WASHINGTON – The Department of Health and Human Services has asked the U.S. District Court for the District of Columbia not to intervene in the Medicare appeals process.

In a brief filed Nov. 7, HHS asks for the dismissal of a case brought by the American Hospital Association that seeks a court order requiring HHS to implement procedures that would curtail a massive appeals backlog.

HHS recently reopened a settlement program that offers certain hospitals an opportunity to receive nearly two-thirds of their contested reimbursement in exchange for dropping their appeals. The agency told the court in its brief that this program, when combined with a number of other administrative and legislative actions, could reduce the appeals backlog to zero by 2019.

Previously, on Sept. 19, the court denied HHS’s request to put litigation with AHA on hold until Sept. 30, 2017, telling the agency it must solve the backlog at the Administrative Law Judge level.

WASHINGTON – The Office of Inspector General has released its work plan for 2017, including post-award audits to assess CMS’s competitive bidding program.

The OIG will review the process CMS used to conduct competitive bidding and to make subsequent pricing determinations for certain medical equipment items and services in selected bid areas under Rounds 1 and 2 of the program. It will also determine the effects of the competitive bidding on Medicare beneficiaries' access to certain types of DMEPOS subject to the program.

Other DME-related items in the OIG’s work plan for 2017:

Diabetes

The OIG is required to report the market share of diabetic testing strips before each subsequent round of the competitive bidding program to help CMS determine how the National Mail Order Re-compete may impact shifts in the market.

The first of three data briefs will determine the market share of diabetic testing strips for the three-month period immediately preceding the implementation of the National Mail Order Re-compete on July 1, 2016 (April through June 2016).

The second report will be for the three-month period immediately after implementation (July through September 2016) and the third report will be for a similar time frame six months after implementation (October through December 2016).

CPAP devices

Prior OIG work found that suppliers automatically shipped PAP device supplies when no physician orders for refills were in effect. The OIG will review claims for frequently replaced PAP device supplies to determine whether documentation requirements for medical necessity, frequency of replacement, and other Medicare requirements are met.

PMDs

The OIG will determine whether potential savings can be achieved by Medicare if certain PMDs are rented over a 13-month period (the period of consecutive months of rental at which the Medicare payment is capped) rather than acquired through a lump-sum purchase.

Orthotic braces

We will determine the reasonableness of Medicare fee schedule amounts for orthotic braces. We will compare Medicare payments made for orthotic braces to amounts paid by non-Medicare payers, such as private insurance companies, to identify potentially wasteful spending. We will estimate the financial impact on Medicare and on beneficiaries of aligning the fee schedule for orthotic braces with those of non-Medicare payers.

WASHINGTON – Industry stakeholders are looking ahead at what a Trump presidency could mean for HME.

“If it was anyone other than Donald Trump, I would be able to tell you a lot more,” said Cara Bachenheimer, senior vice president of government relations for Invacare. “He’s not a traditional Republican. It’s unclear what his congressional agenda is and what his proposals really mean.”

What is clear is that Trump, a businessman with no political experience, struck a chord with Americans who are fed up with politics as usual.

Trump certainly resonated with HME providers, who say they are burdened under the weight of Medicare’s competitive bidding program and an environment of general over-regulation. In September, 64% of respondents to an HME Newspoll said they’d vote for Trump.

“Trump’s mantra is that he wants to slash regulations, he wants to slash bureaucracy—that’s all great for DME,” said John Gallagher, vice president of government relations for The VGM Group. “One of the problems we’ve had is, because of the divided government, none of the committees of jurisdiction had control over CMS. CMS being put back in its bottle would be tremendous.”

With both the White House and both chambers of Congress soon to be under Republican control, stakeholders say they expect a more sympathetic ear to the industry’s plight—especially from lawmakers representing rural America, which came out in droves to support Trump.

