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In brief: HHS proposes changes to Stark Law, Estrella named Homecare Champion

In brief: HHS proposes changes to Stark Law, Estrella named Homecare Champion

WASHINGTON - The Department of Health and Human Services has proposed changes to the Stark Law that would, among other things, create new exceptions that recognize incentives are different in healthcare systems that pay for value- vs. volume-based care.

The proposal includes proper safeguards that ensure the Stark Law will continue to provide meaningful protection against overutilization and other harms, while giving physicians and other healthcare providers added flexibility to improve the quality of care for their patients, HHS says.

“Our proposed rules would be an unprecedented opportunity for providers to work together to deliver the kind of high-value, coordinated care that patients deserve,” said HHS Secretary Alex Azar.

HHS published a request for information in the Federal Register in June, asking for feedback on “how to address any undue regulatory impact and burden of the physician self-referral law.”

The proposal also includes changes to the Anti-Kickback Statute and the Civil Monetary Penalties Law that would address longstanding concerns that these laws limit the ways in which healthcare providers coordinate patient care. The changes would offer flexibility for innovation and improved coordinated care through, for example, outcome-based payment arrangements that reward improvements in patient health. The changes would also make it easier for physicians and other healthcare providers to ensure they are complying with the law by offering specific safe harbors for these arrangements.

Examples of activities that could be protected by the changes include:

·      A specialty physician practice could share data analytics services with a primary care physician practice.

·      A hospital could provide the discharged patients' physicians with care coordinators to ensure patients receive appropriate follow-up care, data analytics systems to help physicians ensure that their patients are achieving better health outcomes, and remote monitoring technology to alert physicians or caregivers when a patient needs healthcare intervention to prevent unnecessary ER visits and readmissions.

·      A physician practice could provide smart pillboxes to patients without charge to help them remember to take their medications on time.

·      A hospital could improve its cybersecurity and the cybersecurity of nearby providers that it works with frequently. To do so, it could donate, for free, cybersecurity software to each physician that refers patients to its hospital.

·      A nephrologist, dialysis facility, or other provider could furnish patients with end-stage kidney disease with technology that is capable of monitoring the patient's health and two-way, real-time interactive communication between the patient, facility, and physician. In addition, the facility could equip the physicians with data analytics software to help them monitor patients' health outcomes.

Karyn Estrella to be recognized as Homecare Champion

WASHINGTON - Karyn Estrella has been named as the 2019 Van G. Miller Homecare Champion.

Estrella, the long-time leader of the Home Medical Equipment Services Association of New England, passed away July 4. She is remembered for her passionate advocacy on behalf of the HME industry.

“Karyn was a force in her meetings with policymakers, but the way she encouraged and supported so many other individuals in New England to become strong HME advocates is probably the most important part of her legacy.” remarked Tom Ryan, AAHomecare president and CEO. “She also played a major role on AAHomecare State Leaders Council, both as Chair of the group and through her ever-present willingness to collaborate with and support her peers in other state and regional associations.”

The award will be presented to Karyn's daughter Lauryn Estrella, who is currently serving as the interim director of HOMES, during the AAHomecare Update at Medtrade Tuesday morning, Oct. 22. She will also be recognized at the Stand up for Homecare reception that night at Stats Brewpub in Atlanta.

The AAHomecare update is open to all Medtrade attendees. Tickets for the Stand Up reception may be reserved here.

Sleep lab, not VirtuOx, buys NovaSom's assets

ATLANTA - SleepMed, one of the largest operators of sleep labs in the United States, has acquired the assets of NovaSom, a leading provider of home sleep testing.

It was previously reported that VirtuOx would buy the Glen Burnie, Md.-based company's assets.

SleepMed, a BioSerenity company, is “excited to invest in NovaSom,” said Roger Anderson, senior vice president of finance and operations.

The company plans to combine its sleep medicine with NovaSom's HST and BioSerenity's technology and cloud platform to expand its U.S. operations.

Previously, in court documents related to its Chapter 11 bankruptcy filing in August, NovaSom sought to sell its assets to VirtuOx through a stalking horse auction for an estimated $5.3 million.

NovaSom, which was founded in 1992, makes AccuSom, an HST with continuous patient support and next-day test results. Its backers have included TPG Biotech and Johnson & Johnson.

