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Affordable Care Act became law in 2010, Cardiologists’ Practice Management Decisions Unclear

Reporter: Aviva Lev-Ari, PhD, RN

Washington-Watch

ACA Delays Decisions in Cardiology

Published: Jun 28, 2013

By Chris Kaiser, Cardiology Editor, MedPage Today
Since the Affordable Care Act became law in 2010, cardiologists have been mired in a fog of uncertainty, leading to delays in making important practice management decisions.

“When I get together with colleagues at national meetings, I get the sense that nobody really understands the future,” said Cam Patterson, MD, MBA, chief of the division of cardiology at the University of North Carolina at Chapel Hill.

That uncertainty “throws a wrench into the planning process,” including recruitment and benchmark setting, he told MedPage Today.

“It’s a major sea change,” added Thomas Tu, MD, director of the cardiac catheterization lab for the Louisville Cardiology Group in Louisville, Ky., who notes that physicians are “struggling” to find ways they can be influential in the new environment.

Patterson noted the plight of young cardiologists seeking jobs in a healthcare market unsure of how or when to make its next move.

“It’s challenging to hire new recruits when budgetary and human resources decisions are essentially on hold until there is a better understanding of what the ACA will bring,” he commented.

Regarding setting benchmarks, Patterson said the days of merely imagining your quality is as good as the next practice or hospital are gone.

Cold, hard data are the new norm, but which data and how best to collect and analyze them, as well as apply the results in a robust and meaningful way, are being worked out slowly.

“As with everyone else, we are scrambling to get a grip on what our quality measures are,” Patterson said.

Education and Prevention Will Be Key

Hospitalists, as well as advanced nurse practitioners and physician assistants, can help ease the workload due to the shortage of primary care providers, a shortage that is particularly acute in California, according to C. Noel Bairey Merz, MD, director of the Barbra Streisand Women’s Heart Center at Cedars-Sinai Medical Center in Los Angeles.

“If the reform happens the way it is intended, we should have an integrated healthcare system where primary prevention — management of hypertension, dyslipidemia, diabetes, smoking cessation counseling, and therapeutic lifestyle changes — is handled at the primary care level,” she said.

The truth of the matter, however, is that it takes twice as long to train the average general physician as it does an average nurse practitioner, and four times as long as the average physician assistant.

“It’s a lot to expect of physician extenders to practice primary care medicine,” Merz toldMedPage Today.

“A better system is the medical home model, with physician team leaders and physician extenders who work on protocols. The physician extenders would be licensed and would be able to work autonomously within a protocol,” she said.

Five years ago, the cardiology department at Geisinger Health Center in Danville, Pa., employed four nurse practitioners or clinical nurse specialists. Today, there are 12 and the department is seeking three more, according to James Blankenship, MD, vice president of the Society for Cardiovascular Angiography and Interventions, as well as an interventional cardiologist at Geisinger.

Blankenship also said that acknowledging the need for more primary care providers is to miss half of the equation. “We will need more specialists, as well.”

Given the newly insured patients coming into the system, as well as the aging Medicare population, cardiologists will be stretched pretty thin. But the field of cardiology has been instrumental in advocating teamwork among the different specialties for years, he said. “That’s a train that’s already on the tracks.”

Merz noted an expectation to see more cardiovascular care teams in response to the ACA. Such teams typically consist of a physician leader, nurse practitioners, pharmacists, behavioral experts, rehab professionals, and others.

These teams are vital for the care of high-risk patients such as survivors of angioplasty, bypass surgery, and heart failure, she said, especially since there aren’t enough cardiologists to do it all.

Echoing Blankenship, Merz said that cardiologists will probably be busier than ever as heart disease remains the leading killer among men and women as the population ages. She noted a decline in the most severe type of heart attack — ST-segment elevation MI, or STEMI — in the Medicare population, a decline that is likely multifactorial, but two reasons stand out as attributable to the decline — the use of low-dose aspirin and statin therapy for primary and secondary prevention, she said.

“At whatever level these medications are prescribed and managed — primary care physician, nurse practitioner, cardiologist — one thing is clear: they work and they should continue to be utilized at the front line of heart disease management,” Merz said.

