Diabetic Foot Warning Signs

“A photo says a thousand words.” Just take a gander at these feet in a youthful Type I diabetic patient. The foot on the right is clearly contaminated, and it didn’t arrive in such a state over night. There are clear changes that have occurred in this foot after some time for it to look as contaminated as it does. How about we analyze the two feet and show some critical cautioning signs for diabetics. These notice signs ought to be searched for by all diabetic patients on a DAILY premise so that their feet don’t wind up like this one.

1. Shading: the foot on the left looks ordinary in shading instead of the foot on the privilege, which shifts in shading from pink to red to purple and even to yellow to green to dark close to the injury.

2. Swelling: the foot on the left is not swollen, and you can see ordinary tendons over the lower leg, the curve of the foot, typical spaces between the toes, hard prominences like the lower leg bones when contrasted with the foot on the privilege, which is swollen from the leg to the tips of the greater part of the toes.

3. Open wounds: it appears glaringly evident yet since diabetic patients are regularly numb in the feet and toes, they may not feel a rankle or cut or rub on their feet which can rapidly get to be tainted. So it is imperative for diabetics to outwardly review their feet for open wounds like the one seen as an afterthought of the enormous toe of the right foot. This injury began as a rankle from despicably fitting shoes.

4. Seepage: once more, it may appear glaringly evident to a few of us, yet generally as diabetics may not feet a rankle or an open wound on their feet, they may not feel discharge or blood depleting out of a rankle or an open wound. So it is critical for diabetic patients to investigate their socks upon evacuation day by day to make certain that there is no seepage present. Seepage shows an opening. It may not be tainted yet, as on account of a rankle which would have clear to clearish yellow liquid. Anyway rankles get to be contaminated diabetic wounds rapidly if not appropriately treated. In the recent case, the waste would be red to yellow to green, showing blood and discharge.

5. Temperature: clearly, we can’t feel the temperature of these two feet. Be that as it may we should expect this patient was staying here before us. In the event that we ran our hand gently over the lower leg to the lower leg to the toes, we would no doubt feel an ordinary or cool foot on the left and a warm to hot foot on the privilege. Another indication of disease.

6. Agony: once more, we can’t tell if the patient is in torment or not from the photograph. Also, since diabetic patients frequently have diabetic fringe neuropathy (counting deadness of the feet), commonly they don’t have torment, even with a disease as evident as this one. Anyhow when the contamination is extreme like this one, occasionally they do feel the torment. As it went up the foot and leg (recall the swollen leg?), this patient began to feel torment. That is the reason he in the long run came into the workplace for a counsel.

7. Glucose: only one more thing to remember, albeit not something we can assess from the photograph. With diabetic contaminations, the glucose (and in addition other lab qualities like WBC) is high. We weigh blood glucose levels in all diabetic patients in our office. Strange qualities are assessed and examined with patients and their PCPs.

8. Fever: once more, something else to check for with suspected diabetic contaminations, alongside all key signs. In our office, we weigh basic signs in all patients.

Dr. Colon works in diabetic wound consideration, podiatric surgery, and podopediatrics (youngsters’ foot issues). Kindly don’t dither to contact our office with respect to inquiries concerning diabetic foot care.

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Coastal Fertility Specialists opens office in Bluffton

Coastal Fertility Specialists opens office in Bluffton

Coastal Fertility Specialists is expanding its practice to include a new office at 7 Mallett Way in Bluffton.

The office is designed to provide a convenient location for patients not in Bluffton, Savannah, Hilton Head Island and Beaufort. The Bluffton office provides monitoring for all forms of infertility treatment including in vitro fertilization, ovulation induction and the use of frozen embryos.

Wound care centers at St. Joseph’s/Candler recognized

The Center for Hyperbarics and Wound Care at St. Joseph’s/Candler has earned the Center of Distinction Award for achieving outstanding clinical outcomes for 12 consecutive months.

The measured outcomes included patient satisfaction higher than 92 percent, a minimum wound healing rate of at least 91 percent within 30 median days to heal, and other quality outcomes.

St. Joseph’s/Candler now has three wound care locations: Candler Hospital in Savannah, Moss Creek Village in Bluffton and Hinesville, Ga.

There were 506 centers eligible for the Center of Distinction award and 172 achieved the honor.

Wound and ostomy nurse joins Center for Hyperbarics

With the addition of an experienced wound and ostomy nurse, the Center for Hyperbarics and Wound Healing has expanded its services to include ostomy care.

Colette M. Grisham recently joined the center, which is a department of Coastal Carolina Hospital.

Grisham has more than 30 years of nursing experience including wound and ostomy care, case management and nursing administration. Most recently, she provided wound and ostomy care at Bon Secours Home Health Care in Hampton Roads, Va.

Zoës Kitchen opens location in Bluffton

Zoës Kitchen, a fast casual restaurant concept serving a menu of Mediterranean-inspired dishes, continued its expansion in South Carolina with the opening of its Bluffton location March 19.

The restaurant marks the company’s 141st location and eighth in South Carolina. It is located at 1250B Fording Island Rd.

Zoës Kitchen menu items are comprised of fresh produce and lean proteins that are predominantly preservative and additive free. Signature dishes include salads, chicken kabobs, chicken rollups and hummus.

Zoës’ Bluffton location seats about 62 guests in the dining room, including an outdoor patio that seats 34.

Wood+Partners welcomes new staff

Wood+Partners Inc., a regional land planning and landscape architecture firm, recently added staff in its Hilton Head Island office.

Wood+Partners has welcomed back Kathleen Duncan as project manager. She brings more than nine years of design and planning experience and is president elect of the South Carolina American Society of Landscape Architecture Chapter.

Eric Walsnovich joins Wood+Partners as a senior project manager. He brings more than 23 years of landscape architecture and sustainable planning experience to the firm. He has a background in public and private gardens, community planning, and municipal and commercial projects.

Village Self Storage adds structure for RV parking

Village Self Storage in Bluffton has added a covered building for RV parking.

The building is located inside the gated property with a security system and will offer electric and water hookups.

Village Self Storage already offers climate-controlled and regular storage, and parking for cars, boats and RVs.

Stoneworks adds three employees

StoneWorks has added three new employees to its team of experienced professionals.

Jordanna Ebanks is the newest member of the StoneWorks team working in drafting and architectural drawing. Ebanks works with the sales and operations teams in the development and operation of all jobs including data input, processing shop drawings and design layout and modeling.

