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Dear Readers,
Innovations in medical devices therapy have dramatically improved the
care of patients with cardiovascular disease. As cardiologists, we can
now offer patients many therapies that improve their quality of life and
help them live longer. Modern device therapies are available for our
patients as a direct result of the ingenuity, contributions,
investments, and sacrifices of many groups of people including subjects
who have volunteered to participate in clinical trials, health care
workers who have enrolled patients, trial sponsors, and federal
agencies. In the past, when trials demonstrated safety and efficacy,
approval by the Federal Drug Administration (FDA) was predictable as was
coverage by the Centers for Medicare and Medicaid (CMS). Most commercial
payors followed suit with coverage soon thereafter.
Cardiac electrophysiologists rely heavily on medical devices such as
ablation technologies and Cardiac Implantable Electrical Devices (CIEDs)
to improve the lives of patients with heart rhythm disorders.
Unfortunately, there is an increasing lag between FDA approval of
medical devices and CMS Coverage. Too often, novel device-based
treatments for cardiovascular diseases, which have been approved by FDA
after demonstrating safety and effectiveness, have not been made
available to our seniors due to the lack of Medicare coverage. It is
rare that a patient can afford the hospital costs associated with our
interventions without coverage by CMS or their insurance. Unfortunately,
we have seen directly the impact that delays in CMS coverage for heart
rhythm therapies have had on our ability to provide the best possible
care for patients. One example is the delay between FDA approval of the
subcutaneous implantable defibrillator (S-ICD) and coverage by CMS. This
was followed by further delays in coverage by private payors. After FDA
approval of the S-ICD in 2012, some insurance companies still deny
coverage for the S-ICD, except in very specific
circumstances1. Other examples of medical devices that
were not covered by CMS for some time after FDA approval include the
Watchman™ left atrial appendage occlusion device and the Micra™ leadless
pacemaker.
The most common argument made by CMS when it does not provide coverage
for a medical device in spite of FDA approval is that CMS believes it
must determine that the new therapy is reasonable and necessary for
patients over the age of 65 years. This argument is unreasonable in most
cases, because Medicare recipients commonly account for a majority of
patients enrolled in cardiac device trials. For instance, the average
age of subjects enrolled in the recent Micra leadless pacemaker pivotal
trial was 76 years.2 Other reasons countering the CMS
stance are that cardiac disease is common in the elderly, CMS coverage
of research devices tested in clinical trials is usually established
prior to trial initiation, and physicians at many hospitals are able to
enroll only patients in clinical trials who are over 65 year old because
commercial carriers usually do not cover the costs associated with
participation in clinical trials.
To address this lag between the FDA approval and CMS coverage, several
new programs were developed by the United States government over
multiple administrations and congresses as a true bipartisan effort. The
first program was part of the CURES Act in 2016, which was designed to
accelerate access to breakthrough devices that address severely morbid
or deadly diseases, with no alternative treatment options. The CMS
Administration, after reviewing 362 public comments received during the
public comment period, finalized the Medicare Coverage of Innovative
Technology (MCIT) rule with an effective date of March 15,
20213. This was to ensure four years of Medicare
coverage for seniors for these breakthrough devices.
In early March 2021, however, after some concerns were voiced about this
program4-5, CMS delayed the implementation of the MCIT
rule for 60 days and opened a new public comment period that ends on
April 16, 2021, questioning the validity of the program and the rule
making process. One concern expressed by CMS is the volume of devices
designated as breakthrough, which is over 400. While we fully support an
approval process that ensures that a reasonable degree of efficacy for
breakthrough technologies has been demonstrated before approval, it is
important to note that fewer than 10% of these devices have been
approved at this time, only one quarter of the devices are for the
treatment of cardiovascular disease, many are for highly select
populations, and many of these may never be approved. Instead, we should
be celebrating the increasing volume of new innovative technologies to
provide new important options to treat these diseases while often
reducing the cost.
Significant changes or cancelation of MCIT could result in limiting
access to breakthrough medical technologies that could improve the
health and well-being of Medicare beneficiaries. For these reasons, we
encourage federal agencies to work together and CMS to implement the
MCIT rule without delay to ensure timely access to breakthrough
technologies.
Sincerely,
Bradley P. Knight, MD, Northwestern University, Chicago, IL,
Thomas F. Deering, MD, Piedmont Heart Institute, Atlanta GA,
Michael R. Gold, Medical University of South Carolina, Charleston, SC,
Suneet Mittal, MD, FACC, FHRS, Valley Health, NY, NY,
Jagmeet P. Singh, MD, DPhil FACC, FHRS, Harvard University, Boston, MA
References .
- Knight BP. Delay in Insurance Preauthorization for a Defibrillator
Nearly Costs Patient with Hypertrophic Cardiomyopathy Her Life. EP Lab
Digest. July 2020.
- Reynolds D, Duray GZ, Omar R, et al., for the Micra Transcatheter
Pacing Study Group. A Leadless Intracardiac Transcatheter Pacing
System. N Engl J Med 2016; 374:533-541 DOI: 10.1056/NEJMoa1511643.
- https://www.regulations.gov/document/CMS-2020-0098-0347
(Accessed April 5, 2021).
- Bach PB. After 4 Years of Trump, Medicare and Medicaid Badly Need
Attention. New York Times. March 29, 2021.
https://www.nytimes.com/2020/12/01/opinion/trump-medicare-medicaid.html.
- Rathi VK, Johnston JL, Ross JS, Dhruba SS. Medicare’s New
Device-Coverage Pathway
— Breakthrough or Breakdown? N Engl J Med March 25, 2021. 384;12.