“Rural America has been forgotten for a long time,” said Gallagher. “Trump’s speech said, we are going to bring jobs back, so we have to make sure we are talking to our members of Congress abut the same thing. We have got to have rural relief (from competitive bidding), and particularly the delay (of the second round of cuts on July 1), to save these businesses before they are gone.”

On a higher level, a big question on everyone’s mind: What about the Affordable Care Act? Trump has vowed to repeal the program, but whether he tries for a complete repeal or keeps certain provisions in place is uncertain.

“There’s a lot of speculation, but we are really focused on the next three or four weeks and getting (bid relief) passed,” said Jay Witter, senior vice president of public policy for AAHomecare. “It’s all about the leadership and the mindset: What can you get done? I think they are still sorting it out.”

In addition to the 20 million Americans who have obtained health insurance through the ACA, the act has also initiated many programs—like those reducing hospital readmissions—that put more emphasis on post-acute care, including the role of HME providers, say stakeholders.

“Everybody would agree that post-acute care is where people get more care at less cost,” said Bachenheimer. “There are so many ramifications in terms of dismantling some of these huge things that Health and Human Services has moved forward.”

Stakeholders who visited Capitol Hill in the days after Trump’s upset say the shock is palpable, but they feel good about the industry’s chances of getting bid relief passed in the lame-duck session, particularly since its champions, including Rep. Tom Price, R-Ga., won re-election.

“We feel strong and good,” said Tom Ryan, president and CEO of AAHomecare. “We need help now. We are losing infrastructure and businesses daily. That was the message a week ago and that hasn’t changed.”

WASHINGTON – The Office of Inspector General has released its work plan for 2017, including post-award audits to assess CMS’s competitive bidding program.

The OIG will review the process CMS used to conduct competitive bidding and to make subsequent pricing determinations for certain medical equipment items and services in selected bid areas under Rounds 1 and 2 of the program. It will also determine the effects of the competitive bidding on Medicare beneficiaries' access to certain types of DMEPOS subject to the program.

Other DME-related items in the OIG’s work plan for 2017:

Diabetes

The OIG is required to report the market share of diabetic testing strips before each subsequent round of the competitive bidding program to help CMS determine how the National Mail Order Re-compete may impact shifts in the market.

The first of three data briefs will determine the market share of diabetic testing strips for the three-month period immediately preceding the implementation of the National Mail Order Re-compete on July 1, 2016 (April through June 2016).

The second report will be for the three-month period immediately after implementation (July through September 2016) and the third report will be for a similar time frame six months after implementation (October through December 2016).

CPAP devices

Prior OIG work found that suppliers automatically shipped PAP device supplies when no physician orders for refills were in effect. The OIG will review claims for frequently replaced PAP device supplies to determine whether documentation requirements for medical necessity, frequency of replacement, and other Medicare requirements are met.

PMDs

The OIG will determine whether potential savings can be achieved by Medicare if certain PMDs are rented over a 13-month period (the period of consecutive months of rental at which the Medicare payment is capped) rather than acquired through a lump-sum purchase.

Orthotic braces

We will determine the reasonableness of Medicare fee schedule amounts for orthotic braces. We will compare Medicare payments made for orthotic braces to amounts paid by non-Medicare payers, such as private insurance companies, to identify potentially wasteful spending. We will estimate the financial impact on Medicare and on beneficiaries of aligning the fee schedule for orthotic braces with those of non-Medicare payers.

HHS asks court to back off

WASHINGTON – The Department of Health and Human Services has asked the U.S. District Court for the District of Columbia not to intervene in the Medicare appeals process.

In a brief filed Nov. 7, HHS asks for the dismissal of a case brought by the American Hospital Association that seeks a court order requiring HHS to implement procedures that would curtail a massive appeals backlog.

HHS recently reopened a settlement program that offers certain hospitals an opportunity to receive nearly two-thirds of their contested reimbursement in exchange for dropping their appeals. The agency told the court in its brief that this program, when combined with a number of other administrative and legislative actions, could reduce the appeals backlog to zero by 2019.