Devonna Taylor recently joined StoneWorks as a design consultant. Her position is a continuation of more than a decade of design experience in the porcelain, natural stone and slab industry.

Amber Young has joined StoneWorks as a client relations specialists. Her responsibilities include customer support, following up with all orders and following up with clients.

Joan Kelly Group welcomes Foote

The Joan Kelly Group of Keller Williams Realty has added LaTisha Foote to its administrative support team as listing coordinator.

Foote brings with more than 10 years of property management and advertising experience, and will be responsible for coordinating, marketing and managing group listings. She also has extensive experience in customer service and client relations from years of working in military housing and community management.

Coastal Signature Homes announces partner

Coastal Signature Homes has announced a new partner, David Renaker.

Having worked 25-plus years in banking, Renaker brings extensive financial experience to the corporation.

A University of South Carolina graduate, Renaker has worked with small and large banks and most recently with Ameris Bank. He will be responsible for all financial administration at Coastal Signature Homes, along with staff management, handling contracts and contractor and vendor relationships.

Gateway Realty adds to staff

Gateway Realty continues to expand its team.

Wayne Corley is now a broker associate. He served with the Peace Corps and has owned several businesses, including a development and construction company. He founded the Corley Group in 2005 as a residential construction consultant and real estate broker.

Mary Jeans-Otto has joined Gateway as a sales agent. She has been involved in the real estate industry for more than 20 years, most recently working with Weichert Realtors.

Alyssa Pascucci has joined Gateway as a sales agent. She began focusing on her real estate career in Malibu, Calif., with Prudential Malibu Realty and Sotheby’s International Realty.

Daniella Augenstein has joined Gateway as a sales agent. Prior to becoming a licensed Realtor, she worked as a model, bank teller and studio director for a boutique-style movement studio in Cleveland.

Jerry Petitt has joined Gateway as a sales agent. As a licensed realtor since 1979, he has extensive sales experience throughout the Southeast, including Virginia, North Carolina and South Carolina.

Margaret O’Hanlon has joined Gateway as a broker/agent. Prior to relocating to the Lowcountry, she was as an associate broker with the Creig Northrup of Long & Foster Real Estate, the No. 1 real estate team in Maryland.

Weichert, Realtors announces award winners

Weichert, Realtors — Coastal Properties employees were honored by the national franchise organization at the Southeast BROKER Council luncheon Feb. 18.

These brokers earned recognition from among associates in 37 states at year’s end:

• Presidents Club: Wendy Burchfield, Jim Livingston, Sherryl Hennessey, Evelyn Meeder.

• Ambassadors Club: Gail Bromiley, Eric Dollenberg, Irene Jackiewicz, Ann Lilly, Jack Tuney.

• Executive Club: Enid Anderson, Lenore Carter, Renee Fordyce, Patricia Griffith, Roberta Hayes, Robyn Henke, Ruth Kimball, Barbara Mccallion, Bill Rupp, Julia Schroeter.

• Sales Achievement: Tom Beavor, The Bell Team, Jane Grant, Terry Green, Tracy Kelly, Terry Kreissl, Julie Morringello, Michael Rigo, Theodora Titus, Steve Wallace, Dave Wright, Chuck Zapiec.

Weichert, Realtors names new hires

Weichert, Realtors — Coastal Properties recently welcomed several additions to its sales team.

Bob Jones entered the real estate industry in 2006. He developed primary and secondary home site communities in Georgia, Alabama, North Carolina and Pennsylvania. He and his family have resided in Indigo Run Plantation for 16 years.

Steven and Jacqui Katz are members of the Country Club of Hilton Head, where Steven serves on the grounds committee. Jacqui completed training in commercial and residential mortgage lending as well as sales/finance within the auto industry.

Steven was the sole proprietor of a landscape/design/build company, Land & Seascapes, for 35 years. Most recently, Jacqui held the position of business manager for Steven’s company.

Barbara Garrard spent 26 years at Lakewood Hospital (a division of the Cleveland Clinic Health System) as a medical technologist and in laboratory management. She moved to Bluffton last year and began her career in real estate.

Mosia Whitfield is a native of Jamaica who has lived in the U.S. since 2007, the last five years on Hilton Head Island. She worked in the food and beverage industry for more than 10 years.

Matthew Frei worked as a software engineer, senior vice presidents for a broadcasting automation company and in corporate engineering for Turner Broadcasting. He has 19 years’ experience in buying, selling and renovating real estate.

 

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Ellwood City Hospital wound care facility gets recognized

Ellwood City Hospital wound consideration facility gets recompense

By

ELLWOOD CITY – The Mary Evans Wound Care and Hyperbaric Center at Ellwood City Hospital, committed to recuperating perpetual wounds, as of late got a Center of Distinction Award from the inside’s guardian organization, Healogics.

Susan DeMeio, program executive, said it is a critical honor, mirroring the nature of consideration at the inside.

The honor is given when an inside attains to remarkable clinical results for 12 continuous months, including patient fulfillment higher than 92 percent and a base middle wound-recuperating rate of no less than 91 percent inside 30 days to mend. There are 506 focuses qualified for the grant, and 172 have accomplished the honor.

“I am amazingly glad for the clinical and medicinal staff for their diligent work and devotion. To accomplish this grant in the first year of opening says a lot to our dedication to our patients and their families in recuperating incessant wounds,” DeMeio said.

The focal point treats a wide range of wounds – diabetes, injury, ulcers, weight ulcers, diseases and other unending wounds – that have not recuperated in a sensible measure of time. Five specialists take part – a specialist, podiatrist, inward solution doctor, plastic specialist and crisis doctor.

Propelled medicines incorporate hyperbaric oxygen treatment, negative weight and wound treatment, bioengineered skin substitutes, organic and biosynthetic dressings.

The focal point is concentrating on a crusade to teach wellbeing suppliers about interminable wounds brought on by diabetes.

DeMeio said the impact of perpetual wounds brought on by diabetes is vital for Ellwood City-region occupants on the grounds that 11 percent of the aggregate populace living here is influenced by diabetes.

Healogics is headquartered in Jacksonville, Fla., and oversees more than 600 injury consideration focuses in the country.

The Ellwood City focus is in the Mary Evans wing of the healing facility and offers administrations Monday through Friday. For more data, call (724) 752-6926.

