In medicine, progress is often viewed in the context of something new: a new technique, a new device, a new drug, or a new understanding of disease processes. Our enthusiasm for novelty is balanced against the need for proof, which is the foundation of evidence-based medicine. In the face of morbidity and mortality, patients grasp for medical therapies in their hope for relief or a cure — some with little or no supportive scientific evidence. Sometimes, purported evidence is nothing but chicanery to enrich the seller by duping the gullible and the desperate. If the damage done by this deceit masquerading as progress was limited to just a few patients, we might see it as the cost of experimentation — trial and error. However, if the damage strikes at the heart of our healthcare system through inflated healthcare expenditures with negligible benefits, then society pays a heavy price, and confidence in medicine erodes. It’s as if we still lived in the nineteenth century with medical practice involving potions, concoctions, and caveat emptor. This unfortunate outcome is prevented in large part by Medicare, Medicaid, and other third-party payers who decide — on behalf of beneficiaries and with input from medical experts — what is worthwhile and how much it is worth. A lay patient with a horrid disease isn’t a good judge of the merit of a proposed treatment, and this is particularly true if the patient has no financial responsibility for his choice. Additionally, the seller of the new treatment is not an unbiased judge of its value. The process of vetting something new in medicine by payers and other interested parties is a long one, and is entirely independent of demonstrating safety and efficacy to the US Food and Drug Administration (FDA).

Coding Is The First Step

Arguably, the crown jewel of the American Medical Association is its copyright of the Current Procedural Terminology (CPT) manual, which is a prime reference source for governments and payers to administer health care. The main body of the manual tabulates well-accepted medical procedures as permanent Category I codes. One of the manual’s appendices tabulates new, emerging technology, services, and procedures as temporary Category III codes — those ending with the letter “T.”¹ These are CPT codes on probation for 5 years, and sometimes longer. To a great degree, a Category III code provides a mechanism for identifying a procedure on a claim for reimbursement that would otherwise fall into a miscellaneous CPT code for lack of specificity within Category I. This is useful for tracking purposes by payers, although a Category III code is no guarantee of coverage or payment. For example, under the Centers for Medicare & Medicaid Services (CMS) Clinical Trial Policy, implemented in 2000 as a result of an executive memorandum by then President Clinton, Medicare pays for routine patient costs in certain clinical trials that are pre-qualified prior to payment.² A Category III code is useful to report the procedure to Medicare that is under investigation within the clinical trial. At present, there are a number of Category III codes for minimally invasive glaucoma surgery (MIGS) (Table 1).

Once a Category III code is assigned, billers and coders have a unique, specific procedure code to report on a claim for the new procedure. The CPT manual doesn’t provide an option to choose a not so accurate, but reasonably close, Category I CPT code rather than the accurate Category III code. Looking for a better-paying CPT code is known as “code shopping” and represents a questionable billing practice and potential healthcare fraud. A possible motivation for code shopping is noncoverage of almost all Category III codes as the default position of Medicare, Medicaid, and third party payers. Substituting a Category I code, with established coverage and payment, would garner quick reimbursement, yet it is prohibited. Surgeons and staff are obliged to use the most recent CPT instructions and to understand the descriptors for the applicable Category III codes.³

Confusion can occur when terminology in the CPT code description is obscure or esoteric. Additionally, surgical techniques might not be appreciated by billing staff trying to abstract an operative report. For assistance with parsing these MIGS Category III codes, review Table 2, which was prepared by the certified procedural coders at Corcoran Consulting Group. Additional information is available in CPT Assistant and from ophthalmic professional societies, such as the American Academy of Ophthalmology, the American Society of Cataract and Refractive Surgery, and the American Glaucoma Society.

Coverage Takes Time

Before paying for a new MIGS procedure assigned to a Category III code, Medicare Administrative Contractors (MACs) and other third party payers are generally skeptical and need persuading.

• Where is the scientific literature?
• Who are the physician champions of the procedure? Are there many or just a few?
• How does the new procedure compare to existing legacy procedures?
• Does the new procedure save money?
• Are there more or less surgical complications created by the new procedure?

Information about the new procedure trickles in slowly. Each MAC or payer makes its own coverage and payment decision. Although there is a tendency to “follow the leader,” there is no obligation to create a homogeneous policy across different jurisdictions. Unless the central office of CMS creates a national coverage determination, which is rarely done, the process is de-centralized and slow. Local coverage determination (LCD) policies are the norm, because CMS devolves decision-making to the MACs.

When this system was set up, the Medicare carriers had the staffing and direct experience with paying claims that did not exist in Baltimore — the home of the Health Care Financing Administration (HCFA) now known as the Centers for Medicare & Medicaid Services.

The speed with which MACs and other payers adopt a favorable coverage and payment policy is a direct result of the amount of supportive scientific information they receive from interested parties and the popularity of the procedure in the medical community. For example, the number of iStent procedures has grown rapidly within Part B Medicare, along with generally favorable LCDs (Table 3), largely through continuing discussions with MACs and other payers. This is not always the case for a new, emerging technology.

