October 27, 2020

Resources for the OBL/OIS: How to financially survive during COVID-19

The past few months and the accelerating novel coronavirus pandemic have created unprecedented challenges for nearly all physicians and healthcare professionals both in the America and abroad. Here in the USA, many states have enacted quarantines, closed “non-essential” businesses, and severely limited or completely banned the performance of “elective” surgical cases. The net effect has been to create significant clinical, administrative, and financial burdens for physicians who own and/or practice in an office interventional suite (OIS). Most OIS owners/physicians have a significant investment in equipment, consumable endovascular stock, and staffing. They may or may not own their building/office space, or even have multiple real estate sites that are owned or leased. These expenses are typically offset by the revenues generated from performing procedures in the OIS – but in general, most OIS situations have high overhead costs that require a fairly robust continuing income stream. This paper will briefly explore strategies to cope with the COVID-19 induced fiscal strains and also list resources available.

“Inflows – Outflows = Net Cashflows”

This equation seems simplistic and trivial but is actually the crux of the issue. With the inability to perform procedures comes a dramatic drop in revenues (inflows): this is likely not optional given multiple state mandates that ban the performance of elective procedures. Many states will allow continued performance of life and/or limb salvaging procedures under some defined conditions – but not all. For most OIS physicians this is the overwhelming stressor and potentially disastrous factor for continuing practice viability. So what options are available to create inflows to keep the practice solvent? As it turns out, there are some limited options that can be employed to create inflows:
  1. See below Federal/HHS resources to support small business/practices
  2. CMS has created multiple blanket waivers including a temporary hold on many Stark provisions – they have temporarily waived requirements that contracts between hospitals and non-employed local physicians be at “Fair market value”. This opens the possibility to collaborate and contract with your local hospital(s) to provide outpatient vascular care and thus off-load those patients from a potentially overburdened inpatient service1
  3. CMS has also created waivers to make telemedicine encounters easier to perform and bill by removing many of the technical audiovisual requirements and allowing audio only phone calls to be billed as a telehealth encounter1
Outflows may also be difficult to manage – one cannot simply stop paying real estate and equipment leases, maintenance contracts, and the other sundry fixed expenses that an OIS has. One approach is to try to define which costs are fixed and which costs are “optional”. Costs defined as fixed (mortgage/rent, liability insurance, malpractice insurance, equipment lease payments, etc.) clearly will need paid. But some costs can be deferred, eliminated, or modified. This includes items such as advertising (radio, print, television), cable television and internet services, office convenience food and coffee services, and other consumables. Medical and endovascular consumable warrant special attention as these items are frequently one of the larger expenses for most OIS. Since case volumes are down or completely on hold, it may well be feasible to postpone or limit purchases or replacement of used stock – so long as enough stock is maintained to conduct those cases the OIS is still able to do within the confines of that particular state’s limits. Probably the single biggest outflows that are modifiable are those involving payroll costs. Many offices furloughed their entire or portions of the workforce and many physicians simply stopped taking a part or any compensation to conserve cashflow. Other offices maintained their employees working or on the payroll, and in some cases the physicians were the only employees that had their compensation limited. This becomes a very individual decision for each center but must be contemplated and actively decided upon.

