Impact of COVID-19 on Diagnostic Cardiac Procedural Volume in Oceania: The IAEA Non-Invasive Cardiology Protocol Survey on COVID-19 (INCAPS COVID).

OBJECTIVES: The INCAPS COVID Oceania study aimed to assess the impact caused by the COVID-19 pandemic on cardiac procedure volume provided in the Oceania region. METHODS: A retrospective survey was performed comparing procedure volumes within March 2019 (pre-COVID-19) with April 2020 (during first wave of COVID-19 pandemic). Sixty-three (63) health care facilities within Oceania that perform cardiac diagnostic procedures were surveyed, including a mixture of metropolitan and regional, hospital and outpatient, public and private sites, and 846 facilities outside of Oceania. The percentage change in procedure volume was measured between March 2019 and April 2020, compared by test type and by facility. RESULTS: In Oceania, the total cardiac diagnostic procedure volume was reduced by 52.2% from March 2019 to April 2020, compared to a reduction of 75.9% seen in the rest of the world (p<0.001). Within Oceania sites, this reduction varied significantly between procedure types, but not between types of health care facility. All procedure types (other than stress cardiac magnetic resonance [CMR] and positron emission tomography [PET]) saw significant reductions in volume over this time period (p<0.001). In Oceania, transthoracic echocardiography (TTE) decreased by 51.6%, transoesophageal echocardiography (TOE) by 74.0%, and stress tests by 65% overall, which was more pronounced for stress electrocardiograph (ECG) (81.8%) and stress echocardiography (76.7%) compared to stress single-photon emission computerised tomography (SPECT) (44.3%). Invasive coronary angiography decreased by 36.7% in Oceania. CONCLUSION: A significant reduction in cardiac diagnostic procedure volume was seen across all facility types in Oceania and was likely a function of recommendations from cardiac societies and directives from government to minimise spread of COVID-19 amongst patients and staff. Longer term evaluation is important to assess for negative patient outcomes which may relate to deferral of usual models of care within cardiology.

Horizon scanning of new and emerging medical technology in Australia: its relevance to Medical Services Advisory Committee health technology assessments and public funding.

OBJECTIVES: In 1998, a formal process using full health technology assessments (HTAs) was implemented to determine the suitability for public subsidy of new and emerging medical technologies in the Australian private healthcare sector. This process is overseen by the Medical Services Advisory Committee (MSAC). In 2004, horizon scanning was introduced in Australia with the stated objective of identifying new and emerging medical technologies into the public healthcare sector, with consideration to the publicly subsidized private healthcare sector. How well horizon scanning works in identifying new and emerging technologies suitable for government subsidized funding in the private healthcare sector is examined in this study. METHODS: A descriptive evaluation of the impact of horizon scanning as an early alert and awareness system identifying new and emerging technologies before these technologies are submitted to MSAC for a full HTA. All MSAC HTAs commenced after the introduction of horizon scanning in 2004 were cross-checked with the list of Prioritizing Summaries or Horizon Scanning Reports to determine whether a prior Prioritizing Summary or Horizon Scanning Report had been carried out. RESULTS: Of the forty-three technologies that were the subject of a full MSAC HTAs in the time period examined, only eleven had been the subject of either a Prioritizing Summary or Horizon Scanning Report. As a result of a full MSAC HTA, twelve of the technologies that were not the subject of a Prioritizing Summary or Horizon Scanning Report were given positive recommendations for public funding. CONCLUSIONS: Horizon scanning was set up to scan the introduction of new and emerging medical technologies into the public healthcare sector, with consideration to the publicly subsidized private healthcare sector. Based on the number of new and emerging technologies that have been the subject of a full MSAC HTA without first being subjected to either a Prioritizing Summary or Horizon Scanning Report, horizon scanning in Australia does not function as an "early alert and awareness system" for funding in the publicly subsidized private healthcare sector in Australia.

A successful practical application of Coverage with Evidence Development in Australia: Medical Services Advisory Committee interim funding and the PillCam Capsule Endoscopy Register.