Patients with chronic diseases already consume a great deal of healthcare resources. The other side of that coin is prevention, noted Kathy Berra, MSN, ANP, president of the Preventive Cardiovascular Nurses Association and a nurse at Stanford Prevention Research Center in Stanford, Calif.

“Prevention is a family affair. It’s been shown that when women take care of themselves, the health of the family improves.”

Emerging as one of the more important gatekeepers for women’s health — including cardiovascular health — are ob/gyns, Berra said.

Gynecologists have increased their efforts to quiz women about heart disease risk factors such as hypertension, high cholesterol, and diabetes. If red flags are apparent, patients can be referred to primary care providers, internal medicine physicians, or cardiologists.

“Ob/gyns are on the front line of women’s health. Perhaps under the ACA model, these specialists will have a closer relationship with cardiologists,” Berra told MedPage Today.

Regarding nurses and other care providers in hospitals, they need to be able to educate patients about how to take care of themselves post-discharge, how to understand the importance of their medications, and how to best re-connect with their nonhospital environment.

Readmission is at epidemic proportions and it can be reined in by patient education at the hospital level. Even pharmacists are getting more involved in patient education.

Scott & White Hospital in Temple, Texas, has a program that encourages adherence by waiving drug copays following an education session, according to James Rohack, MD, director of the Center for Healthcare Policy at Scott & White.

Patients on Seniorcare who are on five medications or more are asked if they want to participate in the program. If they agree, they meet with a pharmacist once a month for 15 to 30 minutes. The pharmacist goes over everything about the patient’s medication, listens to any concerns, and sends him or her home with new medications, waiving the copay.

“Having no copay is a great benefit for patients on fixed incomes, but it goes beyond that. A little bit of education goes a long way and if patients can be reminded once a month about the importance of taking their medications, we will have fewer hospitalizations,” Rohack said.

Accountable Care Organizations

The development of ACOs is probably one of the biggest challenges under the ACA, said Geisinger’s Blankenship.

The promise of ACOs is to have better integrated care, less fragmented care among various providers. Part of this integrated care involves incentives to minimize procedures that are either unnecessary or could be replaced with a less costly treatment.

“Having been under a fee-for-service model for a long time, some in cardiology might find the new paradigm challenging,” Blankenship suggested.

ACOs are supposed to help take the sting out of moving away from the fee-for-service model by providing the opportunity for better coordinated care — which should translate into a higher quality of care.

However, ACOs can be difficult to set up, especially from scratch, as they have a large startup cost, he said.

One of the most important aspects of an ACO is to have a solid network of primary care doctors. Patterson, at UNC Chapel Hill, said the uncertainty of whether his state will expand Medicaid has led to the “very aggressive acquisition of primary care practices.”

“The goal is to have enough physicians and patients so that we will have a low-cost ACO when we are ready to implement that model. We are going to need about 1 million patients to have an efficient ACO,” he said.

But there are also fears that the ACA will deluge cardiologists with paperwork.

“In the clinic, I spend as much time with paperwork as I do with patients — particularly with Medicare and Medicaid patients,” noted John Day, MD, director of Heart Rhythm Services at Intermountain Medical Center in Salt Lake City, Utah. “Many of us are worried we haven’t even seen the beginning of the deluge.”

The intrusion of paperwork and other government regulations tends to erode the time physicians get to spend with patients — “one of the primary reasons I wanted to be a doctor,” Day said.

In addition, Day said that he and many of his colleagues are disappointed that the ACA did not address malpractice concerns. “Perhaps it’s not so much what’s in the bill as what is not in the bill,” he said.

“Malpractice concerns are real; they scare me every day; it affects how you practice medicine. I don’t see how you can rein in costs without addressing the malpractice quagmire,” Day told MedPage Today.

Shifting Sands

“For those of us working in the trenches, we have a vague concept of the changes coming down the road,” said James A. de Lemos, MD, director of the coronary care unit at Parkland Memorial Hospital in Dallas.

“We seem to be too busy to think about the changes, which leads to one of my biggest worries — that I won’t have prepared my troops well enough,” he said.

From a clinical perspective, it’s business as usual, with de Lemos and colleagues focused on growth and the development of referrals and procedure services.

“We are concerned, however, that the entire paradigm is going to shift and what we’re building today might not be financially sound in the ACO model,” de Lemos told MedPage Today.

De Lemos, who is active in cardiovascular biomarker research, suggested that biomarkers will become more important in the ACA era of healthcare.

