September 2nd, 2011
When Patients Can’t Afford a Medication
Beth Waldron, MA
Editor’s Note: The following guest post by Beth Waldron is reprinted with permission from ClotConnect, a valuable resource for patients about blood clots and clotting disorders. Waldron is the program director of the UNC-Chapel Hill Blood Clot Outreach Program.
Prescription Assistance: When Patients Can’t Afford a Medication
Beth Waldron, Program Director of the Clot Connect project, writes….
Approximately 1 in 5 people don’t take a medication prescribed to them because they can’t afford to pay for it [ref 1]. While the cost of some outpatient anticoagulation therapies can be substantial, failure to take an anticoagulant medication as prescribed can have serious, even deadly, consequences.
What can a patient do when prescribed an anticoagulant that they cannot afford?
Help is available for some patients. Many pharmaceutical companies have Patient Assistance Programs (PAP) designed to help patients who cannot afford their medications obtain the medicine they need at either no or very low cost.
There is great variance among the programs offered because each pharmaceutical company establishes its own eligibility criteria for their Patient Assistance Programs along with deciding which medications are included. Most programs have some form of income guideline, require the patient complete an application form, and require a valid prescription and physician signature.
Most Patient Assistance Programs have reimbursement counselors who can answer questions about the application process over the phone.
Below is information on Prescription Assistance Programs for several commonly prescribed brand-name anticoagulants. In addition to the industry sponsored Patient Assistance Programs, several nonprofit organizations are also listed which help patients obtain discounted prescription drugs.
The following tables summarize the contact information detailed in the text. Please see the text listing for program specifics including hours of operation.
A. Injectables – Low Molecular Weight Heparin (LMWH)
|
Brand |
Name |
Website |
Phone |
| Arixtra | fondaparinux sodium Injection | website | 1-866-728-4368 |
| Fragmin | dalteparin sodium injection | website | 1-866-613-4724 |
| Innohep | tinzaparin sodium injection | Phone only | 1-866-742-7646 |
| Lovenox | enoxaparin sodium injection | website | 1-888-632-8607 |
B. Oral Anticoagulants
|
Brand |
Name |
Website |
Phone |
| Coumadin | warfarin | website | 1-800-444-4106 |
| generic warfarin | warfarin | website | 1-800-769-3880 |
| Pradaxa | dabigatran | See text below for online options | 1-800-556-8317 |
| Xarelto | rivaroxaban | website | 1-800-652-6227 |
C. General Prescription Access Resources
|
Organization |
Website |
Phone |
| Partnership for Prescription Assistance | website | 1-888-477-2669 |
| NeedyMeds | website | Online option only |
| RxAssist | website | Online option only |
A. Injectables – Low Molecular Weight Heparin (LMWH)
1. Arixtra® (fondaparinux sodium injection)
The manufacturer of Arixtra®, GlaxoSmithKline, offers a patient assistance program called ‘Bridges to Access’ which provides GSK medicines to eligible low income patients who do not have prescription drug benefits. Individuals who qualify for Bridges to Access receive GSK medicine at little or no cost. Contact the program for specific eligibility requirements.
Contact Information:
Phone: 1-866-728-4368
Hours: 8AM-8PM Monday- Friday
Website
2. Fragmin® (dalteparin sodium injection)
The manufacturer of Fragmin®, Eisai, offers an assistance program which provides Fragmin at no cost to financially needy patients who meet program eligibility criteria. Contact the program for specific eligibility criteria. The Eisai Assistance Program can provide information to patients and healthcare professionals and can address other assistance related questions.
Contact Information:
P.O. Box 29231
Phoenix, AZ 85038
Phone: 1-866-613-4724
Fax: 1-866-272-8805
Hours:
Mon-Fri 8AM – 8PM ET
Website
An application form is available here.
3. Innohep® (tinzaparin sodium injection)
The manufacture of Innohep®, Pharmion Corporation, has created a Patient Assistance Program (PAP). Enrollment is offered to eligible patients who do not qualify for government assistance or have third party insurance coverage and are financially unable to pay for the product. Contact the company for specific eligibility criteria and the application process.
Contact information:
Phone: 1-866-Pharmion (866-742-7646)
4. Lovenox® (enoxaparin sodium injection)
a) For Lovenox® brand:
The manufacturer of Lovenox®, Sanofi-Aventis, sponsors a patient assistance hotline to facilitate access to their Patient Assistance Program which provides access to Lovenox in outpatient settings for under-insured or uninsured patients without the financial resources to pay for the product.