Vein facility included

Ellwood City Hospital has included a vein facility, which utilizes the VenaCure EVLT method, to its patient administrations in the Radiology Department. VenaCure EVLT is an insignificantly obtrusive laser treatment for the disposal of varicose veins that is more than 95 percent viable, as per the doctor’s facility.

“It is a nonsurgical treatment to dispense with varicose veins. It’s another endeavor, yet individuals are getting to be mindful of it and utilizing it,” said Cindy Trimble, radiology director.

“Pretty nearly 40 percent of all ladies and 25 percent of all men have varicose veins,” said Dr. Mark Schnurer, chief of the healing center’s Radiology Department. “Since the customary treatment for this condition – surgical vein stripping and ligation – has a tendency to be an excruciating method with a long recuperation time, patients who experience the ill effects of varicose veins regularly choose to simply endure with them.”

In the VenaCure EVLT treatment, a laser fiber is embedded in the vein through a minor cut site. The laser stimulates the fiber as it is withdrawn from the vein. Vitality discharged from the tip of the fiber causes just the treated vein to close, while the body consequently courses the blood to other sound veins. The patient gets nearby sedative and encounters next to zero uneasiness amid the 45-moment strategy, the healing facility said. After treatment, a patient can continue ordinary exercises instantly.

Extra data on laser varicose vein treatment with VenaCure EVLT is accessible from the Ellwood City Hospital Vein Center at 724-752-6507.

Torment center upgrade

The clinic’s torment facility has been helping patients since May 2014. Dr. Petra Nour, doctor in control, said individuals use it for various reasons including agony from herniated plates, fizzled back surgery, spinal stenosis and shingles. The common treatment is epidural steroid infusions that are fluoroscopy-guided. The agony center treats more or less 30 patients a week.


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“The technique is not difficult. They get just neighborhood analgesic and they can drive themselves to and from the healing center,” Nour said. “The treatment can be rehashed if the outcomes wear off over the long run.”

The agony center additionally advises patients of different choices accessible to them, including active recuperation, and can allude them to a neurosurgeon.

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The center acknowledges most protection, and patients needn’t bother with a referral from their specialist. For an arrangement, call 724-431-0609.

The report covers present scenario and the growth prospects of the Global Negative Pressure Wound Therapy market for the period 2015-2019.

The report covers present scenario and the growth prospects of the Global Negative Pressure Wound Therapy market for the period 2015-2019.

Negative pressure wound therapy is a technique that applies negative pressure to a wound to promote wound healing by removing the fluid and infectious materials from the wound. This therapy is helpful in treating various types of wounds such as acute wound and chronic wound.

Negative pressure wound therapy system consists of a vacuum pump, a foam or gauze wound dressing, drainage tubing, and an adhesive film dressing to cover and seal the wounds.

Global Negative Pressure Wound Therapy market to grow at a CAGR of 7.97 percent over the period 2015-2019.

Covered in this Report

Based on technology, the market can be segmented as follows: Standard Negative Pressure Wound Therapy and Single-use Negative Pressure Wound Therapy.

Equinox Medical, LLC is now one of the fastest growing negative pressure wound therapy (NPWT) wound vacuum company in the wound care market.
The report, Global Negative Pressure Wound Therapy Market 2015-2019, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the Americas, and the APAC and EMEA regions; it also covers the Global Negative Pressure Wound Therapy market landscape and its growth prospects in the coming years.

The report includes a discussion of the key vendors operating in this market.

 

Dowdy receives Wound Care Specialist certification

RUSSELL, Ky. — Phillip R. Dowdy, Jr., D.P.M., Bon Secours Kentucky Health System podiatrist, has achieved certification from the American Board of Wound Management (ABWM). The certification has granted Dowdy the designation of Certified Wound Specialist Physician (CWSP.)

The ABWM organization was formed to establish and monitor a national certification process, recognize competency, promote education/research and elevate the standard of care for wound management. The organization is dedicated to the multidisciplinary team approach in promoting the science of prevention, care and treatment of acute and chronic wounds.

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Dowdy said achieving the recent certification by the ABWM allows him to share his knowledge about wound care.

“Basically, certifications put a stamp on what physicians do. It did it to show what I know about wound care, and so that the public has a better idea, and the hospitals also,” Dowdy said. “I wanted to be able to help patients more as well. It does help doctors to drum up some practices, and to make sure they are doing things the right way.”

To date, the ABWM has certified approximately 3,700 individuals nationwide with the organization’s three wound management designations.

According to Dowdy, attaining the Certified Wound Specialist Physician designation requires three years of experience.

“I already work in a wound care center, but to get the certification, you have to have three-years experience in wound care, and then you can go for the certification based upon the experience that you already have,” he said.

Dowdy is a graduate of Russell High School and Barry University School of Medical Science in Miami Shores, Fla. His residency was completed at Henry Ford Health Systems/Wyandotte Hospital in Wyandotte, Mich. Dowdy also completed a fellowship at Lake Cumberland Regional Hospital in Somerset, Ky., and Jewish Hospital in Louisville, Ky.

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EvergreenHealth adds practicing infectious disease providers

EvergreenHealth has announced the addition of EvergreenHealth Infectious Disease Care to its hospital-owned specialty care practices. The move brings the practice’s three experienced providers to the EvergreenHealth medical staff who have long served the community with disease prevention and wound care services.

As independent practitioners, Francis Riedo, M.D., Robert Geise, M.D., CWS, and Jason Van Winkle, M.D., served patients at their private practice located near EvergreenHealth’s Kirkland campus, while also seeing patients at the main hospital campus. As a new EvergreenHealth practice, the providers will continue to see patients in the same location, while patients gain greater access to a seamless experience within the EvergreenHealth network.

Equinox Medical, LLC is now offering a new distribution package for their Halo Mini Negative Pressure Wound Therapy (NPWT) wound vacuum system.

“We are very pleased to welcome these colleagues to our staff of skilled specialists,” said Evergreen Healthcare CEO Bob Malte. “We are committed to providing comprehensive and compassionate medical care and their considerable talents and dedication to improving patients’ quality of life are a perfect complement to our integrated system of care.”