“It will no longer be prudent to send everyone with a complaint to a cardiologist,” he commented. “Biomarker screening may play a role as a triage method to separate out those who merit a trip to the cardiologist from those who can be treated by primary care doctors.”

Rohack made these suggestions for getting ready for the changes associated with the ACA:

  • Make sure you are actively aware of your quality measures, your individual quality measures.
  • When caring for uninsured adults, make sure you are aware of the potential benefits with health insurance exchanges, because they may qualify.
  • Make sure you are aware of impending deadlines regarding the implementation of certain aspects associated with electronic medical records because penalties can be assessed for missing deadlines.

 

Who Takes the Lead?

There are a lot of moving pieces that will contribute to finding success in the new era of healthcare and leaders must emerge to help forge pathways that others can follow. Hospitalists will be among those leaders, says Jeffrey H. Barsuk, MD, MS, a hospitalist and director of Simulation and Patient Safety for Graduate Medical Education at Northwestern University Feinberg School of Medicine in Chicago.

“At our hospital, we are probably the largest group of physicians involved in healthcare safety, quality, and reform,” he said.

The ACA, he told MedPage Today, is starting to have more of an impact on how he and his colleagues position themselves for the future.

In particular, the new bundled payment and fee-per-encounter models are ideal scenarios where hospitalists can make a difference by bridging gaps in the continuity of care and helping to shorten the length of stay without compromising quality.

Hospitalists can, for example, provide smoking cessation counseling for heart patients, discuss the importance of medication adherence, and check to ensure there are no contraindications to the medications or no potential for drug-drug adverse interactions.

Ultimately, though, clinicians at all levels, primary care practitioners and specialists, will need to work closely together because, as interventionalist Tu noted, government intervention that is not well thought out can backfire. The ACA might save money in the short run, Tu said, but in the long term, there is a great potential “to damage the care of patients and harm the profession of medicine. Already many good people don’t want to be in the field anymore.”

http://www.medpagetoday.com/Washington-Watch/Reform/40164?xid=nl_mpt_DHE_2013-06-29&utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&eun=g406134d0r&userid=406134&email=serbangg@gmail.com&mu_id=5783576 

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FDA Recalls GE’s Infinia Hawkeye 4 Nuclear Medicine System used in Nuclear Medicine Imaging for Detection of Radioisotope Tracer Uptake in the Patient’s body

Reporter: Aviva Lev-Ari, PhD, RN

Hospital Death Forces Recall of GE Healthcare‘s Nuclear Medicine Machines

7/30/2013 7:36:26 AM

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Hospital patients face delays after 120 nuclear medicine machines were recalled across Australia following the death of a patient in the US. Authorities ordered hospitals across Australia to stop using the nuclear medicine imaging systems, preventing patients from being scanned while the machines are checked for safety. A 66-year-old patient being scanned in a veterans’ hospital in New York was crushed when a GE Healthcare Infinita Hawkeye 4 system collapsed when bolts securing the machine came loose.

http://www.devicespace.com/news_story.aspx?NewsEntityId=304157&type=email&source=DS_073013

 

Hospital death forces recall of nuclear medicine machines across Australia

HOSPITAL patients face delays after 120 nuclear medicine machines were recalled across Australia following the death of a patient in the US.

Authorities ordered hospitals across Australia to stop using the nuclear medicine imaging systems, preventing patients from being scanned while the machines are checked for safety.

A 66-year-old patient being scanned in a veterans’ hospital in New York was crushed when a GE Healthcare Infinita Hawkeye 4 system collapsed when bolts securing the machine came loose.

The recall notice was sent to Australian hospitals including the Women’s and Children’s Hospital more than a month later on July 9.

Six of 91 systems in Australian centres checked so far require repair to prevent a similar collapse, according to federal health officials, with 29 still to be checked.

Ten were operating in South Australian hospitals including two at the Royal Adelaide Hospital and one each at the Women’s and Children’s, the Queen Elizabeth Hospital and Lyell McEwin Hospital, with the others in private clinics.

GE Healthcare inspectors have inspected seven of these so far and not found any problems,.

SA Health, however, so far has only released one at the RAH and one at the QEH for use.

It released a statement to The Advertiser saying it had “a fleet of gamma cameras across South Australian public hospitals.”

