Quarterly Cardiovascular News Update and Implications

Occasionally, CFA will highlight a few significant news articles on cardiovascular topics -- clinical or organizational.  Reprinted below are four interesting news items we feel worthy to highlight. 

 For full information, the links to the original news sources are included.  We have included our interpretation of the organizational implications of each item.

• ISCHEMIA and ISCHEMIA-CKD Trial Results Presented at AHA

The results of the ISCHEMIA and ISCHEMIA-CKD studies were presented at the American Heart Association Scientific sessions on Saturday, November 16, 2019.  The multicenter, international randomized trial was designed to determine the differences between a conservative medical therapy approach to treating stable ischemia heart disease (SIHD) and an interventional/surgical approach to SIHD patients.

ISCHEMIA Study Design from the ischemiatrial.org website:

Approximately 400 research centers worldwide will participate in ISCHEMIA enrolling 5,000-6,000 patients.

Eligible participants were recruited following clinically indicated stress imaging testing, but before catheterization, and randomized in a 1:1 fashion to one of two groups:

• Invasive (INV) Management: Study participants in this group will undergo a cardiac catheterization within 30 days of randomization; if significant coronary artery disease is present, coronary revascularization will be performed. In addition, study participants in this group will receive optimal medical therapy (OMT).
• Conservative (CON) Management: Study participants in this group will receive optimal medical therapy (OMT) alone with catheterization and possibly revascularization if the participant is not responding to therapy.

Quoting from the ISCHEMIA Study results summary:

“The trial showed that heart procedures added to taking medicines and making lifestyle changes did not reduce the overall rate of heart attack or death compared with medicines and lifestyle changes alone. However, for people with chest pain symptoms, heart procedures improved symptoms better than medicines and lifestyle changes alone. The more chest pain to begin with, the more symptoms improved after getting a stent or bypass surgery.

These results apply to people with stable symptoms. They do not apply to people having a heart attack, when emergency stent procedures save lives.”

You will find a summary of the ISCHEMIA Study on the American College of Cardiology website.

The ISCHEMIA-CKD Trial results were summarized on the ischemiatrial.org website:

“The trial showed that heart procedures added to taking medicines and making lifestyle changes did not result in a reduced rate of heart attack or death compared with medicines and lifestyle changes alone. The trial also showed that heart procedures did not reduce symptoms appreciably or improve the quality of life compared with medicines and lifestyle changes alone. These results do not apply to people having a heart attack or those with severe chest pain symptoms.”

Implications – The results of the ISCHEMIA Trial will assuredly be questioned, dissected and in some quarters possibly argued as flawed in study design.  The study endpoint time period of 3.3 years will potentially be stated by some as not long enough to more fully illuminate the differences in the two distinct forms of treatment.  But with more than 5,000 patients in a two-track, international randomized trial, the ISCHEMIA Study brings forward new information that will generate discussion, reflection and review of protocols that may prospectively identify patient sub-sets that will clearly benefit from one approach or the other.

• CMS to Reimburse Select Outpatient PCI Procedures in ASC’s in 2020

According to newly finalized rule, CMS will pay for certain angioplasty and stenting procedures performed outside the hospital outpatient setting starting in calendar year 2020.

CMS initially estimated that moving 5% of coronary interventions from the hospital outpatient setting to ASCs would reduce Medicare payments by about $15 million and total beneficiary copays by about $3 million in calendar year 2020.  The agency updated those figures to estimated savings of $20 million and $5 million, respectively, in its final rule.  Reimbursement in ASCs will be available for six specific current procedural terminology (CPT) codes covering percutaneous transluminal coronary angioplasty with or without placement of stents in a single major coronary artery or branch, as well as in each additional branch of a major coronary artery.  The inclusion of these interventions on the CPL comes despite the fact they may involve major blood vessels, which has been considered an exclusion for CMS coverage at ASCs.

“Although the proposed coronary intervention procedures may involve blood vessels that could be considered major, . . . we believe the involvement of major blood vessels is best considered in the context of the clinical characteristics of individual procedures, and we do not believe that it is logically or clinically consistent to exclude certain cardiac procedures from the list of ASC covered surgical procedures on the basis of the involvement of major blood vessels, yet continue to provide ASC payment for similar procedures involving major blood vessels that have a history of safe performance in ASCs,” CMS said.  In support of their decision, CMS cites CPT codes for “mechanochemical destruction of insufficient vein of arm or leg, accessed through the skin using imaging guidance” and “insertion of stents into groin artery, endovascular, accessed through the skin or open procedure.”