Francis X. Riedo, M.D. has been an active member of the EvergreenHealth community for more than 20 years, serving as chair of the Pharmaceuticals and Therapeutics Committee and as Medical Director of Infection Control and Infectious Disease. In 2014, The EvergreenHealth Board of Commissioners honored Dr. Riedo with its Community Service Award, recognizing him for his leadership and his profound impact on enhancing the health and well-being of the community.

Robert E. Geise, M.D., CWS, is a certified wound care and infectious disease specialist, and he currently serves as the Medical Director of the Wound Care Clinic for EvergreenHealth. He also serves as vice president of medical staff, and he was previously chairman of medical specialties at EvergreenHealth.

Jason W. Van Winkle, M.D., brings years of practice in specialized infectious disease patient care as a vital member of the EvergreenHealth team. Van Winkle attended medical school at the University of Washington School of Medicine and received specialized training from Oregon Health Sciences University and Providence Medical Center in Portland.

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DICOM Grid releases new “medical selfie” feature

DICOM Grid releases new “medical selfie” feature

by Lauren Dubinsky , Staff Writer
Selfies are not just for consumer social networking services anymore, they’re now making their way into the medical field. DICOM Grid, an open cloud platform, launched a new feature today called “medical selfie” for its mobile optimized medical image management platform.

“It can be argued that the mobility of health information is no longer a luxury in medicine; it’s an integral part of the system,” Morris Panner, CEO of DICOM Grid, told DOTmed News. “Both patients and providers are demanding it.”

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Features like this are becoming popular as the industry moves toward better patient engagement. “There is no doubt that we are trending toward a health care system that values patient engagement, and a big piece of the puzzle is providing patients with control over their health information,” said Panner.

The new feature will allow patients and care providers to securely share visible light imagery, taken with an iOS device, with their physicians in a HIPAA secure environment. Visible light imagery is able to be evaluated without special equipment and is most commonly used in dermatology and wound care.

For example, the patient can share a photo of a burn, wound or other injury and the physicians can use that to devise a treatment plan and determine if the condition warrants and in-office visit. Patients can also share diagnostic imaging and other related data.

This feature has the potential to help hospitals and practices save money. Instead of using CDs and fax to share information, they can now turn their mobile device into a HIPAA-safe medical communication platform.

“Sharing medical images burned onto physical media like CDs can carry a high price tag for delivery,” said Panner. “Not only can electronic sharing methods like the medical selfie save time, but they have the potential to reduce expensive courier costs.”

Mobile image sharing is also making huge strides in sports medicine. DICOM Grid has orthopedic surgeon clients who bring iPads with the into the operating room to flip through imaging series, and radiologist clients who travel with professional sports teams and use the tablets to share scans.

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CMS put out a price comparison and recommendation for NPWT pump pricing

EXECUTIVE SUMMARY
OBJECTIVES
(1) To compare the prices that suppliers paid for new negative pressure wound therapy pump models to Medicare’s purchase price for the pumps.
(2) To describe how suppliers acquired these new pumps.
(3) To describe the extent to which suppliers reported providing
required services to Medicare beneficiaries who rented these pumps.
BACKGROUND
Negative pressure wound therapy pumps (the pumps) are portable or
stationary devices used for the treatment of ulcers or wounds that have
not responded to traditional wound treatment methods. Medicare pays
for the pumps under Part B coverage of durable medical equipment,
prosthetics, orthotics, and supplies (DMEPOS) as a capped rental item.
Between 2001 and 2007, Medicare payments for these pumps increased
583 percent, from $24 million to $164 million.
When Medicare first started covering pumps in 2001, it covered only one model, which was both manufactured and supplied by Kinetic Concepts,
Inc. (KCI). Medicare reimbursed KCI for this pump based on the
purchase price as identified by KCI. Beginning in 2005, Medicare
expanded its coverage to include several new pump models that are
manufactured by other companies. Medicare reimburses suppliers for
these new pumps based on the purchase price of the KCI pump.
This study compares the prices that suppliers paid for new pump
models to Medicare’s purchase price. Although the new pump models
currently account for a small percentage of the pump market, their
market share may grow rapidly if there is a large difference between the
amount that suppliers pay for these pumps and the amount that they
are reimbursed by Medicare. Wide profit margins may also make
pumps vulnerable to fraud, waste, and abuse.
FINDINGS
Suppliers paid an average of $3,604 for the new pump models,
compared to Medicare’s purchase price of $17,165.
Suppliers
purchased 171 of the 223 new pump models that were provided to
beneficiaries in the first half of 2007. Suppliers paid an average of$3,604 for these pumps. Medicare reimbursed suppliers for these pumps based on a purchase price of$17,165, which is more than four times the average price paid by
suppliers. On a monthly basis, Medicare reimbursed suppliers $1,716 for these pumps for the first 3 months. At this rate, suppliers recouped the average cost of a new pump model in about 2 months. Further, beneficiaries’ coinsurance
payments for pumps cover a substantial portion of the average cost of anew pump model. After just 4 months of rental, a beneficiary’scoinsurance of $1,286 covers over one-third (36 percent) of the average cost of a new pump model.
Suppliers acquired one-quarter of the new pump models byleasing, renting, or exchanging them. Suppliers acquired nearly
one-quarter (52 of 223) of the new pump models provided to
beneficiaries in the first half of 2007 through methods other than
purchasing them. They acquired these pumps through lease-to-own
agreements, daily rentals, hourly rentals, or exchanges of old pumps for
new ones. Suppliers reported not always communicating with beneficiaries’
clinicians, as required; however, they appeared to meet other
standards. Suppliers are required to communicate with the
beneficiary’s treating clinician toassess wound healing progress and to determine whether the beneficiary continues to qualify for Medicare
coverage of the pump. In addition, suppliers must meet certain
standards that include providing delivery and instruction on equipment
usage (either from the supplier or another qualified party), maintaining
and repairing the equipment as needed, and responding to beneficiaries’
questions and complaints about the equipment. Suppliers reported not
having contact with clinicians for almost one-quarter of thebeneficiaries. Suppliers reported delivering the pumps and educating
almost all of the beneficiaries, as well as providing maintenance and
repairs when needed.
RECOMMENDATIONS
Based on the findings in this report, we recommend that CMS:
Reduce Medicare’s reimbursement amount for pumps.
CMS should:
consider two methods to reduce its reimbursement amount for pumps.
CMS should:
Use its inherent reasonableness authority to reduce the reimbursement
amount for pumps. CMS should consider using its inherent
reasonableness authority to reducethe amount that it reimburses
suppliers for pumps.
•Include pumps in the second round of the the Competitive Bidding
Acquisition Program. CMS should include pumps in the second round
of the Competitive Bidding Acquisition Program. This could better
align Medicare’s reimbursement amount for pumps with the amount
that suppliers pay for the new pump models.
In addition,
CMS should: Monitor the growth of the new pump market.
CMS should continue to monitor the growth of the new pump market by tracking trends in market share among different suppliers.
Educate suppliers of new pump models on the importance of
communication with beneficiaries’ treating clinicians.
CMS should:educate suppliers of new pump models that the continued need for a
pump can be determined only through clinician input and that it isinappropriate for suppliers to submit claims for continued pump use
without this input. Follow up on the pump claims that may be inappropriate.
CMS should follow up on the claims in which suppliers: (1) reported having no
contact with the beneficiaries’ treating clinicians, (2) could not be
located, or (3) did not submit any documentation. To help CMS address this recommendation, we will forward information about these claims in
a separate memorandum.
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL
RESPONSE
CMS concurred with four of our recommendations and will consider the
remaining recommendation. It noted that it has worked on a number of
regulatory and administrative initiatives related to the prescription
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GOP looks to Medicare Advantage cuts for political edge – Effing Republicans cutting our seniors benefits again!