Sen. Duckworth visits mastectomy boutique

CHICAGO - Sen. Tammy Duckworth, D-Ill., met with breast cancer survivors during a visit to the Second Act Mastectomy Boutique here. Duckworth is the lead sponsor of the Breast Cancer Patient Equity Act, S. 562, a bill that would expand Medicare coverage to include custom breast prostheses for women recovering from mastectomy surgery. During the event, Duckworth heard from several breast cancer survivors, some of whom have had access to custom prostheses through private payers but have been denied access by Veterans Affairs, Medicare or other private payers that follow Medicare guidelines. “This was a wonderful opportunity for Sen. Duckworth to hear directly from constituents on the importance and impact of passing this legislation for breast cancer survivors,” said Nikki Jensen, vice president of Essentially Woman, who attended the event. S. 562, introduced in February, has four co-sponsors; a companion bill in the House of Representatives, H.R. 1370, has 34 co-sponsors.

FDA clears Dexcom G6 Pro CGM

SAN DIEGO - Dexcom's G6 Pro CGM has received clearance from the U.S. Food and Drug Administration, allowing healthcare professionals to use the device with their patients. The Dexcom G6 Pro is the only single use, professional CGM that gathers real-time glucose data over a 10-day period, and offers both a blinded and un-blinded mode. The data allows providers to adjust a patient's therapy and help them modify daily behavior. “At Dexcom, we are continuing to drive innovation in wearable health technology,” said Kevin Sayer, president, CEO and chairman of Dexcom. “Using the power of Dexcom G6 Pro, clinicians can use the insights gained from a 10-day professional CGM session to adjust treatment plans and empower their patients to live healthier lives.”

How do you like to party? RESNA wants to know

ARLINGTON, Va. - RESNA is seeking suggestions from members on how to celebrate the organization's 40th anniversary at its annual conference, July 7-11, 2020 at the Hyatt Crystal City in Arlington, Va. Send your suggestions to [email protected] by Oct. 23.

Essentially Women focuses on conference

WATERLOO, Iowa - Essentially Women's annual conference will take place Feb. 8-10, 2020, at the Hilton Tampa Downtown in Tampa, Fla., offering education and CEUs.

FOCUS: The EW Conference offers education on a variety of topics, including custom breast prosthesis selection, billing and reimbursement, marketing and opportunities in the CBD market.

“Focus is all about providing our members with education tailored to help them improve their business,” said Nikki Jensen, vice president of EW, a division of VGM. “Our sessions will help attendees gain valuable insight to help them grow professionally and to adjust to the ever-evolving health care industry.” 

Several of the sessions will offer attendees the opportunity to earn CEUs through the American Board for Certification in Orthotics and Prosthetics (ABC) and the Board for Orthotist/Prosthetist Certification (BOC).

Registration for FOCUS: The EW Conference is now open and members interested in attending can receive an early bird discount through Oct. 31. For more information on the event or to register, visit

Bonafide consolidates, expands

THOUSAND OAKS, Calif. - Bonafide Management Systems is consolidating Next Level 11 and Next Project 11 under the Bonafide umbrella as part of the newly formed Bonafide Medical Group, LLC. The move will allow the company to expand its focus from DME to also include acute care and long-term care settings. “I am delighted we were able to combine these important platforms,” said Scott McDaniel, chief commercial officer. “Bonafide is addressing the growing demand among healthcare constituents for the continuum of care as payers and providers seek to improve the visibility overall for revenue cycle management. We see substantial growth opportunities in Bonafide's markets, and I look forward to working closely with the Bonafide team in building the leading provider of healthcare solutions.”

WellSky acquires personal care platform…

OVERLAND PARK, Kan. -WellSky has acquired ClearCare, a software-as-a-service platform used by personal care agencies. The deal allows WellSky to better connect care across the healthcare continuum. “ClearCare adds an important new dimension to WellSky's comprehensive offerings,” said Bill Miller, CEO of WellSky. “ClearCare is an innovative market leader in personal care, and we look forward to building upon that legacy of success.” ClearCare serves more than 4,000 personal care agencies, representing 600,000 caregivers and 500,000 seniors.

…partners with Forcura

OVERLAND PARK, Kan. - WellSky has chosen Forcura, a healthcare technology company for post-acute care, as its partner for documentation workflow and mobile care team coordination. Through this partnership, WellSky Home Health and WellSky Hospice software clients can now use Forcura's streamlined and integrated intake and referrals management tools, robust orders tracking, and care team coordination across field and office staff. “At WellSky, we measure our success by the success of our clients. We saw Forcura and recognized an incredible opportunity to help our clients and their patients flourish,” said Bill Miller, CEO of WellSky. “Forcura's track record of delivering powerful solutions to optimize once time-consuming processes make them an innovative, impactful partner.

