Health Law: Cardiac Procedures in Ambulatory Surgical Centers

The rising trend for cardiologists to perform outpatient procedures in ambulatory surgical centers (ASC) instead of hospitals raises safety questions. ASCs have fewer resources than full-service hospitals and may be unequipped for life-threatening emergencies.

ASCs often provide a more comfortable, convenient, and patient-centered experience than hospital-based outpatient settings - where procedures have traditionally been performed. ASCs are typically more cost-effective for patients, providers, and insurers than hospitals. While ASCs are generally safe, they pose potential risks.
Ambulatory Surgical Centers may be Unequipped for Cardiac Emergencies.

If a patient experiences complications during a cardiovascular procedure, the ASC may lack resources needed for specialized, emergency medical treatment. The patient may need to be transported to a hospital immediately.

Keywords

Cardiovascular procedures, ambulatory surgical centers, cardiac emergencies, myocardial infarction, cardiac complications, pericardial effusion and tamponade; ventricular fibrillation and dysrhythmias; embolization of stents; cardiogenic shock; retroperitoneal hemorrhage; aortic or sinus of Valsalva rupture; coronary artery dissections, percutaneous coronary intervention

At a glance

Intro:

The rising trend for cardiologists to perform outpatient procedures in ambulatory surgical centers (ASC) instead of hospitals raises safety questions. ASCs have fewer resources than full-service hospitals and may be unequipped for life-threatening emergencies.

Discussion:

  • Ambulatory Surgical Centers & Regulation
  • Focus on Percutaneous Coronary Intervention (Angioplasty) Safety
  • Health Law Considerations

Conclusion: Cardiology Patients are Vulnerable - Some More than Others.

References: Cited at foot of article with links as available.

DISCLAIMER: Dr. Dalawari shares interesting and relevant medical-legal news in the press. He also shares case verdicts & settlements from the public record. He has no professional or personal relationship to the cases.

Ambulatory Surgical Centers & Regulation

Some regulations require the ASC to be located near enough to a hospital to transport a patient within 60 minutes. However, a 60-minute delay may jeopardize the health - or life - of a patient with complications requiring immediate, specialized treatment.

In addition to myocardial infarction (heart attack), serious cardiac complications that may occur during cardiovascular procedures in ASCs include pericardial effusion and tamponade; ventricular fibrillation and dysrhythmias; embolization of stents; cardiogenic shock; retroperitoneal hemorrhage; aortic or sinus of Valsalva rupture; and coronary artery dissections, in which a tear forms in a cardiac artery.

Serious potential peripheral/endovascular complications include iliac vein rupture and retroperitoneal bleeds; embolization of vascular closure devices; thrombus or flow limiting dissections; embolism of inferior vena cava (IVC) filter into right ventricle; deep vein thrombosis (DVT) and pulmonary embolisms.

As life-threatening emergencies may require specialized medical care, ASCs are generally required to have a contract in place with a receiving hospital. However, the patient may not survive a 60-minute delay while in transit to a hospital, raising safety questions about measures taken before the procedure and during treatment. Physicians, health care administrators, patients, and insurers are understandably concerned about preventing medical malpractice.

Focus on Percutaneous Coronary Intervention (Angioplasty) Safety.

In recent years, the Centers for Medicare & Medicaid Services (CMS) expanded ASC coverage for cardiac interventional procedures including catheterization procedures, endovenous ablation, and pacemaker placements. Cardiologists are now shifting percutaneous coronary interventions (PCI) procedures - also known as angioplasty - to ASCs due to expanded CMS coverage. While these procedures are generally safe, the potential risks for vulnerable patient populations warrants further study. The risks and benefits of PCI received an uptick in attention during 2020 after CMS authorized ASC coverage.

Each year, more than 600,000 PCI procedures are performed in the US, costing more than $12 billion. Potential overuse may pose undue risk to patients. Professional medical organizations including the American College of Cardiology and American Heart Association have addressed concerns by formulating appropriate use criteria (AUC).
Emerging Cardiology Safety Concerns

Recent articles in the Journal of the American College of Cardiology and JACC Cardiovascular Interventions discuss the focused attention that physicians are devoting to PCI safety in the ASC setting. It is essential to analyze data stratified by patient subgroups to identify demographic traits, clinical characteristics, and comorbidities that may be associated with greater risks of complications. Research is ongoing, and identifying high-risk patients may prompt doctors to reconsider the procedure or setting.

Patient safety is also paramount for the Society for Cardiovascular Angiography and Interventions (SCAI) which supports CMS payments for PCI in ASCs, so long as the quality of care equals that of a hospital-based outpatient setting. While the SCAI generally considers PCI procedures in the ASC setting safe, the SCAI, like other organizations, notes the value of further study to identify patients at high risk.

AUC development and patient subgroup assessments facilitate cost containment and patient safety measures. For example, safety data from recent clinical trials discussed in JAMA may lead to modified AUCs for PCI. Researchers evaluated the ISCHEMIA clinical trial data from 2018 - 2019 to assess the appropriateness of PCI among patients with stable ischemic heart disease (SIHD). PCIs were classified as appropriate, maybe appropriate, or rarely appropriate. Based on current AUC definitions, 3.3% of PCI patients were classified as rarely appropriate; yet under modified AUC definitions, 22.3% were classified as rarely appropriate. This marked increase was largely due to a reclassification of asymptomatic patients. The American College of Cardiology notes that updating AUC and guidelines to remain consistent with evidence from clinical trials may decrease costs and risks.