 

 

  • A new round of cuts to a popular program that provides health care to seniors will touch off a spate of partisan finger-pointing in the coming weeks, handing Republicans a new opportunity to blast the Obama administration.

 

 

  • Posted Mar. 24, 2015 at 8:30 AM

    WASHINGTON — A new round of cuts to a popular program that provides health care to seniors will touch off a spate of partisan finger-pointing in the coming weeks, handing Republicans a new opportunity to blast the Obama administration.

    The Centers for Medicare and Medicaid Services (CMS) is expected to announce in April how much it will cut from payments in 2016 to health insurers for Medicare Advantage, the popular program that covers seniors through private HMO and PPO plans. CMS in February recommended a 0.9 percent cut, though the agency may cut up to 0.95 percent, which would result in seniors paying higher premiums.

    The Affordable Care Act (ACA) requires cuts to the Medicare Advantage program to bring it into alignment with traditional Medicare programs. Those cuts have already been made. In recent years, the Obama administration has cut another 10 percent off the Advantage program.

    The program insures more than 15 million seniors nationwide, through either HMOs or PPOs. Projected costs reached $156 billion in 2014.

    And Republicans are already preparing to take advantage when CMS’s final decision is announced on April 6 — when lawmakers are home for the Easter recess.

    “Your work to protect Medicare Advantage is a topic your boss cannot talk about enough,” a top official at the National Republican Congressional Committee (NRCC) told GOP staffers in an email on Friday. “This would be a great opportunity for your boss to speak directly to seniors in the district about this important issue.”

    Both parties have used the other side’s proposals as wedges to appeal to seniors, a vote-rich bloc that is sensitive to benefit cuts. Democrats have routinely attacked Republicans over Wisconsin Rep. Paul Ryan’s budget proposals, which would have cut Medicare spending by $129 billion over a decade, according to the liberal Center on Budget and Policy Priorities. Republicans have fired back, accusing Democrats of cutting $716 billion to Medicare — and $156 billion to Medicare Advantage — under the ACA.

    “It was President Obama and Congressional Democrats that cut $152 billion from the popular Medicare Advantage program when they passed ‘Obamacare’ without a single Republican vote,” said Ian Prior, an NRCC spokesman. “Now that those cuts are starting to negatively impact Medicare Advantage and the 15 million seniors covered by the program, it’s important for voters to remember that it is the Democrats that are solely responsible.”

    Democrats pointed to the House Republican budget, released last week, which would turn Medicaid into block grants and reduce funding for Medicare.

    “Democrats have continually fought to strengthen Medicare while Republicans have been working to weaken it. This contrast comes into sharp focus on a day when the House Republicans released yet another budget that would end Medicare as we know it,” said Matt Thornton, a spokesman for the Democratic Congressional Campaign Committee.

    Medicare Advantage’s political clout has grown as reliance on the program has increased. In 1991, 18 percent of all Medicare recipients were enrolled in the Advantage program; today, it’s 30 percent. In states like California and Florida, Advantage enrollees account for 38 percent of all Medicare patients, according to the Kaiser Family Foundation.

    An analysis sponsored by America’s Health Insurance Plans, an industry group that opposes the reductions, found the cuts would cost between $40 and $120 per member, per month over a three-year period.

    An increase in health care costs is likely to play a role in the battle for the Senate in 2016, where Republicans hold an eight-seat advantage. Republicans will attack Democratic candidates running in GOP-held states like Illinois, Pennsylvania and Wisconsin for voting to implement the steep cuts.

    In Florida, one Democratic candidate is already playing proactive offense. Rep. Patrick Murphy, who is likely to formally announce he will run for Senate next week, co-signed a letter last week with Rep. Brett Guthrie, R-Ky., urging CMS to maintain current payment levels. The letter attracted 239 signatures from Democrats and Republicans; a similar letter earned support from 53 senators.

    “Further cuts to this important program could limit health care options and deprive beneficiaries of the services they need,” Murphy said in a statement. “The seniors I represent cannot afford higher out-of-pocket costs and slashed benefits.”

    But some party strategists wonder if the familiar attacks over cuts to Medicare Advantage, which dominated the airwaves in 2010, 2012 and 2014, still carry the same political sting. While the ACA made up a huge percentage of GOP advertisements in 2010, and the Ryan budget handed Democrats a potent weapon in 2012, some think voters aren’t paying attention anymore.

    “I think the dueling Medicare attacks are falling on deaf ears. We need to figure out how to frame this argument in a new way so that voters will actually believe this could affect them,” said one Democratic strategist who was involved in crafting attack ads on Medicare Advantage. “It may be that when voters hear ‘Medicare cuts’ they just tune out.”

    Republicans, too, used the ACA less in 2014 than they had in previous years — and that number continued to drop as the campaign progressed. Analysis by Kantar Media’s Campaign Media Analysis Group in 2014 found the number of Republican ads attacking Obamacare declined precipitously throughout the year, while the economy became a more dominant issue.