Previously, on Sept. 19, the court denied HHS’s request to put litigation with AHA on hold until Sept. 30, 2017, telling the agency it must solve the backlog at the Administrative Law Judge level.

CMS announces 2017 premiums

WASHINGTON – For about 70% of Medicare beneficiaries, the average monthly premium for Part B services will be about $109 in 2017, compared to $104.90 for the past four years, CMS announced Nov. 10.

Premiums for this group are protected from sharp increases by a statutory “hold harmless” provision designed to protect seniors, the agency says.

“This year, as in the past, the Secretary has exercised her statutory authority to mitigate projected premium increases for these beneficiaries, while continuing to maintain a prudent level of reserves to protect against unexpected costs,” CMS stated in a press release. “The Department of Health and Human Services (HHS) will work with Congress as it explores budget-neutral solutions to challenges created by the ‘hold harmless’ provision.”

For the remaining 30% of beneficiaries, the average monthly premium for Part B services will be $134 in 2017, a 10% increase from the premium in 2016, CMS says.

Beneficiaries not subject to the “hold harmless” provision include those who do not receive Social Security benefits, those who enroll in Part B for the first time in 2017, those who directly billed for their Part B premium, those who are dually eligible for Medicaid and have their premium paid by state Medicaid agencies, and those who pay an income-related premium, CMS says.

Philips, Masimo settle lawsuits

AMSTERDAM and IRVINE, Calif. – Royal Philips and Masimo have entered into a business partnership agreement that ends all pending lawsuits between the two companies.

As part of the agreement, Philips is released from having to pay a $467 million jury verdict that was awarded to Masimo in October 2014. Instead, it will pay $300 million to Masimo in the fourth quarter, and will make certain marketing and product integration commitments over the coming years.

“I am very satisfied that we have reached an agreement that is beneficial for both companies and that we have ended our legal disputes,” said Frans van Houten, CEO of Royal Philips in a press release. “Going forward, Philips and Masimo will completely focus on jointly delivering meaningful innovations to our customers.”

Philips and Masimo have agreed to jointly market and sell in North America and certain markets in Asia and Europe Masimo’s non-invasive sensor technologies, such as its rainbow and SET platforms, in conjunction with Philips’ patient monitoring and select therapy solutions.

Additionally, Philips will in the future integrate Masimo SedLine brain functioning monitoring, O3 regional oximetry and Nomoline capnography technologies in certain Philips IntelliVue monitors.

“This business partnership agreement marks an important day for us and our customers as two leaders in patient monitoring collaborate to develop solutions designed to enhance clinical outcomes and patient safety,” van Houten said.

Entering into the agreement has minimal impact on Philips’ income from operations in the fourth quarter of 2016, according to the release.

Masimo expects to use some of the after-tax proceeds from the agreement to repay amounts outstanding under its revolving line of credit, the release says.

Happy Veterans Day: Apria participates in ribbon campaign, Geriatric Medical joins forces with Operation Hat Trick

LAKE FOREST, Calif. - Apria Healthcare is encouraging its employees to participate in November’s “Yellow Ribbon Campaign” by placing a yellow ribbon, a symbol of remembrance and awareness, outside their cubicle, homes and facilities to show their support for service members. Apria has a long history of helping veterans transition back into the workforce through company-wide and nationwide initiatives. In 2016, the provider initiated a Facebook “friending” campaign and created Veteran Connect, an internal platform for Apria veterans and employees to network and share experiences with one another. It also joined the Department of Defense Military Spouse Employment Partnership (MSEP), an employment and career program that connects military spouses with employers and was awarded the Patriot Award from the Employer Support of the Guard and Reserve Committee (ESGR), for supporting veterans who have served in the National Guard or Reserve.