Federal/HHS resources for the OIS during the COVID-19 Crisis

Finally, the most significant assistance to inflows may well be the host of federal stimulus programs that were enacted by Congress and the Health and Human Services Department in response to the COVID crisis. The CARES (Coronavirus Aid, Relief, and Economic Security) Act created multiple pots of stimulus monies and directed HHS to provide direct relief to a broad range of health care providers including but not limited to hospitals, clinics, and physicians. These stimulus monies in total exceed three trillion dollars! Many if not most OIS practices are eligible for multiple of these programs and each has its own requirements and limitations. The most important programs are listed and described below:
  1. Paycheck Protection Program (PPP)2. This program was intended to assist small businesses with less than 500 employees maintain their workforce and prevent further job losses/furloughs. The program provided for a loan of up to 2.5 times the average monthly payroll for that business and payroll costs could include both health insurance premiums as well as retirement plan costs. The loan would be forgivable (become essentially a grant) if the practice complies with the requirements of retaining their employees and expending at least 60% of the loan proceeds on actual payroll costs as defined above. President Trump signed a modification of these requirements on June 5, 2020 which loosens and further modifies these conditions. Applications are made through any SBA approved bank but the initial demand for this loan was significant and the initial nearly $350 billion was exhausted by April 16, 2020. Subsequent additional monies were made available on August 27,2020. For further up to date info please see the references below
  2. Economic Injury Disaster Loans (EIDL)3. This loan program existed and predated the COVID crisis and allows small businesses to access monies to offset revenue losses created or influenced by defined disasters. The program allows for a rapid advance of up to $10,000 and this specifically was deemed non-repayable for the COVID crisis. Applicants to not have to be approved for a loan to receive the advance but must apply for said loan formally. The amount advanced (if any) is deducted from total loan eligibility going forward. Any EIDL loans granted may be converted to a PPP program loan and thus forgiven and the any EIDL monies granted (including the advance $10,000) are deducted from the total PPP amount the applicant may receive. If the EIDL is taken and not converted to a PPP, the repayment terms are relatively flexible and more information is available at the SBA site3
  3. HHS “Tranche 1”4. The CARES Act also allocated and directed HHS to disburse approximately $100 billion as part of the Public Health and Social Services Emergency Fund. Thus far 2 separate tranches of funding have been made available. “Tranche 1” was $30 billion and was automatically distributed to hospitals and providers based on FY 2019 Medicare billing. Essentially, providers were allocated a percentage of the $30 billion based on their percentage of the total 2019 Medicare funds that they received- after the math was completed this amounted to roughly $63,000 per $1 million received from Medicare in 2019. Tranche 1 dollars were electronically transmitted to the bank accounts on file with Medicare as an ETF beginning on April 10, 2020
  4. HHS “Tranche 2”4. This is an additional $20 billion which, unlike Tranche 1, required physician practices to apply for consideration. Most, if not all, of the monies were directed to rural providers, clinics, and other designated recipients and many OIS physicians were not eligible. No OIS based physician contacted in the preparation of this white paper was successful in receiving Tranche 2 funds
  5. Medicare Accelerated and Advance Payments Program5. This program predated the COVID crisis but HHS made applying for the Accelerated and Advance Payments simple and concise to address the revenue shortfalls practices because of the pandemic. The program allows the physician to receive an advance based on the last quarter of 2019 – an advance payment up to and equal to 100% of that amount will be electronically transmitted to the bank account receiving current CMS payments. Repayment for Part B physicians begins 120 days from disbursement and repayment will be effectuated by recoupment from claims starting at the 120 day mark. Practices have 210 days to complete repayment/recoupment. Program eligibilty is found at the below references. It should be noted that effective April 26,2020 CMS suspended the Advance Payment Program to Part B suppliers (ie physicians) and will no longer accept applications for this program.
Outflows may also be difficult to manage – one cannot simply stop paying real estate and equipment leases, maintenance contracts, and the other sundry fixed expenses that an OIS has. One approach is to try to define which costs are fixed and which costs are “optional”. Costs defined as fixed (mortgage/rent, liability insurance, malpractice insurance, equipment lease payments, etc.) clearly will need paid. But some costs can be deferred, eliminated, or modified. This includes items such as advertising (radio, print, television), cable television and internet services, office convenience food and coffee services, and other consumables. Medical and endovascular consumable warrant special attention as these items are frequently one of the larger expenses for most OIS. Since case volumes are down or completely on hold, it may well be feasible to postpone or limit purchases or replacement of used stock – so long as enough stock is maintained to conduct those cases the OIS is still able to do within the confines of that particular state’s limits. In summary, the COVID pandemic has presented formidable and new challenges to the OIS physician. Navigating this crisis will require physicians to maximize their inflows, minimize what outflows can be limited, and utilize federal and HHS stimulus monies to weather this storm.
Content Source: https://oeisociety.com/obl-financial-survival-covid-19/ Aurthor: Bob Tahara MD FSVS FACS RVT RPVI