The role of financial motivation to perform unnecessary procedures that pose undue risk has received considerable attention. In fact, several hospitals and clinicians were penalized under the US False Claims Act for questionable Medicare billing for PCI procedures deemed unnecessary, according to a recent JAMA article.

Health Law Considerations.

A patchwork of federal and state laws nationwide governs Ambulatory Surgical Centers. For example, while CMS authorizes payment for PCI procedures in Ambulatory Surgical Centers, some states do not presently authorize providers to perform PCI procedures in Ambulatory Surgical Centers.

In addition, laws governing the standards of care for physicians and other clinicians vary from state to state. As medical errors can be devastating to patients and their families, physicians and patients are motivated to protect against the consequences of medical malpractice. To provide professionally responsible health care, doctors, health care administrators, and health insurance companies turn to expert guidance. Ideally, physicians seek good health outcomes for their patients, and hope that any independent medical examination (IME) or expert medical witness would agree that the care was appropriate.

For facilities, health care administrators, and physicians, medical malpractice prevention begins with planning. The elements of an Ambulatory Surgical Center practice, including hybrid models with office-based labs (OBLs), involvement of physician practices, and agreements with local hospitals raise important questions of safety precautions, insurance coverage and applicable policies. Physicians, allied health professionals, or the business entity itself may be implicated.

When a patient experiences a poor outcome after a procedure, the outcome may - or may not - be due to a medical error. If a medical error occurred, it's essential to determine responsibility. Was there a physician-patient relationship, or other relationship that conferred a duty to that patient? If so, what was the applicable standard of care? Was the standard of care met? Did a breach in the standard of care cause the harm suffered? If so, were the damages slight or extensive? If a patient suffers from a medical error, it's important to identify which person or organization may be responsible, and which insurance policy may provide coverage.

Cardiology Patients are Vulnerable - Some More than Others.

Medical experts acknowledge that performing cardiac procedures in Ambulatory Surgical Centers raises safety questions. Treatment delays during transit for emergency care may be problematic, and unnecessary procedures may pose undue risk. Moreover, high risk patients may not be ideal candidates for procedures in Ambulatory Surgical Centers. For such vulnerable patients, the risk of serious harm is foreseeable: specialized emergency treatment is only available in hospitals to which the patient might arrive too late.

DISCLAIMER:Dr. Dalawari shares interesting and relevant medical-legal news in the press. He also shares case verdicts & settlements from the public record. He has no professional or personal relationship to the cases.

Do you have questions about a medical case or need help understanding treatment plans and options?

Cardio Med Legal Dr. Jasdeep Dalawari

(804) 500-0685 - info@cardiomedlegal.com

References:

1. Box LC, Blankenship JC, Henry TD, et al. SCAI position statement on the performance of percutaneous coronary intervention in ambulatory surgical centers. Catheter Cardiovasc Interv. 2020;96(4):862-870. doi:10.1002/ccd.28991
https://onlinelibrary.wiley.com/doi/10.1002/ccd.28991

2. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/ASCs

3. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/AmbSurgCtrFeepymtfctsht508-09.pdf

4. https://www.cms.gov/Center/Provider-Type/Ambulatory-Surgical-Centers-ASC-Center

5. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment

6. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c14.pdf

7. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_l_ambulatory.pdf

8. https://www.federalregister.gov/documents/2019/11/12/2019-24138/medicare-program-changes-to-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center

9. https://www.ahajournals.org/doi/10.1161/JAHA.118.010373

10. https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/angioplasty-and-stent-placement-for-the-heart

11. Li K, Kalwani NM, Heidenreich PA, Fearon WF. Elective Percutaneous Coronary Intervention in Ambulatory Surgery Centers [published online ahead of print, 2020 Nov 4]. JACC Cardiovasc Interv. 2020;S1936-8798(20)32098-7. doi:10.1016/j.jcin.2020.10.015

12. Dehmer GJ. Elective Percutaneous Coronary Intervention in Ambulatory Surgery Centers: Is This a Bridge Too Far? [published online ahead of print, 2020 Nov 4]. JACC Cardiovasc Interv. 2020;S1936-8798(20)32150-6. doi:10.1016/j.jcin.2020.10.025

13. American College of Cardiology. Rarely Appropriate PCI May Increase if AUC Modified to Incorporate Clinical Trial Data. ACC Website: October 14, 2020. Accessed November 29, 2020. Available at https://www.acc.org/latest-in-cardiology/articles/2020/10/14/12/42/rarely-appropriate-pci-may-increase-if-auc-modified-to-incorporate-clinical-trial-data

14. Malik AO, Spertus JA, Patel MR, Dehmer GJ, Kennedy K, Chan PS. Potential Association of the ISCHEMIA Trial With the Appropriate Use Criteria Ratings for Percutaneous Coronary Intervention in Stable Ischemic Heart Disease [published online ahead of print, 2020 Sep 21]. JAMA Intern Med. 2020;180(11):1540-1542. doi:10.1001/jamainternmed.2020.3181

15. Howard DH, Desai NR. US False Claims Act Investigations of Unnecessary Percutaneous Coronary Interventions. JAMA Intern Med. 2020;180(11):1534–1536. doi:10.1001/jamainternmed.2020.2812

Jasdeep Dalawari MD

About Jasdeep Dalawari MD

Experienced General and Specialist Physician with a demonstrated history of working in the medical practice industry. Skilled in Interventional, Endovascular, Vascular, and General Cardiovascular Medicine; Emergency Medicine; Healthcare Consulting, including Peer Review, Expert Witness, and Utilization Review; and Medical Education. Strong healthcare services professional with an MS focused in Health Administration from Virginia Commonwealth University.