“Five were identified as being in scope of the review,” the statement says. “Use of these five cameras was suspended immediately and GE is currently in the process of reviewing the machines. Two cameras have already been cleared and have resumed scanning.

“SA Health is working with GE Healthcare to minimise the impact on patients during this review.

“However some patient appointments have required rescheduling or rebooking on a different camera. There have been no incidents involving SA Health cameras.”

The systems, estimated to be worth from $300,000 to $800,000 depending on the model, track radiation emitted by radioactive fluids injected into patients to build images of organs and deep tissue to diagnose a range of diseases.

Information generated can pinpoint diseases before anatomical changes in organs and has some advantages over some other scanning techniques such as MRI and CAT scans.

Patients lie on their back with lead encased panels housing gamma cameras above and around them to track the radiation, and the entire machine can weigh in excess of 2000kg.

No deaths or injuries related to the safety issue have been reported in Australia.

The Therapeutic Goods Administration released a statement over the recall, advising patients to speak to their health professional if they have concerns.

“Due to the prevalence of affected nuclear medicine imaging systems in Australia and the need to have such systems inspected regarding this issue before use, there may be delays in accessing some diagnostic scan services,” the statement says.

In its letter to hospital officials GE Healthcare chief medical office Dr Douglas Hansell says: “Please be assured that maintaining a high level of safety and quality is our highest priority.’

http://www.news.com.au/national-news/south-australia/hospital-death-forces-recall-of-nuclear-medicine-machines-across-australia/story-fnii5yv4-1226680886436

 

GE Healthcare Nuclear Medicine Systems

Recall Class:  Class I

Date Recall Initiated: June 13, 2013

Products: Infinia Nuclear Medicine Systems, VG and VG Hawkeye Nuclear Medicine Systems, Helix Nuclear Medicine Systems, Brivo NM615, Discovery NM630, Optima NM/CT640, Discovery NM/CT670

Models: Infinia 3/8, Infinia-II 3/8, Infinia VC, Infinia II VC, Infinia 3/8 Hawkeye, Infinia VC Hawkeye, Infinia II 3/8 Hawkeye, Infinia II VC Hawkeye, Infinia II 3/8 HE4, Infinia II 5/8 HE4, Infinia II VC HE4, Varicam, Millennium VG 3/8, Millennium VG 5/8, Millennium VG 3/8 Hawkeye, Millennium VG 5/8 Hawkeye, Discovery VH, Helix nuclear medicine systems, Brivo NM615, Discovery NM630, Optima NM/CT640, Discovery NM/CT670

These affected products were distributed from October, 1992 through June, 2013.

Use:  These Nuclear Medicine systems are used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient’s body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET – also known as Coincidence Detection). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.

Recalling Firm: 
GE Healthcare, LLC
3000 N Grandview Blvd.
Waukesha WI 53188-1615

Manufacturer:  
GE Medical System Israel Ltd
4 Hayozma St.
Tirat Hacarmel, Israel

Reason for Recall: GE Healthcare became aware of an incident at a VA Medical Center facility in the US. A patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. On July 03, 2013 GE notified hospitals that they were recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall. GE advised hospitals that they cease use of their Nuclear Medicine systems until GE can complete an inspection of the system. In the second notification, GE included all Nuclear Medicine Systems.

Public Contact: For questions about this recall contact GE Healthcare Service Representative at 1-800-437-1171

FDA District: Minneapolis District Office

FDA Comments:

On June 17, 2013 GE sent an Urgent Medical Device Correction letter to all affected customers. The letter identified the affected product, recommended that qualified service personnel maintain the equipment and that Preventative Maintenance procedures were executed according to labeling. In addition, the Safety Chapter Sections should be re-reviewed with personnel to ensure proper operation of the equipment.

On July 03, 2013 GE notified customers again via an Urgent Medical Device Recall letter (including confirmation of delivery for US customers) and follow-up telephone calls. Healthcare facilities are instructed to cease use of their Nuclear Medicine system until a GE Healthcare Field Engineer is able to do a complete inspection of the system and perform any necessary repairs at no cost. A GE Healthcare representative will contact the hospitals to arrange for the inspection.

