Rare Genes Partnering Forum (September 14, 2017, Irvine)

For an unusual conference, see Rare Genes Partnering and Investor Forum, a two day conference in Irvine California on September 14, 2017.  Website here.

Cut/paste of Agenda after the break.

Class III Devices (PMA) Are Excluded from Competitive Bidding.

 

We noted that the legislative authority for competitive bidding appears to exclude CLASS III DEVICES (e.g. PMA devices).   

See page 17996, right column, at this link:

   https://www.cms.gov/Regulations-and-Guidance/Regulations-and-Policies/QuarterlyProviderUpdates/Downloads/cms1270f.pdf

   From a quick view of the current Statute governing competitive bidding, it appears Social Security Act at 1847(a)(2) excluding PMA from competitive bidding has not changed since 2007 (see here:   https://www.ssa.gov/OP_Home/ssact/title18/1847.htm    )

 

Screen Shots of Medicare MEDCAC Database 1999-2017

https://www.cms.gov/medicare-Coverage-database/indexes/medcac-meetings-index.aspx?year=All&bc=AAAIAAAAAAAAAA%3d%3d&#ResultsSection
 
Taken 8/25/2017.

 

2017

[2 Records]

MEDCAC Meetings

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MEETING DATE	MEDCAC TITLE	SELECT ALL
03/22/2017	Health Outcomes in Heart Failure Treatment Technology Studies
08/30/2017	Health Outcomes After Bariatric Surgical Therapies in the Medicare Population
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2016

[2 Records]

MEDCAC Meetings

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MEETING DATE	MEDCAC TITLE	SELECT ALL
04/27/2016	Treatment Resistant Depression
07/20/2016	Lower Extremity Chronic Venous Disease
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2015

[2 Records]

MEDCAC Meetings

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MEETING DATE	MEDCAC TITLE	SELECT ALL
03/24/2015	Molecular Pathology Testing to Estimate Prognosis in Cancer
07/22/2015	Lower Extremity Peripheral Artery Disease
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2014

[1 Record]

MEDCAC Meetings

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MEETING DATE	MEDCAC TITLE	SELECT ALL
04/30/2014	Lung Cancer Screening with Low Dose Computed Tomography
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2013

[2 Records]

MEDCAC Meetings

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MEETING DATE	MEDCAC TITLE	SELECT ALL
01/30/2013	Beta Amyloid Positron Emission Tomography (PET) in Dementia and Neurodegenerative Disease
05/01/2013	Genetic Tests for Cancer Diagnosis
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2012

[4 Records]

MEDCAC Meetings

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MEETING DATE	MEDCAC TITLE	SELECT ALL
01/25/2012	Management of Carotid Atherosclerosis
03/21/2012	Anti-VEGF Treatment of Diabetic Macular Edema
05/16/2012	Evidentiary Characteristics for Coverage with Evidence Development (CED)
11/14/2012	Management of Heart Failure with the Use of Ventricular Assist Devices
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2011

[3 Records]

MEDCAC Meetings

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MEETING DATE	MEDCAC TITLE	SELECT ALL
01/19/2011	The Impact of ESA Use on Renal Transplant Graft Survival
05/11/2011	Cochlear Implants for Sensorineural Hearing Loss
11/09/2011	The Use of ECG Based Signal Analysis Technologies to Detect Myocardial Ischemia or Coronary Artery Disease
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2010

[5 Records]

MEDCAC Meetings

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MEETING DATE	MEDCAC TITLE	SELECT ALL
01/27/2010	Pharmacogenomic Testing in Cancer
03/24/2010	Erythopoiesis Stimulating Agents (ESA) in Anemia Related to Kidney Disease
04/21/2010	Radiation Therapy for Localized Prostate Cancer
09/22/2010	On Label and Off-Label Use of Bone Morphogenetic Proteins (BMPs)
11/17/2010	On Label and Off-Label Use of Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer
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2009

[5 Records]

MEDCAC Meetings

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MEETING DATE	MEDCAC TITLE	SELECT ALL
02/25/2009	Genetic (Genomic) Testing
05/06/2009	Screening Genetic Tests
06/17/2009	Bayesian statistical methods and Medicare evidence MEDCAC
10/21/2009	Catheter Ablation for the Treatment of Atrial Fibrillation
11/18/2009	Lymphedema
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2008

[4 Records]

MEDCAC Meetings

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MEETING DATE	MEDCAC TITLE	SELECT ALL
04/30/2008	Medicare Evidentiary Priorities
05/21/2008	Desirable Characteristics of Clinical Trials on Rehabilitative Strategies for Stroke
08/20/2008	FDG Positron Emission Tomography (PET) for 9 Cancers (brain, cervical, small cell lung, ovarian, pancreatic, testicular, prostate, bladder and kidney
11/19/2008	Computed Tomography Colonography (CTC)
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2007