Medline, Bleep partner on DreamPort

NORTHFIELD, Ill. - Medline and Bleep have partnered to co-brand and distribute the DreamPort Sleep Solution, a small, lightweight CPAP mask. The patented DreamPort Sleep Solution uses hypoallergenic medical grade adhesive strips to reduce leaks and hold the DreamPort in place. They are easy to apply, do not leave marks on the face, fit every nose shape and don't constrict movement, enabling patients to sleep in any position. "We couldn't be more excited to work together with Medline to accomplish their goal of Advancing the Health of Healthcare," said Stuart Heatherington, founder and CEO of Bleep. "We value Medline's commitment to customers, organizational strength and dedication to improving patient outcomes, and we look forward to our future growth together."

One Drop now available at Walmart

NEW YORK - One Drop, a provider of digital therapeutic solutions for people with diabetes, is now offering its glucometer kit and supplies at Walmart. Each kit includes a Bluetooth glucose meter, lancing device, carry case, test strips and lancets, as well as one year of free access to One Drop's certified diabetes coaches for 24/7 support. "Access to affordable care options is a huge issue in the United States, and most people struggle with insurance, scheduling and co-pays,” said Jeff Dachis, One Drop founder and CEO. "We're meeting people where they are and empowering them with the tools, information and support they need to make better choices for their health."

Cerner integrates with Brightree platform, ResMed devices

KANSAS CITY - Cerner has designated ResMed's Brightree Home Health and Hospice platform as its preferred solution to integrate with its Cerner Millennium electronic health record. Cerner also plans to connect other ResMed digital health data platforms, including those that support its more than 10 million connectable sleep apnea and respiratory care devices, to its EHR and HealtheIntent population health platform. “Supporting seamless transitions of care between acute and post-acute settings is a fundamental part of ResMed's strategy to improve people's quality of life and reduce health care costs,” said Raj Sodji, president of ResMed's SaaS business. “A person's health data is their own and should move with them, giving providers the information they need to deliver personalized care.” Cerner's health technologies connect people and information systems at more than 27,500 contracted provider facilities worldwide.

BraunAbility formalizes commitment to people with disabilities

INDIANAPOLIS - BraunAbility has committed to recruiting more people with physical disabilities into its workforce. The company has made the commitment as it opens the doors to its new global headquarters in Carmel, Ind., which has been designed to be accessible and accommodating to people with mobility challenges, and as it celebrates National Disability Employment Awareness Month in October.  BraunAbility has committed to: ensuring that it sends each job opening directly to more than 20 disability referral sources throughout the state; and continuing to participate in the Eskanazi Health's summer internship program specifically for college students with physical disabilities. “BraunAbility was founded by a person who used a wheelchair, and we have employed people with physical disabilities over the past five decades,” said Staci Kroon, CEO. “This new effort will formalize our commitment to disability inclusion and helps us continue living up to our aspiration of seeing the world through the eyes of our customers.” The company's new global headquarters features doorways that are a minimum of 36 inches wide; conference rooms equipped with automatic, powered sliding doors; height-adjustable desks; ADA appliances in social spaces and restrooms; and more.

Time's nearly up: Medtrade Advance rates end Tuesday

ATLANTA - Advance rates for Medtrade are in effect—but only until Tuesday, Oct. 15. With advance rates, the Expo Pass is $100 and the Conference Pass is $299. Advance rates offer savings on registration add-ons: Audit Happy Hour, Power Lunch, and Rise & Retail Breakfast Roundtables. Medtrade takes place Oct 21-23, 2019, at the Georgia World Congress Center in Atlanta. Register here.

Short takes: GF Health Products, SoClean

GF Health Products has achieved ISO 13485:2016 and MDAP certification at six of its facilities, including its corporate headquarters in Atlanta and its manufacturing facility in Fond du Lac, Wis. “We are extremely proud of our employees' efforts as this certification provides a critical building block for our continued growth in the medical device market and is yet another example of our ongoing dedication to quality,” said Cherie Antoniazzi, senior vide president of quality, regulatory and risk management…SoClean is now being sold at thousands of retail locations throughout the U.S., U.K. and Canada as a result of recent partnerships with, Wellwise  by Shoppers Drug Mart and Alliance Healthcare, according to the Monadnock Ledger-Transcript. “Our relationships with these partners allow us to significantly expand our awareness of our product around the globe so that even more sleep apnea sufferers have easy access to the SoClean device,” said Dean Marcarellli, chief marketing officer. “We want to make it easier to find and purchase our product from your neighborhood pharmacy or local retailer.”


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