In order for a patient to be eligible for assistance, patients must be a legal U.S. resident and have an annual income at or below 250% of the Federal Poverty Line. Specific dollar amounts vary by family size and can be found on the assistance program’s website listed below.
Contact Information:
Phone: 1-888-632-8607
Fax: 1-888-875-9951
Hours: Monday-Friday, 8:00 a.m.-8:00 p.m. (EST)
On call Saturday and Sunday, 9:00 a.m.-5:00 p.m. (EST)
Website
The application for assistance is available here.
b) For generic enoxaparin:
We are unaware of a patient assistance program for generic enoxaparin at this time.
B. Oral Anticoagulants
1. Coumadin®, Jantoven® (warfarin)
a) For Coumadin® brand:
The manufacturer of Coumadin®, Bristol-Myers-Squibb, participates in ‘Together Rx Access’ a program which offers a discount savings card good for Coumadin® brand. Card discounts range from 25-40 percent, depending upon the pharmacy and other factors. Individuals may be eligible for the Together Rx Access Card if they do not qualify for Medicare, do not have public or private prescription drug coverage, and have a household income of up to $45,000 for a single person or $90,000 for a family of four (income eligibility is adjusted for family size). Contact the program for detailed requirements.
Contact information:
Phone: 1-800-444-4106
b) For generic warfarin:
Generic warfarin is available through Rx Outreach, a nonprofit charitable organization that provides low-cost prescription medications to people in need across the U.S. Prescriptions are mailed directly to the patient after receipt of an Rx Outreach form, a prescription, and modest payment.
Rx Outreach is available regardless of age, use of another discount medicine program or patient assistance program. To use Rx Outreach, income needs to be less than a certain amount of money each year. This amount differs depending on the number of financially dependant people living in the house. Exact figures can be obtained by contacting the program.
Contact Information
Rx Outreach
P.O. Box 66536
St. Louis, MO 63166-6536
Phone: 1-800-769-3880
website
3. Pradaxa® (dabigatran)
The manufacturer of Pradaxa®, Boehringer Ingelheim, offers a Patient Assistance Program for patients who are without prescription insurance coverage, and who meet certain household income levels. Call the program at the number below for specific eligibility criteria and information on completing the application process.
Contact Information
Boehringer Ingelheim CARES Foundation-Patient Assistance Program
Phone: 1-800- 556-8317
Hours: Monday-Friday 7:30am – 5:30pm CST
Online: The patient assistance program does not have a direct informational website, however an online application can be made at www.RxHope.com, an independent web-based patient assistance resource which processes patient assistance requests.
A print application can be found here.
4. Xarelto® (rivaroxaban)
The Johnson & Johnson Patient Assistance Foundation provides assistance to patients who, because of financial burden and lack of prescription medication coverage, may have difficulty paying for their treatment. Xarelto® (rivaroxaban tablets) is available to qualified individuals through the Johnson & Johnson Patient Assistance Foundation. For specific eligibility requirements, contact the program.
Contact information:
Phone: 1-800-652-6227
Hours:
Monday through Friday, 9 AM TO 6 PM, ET.
Website
An application is available here.
C. General Prescription Access Resources
There are several websites which serve as clearinghouses for information on prescription patient assistance programs and are good first stops to consult when looking for assistance, for any medication.
1. Partnership for Prescription Assistance
The Partnership for Prescription Assistance helps qualifying patients without prescription drug coverage obtain medicines either for free or nearly free. The PPA is sponsored by a consortium of pharmaceutical research companies to offer a single point of access to more than 475 public and private programs, including nearly 200 offered by pharmaceutical companies. The program covers about 2,500 different brand-name medications and numerous generics.
Another helpful service the PPA offers is information on nearly 10,000 free community health clinics and can connect patients to one in their area. Additionally, this resource also includes connection to many regional and local based assistance programs.
PPA has both a website and a toll-free phone inquiry line. The call center accepts calls in English, Spanish and approximately 150 other languages.