Geriatric Medical joins forces with veterans group

WOBURN, Mass. – Geriatric Medical & Surgical Supply has partnered with Operation Hat Trick to raise awareness of the importance of supporting wounded service members and veterans and helping them recover. Geriatric Medical and 47Brand have designed OHT hands to raise money for the organization, which pays for adaptive equipment for amputees, services docs, critical care, emergency rent and other help. “My grandfather originally conceived our company during the waning days of World War II on the decks of a naval destroyer being built at the Boston Naval Shipyard,” said Jeffrey Seigal, Geriatric Medical CEO. “As a third generation family business and an active member of the community, Geriatric Medical is proud to support America’s bravest through its relationship with OHT.”     

Nevada ends tax on DME

CARSON CITY, Nev. – Residents of Nevada has voted to exempt DME from the state sales tax. Question #4 passed overwhelmingly with 72% of the vote. “It’s a major win for the citizens of Nevada,” said Rich Pozesky, president of The Nevada State Association of Medical Product Suppliers, in a release. “This is only step one of the process; however, we are confident that this issue will eventually be law in our state.” Earlier this year, a coalition of HME providers gathered more than 100,000 signatures to put the issue on the November ballot. While the majority of voters voted in favor of the measure, it must pass two election cycles for it to go into effect.

Numotion makes inroads into Texas

FORT WORTH, Texas – Numotion has acquired Home Medical Equipment (HME) of Texas to extend its reach and capacity in the state. HME of Texas has been in business for more than 20 years, serving all of Texas from its location in Fort Worth. “Their knowledge of the Texas market, specifically the eastern and western parts of the state, will improve our coverage and enable us to positively impact many more lives by serving the mobility needs of our customers,” said Mike Swinford, CEO, in a press release. HME of Texas also brings extensive experience with the Applied Income Program of the Texas Department of Aging and Disability Services (DADS). Numotion will apply best practices from HME of Texas to streamline and improve how it interacts with DADS to ensure that choice and mobility needs for customers are optimized. Short term, HME of Texas’ 13 employees will continue to operate from its location in Forth Worth. Next year, that location, along with Numotion’s current branch in Fort Worth, will move into a new facility to align resources and better serve customers.

Quantum hits milestone with iLevel

EXETER, Pa. – Quantum Rehab says its iLevel power-adjustable seat height technology has now been embraced by more than 5,000 users. Launched in July 2015, iLevel elevates the seat of a wheelchair up to 10 inches and, thanks to Extra Stability Technology, allows for full functionality at walking height and speeds up to 3.5 mph. Quantum says the success of iLevel is due to both user demand and an ever-changing understanding by payers toward funding the technology. “Consumers are telling the industry that static wheelchair height in complex rehab is less and less acceptable in their lives,” said John Storie, director of sales for eastern America. “We are witnessing ‘standing height’ mobility become the new norm. As iLevel numbers demonstrate, consumers are shifting toward demanding the most functional, inclusive mobility technologies possible.”

FDA clears 3B Medical’s remote settings

WINTER HAVEN, Fla. – 3B Medical has received 510(k) clearance from the U.S. Food and Drug Administration for the remote device setting capabilities of iCodeConnect, the company announced Nov. 10. “With this software enhancement, therapy and prescription settings can now be adjusted and applied to Luna CPAP and Auto-CPAP devices remotely through 3B’s patient management portal,” the company stated in a press release. “This capability allows clinicians to make prescription changes and update all device settings through iCodeConnect easily and efficiently.” iCodeConnect allows clinicians to manage patient records, develop patient compliance reports, track overall treatment progress of patients, and more.

HealthLinc scores distribution deal for Keeogo

VANCOUVER – HealthLinc Medical Equipment, doing business as HME Mobility & Accessibility, will distribute the Keeogo powered walking assistance device in British Columbia. Keeogo was developed by B-TEMIA, a medical device manufacturer founded in 2010 that specializes in what it calls “human augmentation systems.” The Keeogo has been used by individuals with degenerative medical conditions, such as knee/hip osteoarthritis, multiple sclerosis, Parkinson’s disease, stroke, incomplete spinal cord injury and other conditions that limit mobility. The Keeogo is currently part of a multi-center pivotal clinical trial, part of the process of getting clearance from the U.S. Food and Drug Administration, to enter the U.S. market.