[3 Records]

MEDCAC Meetings

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MEETING DATE	MEDCAC TITLE	SELECT ALL
07/18/2007	Percutaneous Transluminal Angioplasty (PTA) and Stenting of the Renal Arteries
09/12/2007	Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA)
10/22/2007	CMS Evidentiary Priorities
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2006

[5 Records]

MEDCAC Meetings

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MEETING DATE	MEDCAC TITLE	SELECT ALL
03/30/2006	Compendia for coverage of off-label uses of drugs and biologicals in an anti-cancer chemotherapeutic regimen
05/18/2006	Non-invasive diagnostic imaging compared with coronary artery angiography in the diagnosis of coronary artery disease
08/30/2006	Glycemic Control
11/30/2006	Spinal Fusion for the Treatment of Low Back Pain Secondary to Lumbar Degenerative Disc Disease
12/13/2006	Clinical Trial Policy
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2005

[5 Records]

MEDCAC Meetings

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MEETING DATE	MEDCAC TITLE	SELECT ALL
01/25/2005	Physician-supervised behavioral interventions for patients with symptomatic coronary artery disease
03/29/2005	Usual Care of Chronic Wounds
05/24/2005	Treatments for Vertebral Body Compression Fractures
10/06/2005	Treatments for Bone Fractures That Fail to Progress to Union
11/29/2005	Age-related Macular Degeneration
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2004

[3 Records]

MEDCAC Meetings

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MEETING DATE	MEDCAC TITLE	SELECT ALL
07/14/2004	Transmyocardial revascularization (TMR) / Percutaneous Myocardial Revascularization (PMR)
09/28/2004	Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA)
11/04/2004	Bariatric Surgery for Treatment of Morbid Obesity
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2003

[3 Records]

MEDCAC Meetings

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MEETING DATE	MEDCAC TITLE	SELECT ALL
02/12/2003	Implantable Cardioverter Defibrillators
03/12/2003	Ventricular Assist Devices as Destination Therapy
09/09/2003	Ocular Photodynamic Therapy with Verteporfin for Macular Degeneration
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2002

[4 Records]

MEDCAC Meetings

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MEETING DATE	MEDCAC TITLE	SELECT ALL
01/10/2002	Positron Emission Tomography (FDG) for Alzheimer's Disease/Dementia (Diagnostic Imaging Panel)
04/16/2002	Positron Emission Tomography (FDG) for Alzheimer's Disease/Dementia (Executive Committee)
06/12/2002	Deep Brain Stimulation for Parkinson's Disease (Medical and Surgical Procedures Panel)
09/25/2002	Deep Brain Stimulation for Parkinson's Disease (Executive Committee)
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2001

[6 Records]

MEDCAC Meetings

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MEETING DATE	MEDCAC TITLE	SELECT ALL
02/21/2001	Ambulatory Blood Pressure Monitoring (Medical Devices and Prosthetics Panel)
02/22/2001	Electrostimulation for Wounds & Sacral Nerve Stimulation for Urge Urinary Incontinence (Executive Committee)
06/14/2001	Ambulatory Blood Pressure Monitoring (Executive Committee)
06/19/2001	Positron Emission Tomography (FDG) for Breast Cancer (Diagnostic Imaging Panel)
06/20/2001	Levocarnitine for End Stage Renal Disease (Drugs, Biologics, and Therapeutics Panel)
10/17/2001	Levocarnitine for End Stage Renal Disease & Positron Emission Tomography (FDG) for Breast Cancer (Executive Committee)
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2000

[6 Records]

MEDCAC Meetings

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MEETING DATE	MEDCAC TITLE	SELECT ALL
03/01/2000	Executive Committee
04/12/2000	Urinary Incontinence (Medical and Surgical Procedures Panel)
06/06/2000	Urinary Incontinence (Executive Committee)
10/17/2000	Electrostimulation for Wounds (Medical and Surgical Procedures Panel)
10/18/2000	Sacral Nerve Stimulation for Urge Urinary Incontinence (Medical and Surgical Procedures Panel)
11/07/2000	Positron Emission Tomography (FDG) (Executive Committee)
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1999

[3 Records]

MEDCAC Meetings

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MEETING DATE	MEDCAC TITLE	SELECT ALL
09/15/1999	Autologous Stem Cell Transplantation (AuSCT) for Multiple Myeloma (Drugs, Biologics, and Therapeutics Panel)
11/15/1999	Human Tumor Assay Systems (Laboratory and Diagnostic Services Panel)
12/08/1999	Autologous Stem Cell Transplantation (AuSCT) for Multiple Myeloma & Human Tumor Assay Systems (Executive Committee)