Implications – There has been a longstanding interest on the part of some interventional cardiologists in adding invasive and interventional cath lab capabilities to ASC’s in which they have (or could acquire) an ownership interest.  Federal reimbursement policies, as well as state law (for example, it is prohibited in California, among other states) has prevented the proliferation of such services.  This may now change.  Hospitals in markets with competing ASCs should monitor this situation and prepare for potential proliferation of this important service capability.

• Association Between Aging and Heart Disease Mortality from 2011 to 2017

Was the rapid increase in the number of adults aged 65 years and older from 2011 to 2017 associated with mortality related to heart disease?  A new study published in JAMA online finds the answer to be “yes.”  A deceleration in the rate of decrease of heart disease (HD) mortality between 2011 and 2014 has been reported.  In the context of the rapid increase in the population of adults aged 65 years and older, extending the examination of HD mortality through 2017 has potentially important implications for public health and medical care.  The total size of this population of US adults aged 65 years and older increased 22.9% from 41.4 million to 50.9 million between January 1, 2011, and December 31, 2017, while the population of adults younger than 65 years increased by only 1.7%.  During this period, the age-adjusted mortality rate decreased 5.0% for HD and 14.9% for CHD while increasing 20.7% for heart failure and 8.4% for other HDs.  The number of deaths increased 8.5% for HD, 38.0% for heart failure, and 23.4% for other HDs while decreasing 2.5% for CHD.  A total of 80% of HD deaths occurred in the group of adults aged 65 years and older.  The substantial increase in the growth rate of the group of adults aged 65 years and older who have the highest risk of HD was associated with an increase in the number of HD deaths in this group despite a slowly declining HD mortality rate in the general population.

Implications – The substantial increase in the growth rate of the group of adults aged 65 years and older who have the highest risk of HD was associated with an increase in the number of HD deaths in this group despite a slowly declining HD mortality rate in the general population. With the number of adults aged 65 years and older projected to increase an additional 44% from 2017 to 2030, innovative and effective approaches to prevent and treat HD, particularly the substantially increasing rates of heart failure, are needed.

For your review, you can find this important study in full here.

CMS Confirms Substantial Cuts to Cardiac CT Reimbursement in 2020

The Centers for Medicare & Medicaid Services (CMS) has rendered its final rule regarding 2020 reimbursement rates associated with cardiac computed tomography performed in hospitals, and imagers are not happy.  In July, the agency announced proposed cuts of nearly 30% compared with 2018 rates for the three main billing codes as part of the Hospital Outpatient Prospective Payment System (OPPS). In an addendum to its final rule, CMS cut the reimbursement for all three of the following codes to $182.20, a drop of $19.54 compared with 2019 rates:

• 75572: Heart CT with contrast for evaluation of cardiac structure and morphology
• 75573: Heart CT with contrast for evaluation of cardiac structure and morphology in the setting of congenital heart disease
• 75574: CT angiography of the heart, coronary arteries, and bypass grafts with contrast

The full document has been posted to the federal register, with a formal publication date of November 12, 2019.  The Society of Cardiac CT along with the American College of Cardiology (ACC) and the American College of Radiology (ACR) mounted a concerted effort over the past several months to convince CMS to rethink its suggested cuts, sending letters and encouraging members to submit comments on the proposal as well as establish how much their institutions bill for cardiac CT, but to no avail.

Implications -- SCCT President Ron Blankstein, MD (Brigham and Women’s Hospital, Boston, MA), states that “This is a very big deal for the field of cardiac CT,” he told TCTMD, adding, “The current methodology that CMS is using is vastly underestimating the cost of cardiac CT and therefore the payment rate.” Any negative change in reimbursement for important tests such as cardiac CT could ultimately have a negative impact on overall usage and thus the early diagnosis of CHD.

If you are interested in learning more about any of these important issues or in cardiac services strategic development, service expansion and/or other programmatic needs for cardiovascular or other services, please contact CFA at (949) 443-4005 or by e-mail at cfa@charlesfrancassociates.com.