AAHomecare returns to Crystal City

ARLINGTON, Va. – AAHomecare is relocating its offices from Washington, D.C., to Arlington, Va., to save on rent andput membership dues to better use. The change will also allow the association to reach Capitol Hill faster, it says. “This move provides us the opportunity to budget more for lobbying, industry studies, education, member services, and innovative industry techniques that will help our members flourish in these difficult legislative and regulatory times,” AAHomecare stated in a release. The association will be moving to 241 18th Street South, Suite 500, Arlington, Va., 22202. The move will be completed by Nov. 16. AAHomecare's main phone number (202-372-0107) and individual staff phone numbers will remain unchanged.

People news: Walnut Medical Services

Johnstown, Pa.-based Walnut Medical Services has promoted Jodi Clark to director. Clark began her career at the company in 1991 and has held various positions there, most recently assistant director. In her new role, she will manage all operations. Walnut Medical Services is a provider of HME and supplies with four locations in west central Pennsylvania.

WASHINGTON – For about 70% of Medicare beneficiaries, the average monthly premium for Part B services will be about $109 in 2017, compared to $104.90 for the past four years, CMS announced Nov. 10.

Premiums for this group are protected from sharp increases by a statutory “hold harmless” provision designed to protect seniors, the agency says.

“This year, as in the past, the Secretary has exercised her statutory authority to mitigate projected premium increases for these beneficiaries, while continuing to maintain a prudent level of reserves to protect against unexpected costs,” CMS stated in a press release. “The Department of Health and Human Services (HHS) will work with Congress as it explores budget-neutral solutions to challenges created by the ‘hold harmless’ provision.”

For the remaining 30% of beneficiaries, the average monthly premium for Part B services will be $134 in 2017, a 10% increase from the premium in 2016, CMS says.

Beneficiaries not subject to the “hold harmless” provision include those who do not receive Social Security benefits, those who enroll in Part B for the first time in 2017, those who directly billed for their Part B premium, those who are dually eligible for Medicaid and have their premium paid by state Medicaid agencies, and those who pay an income-related premium, CMS says.

WASHINGTON – Amid the chaos in Washington, D.C., industry stakeholders have been crisscrossing the Hill to ensure relief from Medicare’s competitive bidding program doesn’t get lost in the shuffle.

Members of AAHomecare, The VGM Group and others made at least 16 visits in two days last week, and also have spoken with the office of House Speaker Paul Ryan.

“The feedback from Speaker Ryan’s staff is that it’s in the mix, but they can’t give us a specific vehicle or any clarity to the issue,” said Jay Witter, senior vice president of public policy for AAHomecare. “He’s still negotiating with his caucus. There’s all sorts of people vying for power.”

Ryan in September offered assurance that bid relief would be taken up in the lame-duck session, which may end sooner rather than later on Dec. 9.

As to a vehicle, there are a few opportunities, say stakeholders.While it looks unlikely that there will be any sort of Medicare package passed before the end of the year, stakeholders say language addressing bid relief could get included in the 21st Century Cures Act or in an omnibus spending bill.

In lieu of an omnibus bill, lawmakers could pass a continuing resolution to keep the government funded through March. That would, however, lessen the industry’s chances of being included, because House Republicans have indicated they would like the CR to be “clean,” stakeholders say.

“This is a critical time,” said Cara Bachenheimer, senior vice president of government relations for Invacare. “Decisions are being made and as soon as they come to an agreement on the budget, that’s going to drive the timing. Then things will happen very, very quickly.”

Another less likely option, say stakeholders: getting legislation passed by unanimous consent. In July, the Senate began a “hotline process” to pass an amended version of H.R. 5210, which had already been passed by the House of Representatives earlier in the month, but that effort failed.