Contact Information:
1-888-4PPA-NOW (1-888-477-2669)
Hours: Monday-Friday 9AM-5PM ET
Website
2. RxAssist
RxAssist is a web based medication assistance resource center established in 1999 with funding from The Robert Wood Johnson Foundation. RxAssist includes a comprehensive database of patient assistance resources. RxAssist is part of the Center for Primary Care and Prevention at Memorial Hospital of Rhode Island and is sponsored by AstraZeneca.
Contact information:
3. NeedyMeds
NeedyMeds, a non-profit information resource which helps people in need find assistance programs to help them afford their medications and costs related to health care. It offers an online index of over 570 patient assistance programs and services. Information is available in English and Spanish. NeedyMeds also includes databases on disease-based assistance, free and low-cost clinics, government assistance programs.
Contact Information:
References:
1. Mazer, M., Bisgaier, J., Dailey, E., Srivastava, K., McDermoth, M., Datner, E. and Rhodes, K. V. (2011), Risk for Cost-related Medication Nonadherence Among Emergency Department Patients. Academic Emergency Medicine, 18: 267–272.
Disclosure: I have no financial disclosures relevant to this blog post.
Last updated: August 2, 2011
Disclaimer: ClotConnect.org, its contributors, authors, advisors, members and affiliate organizations do not assume any liability for the content of the website, blog and educational materials. Medical information changes rapidly. While information is believed to be correct, no representation is made and no responsibility is assumed for the accuracy of information contained on or available through this web site and blog. Information is subject to change without notice.
September 1st, 2011
How Is TAVI Like a European Toaster?
Richard A. Lange, MD, MBA and L. David Hillis, MD
Approval of TAVI and electric toasters is governed by the same regulatory framework in Europe, the “CE mark” — a mandatory conformity stamp for products placed on the market in the European Economic Area.
Because high-tech (and low-tech) devices are approved in Europe faster than in the United States, many companies and consumers scold the FDA for taking so long to evaluate products. Some are urging a more “European approach.”
How does the European regulatory process stack up?
- Manufacturers that sell devices in Europe must satisfy the “essential requirements” of safety and performance, but they do not necessarily need to show that a device benefits patients.
- Clinical efficacy trials are often performed after approval in Europe (but before approval in the United States).
- Isolated instances of device complications have disproportionately occurred in countries (i.e., in Europe) that grant earlier approval.
- Unlike the U.S., Europe has no centralized process for approving medical devices, so manufacturers are free to seek approval from any EU country. In other words, manufacturers can choose agencies that offer the least-burdensome and fastest reviews.
So does this make you feel better about your toast or more concerned about your TAVI?
All things considered, do we really want to be more European?
Editor’s Note: This post is a response to one by Stephen Fleet titled “TAVI–When Will It Come to an Operating Theater Near Me?”
September 1st, 2011
Paris or Orlando? A Tale of Two Cities
Larry Husten, PHD
‘
Paris, where the European Society of Cardiology is currently holding its annual meeting, is one of the world’s great cities. Orlando is the world capitol of medical meetings. Here are just a few of the differences. (Thanks as indicated for the suggestions.)
Paris has a bewildering variety of long-distance trains, commuter trains, and subways. In Orlando you can take a monorail to Disney World.
Air conditioning in Orlando is ubiquitous. There is no French word for “air conditioning.”
Nearly every restaurant in Orlando has waiters dressed in costumes. Waiters in Paris pretend they don’t speak English.
Orlando has amusement parks. Paris has the Louvre.
The average BMI is quite different! (Chris Cannon)
As different as Beaujolais and Coke. You guess which is which. (James Rudd)
In Orlando service is not included in the meal price, whereas in Paris it’s included but not evident. (anonymous)
Orlando has oranges, Paris l’Orangerie. (anonymous)
In Orlando you get bottomless cups of bad coffee. In Paris you get a tablespoon of good coffee, and it’s called a large cup. (anonymous)
Take your kids to Orlando. Take your spouse to Paris.
August 31st, 2011
New Resuscitation Strategies Fail to Improve Outcomes After Cardiac Arrest
Larry Husten, PHD
Two trials from the Resuscitation Outcomes Consortium (ROC) investigators were unable to demonstrate meaningful improvements to resuscitation strategies after cardiac arrest. The two trials, one testing an impedance threshold device and the other examining a strategy of early versus late rhythm analysis, have been published in the New England Journal of Medicine.