BACKGROUND: In August 2002, an application for the listing on the Medicare Benefits Schedule (MBS) of PillCam Capsule Endoscopy (formally M2A) as a diagnostic procedure for obscure gastrointestinal bleeding (OGIB) was made to the Medical Services Advisory Committee (MSAC). As a result of this application, in May 2004 PillCam Capsule Endoscopy was approved with interim funding until April 2007. This funding was conditional on the collection of Australian data on the long-term safety, effectiveness, and cost-effectiveness of capsule endoscopy. METHODS: A review was conducted of how the data were collected, the methodological difficulties associated with the collection and analysis of the data, and the outcomes of the data. RESULTS: The PillCam Capsule Endoscopy Register ran from 2004 to 2007 and amassed data on 4,099 patients forming the largest database on PillCam in the world. Based on these data, in November 2007, MSAC recommended that full public funding be supported under the current MBS Item Number 11820 as capsule endoscopy is as safe as and more effective than comparable diagnostic tests. It is the preferred choice of patients and has the potential to reduce the number and cost of previous investigations. CONCLUSIONS: This form of CED proved to be ideally suited to PillCam Capsule Endoscopy. The PillCam Capsule Endoscopy Register provided data that made it possible to validate assumptions used in the economic modeling in the assessment carried out for MSAC in response to the application for funding. DISCUSSION: The use of interim funding requires both risk and cost sharing among the key players: industry, government, the medical profession, and the hospitals. Although the characteristics of PillCam Capsule Endoscopy proved to be suited to data collection, this may not be the case with other emerging health technologies. If interim funding coupled with data collection is to become an effective mechanism for bridging the evidence gap, work needs to be carried out by health technology assessment agencies to provide guidance on the design of registers so that they cater for the unique characteristics of individual procedures.

Are repeat upper gastrointestinal endoscopy and colonoscopy necessary within six months of capsule endoscopy in patients with obscure gastrointestinal bleeding?

BACKGROUND AND AIM: Medicare reimbursement for capsule endoscopy for the investigation of obscure gastrointestinal bleeding in Australia requires endoscopy and colonoscopy to have been performed within 6 months. This study aims to determine the diagnostic yield of repeating these procedures when they had been non-diagnostic more than 6 months earlier. METHODS: Of 198 consecutive patients who were referred for the investigation of obscure gastrointestinal bleeding, 50 underwent repeat endoscopy and colonoscopy solely to enable reimbursement (35 females and 15 males; mean age 59.4 [range: 21-82] years). The average duration of obscure bleeding was 50.16 (range: 9-214) months. The mean number of prior endoscopies was 3 (median: 2) and 2.8 colonoscopies (median: 2). The most recent endoscopy had been performed 18.9 (median: 14; range: 7-56) months, and for colonoscopy, 19.1 (median 14; range 8-51) months earlier. RESULTS: A probable cause of bleeding was found at endoscopy in two patients: gastric antral vascular ectasia (1) and benign gastric ulcer (1). Colonoscopy did not reveal a source of bleeding in any patient. Capsule endoscopy was performed in 47 patients. Twenty four (51%) had a probable bleeding source identified, and another five (11%) a possible source. These included angioectasia (17 patients), mass lesion (2), non-steroidal anti-inflammatory drug enteropathy (2), Cameron's erosions (2), and Crohn's disease (1). Four patients undergoing repeat capsule endoscopy had a probable bleeding source detected. CONCLUSION: The yield of repeat endoscopy and colonoscopy immediately prior to capsule endoscopy is low when these procedures have previously been non-diagnostic. Such an approach is also not cost-effective.

The Australian experiment: the use of evidence based medicine for the reimbursement of surgical and diagnostic procedures (1998-2004).

BACKGROUND: In 1998 a formal process using the criteria of safety, effectiveness and cost-effectiveness (evidence based medicine) on the introduction and use of new medical procedures was implemented in Australia. As part of this process an expert panel, the Medical Services Advisory Committee (MSAC) was set up. This paper examines the effectiveness of this process based on the original criteria, that is, evidence based medicine. METHOD: The data for this analysis was sourced primarily from that made available in the public domain. The MSAC web site provided Minutes from MSAC meetings; Annual Reports; Assessment and Review reports; Progress status; and Archived material. RESULTS: The total number of applications submitted to the MSAC has been relatively low averaging approximately only fourteen per year. Additionally, the source of applications has quickly shifted to the medical devices, equipment and diagnostic industry as being the major source of applications. An overall average time for the processing of an application is eighteen months. Negative recommendations were in most cases based on insufficient clinical evidence rather than clinical evidence that clearly demonstrated a lack of clinical effectiveness. It was rare for a recommendation, either positive or negative, to be based on cost-effectiveness. CONCLUSION: New medical procedures are often the result of a process of experimentation rather than formally conducted research. Affordability and the question of who should pay for the generation, collection and analysis of the clinical evidence is perhaps the most difficult to answer. This is especially the case where the new procedure is the result of a process of experimentation with an old procedure. A cost-effective way needs to be found to collect acceptable levels of evidence proving the clinical effectiveness of these new procedures, otherwise the formal processes of evaluation such as that used by the Australian MSAC since 1998 will continue to run the risk of committing Type II errors, that is, denying access to medical procedures that are beneficial and efficient.