“That’s the most difficult play,” said Tom Ryan, president and CEO of AAHomecare.“We have gotten everybody lined up and we continue to lobby.”

In their conversations with lawmakers since the elections, stakeholders are hearing that grassroots efforts to raise the noise level are making it to the ears of lawmakers. A new weapon in the toolbox: data highlighting a 39% decrease in PTANs and a 37% decrease in tax ID numbers for HME providers, said Ryan.

“That was an ‘a-ha’ moment for many of the legislators,” he said. “There’s significant loss in the infrastructure of this industry and they said they want CMS to respond to those statistics.”

YARMOUTH, Maine – Respondents to a recent HME Newspoll are split over whether 2017 will be a better year for the HME industry, with 51% saying they expect market conditions to worsen and 49% saying they’ll improve.

2017 will be the year of consolidation and closures, according to one respondent. 

“My company has already laid off 20% of its workforce and closed five of the 65 locations we have,” the respondent said. “We are looking to close an additional three locations in 2017 and lay off another 10% of the workforce. All these closure are in rural markets.”

A number of respondents cited shrinking reimbursement rates and the rollout of competitive bid rates to rural areas as a major concern, along with the “monkey see, monkey do” effect on non-Medicare payers.

“Now that most insurance companies have rolled out new fee schedules based in whole or in part on the Medicare competitive bid rates, there is not reason to think they’ll ever go back to higher rates,” said one respondent.

Others are more optimistic, saying 2017 will be a “comeback” year now that reimbursement rates have finally hit rock bottom.

“I know I’ve been saying this for years, but I seriously don’t see how it can possibly get any worse,” wrote one respondent. “We are finally getting some traction in Congress.”

In light of the fallout from competitive bidding, some say the industry will experience a period of stability as providers restructure by offering new cash oriented products and service lines that have been developed over the last few years.

It’s also impossible to look ahead without considering the implications of a Trump presidency on the HME industry. Many, like Laurence von Euw, manager of Lockport Home Medical in Lockport, N.Y., are encouraged by the president-elect’s business-friendly platform.

“Trump’s campaign ran on promises of lower taxes, including decreasing corporate tax rates to about 15% from the current 35% rates, and doing away with onerous regulations on small business,” said von Euw. “This will increase retail sales.”

Meanwhile, Ricky Hubbard, general manager of Zurcare in Starkville, Miss., which is slated to close its doors Nov. 30, says 2017 will be a mixed bag.

“With the nomination of a new Republican president and Congress’ intentions to repeal or replace Obamacare, the HME industry’s future is looking up,” he said. “However, I do not believe there will be improvements above and beyond the cuts we received in January 2016. I also believe that the current policies CMS has in place, including the audit process, will not change in HME’s favor.”

LIVERMORE, Calif. – Providers should strap in: After a protracted lull, RAC audits will likely pick back up in January, now that CMS has tapped Performant Recovery, based here, to perform post-payment reviews for DME and home health/hospice claims nationwide.

Stakeholders say Performant will likely kick-start its efforts with reviews* it had previously been performing as the RAC for Jurisdiction A—reviews whose targets were everything from vacuum erection devices to respiratory assist devices to portable oxygen systems to vents.

“I think one thing that we can glean is that, because the RACs need CMS approval for their reviews, to get started right away, they will carry over a lot of those previous reviews,” said Wayne van Halem, president of The van Halem Group.

CMS’s award to Performant signals the agency’s move to a single RAC for DME claims for all four jurisdictions. It initially planned to have this new structure in place in 2014, but it has been slowed down* by pushback surrounding changes* to the new contract and several protested awards, including an award to Connolly* in December of 2014.

Because Performant will be conducting post-payment reviews of DME claims paid during a three-year span, providers should be on the lookout that the RAC applies the correct coverage policies, stakeholders say.