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October 25, 2020

How the New Vascular Access Guideline Update Affects Interventional Practices


Lead author Charmaine E. Lok, MD, MSc, FRCP(C) discusses trends in the field, the guideline-writing process, essential elements to a comprehensive care plan, and KDOQI in the COVID 19 era.  

First, congratulations on completing the updated KDOQI guidance, the first since 2006. Looking back, what have been some of the biggest trends or paradigm shifts in the field since then?

Thank you—the congratulations goes out to the entire multidisciplinary work group that worked so tirelessly with me to complete this important project. A wave of changes has occurred in over a decade since the last version of the Kidney Disease Outcomes Quality Initiative (KDOQI) vascular access guidelines were published in 2006. Those guidelines were highly influential in promoting a “fistula first” approach to access choice and encouraging the use of arteriovenous access (fistula and graft) surveillance. Indeed, the impact of those guidelines was seen in the first wave of changes, with a positive trend in increasing fistula creation and the uptake of surveillance. Concurrently or shortly thereafter, there was a wave of reporting of new, more rigorous studies to inform practice. These studies, along with the realization that successful fistula maturation and use were more variable than anticipated after its creation, brought a trend of increasing intervention (particularly endovascular) to improve outcomes, an initial increase in catheter use, and stimulus to innovate to improve all vascular access types.

How does the KDOQI process of evidence review and guideline writing work?

The process is very comprehensive. There are two separate groups—the KDOQI work group and an independent evidence review team (ERT). The work group comprises multidisciplinary experts in vascular access. The ERT is a seasoned team from the Minneapolis VA Center for Chronic Disease Outcomes Research. The work group develops a “scope of work” document that contains important topics and questions to be addressed in the guidelines. These are structured using a series of PICOTs–whereby the Population, Intervention, Comparator, Outcomes, and Time frames of each question or topic are given to the ERT to search. The ERT provides the work group with the evidence and quality of the evidence to use to write the guideline statements (previously known as guideline recommendations) using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Evidence to Decision frameworks.1 The work group determines the strength of the recommendations based on a matrix that includes not only the quality of the evidence but also the clinical importance, pros, cons, implications, and other factors. Work group members worked in teams, and individual members developed the statements. All statements were reviewed in a transparent and iterative process whereby the entire work group was involved in finalizing each statement. The frequencies of meetings ranged from weekly to monthly until the guidelines were completed.

The 2019 guideline emphasizes individualized plans for each patient. Can you tell us more about how the committee arrived at this as a central theme? What variable elements are essential to a comprehensive care plan?

The work group considered the end-stage kidney disease (ESKD) and dialysis “landscape” and realized that population metrics may not necessarily be the most fitting for an individual patient who would benefit from individualized care of their vascular access. For example, although fistulas are preferred and catheters should be avoided in the majority of people, this is not the case for all and not the intent of previous guidelines. Thus, the work group developed an overarching goal that would focus on the patient yet achieve outcomes desirable on a population basis. The overarching goal of these guidelines is to help patients achieve reliable, functioning, complication-free dialysis access to provide prescribed dialysis while preserving future dialysis access site options as required by the individual patient’s ESKD life plan.2 This goal first requires knowledge and understanding of the patient’s medical conditions, their personal goals and preferences for kidney replacement therapy (hemodialysis, peritoneal dialysis, transplant, or optimal nondialytic care), and the corresponding dialysis access based on these factors. This requires a coordinated multidisciplinary approach to plan for the most imminent and subsequent accesses for the patient’s life plan. For each access, there must be a creation plan, contingency plan, and succession plan, with an underlying vessel preservation plan.2

How did the writing committee mitigate the paradox of formalizing generalizable guidance based on the need for developing individualized care?

