit of 95165 (i.e., in accordance with pre-1998 Medicare guidelines). Because the majority of allergy patients are non-Medicare, however, physicians worry that private payers may adopt HCFA regulations, Thompson says. She adds that some carriers have already placed a limit on what they will pay per year for allergy treatment.
Private carriers often adopt beneficial HCFA policies, which gives additional urgency to efforts by allergy organizations to convince HCFA to modify those policies further and to return to the traditional definition of a dose. These efforts were aided by an April 2000 article in CPT Assistant that restated the definition of a dose as "the amount of antigen administered in a single injection from a multiple-dose vial." The volume of the dose is not mentioned and appears not to be a factor.
Given CPT's current policy, many private carriers are not expected to adopt the HCFA guidelines. The situation is far from settled: Although a further clarification from HCFA is anticipated, its contents are unknown at this time.
If you're billing incorrectly for 95165, you're not alone a recent survey found that 40 percent of physicians code this service incorrectly. These findings are prompting audits that are also targeting improper documentation and supervision, so make sure you fix your problems before the OIG and CMS start scrutinizing your billing practices.
Recently, the Office of the Inspector General (OIG) surveyed 600 ENT, general allergy and family practice offices that bill for allergy services to define how physicians interpret and bill 95165 (Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy; single or multiple antigens [specify number of doses]), according to the American Academy of Otolaryngic Allergy (AAOA) Coding Advisory. Because CPT and Medicare differ in how they define the dose specified in 95165, the survey discovered that 40 percent of physicians bill the code incorrectly. Therefore, you should pay close attention to the two billing methods for 95165.
Bill Based on Payer-Defined Dose
The AMA and CMS have two different definitions of a dose as defined in 95165. CPT defines a clinical dose as "the amount of antigen(s) administered in a single injection from a multiple-dose vial," says Susan Callaway, CPC, CCS-P, an independent coding auditor and trainer in North Augusta, S.C. "On the other hand, Medicare defines a billable dose, not a clinical dose, as 1 cc."
Although a physician may administer any amount of an antigen, based on clinical judgment, Medicare allows billing only the maintenance concentrate, says J. Spencer Atwater, MD, president of the Joint Council of Allergy, Asthma and Immunology. Because CMS calculates the antigen costs and administrative overhead based on preparing 1 cc, you may report only a concentrated dose or the highest concentration of the vaccine that the family physician (FP) plans on using as the therapeutically effective dose.
Let's compare these two definitions and how they impact billing. Consider how you would report 95165 for non-Medicare carriers in the following clinical example:
A physician prepares a 10-dose multidose vial for a patient and administers one injection to the patient containing one dose from the vial.
For the antigen preparation and provision, you should report 95165 x 10. Because CPT interprets a dose as the equivalent to the amount of serum drawn up in the injection, and the vial contains 10 doses, the antigen preparation and provision code should contain a 10 in the units box. In addition, assign 95115 (Professional services for allergen immunotherapy not including provision of allergenic extracts; single injection) for the one injection.
Using the same clinical example, if the 10-dose multi-dose vial is 5 ccs, you should bill Medicare for 95165 x 5 and 95115. Because Medicare interprets a billable dose as the amount of maintenance concentrate contained in the vile, you should report one unit per cc or five units of 95165. "You may not bill for dilutions of the maintenance concentrate," Atwater says.
For all other carriers, the clinical dose definition applies, the AAOA states. Therefore, if you incorrectly assume that all payers follow Medicare's definition of 95165, you will forfeit the reimbursement for the clinical dose. Suppose you bill the above example to a third-party payer that follows the drawn-up definition, but instead use Medicare's cc formula. The error will cost your practice $9.93 per unit (95165 contains 0.27 nonfacility relative value units based on the Medicare Physician Fee Schedule). That means you will lose a total of $49.65 for the five additional units, assuming that the commercial plan's conversion factor is the same as Medicare's ($36.79). Because most private insurers pay more than Medicare, the incorrect billing will probably cost more.
To make sure that you bill the correct amounts to each payer, write a procedure policy that explains your dose system, says Barbara Cobuzzi, MBA, CPC, CPC-H, an otolaryngology coding and reimbursement specialist and president of Cash Flow Solutions, a medical billing firm in Lakewood, N.J. "Flag Medicare charts and vials to make sure that you're using the right method."
Chart Must Show Immunotherapy Medical Necessity
Improper billing methods can open the door to the OIG's finding a host of other 95165-related problems that you can avoid by encouraging your FP to improve documentation. The "Medicare Antigen Preparation" survey also states that many charts lack proper medical-necessity documentation for 95165. "The OIG is concerned about the potential for overprescribing immunotherapy," Callaway says. Therefore, it wants documentation to prove that the patient had year-round allergies and not just an occasional runny nose.
"Your FP, however, does not need to document the reason for immunotherapy every time he bills 95165," Callaway says. The chart should instead note that the patient's allergy testing results indicated that immunotherapy was necessary.
Note the Supervising Physician
Most important, your practice needs to follow Medicare's direct-supervision requirements for 95165. In contrast, the OIG's survey found that many FPs were billing for antigen preparation services performed in the absence of the supervising physician. If an auxiliary staff member, such as a registered nurse or technician, prepares the antigens, the FP must provide direct personal supervision of the services for the employee to bill 95165 incident-to the physician based on Medicare incident-to rules, Cobuzzi says.
Direct supervision does not mean that the FP must be in the same room when an NPP or aide prepares the antigens. But the physician must be present in the office suite and immediately available to provide direction and assistance throughout the time the staff person is performing the service, according to the Medicare Carriers Manual sections 2050.1-2050.2.
To substantiate that your office meets the supervision requirements, Empire Medicare suggests that whenever you bill services incident-to a physician, you should note that "Dr. Smith is here supervising," Cobuzzi says. "That way, Medicare doesn't have to go through your appointment books to make sure the doctor is present during the hours the technician is mixing the antigens."