    Equinox Medical is the fastest growing negative pressure wound therapy (NPWT) pump and black foam dressing company in the USA. FDA approved wound dressings are mandatory to use in nursing home and hospitals.

 

KCI AND ITI PATENT BATTLE IS BLOODY

The bloody patent battle over a healing machine


How a simple device for closing wounds made fortunes for its inventors, for its marketers, and for Wake Forest University – until rivals claimed it was too simple.


A negative-pressure wound-therapy device made by Kinetic Concepts Inc.

FORTUNE — A patent royalty is a beautiful thing. It is so much sweeter than found money because it is more than just good luck. It means that one party is paying another to use an invention. And before the lawyers got to arguing over claim constructions and prior art, before the government regulators and hospitals screamed enough was enough, and before the Russians came to Texas to explain Soviet-era library policies, there were few things more beautiful or lucrative in the world of patent royalties than the VAC.

It’s pronounced “vack” and stands for vacuum-assisted closure. Here’s what it is: You cut a piece of foam to size and place it in a wound as a barrier and protector. Then you cover the wound and seal it up. One end of a tube goes through the seal and the other goes into a small pump. The pump produces negative pressure, creating an even vacuum through the foam, and the wound is pulled together and heals. If it sounds simple, it’s because it is simple.

For much of the past 20 years this device was controlled by a San Antonio company called Kinetic Concepts Inc. The VAC transformed KCI from a second-tier medical manufacturer into a global juggernaut.

For Wake Forest University, which licensed the VAC patents to KCI, the device has meant about $500 million in royalties. Based almost entirely on the VAC deal, the university was ranked fifth by the Association of University Technology Managers in its most recent survey of licensing income, trailing only Columbia, New York University, Northwestern, and the University of California system. In recent years the KCI payments have propped up the bottom line of the university’s medical center, and the VAC money has paid for research, recruiting, and construction that probably wouldn’t have happened otherwise.

As you might imagine, all that success gave KCI and Wake Forest a powerful incentive to build a fence, to protect the patents at all cost. And it gave everybody else an equally powerful incentive to find a way through the fence.

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This is the story of what happens when there are billions of dollars wrapped up in a prosaic piece of technology that at its core is closer to your kid’s science-fair entry than the Human Genome Project, one that despite all the commercial success and some 4 million or so patients still has its share of doubters in the medical community. It’s a story about luck and timing and the squeezing of the health care dollar. It is about betrayal and wrangling over patents. And mostly it is about invention, the tenuous and uncertain act of breathing life into an idea that may or may not have been yours all along.

Dr. Louis Argenta says he invented the VAC, and he has the patents to prove it. He’s a plastic surgeon at Wake Forest Baptist Medical Center in Winston-Salem, N.C., but is quick to point out that he isn’t that kind of plastic surgeon. He deals with messy and nasty injuries that often can’t or won’t heal on their own. One night in the late 1980s, he was lying in bed and unable to sleep. He was reading The Gulag Archipelago and was worried about a patient who was slowly dying from an infected wound that couldn’t be closed with surgery because the stitches would make things worse. “And, just suddenly,” he would say later, “the concept of just using a giant vacuum — we had played with vacuums in the laboratory a little bit, but this was the concept of using a giant vacuum to pull this whole thing together.” He sketched a rough drawing in the margins of his book, and his wife told him to go back to sleep.



The next morning he talked to his lab manager, Michael Morykwas, a biomedical engineer, and they began working on a prototype. They tried it with success on pigs. But before they could put a device on a patient, they needed the approval of the hospital’s ethics committee, which hemmed and hawed but eventually consented. The primitive VAC, Argenta would say, saved his patient’s life.

For the next few years Argenta and Morykwas tinkered with their invention. In 1991 the university applied for a patent on their behalf and began shopping the device around. Wake Forest agreed to pay them half of any royalties, which to date has meant about $120 million apiece. But back then, getting rich seemed like a pipe dream. The leading medical journal for plastic surgery rejected a paper on their research, and there was little interest from the health care industry’s biggest players. A licensing deal was struck in 1993 with KCI, which had a business renting and selling medical beds with air chambers. It already had products that used pumps. This would be one more. The first VAC hit the market in 1995, two years before the patents were granted and any research was published.

Negative pressure is suction, and suction has long been used to drain wounds and draw infections to the surface. What’s different in wound therapy is that the pressure is maintained. Before the VAC came on the scene, the prevailing belief was that long periods of suction would damage the healthy skin that surrounds a wound.

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By 1999, KCI had built a $50-million-a-year VAC business through word of mouth, a go-go sales force, and top-notch customer service. That’s nothing to sneeze at, but it was only the beginning. In late 2000, Medicare began reimbursing for the use of the VAC, and suddenly a therapy on the fringes came with its own revenue stream as doctors used the devices to treat diabetic ulcers and pressure sores. With the government’s seal of approval, VAC revenue climbed to nearly $500 million by the end of 2003, on the way to becoming a billion-dollar product line.

That brought the money. Respect came in the field hospitals for U.S. troops in Iraq and Afghanistan.

In clinical language, the immense destruction caused by an improvised explosive device, or IED, is referred to as a high-energy soft-tissue injury. These can be devastating wounds, prone to infection and hard to close. Slight variations in healing can mean the difference in whether or where a limb is amputated. Dr. Chris Coppola operated on these wounds during two trips to Iraq. The dust and sand swirled everywhere, forcing the surgeons to use shipping containers as ORs. The VAC became such a critical part of their treatment that the medical staff pushed the military brass to give the device quick clearance for use during the airlift of wounded soldiers from the field to hospitals in Germany.

“We got our Ph.D. in the VAC over there,” Coppola says, and there is little enthusiasm in his voice when he remembers this education. Now a pediatric surgeon in Danville, Pa., Coppola has written two memoirs of his time in Iraq, and he was one of the authors of a widely circulated medical journal article on the use of the VAC for treating traumatic injuries. “Little by little we gain knowledge,” he says, “and it’s a quite sad reality that we learn more about surgery and trauma during the years of war than we do in the time between wars.”

It is not surprising that a low-tech product with such a fantastic combination of margin and mission would attract attention from competitors. Medical devices are particularly vulnerable to being copied because, unlike pharmaceuticals, the patents tend to build on previous discoveries and they don’t rely on a unique molecule. And over time, as a company fights to hold on to its patents, it is forced to draw an ever sharper line between what’s covered by the patent and what isn’t.