“The biggest risk is, what version of the LCD are they looking at?” said Kim Brummett, vice president of regulatory affairs for AAHomecare. “For repeat rentals and supplies patients, (the contractor) needs to be very aware of what’s required when the patient actually received the services.”

While post-payment reviews are never pleasant, changes to the new contract mean several improvements for providers, including a more meaningful discussion period, stakeholders say. Previously, providers had the option of a discussion period, but because the RAC immediately signaled the MAC to start the overpayment process, the only way they could hold onto their money was to file an appeal.

“This is a true passing of the baton,” said Andrea Stark, a reimbursement consultant for MiraVista. “You get the results of the review and then you can sit on it for 30 days. You can provide counter evidence or missing evidence, all the while avoiding an overpayment going to the MAC (right away). That should be more effective.”

Other changes to the new contract that benefit providers: Performant can’t collect contingency fees until the second level of appeals is exhausted, and it will be held to a 95% accuracy rate and a less than 10% turnover rate on appeal, stakeholders say.

“That forces them to be more comprehensive with their reviews,” van Halem said.

The only change to the new contract that could pose a problem for providers, stakeholders say: Performant is required to participate in 50% of hearings at the administrative law judge level, a provision CMS added as a result of the high overturn rate at the ALJ.

“When the contractor is there, there’s a vested interest that the claim remain unpaid,” van Halem said. “That will be more challenging for providers.”

https://www.performantrac.com/IssuesUnderReview.aspx

http://www.hmenews.com/article/cms-sets-timeline-new-rac

http://www.hmenews.com/article/new-national-rac-hme

http://www.hmenews.com/article/cms-kick-starts-new-audit-program

WASHINGTON – The Council for Quality Respiratory Care this week urged lawmakers to pass legislation that would delay steep cuts to reimbursement for home oxygen.

The Patient Access to Durable Medical Equipment Act would reinstate the phase-in period of cuts to soften the blow on suppliers.

“It’s time for leaders in the House and Senate to work together to enact the critical provisions of the bill,” said Dan Starck, CQRC chairman, in a release. “It remains clear that more time is needed to adequately measure and monitor the impact of earlier cuts that took effect on Jan. 1 before Medicare implements deeper cuts on home respiratory care.”

In July, the Senate began a “hotline process” to pass an amended version of H.R. 5210, which had already been passed by the House of Representatives earlier in the month, but that effort failed.

Lawmakers, patient groups, physicians and health systems have voiced growing concerns with the impact of the program on beneficiary access.

Lincare hit with another overtime-related lawsuit

PHILADELPHIA – Jeffrey Sawyer has filed a class action lawsuit against Health Care Solutions at Home and Lincare, alleging the companies failed to properly compensate him for all the hours he worked, according to PennRecord.

Sawyer, who filed a complaint on Oct. 31 in the U.S. District Court for the Eastern District of Pennsylvania, alleges that he worked for more than 40 hours per week without being paid overtime compensation, and that the companies failed to properly figure base pay and maintain correct records, according to PennRecord, which cover’s Pennsylvania’s legal system.

Sawyer requests a trial by jury, and seeks damages, liquidated damages, court costs, interest and any further relief the court grants, PennRecord says.

This isn’t the first time Lincare has been hit with such a lawsuit: The U.S. District Court for the Eastern District of California ruled in August that non-exempt employees who work in California for Alpha Respiratory and Lincare could proceed with their lawsuit* as a class action. Honorable Judge Morrison England ruled that non-exempt employees who worked for the companies in California since Oct. 21, 2010, can seek back overtime wages and premiums for missed meal breaks.

The lawsuit in California alleges Alpha Respiratory and Lincare failed to pay their hourly employees in California overtime wages, failed to provide the legally mandated meal and rest breaks, and failed to provide accurate wage statements required by state law.

Vertess closes multiple deals in Q3

TUCSON, Ariz. – Vertess, a healthcare M&A advisory firm, closed two major healthcare transactions in the third quarter, it announced yesterday.