We took an approach of “individualization of best care with standardized processes.” Perhaps the best way to describe this is with an everyday analogy. Most people need a motor vehicle to travel from point A to point B. That vehicle can be likened to the patient’s vascular access through their journey with ESKD. Although one person’s goals and preferences can be met by one type of car, it may not be suitable for another. For example, an adventurous youth may prefer and need a sports car (such as a radiocephalic fistula) to meet his or her needs, while a parent of three children may need a van (such as a graft). Grandpa may just need a rental car temporarily (such as a catheter). Regardless, standardized processes to prepare for and maintain that vehicle to keep the individual safe in their journey is required. Individuals need to be eligible for a car (vascular access) and prepare for and get their driver’s license (have the appropriate preoperative assessments). A good car (vascular access) should be bought from a reputable dealer (a skilled, knowledgeable, and committed surgeon/interventionalist in a qualified facility). Once purchased (created), processes are in place to keep the car working well and the patient safe (use of seat belts, oil changes, etc), with a regular maintenance schedule for longevity (regular access monitoring, careful cannulation is required, etc). If a car problem is detected (eg, flat tire or access stenosis), a plan to rectify it should be in place (access contingency plan such as angioplasty of stenosis). Care is taken to plan ahead (access succession plan). The next car (vascular access) is already in mind and plans are in place to obtain it, before the current one fails. For example, the pace of that youth’s life and work circumstance changes and as the sports car gains more mileage and wears down, a different car may be more appropriate. Rather than waiting until the sports car is nondrivable (access loss), the youth has put funds aside and shopped for that new car already, rather than needing a rental car (catheter). The work group recognizes that the best access for each individual patient and their access needs is best determined by the patient and their health care team (rather than a one-size-fits-all statement from the guidelines). However, the guidelines provide the standardized processes to help guide the individual patient and the team in the most optimal creation, maintenance, and salvage of the accesses that they choose.

Which changes or recommendations are most likely to affect interventional practices?

Guideline 1 discusses the ESKD life plan, which is a new concept worth reviewing and understanding for all clinicians involved with dialysis access. Table 1 outlines some select statements that may specifically impact interventional practices.

The last several years have seen considerable development in interventional options for creating and treating accesses. How does the guidance approach the use of newer technologies?

The guidelines are highly supportive of the use of newer technologies. Given the rigorous and high standards set by the ERT, the work group recognized that many newer technologies lack sufficient evidence for recommendation. However, the guidelines were very careful not to recommend against new technologies in this situation but encourage further study to inform the next set of guidelines. Thus, many statements have wording to the effect of “…based on the operator’s discretion and best clinical judgment, as there is insufficient evidence….” The work group was very mindful that the guidelines should encourage and not limit new technologies, their development, and rigorous study.

How do you recommend teams dedicated to dialysis access management approach absorbing and implementing the new guidance?

A good initial approach is to read the introduction section of the guidelines (pages S17-S24). The introduction is then followed by a summary of guidelines statements that start on page S25; this allows the reader to become familiar with the range of topics covered. A guideline statement or topic of interest can then be selected for further review. Each guideline section or topic can be read independently, as each is accompanied by a rationale/background, detailed justification, special discussions, implementation considerations, monitoring and evaluation, and future research subsections. Therefore, the reader will have a more thorough understanding of the statements and their implications. Such an approach will enable the reader to use the guidelines in a digestible but comprehensive way.

The updated KDOQI guidelines were in progress for years before the world knew of the COVID-19 pandemic. With chronic kidney disease and ESKD patients representing a particularly susceptible population that requires regular, frequent health care contact, how would you briefly summarize a KDOQI P-L-A-N–like approach to their care during this time?