The first chink in KCI’s armor came in 2006, when a small company named BlueSky won the right to sell a competing product that used gauze instead of foam dressings. Other companies rushed into the market, including the British health care giant Smith & Nephew, which snatched up BlueSky and began planning a larger challenge.

Most doctors preferred foam dressings over gauze. The foam version was tested and proven, backed by years of KCI’s research. So as Smith & Nephew and others sought to break KCI’s lock, it became clear that they would need to offer foam dressings, and to do that they would have to show that the device of Lou Argenta and Mike Morykwas didn’t really deserve patent protection, that the two men may have thought they invented the VAC but had really done no such thing.

At the heart of much of patent litigation is the concept of prior art: whether earlier research or invention makes a patent invalid. It can be tricky terrain because researchers — particularly in that distant era before the web brought everything to our desktop — aren’t always aware of everything in their discipline.

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If you are a patent attorney hunting for undiscovered prior art on wound care, the place to search is Russia, which had both a tradition of innovation in this area and its own war in Afghanistan in the 1980s to push surgical advancements. That’s how, in 2008, Smith & Nephew found the research of Nail Bagaoutdinov, who had been a surgeon in Kazan, a provincial capital some 500 miles east of Moscow. In 1985 he began using negative pressure — including foam dressings — to treat infected wounds. A year later he wrote a brief paper on the results. This was the prior art that Smith & Nephew had been looking for. In late 2008 the company began selling foam-based therapy in the U.S., eager for a court fight.


Dr. Nail Bagaoutdinov began using negative pressure to treat wounds at a hospital in Kazan, Russia, in 1985.

KCI obliged, and the battle moved to a federal courtroom in San Antonio. KCI tried to exclude Bagaoutdinov’s work, arguing that the decay and disarray of the Soviet Union’s library system meant that the research fell into an abyss known as “gray literature” and didn’t qualify as prior art. Smith & Nephew countered with its own experts, including a top deputy of the Russian Federation’s Department of Libraries, flown into Houston to be deposed.

KCI lost the argument, and Bagaoutdinov’s work was allowed at trial. He testified about his research and how he had tried to get a patent, or what in the Soviet Union was called an inventor’s certificate. But he said his request was rejected because his invention too closely resembled the Bier Cup — a glass cup attached to a tiny hand pump — which has been around since the 1890s.

In March 2010 the jury rejected Smith & Nephew’s arguments and said that KCI’s patents were still valid, at least in the U.S. But eight months later the verdict was set aside. The patents, wrote Judge Royal Furgeson, were invalid based on the concept of obviousness, meaning that a person with skill in this area could have taken the existing research and arrived at the VAC. “The Bagaoutdinov references, while they may not have been easily accessible to the inventors, disclose almost all the claims asserted,” his ruling said.

KCI and Wake Forest filed a notice of appeal, and they started figuring out how to maintain market share in a new environment, one where there was no monopoly and customers knew it.

Smith & Nephew, a company with annual sales of $4.2 billion, has been a global player in bandages and wound care for years, but Thomas Dugan, the president of its North American wound-care business, said the company struggled to find traction in the negative-pressure market. “We didn’t have foam dressings. We just had gauze,” Dugan says. “We were in there, putting our feet in the water, learning a lot, getting beat up a little bit, and then as we progressed, we obviously extended our presence as we got into the foam market. And that’s what really started to open up the opportunity.”

That opportunity, the competition in pricing and products, brought growth in KCI’s VAC business to a halt. Since 2008 it has been stuck at about $1.4 billion in annual revenue. At trial, Dr. Jim Leininger, the company’s founder, grimly recited the list of customers who had already abandoned the VAC for less expensive systems. There were hospitals in Laredo, Texas, and Memphis and Nashville, and nursing homes in Texas and beyond. Each of these switches underscored the scramble among both health care providers and suppliers to protect their bottom lines.

One of the most bitter fights has taken place at San Antonio’s University Hospital, which occupies a sprawling campus just a few miles from the KCI Tower. University Hospital gets a third of its revenue from the taxpayers of Bexar County, and it is pushing hard and with considerable success to transform itself from the area’s public hospital to an institution that attracts more affluent — i.e., better insured — patients.

University was an early adopter of the VAC, but the relationship soured as costs increased. In 2009 the hospital spent $2.2 million on VAC expenses — a third more than in the previous year — at a time when it was feeling a squeeze from all directions. Moreover, it was getting little sympathy or relief from KCI.

“We were spending a lot of money, and it was becoming very expensive for the health system, these wound VACs, and we were getting direction from the C-suite that we needed to find a way to minimize the bleeding, if you will,” says Francine Crockett, the hospital’s vice president of supply-chain management.

Her team brought in another vendor, a company called Innovative Therapies Inc., which had been started in 2006 by former KCI employees. It uses a competing patent developed in Sweden in the 1970s that had languished until KCI made negative pressure a commercial success.



KCI has sued Innovative Therapies, alleging patent infringement and the violation of confidentiality and noncompete agreements. The litigation is still pending.

“This is bullyism,” says Richard Vogel, Innovative Therapies’ president. “It’s a patent that should never have been issued, because it’s anticipated by all sorts of prior art, but you have a right to that patent, and you are going to declaim loudly to the world that these are your patents, you own this space, and you are going to bully anybody and everybody into submission. And what’s more, you actually do it. You will spend tens of millions of dollars beating up on small companies and on large companies. You’ll sue customers. You’ll sue doctors. Well, after a while, people just throw up their hands and say, ‘We don’t want to have to deal with this.’ And to a large extent, that’s what happened.”

Beginning in 2010, the surgical-supply cabinets at University started carrying both KCI and ITI pumps and materials, and the upstart quickly gained a third of the business while officials evaluated the products. The hospital recently gave ITI single-vendor status for most of its operations.

Health care spending doesn’t exist in isolation, and one treatment can often prevent a more expensive expenditure at a later date. But it’s not often that providers get credits from payers for avoiding a future expense. Doctors like negative pressure because they can discharge patients sooner and don’t have to change bandages as frequently. But as Medicare’s negative-pressure payments grew from $24 million to $164 million per year between 2001 and 2007, the agency wasn’t looking only at the length of stay. It just saw an exploding line item with a huge markup. Pumps were being reimbursed at an average annual price of $17,000, about four times what suppliers paid for the equipment.