Physicians: No action is required beyond the recommendations provided in the Urgent Medical Device Recall letter.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Additional Links

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm362946.htm

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Could Teleradiology contribute to “cross-borders” standardization of imaging protocols in cancer management?

Writer: Dror Nir, PhD

Teleradiology is accepted as a legitimate medical service for several years now.  It has many clinical utilities worldwide, ranging from services for expert or second opinions to comprehensive remote management of radiology departments in hospitals. Rapid advances in web-technologies infrastructure eliminated the barriers related to the transfer, reading and reporting of radiology images from remote locations. Today’s main controversies are related to issues that are relevant also to “in-house” radiology departments; e.g. clinical governance, quality assessment, work-flow and medico-legal issues.

The concept of Teleradiology is as simple as plotted in this chart.

fig1

Images are automatically uploaded from the imaging system itself or from the institution’s PACS. Reports are sent to the “client” within few hours.

The value for the users goes well beyond mere image interpretation, for example:

  • On-site physicians have more time to spend with patients.
  • Offering of additional subspecialty/multidisciplinary expertise.
  • Comprehensive image-interpretation and reporting service at reduced time-span and reduced cost
  • Sharing images and reports with referring physicians and patients with no effort.

As an example for “cross-border” standardization of a major existing radiology service, let’s consider the use-case of centralized review of mammography images. I know, quite ambitious! And; politically very challenging!

But; seem to be technologically and clinically feasible, at least according to the below quoted publication:

Teleradiology with uncompressed digital mammograms: Clinical assessment

Julia Fruehwald-Pallamar, Marion Jantsch, Katja Pinker, Ricarda Hofmeister, Friedrich Semturs, Kathrin Piegler, Daniel Staribacher, Michael Weber, Thomas H. Helbich

published online 13 April 2012.

Abstract 

Purpose

The purpose of our study was to demonstrate the feasibility of sending uncompressed digital mammograms in a teleradiologic setting without loss of information by comparing image quality, lesion detection, and BI-RADS assessment.

Materials and methods

CDMAM phantoms were sent bidirectionally to two hospitals via the network. For the clinical aspect of the study, 200 patients were selected based on the BI-RAD system: 50% BI-RADS I and II; and 50% BI-RADS IV and V. Two hundred digital mammograms (800 views) were sent to two different institutions via a teleradiology network. Three readers evaluated those 200 mammography studies at institution 1 where the images originated, and in the two other institutions (institutions 2 and 3) where the images were sent. The readers assessed image quality, lesion detection, and BI-RADS classification.

Results

Automatic readout showed that CDMAM image quality was identical before and after transmission. The image quality of the 200 studies (total 600 mammograms) was rated as very good or good in 90–97% before and after transmission. Depending on the institution and the reader, only 2.5–9.5% of all studies were rated as poor. The congruence of the readers with respect to the final BI-RADS assessment ranged from 90% and 91% at institution 1 vs. institution 2, and from 86% to 92% at institution 1 vs. institution 3. The agreement was even higher for conformity of content (BI-RADS I or II and BI-RADS IV or V). Reader agreement in the three different institutions with regard to the detection of masses and calcifications, as well as BI-RADS classification, was very good (κ: 0.775–0.884). Results for interreader agreement were similar.

Conclusion

Uncompressed digital mammograms can be transmitted to different institutions with different workstations, without loss of information. The transmission process does not significantly influence image quality, lesion detection, or BI-RADS rating.

Keywords: Breast cancerImagingDigital mammographyTeleradiologyComparative studies

 

What could be the benefits from centralizing mammography interpretation through Teleradiology?

  • A baseline protocol that could enable pulling together large number of cases from different populations without having to worry about differences in practice and experience of reporters. This will enable better epidemiology studies of this disease.
  • Quantified measure, in real-time, of the relative quality of imaging between institutions could contribute to bringing all screening services to a maximal level.
  • Development of comprehensive training program for radiologists involved in mammography based screening of breast cancer.
  • Better information sharing between all players involved in the pathway of each individual patient could improve clinical decision making and patient’s support.
  • Lower costs of screening programs, disease treatment and follow-up.

Who could organize and carry out such an operation?

There are many reputable large university hospitals already offering Teleradiology services. They are already supported by government’s funds in addition to the fact that the service itself is carrying profits. I’m not listing any of these for obvious reasons, but; google “teleradiology” will bring you many results.

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