Each patient should have their P-L-A-N (Patient Life plan and Access Needs) established, since a patient with ESKD may far outlive the pandemic. Nevertheless, the P-L-A-N should consider the impact of the COVID-19 pandemic and what local services are practically available to the patient. Of note, on March 26, 2020, the Centers for Medicare & Medicaid Services stated, “We have received feedback that providers are experiencing difficulties scheduling for placement or repair of arteriovenous fistulas, arteriovenous grafts, peritoneal dialysis catheters, and intravenous catheters. We wish to clarify that these planned procedures are essential in that establishing vascular access is crucial for [ESKD] patients to receive their life-sustaining dialysis treatments.” Fortunately, the P-L-A-N is intended to be (and should be) regularly reviewed; consequently, it can be updated based on progress in overcoming the COVID-19 pandemic. The P-L-A-N was specifically designed to accommodate changes in the patient’s clinical and life circumstances, including the impact of the COVID-19 pandemic.   Content Sourcce: https://evtoday.com/articles/2020-june/kdoqi-qa-how-the-new-vascular-access-guideline-update-affects-interventional-practices?c4src=home

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October 23, 2020

Impact of COVID-19 on Peripheral Arterial Disease Treatment

As of May 3, 2020, more than four million people worldwide have been diagnosed with coronavirus disease 2019 (COVID-19). The number of vascular surgeries has been significantly reduced according to the guidance provided by the American College of Surgeons, including surgeries related to peripheral arterial disease (PAD).

Since January 23, 2020, Beijing initiated the first-level response mechanism for public health emergencies; our center stopped elective surgeries and most semielective surgeries. To study the impact of COVID-19 on PAD, we collected the clinical data and perioperative results of patients with PAD undergoing surgery in our center from January 24, 2020 to March 31, 2020 (group A) and compared with the same period last year (group B).

Table I

Baseline patient characteristics and perioperative results

Variablesa Group A Group B P
The number of patients with PAD undergoing surgery 15 50 -
Age, years 70.93 ± 10.18 69.22 ± 9.67 0.554
Male 12 (80) 38 (76) 1.000
Rutherford 4–6 13 (86.7) 29 (58) 0.042
Perioperative complicationsb 4 (26.7) 2 (4) 0.022
Perioperative death 1 (6.7) 1 (2) 0.551
aCategorical variables are presented as number (%) and continuous variables as mean ± standard deviation. Categorical variables across groups were compared using Pearson's χ2 test or Fisher's exact test. Across-group comparison of means was completed using an analysis of variance. Results with P values < 0.05 were considered statistically significant.
bComplications during this pandemic included 2 cases of acute coronary syndrome (ACS), 1 case of acute respiratory distress syndrome (ARDS), and 1 case of severe pulmonary infection. The 2 complications in last year included 1 ACS and 1 complication of puncture site.

During this pandemic, the surgical indications of patients with PAD became more stringent, and the patients' willingness to seek medical treatment also changed. The number of patients with PAD undergoing surgery in our center was significantly reduced, but their degree of limb ischemia was significantly more serious than last year, leading to an increased rate of perioperative complication. Although there is no different in perioperative mortality between these two groups, further follow-up is still needed for long-term results.

Unfortunately, there was one patient who died before surgery this year; this patient admitted to our center during this pandemic complicated with toxic shock; bedside hemofiltration and debridement were performed, but the patient still died of respiratory failure. With the conditions of patients with PAD getting more serious when they come to the hospital, it is necessary to choose appropriate treatment to control perioperative complications and mortality. Before this, it is more important for patients to maintain the medical treatment for PAD. Also, continuity of follow-up is key; it is necessary to evaluate the patient's condition through telephone and phone application (obtain pictures of the patient's ischemia limb) and urge them to go to hospital in time when the condition worsens. Finally, on the basis of controlling the COVID-19 pandemic, daily medical activities should be resumed as soon as possible to provide reasonable treatment for more patients with PAD.

  Content Source:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7265821/ Author Information:
Department of Vascular Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, China
Hai Feng: moc.361@svyyhf

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