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In 2009, Medicare cut negative-pressure reimbursements by 9.5%. Now it’s rolling out competitive bidding in the industry, having companies vie for the right to sell pumps in some of the nation’s largest markets.

As part of that process, the government tried to answer some key questions. First, were foam dressings better than gauze? And second, was there any difference between the devices? KCI had claimed there were differences on both counts, with the hope of getting its own billing code — and reimbursement rate. A report commissioned for the Department of Health and Human Services said there were no differences.

But the wound healers may have bigger problems. The government’s report also contained this finding: “None of the high-quality reviews concluded that negative-pressure wound therapy provided additional benefit when compared to other interventional treatments.”

Dr. William Lineaweaver is a Mississippi plastic surgeon who specializes in burn reconstruction and is the editor of the Annals of Plastic Surgery, which 15 years ago published the first research paper on the VAC, in a sense paving the way for all that was to happen by reporting that the device promoted healing.


Expansion of the Comprehensive Cancer Center at Wake Forest’s Baptist Medical Center. The school has collected nearly $500 million in royalties on VAC patents.

Lineaweaver wasn’t the editor then, but he dismisses negative pressure as overused and unvalidated, a patient-management tool that is less about healing wounds than about cutting surgical costs. “It took advantage of the fact that reconstructive surgery has more and more to offer but is being reimbursed less and less,” Lineaweaver says.

There is plenty of evidence that negative pressure works by increasing blood flow and encouraging the formation of healthy tissue. But the research studies tend to be anecdotal, unlike the randomized trials that might be required of a drugmaker to gain FDA approval. The industry has told the government that it needs to look beyond clinical data and pay more attention to expert opinions and compelling observational studies.

In August the U.S. Court of Appeals for the Federal Circuit reversed Judge Furgeson’s invalidation ruling and sent the case back to San Antonio. The patents are still valid, for now. But KCI was by then no longer a party to that action. Instead of joining with Wake Forest in protecting the patents, as it first said it would do, the company reversed course and said the ruling from Texas — along with similar rulings in Europe — had freed it from the licensing agreement because there were no valid patents to license. Its last royalty payments, of $86 million, were in 2010. The patents expire in 2014. Wake Forest and KCI have gone to court, each accusing the other of acting in bad faith.

KCI said the university was dragging its feet on arbitration and wanted an exorbitant payout of more than $200 million for what courts here and in Europe had ruled were invalid patents. Wake Forest said KCI had abandoned its partner at a time of need, had been shorting it on payments for two years, and had timed its legal action to squeeze inside a deadline of having to pay a semiannual royalty payment of more than $40 million.

Wake Forest officials declined to be interviewed but released a short statement saying the university was pleased with the appellate court’s ruling and intended to enforce its patents against those using them without compensating the university. (Update: On Nov. 1, Smith & Nephew said it had reached a settlement with Wake Forest. The full terms weren’t disclosed, although the company’s third-quarter results and discussion with analysts suggest the agreement cut into profit by around $8 million and wouldn’t have a significant long-term impact on its wound-care business.)

John Bibb, the general counsel for KCI, says, “I wouldn’t say the relationship deteriorated so much as the strength of the patent portfolio, frankly, deteriorated. If you think about it from the context of the commercializing company, it’s hard to pay royalties for patents that have been invalidated everywhere they’ve been asserted.”

KCI was bought in 2011 for $6.3 billion by a private equity firm, Apax Partners, along with two Canadian pension funds, an arrangement that gives it the ability to retool and reinvest out of the glare of Wall Street. Shortly after the deal closed, Apax moved in a new management team, replacing KCI’s chief executive and the head of its global VAC business. Joe Woody, the new chief executive, spent six years at Smith & Nephew and was one of the architects of the company’s assault on KCI’s dominance. He says that despite that history, he’s gotten a warm reception as he repositions KCI to move past the days of product exclusivity. That means cutting costs, being sensitive to price, and keeping the focus on innovation and customer service as the company tries to grow here and abroad, where diabetes and related circulation problems are surging.

“The competitive environment is much like any other medical device company would face now that we have patents that are invalidated and we are in a different market position,” Woody says.

With all that’s happened, including shifts in a legal position that had been at the core of KCI’s corporate culture, I asked Woody and Bibb whether the Wake Forest patents should have ever been granted by the U.S. Patent Office. The line went quiet, and after an awkward period of silence, a spokesman said it was a speculative question and time to move on.

Not that long ago, an MIT student came out with a prototype for a hand-powered negative-pressure pump that she said could sell for $3 and be a boon in the developing world, where most people can’t afford the Cadillac-priced products of Western health care. Perhaps unsurprisingly, amid the praise for her resourcefulness was ridicule that she had done little more than cobble together a device from products found at a hardware store.

That’s the argument used against the VAC, and it both misses and is exactly the point. Maybe the VAC was there all along, just waiting to be found. But somebody had to find it and — more to the point — claim ownership. The patents gave the idea value, and the value helped create a market, and the market created fortunes. KCI’s founder, Jim Leininger, is a billionaire. Lou Argenta and Mike Morykwas have split about $250 million in royalties, and Wake Forest’s portion has helped build its campus and its reputation. And then there is one more inventor, a Kansas doctor named David Zamierowski, who received more than $200 million from KCI. His patents on the use of negative pressure predated the VAC and were licensed in part as a precaution, just to be safe — a fence around the fence.

Nail Bagaoutdinov never got inside that fence. He just helped tear it down. For his time, Smith & Nephew paid him $350 an hour, far less than the million-dollar bonus he originally sought.

He left Russia in 1995 and emigrated to the U.S., where he learned English so he could continue to practice medicine. Like many doctors born overseas, he now works in rural America, rotating through emergency rooms in eastern Kentucky. When we talked, he had just come off a night shift and apologized for being tired.

There was no bitterness in his voice about what might have been, and he said he was surprised when his work became the central piece of evidence in patent trials around the world.

“Negative pressure, it’s not complicated,” he said.

Bagaoutdinov doesn’t claim to be the inventor of the VAC. To this day he has never used one. His device was a much cruder affair. He said he thought he had come up with something new, but there was no way to know for sure. At the time, he was just a surgeon at Kazan City Hospital No. 8 and was unable to take his idea to the next step.

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