In the first trial, 8718 patients were randomized to treatment with an active or sham impedance threshold device (ITD) intended to improve venous return and cardiac output during CPR. There was no significant difference between the groups in the percentage of subjects who survived to hospital discharge with satisfactory function:
- 6.0% (260 patients) in the sham-ITD group and 5.8% (254 patients) in the active-ITD group
In the second trial, which utilized a cluster-randomized design, 9933 patients with out-of-hospital cardiac arrest received either CPR for 30-60 seconds or CPR for 180 seconds prior to ECG analysis. Once again, no difference in the primary outcome of survival to hospital discharge with satisfactory functional status was observed:
- 5.9% (273 patients) in the later-analysis group and 5.9% (310 patients) in the early-analysis group
There were no significant differences in any of the secondary outcomes or among subgroups in either of the trials.
In an accompanying editorial, Arthur Sanders writes that although the early versus late rhythm analysis trial ruled out any significant difference between the two groups, it did not answer “the more critical question” of whether any CPR before rhythm analysis is beneficial.
More generally, Sanders argues that “there are fundamental tensions between the principles of randomized trial design and the practice of resuscitation that make the conduct of any clinical trial of out-of hospital cardiac arrest challenging.” Out-of-hospital cardiac arrest should be considered a public health problem rather than a disease process and might be better tackled with a continuous-quality-improvement model, he writes.
August 31st, 2011
TAVI—When Will It Come to an Operating Theater Near Me?
Stephen Fleet, MD
At the ESC meeting in Paris, Gerhard Schuler from Leipzig reviewed the current indications for Transcatheter Aortic Valve Implantation (TAVI).
TAVI is considered appropriate for:
- Inoperable patients with severe aortic stenosis with a baseline 1-year mortality risk of 50%.
- Patients with severe aortic stenosis and a surgical risk of greater than 15%.
- Valve-in-valve implantation for degenerated bioprosthetic valves with severe aortic stenosis.
Specific patient types suitable for TAVI include those with porcelain aorta, general frailty, poor pulmonary function from COPD or pulmonary fibrosis, open bypass grafts at risk during re-operation, “hostile” thorax due to prior radiation therapy, and cirrhosis of the liver.
Potential complications include stroke, need for permanent pacemaker, and vascular injury.
The seminal PARTNER trial reported a rate of death from any cause at one year to be 30.7% with TAVI and 50.7% with standard therapy (including balloon aortic valvuloplasty).
As I observed video presentations of elegant transcatheter valve implantations in European patients, I was struck by the fact that Europe is now roughly 5 years ahead of the U.S. with regard to routine TAVI. In fact, Europeans are beginning to explore whether indications should be broadened to patients at less risk.
U.S. clinicians, with no shortage of patients who meet TAVI guidelines, cannot help feeling frustrated by the slow uptake of new technologies in our country. In many ways we in the U.S. have become the old world, hampered by red tape and bureaucracy. In the words of Edward R. Murrow, we need to “remember that we are not descended from fearful men.”
August 30th, 2011
Intra-Aortic Balloon Counterpulsation (IABP) Burned to a CRISP
Richard A. Lange, MD, MBA and L. David Hillis, MD
Intra-aortic balloon counterpulsation (IABP) is a bust in AMI patients without cardiogenic shock, according to the Counterpulsation to Reduce Infarct Size Pre-PCI Acute Myocardial Infarction (CRISP AMI) trial.
This open-label, 30-center, randomized, controlled trial was performed to determine if a routine strategy of IABP before primary PCI (and continued for at least 12 hours afterward) would reduce infarct size in patients with acute anterior STEMI without cardiogenic shock. A 6-month follow-up for clinical events was also conducted.
The routine use of IABP in patients with anterior STEMI without cardiogenic shock did not lead to a reduction in infarct size or to an improvement in clinical outcomes at 6 months.
|
Endpoints |
IABP + PCI (n=161) |
PCI (n=176) |
P value |
| 4 days | |||
| – Infarct size |
42% |
37.5% |
0.06 |
| 30 days | |||
| – Major bleeding or transfusion |
3.1% |
1.7% |
0.49 |
| – Major vascular complications |
4.3% |
1.1% |
0.09 |
| 6 months | |||
| – Death |
1.9% |
5.2% |
0.12 |
| – Composite (death, recurrent MI, heart failure) |
6.3% |
10.9% |
0.15 |
As the accompanying editorial points out, five randomized trials have previously assessed the role of IABP in patients with AMI without cardiogenic shock; in aggregate, they also show no mortality benefit (21 deaths in 518 patients in the IABP groups vs. 21 deaths in 536 patients in the control groups).