Outcomes of sleeve gastrectomy for morbid obesity: a safe and effective procedure?

BACKGROUND: Sleeve gastrectomy is being performed with increasing frequency in Australia for the treatment of morbid obesity. The aims of this study were to show that sleeve gastrectomy can be performed safely with a low rate of complications and effective short to medium term weight loss. METHODS: A retrospective review of prospectively collected data from a single surgeon series between 2006 and 2009. RESULTS: A total of 185 patients were treated with laparoscopic sleeve gastrectomy (LSG) over a three-year period. The percentage excess weight loss (%EWL) was 47.2% at one year, 60.7% at two years and 66% at three years. There were no leaks; two staple line bleeds requiring reoperation via laparoscopy, one port site infection and one port site incisional hernia. There were no deaths. The average operating time was 111 min and the average hospital length of stay was 2.35 days. CONCLUSION: Laparoscopic sleeve gastrectomy can be performed safely and with excellent weight loss. More long term follow up is required.

Review of a decision by the Medical Services Advisory Committee based on health technology assessment of an emerging technology: the case for remotely assisted radical prostatectomy.

OBJECTIVES: In April 1998, the Medical Services Advisory Committee (MSAC) was established by the Australian federal government. Since that time, all new medical procedures must be evaluated for safety, effectiveness, and cost-effectiveness as a condition of the surgeon receiving public funding by means of the Medicare Benefits Schedule (MBS). Over these first 8 years, a significant number of applications for the public funding of new procedures have been given negative recommendations by the MSAC based on insufficient clinical evidence or lack of cost-effectiveness. In August 2006, after almost 2 years of processing, the MSAC made the decision to fund the new procedure, laparoscopic remotely assisted radical prostatectomy (LRARP). However, they stated that there was still uncertainty about the comparative cost-effectiveness. METHODS: An observational study using provisional cost-utility data for LRARP based on a combination of costs taken from consecutive patients at the Epworth Hospital, Melbourne, Australia, and utilities from the prospectively collected data on all patients undergoing surgery for prostate cancer over a 4-year period at the Vattikuti Urology Institute, Michigan, United States. RESULTS: The incremental cost for LRARP compared with the open surgery alternative is A$2,264 or A$24,457 per quality-adjusted life-year, well below the range accepted by the Australian pharmaceutical equivalent of the MSAC (the PBAC) of A$42,000 and A$76,000. This figure does not take into account additional benefits such as reduced time away from employment, reduced blood loss, reduced possibility of infection, and reduced scarring. CONCLUSIONS: This case study of LRARP demonstrates that there is sufficient crude evidence to show that this new procedure is likely to be superior to the existing procedure in terms of safety, effectiveness, and cost-effectiveness. The decision to allow MBS funding was correct and will allow for the collection of additional evidence, on both economic and clinical outcomes.

Cardiac sarcoidosis: an elusive diagnosis.

The diagnosis of sarcoidosis of the heart can be elusive, and is seldom established in life. We report the case of a 43-year-old man who underwent heart transplantation for presumed idiopathic dilated cardiomyopathy. Endomyocardial biopsy before transplantation showed only a mild infiltrate of lymphocytes. Histology of his explanted heart revealed extensive noncaseating granulomas and scarring, typical of sarcoidosis. A diagnosis of sarcoidosis had been made several years before by mediastinoscopic biopsy, after routine chest X-ray revealed mediastinal lymphadenopathy. Aside from the cardiac manifestations, the patient had no other symptoms of this disease. We discuss the inherent difficulties in the diagnosis of this rare but important condition, its varying presentations relating to the underlying pathology, as well as treatment options, including the role of transplantation.