Limitations of Coverage

Before an LCD is issued, but after the Category III code becomes effective, there are claims for reimbursement by surgeons and facilities. The claims almost certainly face an uphill battle and scrutiny before payment is made, and subsequent claims face the same gauntlet even if the first claim was paid. Billers experience many hiccups during this process, and only the most determined surgeons with a strong belief in the new technology will persist. It is very tempting to let other surgeons go first and take a wait-and-see approach.

Once an LCD is issued, limitations of coverage remain.

• The list of covered ICD-10 diagnosis codes is short and restrictive
• Only certain stages of glaucoma are covered
• Off-label use of the new technology is not covered
• The place of service may be effectively constrained by the physician’s site-of-service differential or the reimbursement rate for the facility
• Additional chart documentation with the claim may be required to demonstrate medical necessity

Periodic revisions of LCDs can be expected. If all goes well, the provisions of the LCD become less restrictive over time, as experience accumulates and the new technology gains respect. After 5 years, with a strong track record of paid claims, AMA will consider promoting a temporary Category III code to permanent Category I status. This occurred in 2014 when 0192T was promoted to 66183, and in 2011 when 0176T was promoted to 66174 and 0177T to 66175. Alternately, a Category III code may sunset and be removed from the CPT manual if adoption of the technology is nonexistent or tepid.

Payment Limitations

The Medicare Physician Fee Schedule does not contain Relative Value Units for Category III codes — only Category I codes are assigned payment rates. The MACs adjudicate claims and set rates for surgeon claims for reimbursement, frequently with unexpected results. When the process works well, the Carrier Medical Directors seek input from Ophthalmology Carrier Advisory Committee members to identify a comparable surgical procedure that is very nearly equivalent to the new MIGS procedure. For example, National Government Services (NGS), the Medicare Administrative Contractor for Minnesota, Wisconsin, and Illinois, determined that the iStent procedure (0191T) is similar in work, surgical skill, instrumentation, and duration to trabeculotomy ab externo (65850). Furthermore, because the CMS software for claims processing contains no instructions for how to handle modifiers with Category III codes, this can lead to surprises. Because iStent is only inserted at the time of cataract surgery, there are two concurrent procedures. Some claims follow a traditional approach of reducing payment on the lesser procedure by 50%, while other claims are paid at 100% for both procedures. This leads to significantly different payment rates for surgeons around the country. For those ophthalmologists who comanage cataract surgery and use modifiers 54/55, there is no practical way to handle a concurrent claim for 0191T, or any other Category III code, for shared post-op care. The surgeon is obliged to perform the postop care, which just might be best for patients for a new MIGS procedure.

CMS does, in many cases, establish facility payment rates for Category III codes. The facility payment rates, for hospital outpatient departments and ambulatory surgery centers, fall with the Outpatient Prospective Payment System (OPPS) (Table 4).

Beneficiaries Financial Responsibility

As we’ve seen, reimbursement for new technology is bumpy and difficult to foresee. In cases where pre-authorization is denied or health insurance coverage is uncertain, the beneficiary may be financially responsible. Relatively few patients (~10%) can accept this uncertainty and have sufficient financial resources to pay out-of-pocket. Surgeons and facilities may face bad debt when the beneficiary refuses to pay after the fact. Additionally, the regulations of Part B and Part C Medicare generally favor the beneficiary, and do not hold them financially responsible unless the provider strictly follows the rules for financial waivers or the Advance Beneficiary Notice of Noncoverage (ABN).

In this regard, the presurgical informed consent process is conflated with economic counseling and financial arrangements. When the reimbursement uncertainty is too great, a surgeon must offer the patient an alternative glaucoma procedure or take a different tact for treatment.

A Slow Process

It is exciting to learn and perform a new surgical procedure. Optimism about something new is pervasive. Yet, payers are usually not enthralled, at least not initially. They need to be convinced. That takes time and persistence. Until the merits of the new procedure become manifest, reimbursement is hard to come by, and without reimbursement, it is very difficult for a surgeon or a facility to move forward.

So, it is a chicken and egg kind of problem. As we strive to practice evidence-based medicine, progress can be slow. Only the MIGS procedures with superior results and widespread surgeon acclaim can expect to garner reimbursement quickly. GP

References

1. McInnes JS. Category III CPT codes: Coming of age in the new health care environment. Orthopedics Today. August 2009. Accessed online May 15, 2017. http://www.healio.com/orthopedics/business-of-orthopedics/news/print/orthopedics-today/%7B6d3ef68e-4657-414f-a9d5-f3bb66d57d8a%7D/category-iii-cpt-codes-coming-of-age-in-the-new-health-care-environment
2. Centers for Medicare & Medicaid Services. National Coverage Analysis (NCA) Tracking Sheet for Clinical Trial Policy (CAG-00071R). Accessed online May 15, 2017 https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=186&NcaName=Clinical+Trial+Policy&ExpandComments=n&CommentPeriod=0&ver=26&fromdb=true&bc=BEAAAAAACAAAAA%3D%3D&
3. Corcoran, KJ Coding For Minimally Invasive Glaucoma Surgery. Glaucoma Physician. 2017;21(3): 34-39.

Kevin J. Corcoran, COE, CPC, CPMA, FNAO, is president and co-owner of Corcoran Consulting Group.