Based on this (and previous) studies, what is the role of IABP in AMI? In the absence of cardiogenic shock, there’s no benefit.
What about IABP for AMI and cardiogenic shock? Even though it’s “guideline-recommended,” it’s not been properly studied. A randomized trial is underway, with plans to enroll 600 patients with STEMI and shock
Would you enroll your patients with cardiogenic shock in this trial, knowing there’s a chance they won’t get IABP?
August 30th, 2011
No Benefit for Routine Counterpulsation Found in CRISP AMI
Larry Husten, PHD
Routine use of intra-aortic balloon counterpulsation (IABC) in STEMI patients who do not have cardiogenic shock does not reduce infarct size, according to a new trial. Results from the CRISP AMI (Counterpulsation to Reduce Infarct Size Pre-PCI Acute Myocardial Infarction) trial were presented at the European Society of Cardiology meeting in Paris by Manesh Patel and published simultaneously in JAMA.
Some 337 STEMI patients at 30 sites were randomized to either standard care or routine IABC placement prior to reperfusion. There were no significant differences between groups in infarct size expressed as a percentage of LV mass as measured by MRI 3 to 5 days after PCI:
- 42.1% in the IABC group compared with 37.5% in the standard care group. This 4.6% difference was not significant (p=0.06).
The same pattern was observed in patients with large infarcts (proximal LAD and TIMI flow scores of 0 or 1):
- 46.7% in the IABC group compared with 42.3% in the standard care group. The difference of 4.4% was not significant (p=0.11).
Fifteen patients in the standard care group crossed over and received IABC. IABC treatment resulted in a short but significant delay to treatment: The time from first contact to first coronary device was 68 minutes in the standard care group and 77 minutes in the IABC group (p=0.04).
There were no significant differences in clinical outcomes between the groups, although the trial was not powered to detect differences. At 30 days, the rate of major bleeding or transfusion was 3.1% in the IABC group compared with 1.7% in the standard care group. Rates of major vascular complications were 4.3% and 1.1%, respectively. There were three deaths in the IABC group and nine in the standard care group.
In an ESC press statement, Patel said that the trial did not support the use of routine IABC, adding: “Physicians should be vigilant about identifying those patients who are at risk for rapid deterioration and may benefit from counterpulsation.”
In an accompanying comment, Gjin Ndrepepa and Adnan Kastrati write that the “clear message” of the trial “is that the routine use of IABC neither reduces infarct size nor improves clinical outcome among patients with STEMI without cardiogenic shock; accordingly, use of this device should be discouraged in these patients. For patients with STEMI and cardiogenic shock, IABC remains a frequently used intervention.”
August 30th, 2011
New Results from EMPHASIS-HF Show Big Benefits For High-Risk Subgroups Taking Eplerenone
Larry Husten, PHD
Last November the main results of the EMPHASIS-HF trial demonstrated that eplerenone was significantly better than placebo in reducing the risk for death and hospitalization in patients with systolic heart failure and mild symptoms. Now a new analysis of the trial, presented by Bertram Pitt at the European Society of Cardiology meeting in Paris, reinforces the earlier findings — and demonstrates an especially dramatic benefit in multiple high-risk subgroups.
Because EMPHASIS-HF was terminated early for efficacy, there was a possibility that the observed effect seen in the trial might have been exaggerated. In some countries, however, where eplerenone was not commercially available, the blinded study continued. Pitt therefore showed the results for the primary endpoint for an additional 10 months, in which no discernible attenuation of effect was observed:
- CV death or hospitalization for heart failure until March 2011: 21.1% for eplerenone versus 28.5% for placebo (HR 0.66, CI 0.57-0.77, p<0.0001)
Pitt also presented the results for high-risk subgroups, showing large reductions in the primary endpoint:
- Age 75 or older: 23.6% versus 32.7%, HR 0.66, CI 0.49-0.88, p=0.004
- Type 2 diabetes: 21.6% versus 35.3%, HR 0.54, CI 0.42-0.70, p<0.0001
- Renal impairment: 24.4% versus 34.5%, HR 0.62, CI 0.49-0.79, p<0.0001
- Systolic BP below median: 20.6% versus 29.4%, HR 0.63, CI 0.51-0.79, p<0.0001
He also reported that although potassium levels increased in patients on eplerenone in the high-risk subgroups, there were no significant increases in serious hyperkalemia or other related problems.
