The Trump administration has proposed a policy to gradually reopen the U.S. for business, part of which is to allow a resumption of elective procedures and treatments in outpatient settings. While patients with urgent medical needs presumably are being treated already, the policy would seem to promise a boost in volumes for certain devices, such as coronary artery stents, knee implants and transcatheter aortic valve replacement (TAVR) devices, all of which enjoy at least limited Medicare coverage for outpatient use.

The administration unveiled its plan to nudge the economy along gradually to a reopening, which in each region requires a downward trend in symptoms of influenza-like illness and for COVID-like syndromic cases for 14 consecutive days. There is a similar requirement for diagnoses and the utilization rate for hospital capacity, and the provision for elective surgeries in phase I carries the stipulation that any related outpatient procedures be done only at facilities that adhere to Centers for Medicare & Medicaid Services (CMS) guidelines. These guidelines expand to elective procedures conducted in inpatient settings in the second phase of the program.

The extent to which those in need of even urgent care in recent weeks is not easily documented, but physicians are of the belief that patients are staying away from hospitals and other health care settings to avoid the SARS-CoV-2 virus. Several medical societies have drafted guidelines for when a patient’s need is greater than the risk of contracting COVID-19; however, an individual’s fear might be too great to overcome even something as urgent and dangerous as ST-elevated myocardial infarction.

IPO list deletions may affect inpatient/outpatient ratios

CMS has altered its coverage policies for several device/procedure types in recent years, including for a few orthopedic implant procedures. One example is the removal of total hip arthroplasty (THA) from the Medicare inpatient-only (IPO) list in the Medicare physician fee schedule for the current calendar year. The “doc fee” final also withdrew several spinal procedures from the IPO, while the removal of total knee arthroplasty (TKA) was established in the Medicare outpatient prospective payment system for 2018, a move the agency had proposed in the draft in July 2017.

Several cardiovascular device procedures are done on an outpatient basis in the U.S., including angioplasty and stenting of the coronary arteries. A May 2017 report on costs and utilization from the Agency for Healthcare Research and Quality (AHRQ) lists eye lens and cataract procedures as the most frequently performed in an ambulatory setting, at 99.9%. Meanwhile, excision of semilunar knee cartilage takes place at such sites nearly 99% of the time. One caveat regarding this report is that it is based on 2014 data. As a result, some of the data points likely have shifted considerably, particularly given changes in Medicare coverage policy.

The data suggests that all procedures involving the eye took place in an outpatient setting 99.5% of the time. Meanwhile, the outpatient rate for all cardiovascular procedures was 26.2%, and this presumably includes coronary artery bypass graft (CABG). With that said, volumes for CABG have trended down steadily over the past two decades as angioplasty and stenting have gained ground. The AHRQ report suggests that the outpatient/inpatient ratio for all orthopedic procedures was nearly arithmetically even, given that outpatient procedures accounted for 49.5% of all such procedures.

THA, TKA ratios both lower than 10% in 2014

Analysts with Wells Fargo Securities LLC, of San Francisco, noted that elective procedures in outpatient settings have consistently grown relative to inpatient ones. According to the organization’s breakdown of the AHRQ numbers, roughly 98% of arthroscopies took place in outpatient settings. At the same time, 80% therapeutic procedures directed to the joints registered as outpatient procedures. Arthroplasties excluding the hip and knee registered as outpatient procedures more than half the time, albeit at a lower rate than seen in some procedures at 53%. While CMS has become more permissive of outpatient TKA and THA since 2014, only 4% of total and partial hip replacements were conducted in outpatient settings, a rate that rises to 9% for TKA.

Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), said, “the top priority for medical technology innovators is to support patients and health care professionals as they confront the COVID-19 pandemic.” To that end, it is crucial “that we ensure a smooth and appropriate transition for patients to have access.” Leahey said MDMA members “commend the administration for providing federal guidance” regarding elective procedures. In addition, the return to elective procedure conduct will rely on physicians and the circumstances in each region. He concluded that MDMA will continue to engage with other stakeholders to ensure appropriate access to needed treatments.

For his part, Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said his organization appreciated the president’s unveiling "of a plan that would safely allow elective surgeries to resume.” He added that the term elective is inclusive of surgeries that are “important to the patient’s health and must often be performed.” Whitaker went on to thank the administration for working with stakeholders, including health care professionals, “who helped make the case that we need to work responsibly to get these patients the care they need.”

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