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Service providers to the medical device manufacturing industry offering reimbursement services.

Minnesota rolls out incentive-based pay-for-performance program

July 19, 2010 by MedCity News

In an attempt to reduce costs, Minnesota health officials launched an incentive-based payment system for hospitals and ambulatory firms to offer better care.

MedCity News logo

By Thomas Lee

To improve healthcare in Minnesota, the state is now offering providers a little more than the proverbial pat on the back.

Earlier this month, Minnesota health officials launched an incentive-based payment system for hospitals and ambulatory firms who treat patients enrolled in the state's health insurance programs.

Medicare Proposes FY2011 Inpatient Payments for Acute Care Hospitals

May 25, 2010 by Kathryn Barry

Medicare's FY2011 Inpatient Prospective Payment System (IPPS) proposed rule was released on Medicare's website March 19 and published in the Federal Register (PDF) May 4. The attached worksheet specifies Medicare's proposed FY2011 national average payments for a range of spinal procedures (PDF), effective October 1. Upon close review, you will see:

FDA: ReGen's Menaflex data inadequate

March 22, 2010 by MassDevice staff

The Food & Drug Administration says ReGen Biologics Inc. didn't prove the safety of its controversial Menaflex knee implant, ahead of a March 23 panel meeting to re-evaluate the device's 2008 510(k) clearance.

FDA logo

The Food & Drug Administration said ReGen Biologics Inc. (OTC:RGBO) failed to produce adequate evidence that its Menaflex knee implant was safe before it was cleared to hit the market in late 2008.

Documents released by the federal watchdog agency question whether the Hackensack, N.J.-based company supplied enough data on pre-clinical mechanical testing of the device, which is designed to repair damage to the meniscus cartilage in the knee. The documents also question ReGen's claims that the device is similar enough to other devices for shoulder, bladder and hernia repair to merit the FDA's fast-track 510(k) clearance process.

Healthcare reform is a matter of scale

February 15, 2010 by Edward Berger

Optimal healthcare reform requires reimbursement models matched to providers' organizational capabilities.

Healthcare reform is a matter of scale

I've recently encountered a number of articles questioning the usefulness of comparative effectiveness research. For example, Keith Winstein, writing in the Wall Street Journal Feb. 10, details the failure of medical practice to adapt to findings from the Courage trial — reported to great acclaim in the New England Journal of Medicine in 2007 — about the relative effectiveness of drug therapy and stenting in relieving chronic chest pain.

Clearing a path to reimbursement, Part II

January 24, 2010 by Edward Berger

Demonstrating clinical evidence is the place to begin ensuring that your new medical technology can win reimbursement.

Clearing a path to reimbursement, Part II

If "Do you have a code?" is the wrong question to ask when assessing the reimbursement prospects of an innovative device, drug, or diagnostic, is there a right one — a single question that can separate the life science reimbursement gold from the technological base metals that insurers won't likely pay for? Yes there is, and it's a question I don't often hear asked in a clear and concise way:

"Can you demonstrate, with evidence strong enough to withstand rigorous review, predictable clinical benefits to a defined patient population?"

Stated even more simply: "Can you prove your technology's clinical utility?"

CMS shifts coverage on HIV screening

December 8, 2009 by MassDevice staff

The Centers for Medicare and Medicaid Services will cover annual HIV screening for at-risk individuals and pregnant women, hoping to slow the spread of the virus among older populations.

CMS shifts coverage on HIV screening

The Centers for Medicare and Medicaid Services shifted gears on its reimbursement policy for both standard and rapid HIV tests, in an attempt to catch more undiagnosed cases in vulnerable populations.

The national insurer changing a statute to make it easier for people whose behavior puts them at greater risk of contracting the virus to get annual screening.

CMS said it will now reimburse physicians for annual HIV screening for the following populations:

  • Men who have had sex with men after 1975;
  • Men and women having unprotected sex with multiple partners;
  • Past or present injection drug users;

MassDevice Q&A: Charles Mathews

October 1, 2009 by Brad Perriello

The Boston Healthcare Associates reimbursement expert dishes on the healthcare reform push and how it will affect medical device makers, ahead of his keynote speech at the MassMEDIC 11th Annual Medtech Investors Conference.

MassDevice Q&A: Charles Mathews

Charles Mathews is no stranger to Capital Hill, having worked as a legislative aide to Reps. David Price (D-N.C.) and Rob Andrews (D-N.J) in the early years of the decade. That experience comes in handy in his role a director at Boston Healthcare Associates, where he's keeping tabs on the ever-evolving debate over healthcare reform in Washington.

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Preferred Vendors

Consulting, Regulatory

Emergo Group, Inc.
Regulatory charts and consulting

Plastics / Molded Products, Original Equipment Manufacturer

SMC Ltd. (Scientific Molding Corp.)
Manufactures injection-molded, single-use disposable medical devices

Consulting, Legal

National Standards Authority of Ireland
Provides regulatory compliance services

Reimbursement, Salesforce Development and Training, Reimbursement

Medical Education Training Associates LLC (META)
Provides a suite of consulting services for medical device companies
Reimbursement Planning, Health Policy Training
Salesforce development and Management training

Legal

Greenberg Traurig LLP
Provides legal services

Original Equipment Manufacturer

Admet
Static and Dynamic testing systems for materials, components, and devices. Systems range from 50 grams to 600kN of force capacity in tension, compression, torsion, and more.
Provides grips, fixtures, heating and cooling systems, and fluid baths.

Machining, Prototype Manufacturing, Design / Engineering

Roush Life Sciences
Provides design and engineering, rapid prototyping, tooling, engineering and manufacturing services for life science companies
A Division of Roush Enterprises

Publishing, Software / IT, Consulting

Cine-Med Inc.
Produces medical films and publishes continuing education. materials for medical device companies
McClellan Automation Systems
Manufactures custom automated systems and special process machinery

Assay Testing, Other

Instron
Precision testing instrumentation and services for materials, components, and structures in R&D, Quality Control and Production environments.

Communications / PR, Marketing

Seidler Bernstein
Provides marketing and PR services
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