August 30th, 2011
Is Warfarin Still the First Choice in Atrial Fibrillation?
Stephen Fleet, MD
There’s an old maxim in medicine that one shouldn’t be the first to prescribe a new drug, nor the last.
A fascinating debate between Michael Ezekowitz from the U.S. and Felicita Andreotti from Italy highlighted the differences between warfarin and the newer oral anticoagulants (NOACs) apixaban, rivaroxaban, and dabigatran.
Even Dr. Ezekowitz, the warfarin protagonist for purposes of the debate, had to concede the superiority of the NOACs, now supported as safer and more effective in three clinical trials: RE-LY, ROCKET-AF, and ARISTOTLE. In general, the factor Xa inhibitors prevent ischemic strokes, reduce mortality, and limit the incidence of dreaded intracranial hemorrhage, with less bleeding as well.
How, then, could a cardiologist not rush to the electronic prescription pad and immediately take most patients off warfarin and prescribe NOACs?
Well, for one thing, there’s the cost. True, INR monitoring comes with societal and health care costs, plus the cost of paying for excess strokes. The patient, however, is more concerned with the copay: “Do I have to pay $10 per month for a generic drug or hundreds for a newer medication?”
There’s also the question of patient subgroups. Until we have more information, subgroups such as patients with prosthetic metal valves will need to remain on warfarin. The current lack of a specific drug antidote to the NOACs concerns many observers as well.
I also find intriguing the way statistical data are presented. For example, in the ARISTOTLE trial, death occurred in 3.52% of the apixaban group and 3.94% of the warfarin group. You can declare, then, that by using apixaban instead of warfarin 8 deaths are prevented for every 1000 patients treated. On the other hand, you could say that 96.48% of the apixaban group and 96.06% of the warfarin group didn’t die. Is that really a compelling difference for the individual patient sitting before you in the exam room?
For now, I think I’m going to continue prescribing warfarin for patients who are already well controlled on that medication. For those with poorly controlled INRs or new patients, perhaps the time for NOACs is now.
August 29th, 2011
Not Shocking: French Studies Evaluate Remote Monitoring of ICDs
Larry Husten, PHD
Remote monitoring of ICDs can reduce inappropriate shocks, but the overall clinical benefit and cost-effectiveness of the technology has not yet been demonstrated, according to two new studies presented at the ESC meeting in Paris.
Salem Kacet presented the ECOST (Effectiveness and Cost of ICD Follow-Up Schedule with Telecardiology) study in which 433 ICD patients were randomized to follow-up with remote monitoring or in-office visits in 43 French centers. The trial found that daily remote monitoring was noninferior to in-office visits for the primary endpoint of cumulative survival free of major adverse events (HR 0.91, CI 0.68-1.23, p<0.05).
Kacet emphasized the secondary effectiveness endpoint, which found a 52% reduction in the number of patients who had inappropriate shocks:
- Eleven (5%) patients in the remote monitoring group had inappropriate shocks versus 22 (10.4%) in the control group (p=0.03).
- Three patients in the remote monitoring group were hospitalized for a cause related to their inappropriate shocks, versus 11 in the control group (p=0.02).
Kacet also noted that the reduction in inappropriate shocks would have a significant impact on battery longevity. He did not present the cost-effectiveness component of the study.
The results of the EVATEL (EVAluation of TELe follow-up) study, presented by Philippe Mabo, were less positive. Some 1501 patients were randomized to the remote follow-up group, consisting of a transmission to the implant center every 3 months, or to the control group, consisting of an in-office follow-up at the implant center every 3 months. No significant difference in the incidence of the first major cardiovascular event was observed (28.5% in the control group vs. 30.2% in the remote monitoring group, p=ns). However, the trial failed to meet the primary noninferiority endpoint, either in the intent-to-treat analysis (p=0.0268) or in the per-protcol analysis (p=0.0862).
Commenting on the studies, AHA spokesperson Mariell Jessup said in an interview that remote monitoring may improve outcomes and reduce inappropriate shocks, but that it can not be recommended until its benefits are proven and it has been shown to be cost-effective.
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