Vertess represented Metro-Med, Inc., a Burbank, Calif.-based specialty provider of respiratory equipment and related services, in an acquisition by Good Night Medical, LLC, a Cleveland-based DME company with additional operations in Arkansas, Texas and Massachusetts.

Vertess also represented Integrity Medical, a Savannah, Ga.-based provider of complex rehabilitation technology, in an acquisition by National Seating & Mobility, a national provider based in Franklin, Tenn.

"Both of these acquisitions were very beneficial to our clients, as well as the buyers, who were able to strategically expand in core areas they had identified," said Bradley Smith, Vertess managing director/partner.

Also in the third quarter, Vertess represented Alpine Investors in its acquisition of Acumen, a provider of fiscal agent services based in Mesa, Ariz.

Vertess has expertise in diverse healthcare and human service verticals, ranging from behavioral healthcare, substance abuse treatment and cognitive disabilities, to DME, home care/hospice, urgent care centers and other specialized services and products.

Inogen makes list for third time

GOLETA, Calif. – Inogen has been named one of the 500 fastest growing technology, media, telecommunications, life sciences and energy tech companies in North Americaby Deloitte Technology. It’s the third year in a row that Inogen, which saw its revenue grow 227% between 2012 and 2015, has made the list. "It is an honor to be named to Deloitte’s Technology Fast 500 for the third year in a row,” said CEO Raymond Huggenberger in a release. “We believe that the awareness of our innovative oxygen concentrators continues to expand among oxygen therapy patients and homecare providers, and that is a primary driver fueling our growth across all of our sales channels."The company reported total revenues of $54.4 million for the third quarter of 2016.

Philips wants you to #BreatheBoldly

AMSTERDAM – In honor of World COPD Day on Nov. 16, Royal Philips has launched Breathe Boldly, a campaign that encourages people to post a photo or video of themselves on social media that shows them performing an activity while breathing through a straw. People are asked to use the hashtags #BreatheBoldly and #COPD. The campaign is meant to raise awareness of COPD and show support for those living with the disease, which causes more than 3 million deaths each year. “We’re hopeful that Breathe Boldly will not only increase global awareness of the disease, but also help people better identify symptoms of COPD, and gain a better understanding of what it is like to live with this disease that impacts so many people worldwide,” said John Frank, general manager for Philips Sleep & Respiratory Care.

Cryogenic to invest $1 million in Hoosier state

INDIANAPOLIS – Cryogenic Solutions announced this morning that it plans to double its footprint here, according to local news reports. The company says it will invest $1 million to increase its headquarters from 15,000 to 30,000 square feet and create up to 31 new jobs. The company, which repairs home medical equipment, in September acquired Inventory Solutions, a national supplier of refurbished respiratory products based in New York.

Inspire Medical raises $37M for sleep apnea device

MAPLE GROVE, Minn. – Inspire Medical Systems has accumulated $37.5 million in venture funding as it prepares to increase sales of its pacemaker-sized, implantable device used to treat sleep apnea. New York-based investor Amazak Health led the round of funding, CEO Tim Herbert told the Minneapolis/St. Paul Business Journal. Previous investors, including OrbiMed Advisors and Medtronic, also participated in the round. The company received $12.5 million a few weeks ago and will get the rest next year. In 2014, the Food and Drug Administration approved the device, which uses electrical pulses to prevent the tongue from collapsing and blocking a patient’s airway, for sale in the U.S. Inspire generated about $8 million in revenues last year and expects sales of $16 million in 2016. It has 80 employees.

Driver group seeks to halt sleep screening rule

WASHINGTON – The Owner-Operator Independent Drivers Association has filed a challenge against a 2015 U.S. Department of Transportation rule that altered the driver medical examination process to include sleep apnea screening, according to Overdrive Magazine. In a challenge filed Nov. 11 with the 8th Circuit Court of Appeals, OOIDA claims the DOT sidestepped the regulatory process for requiring sleep apnea screening by slipping a provision into the final rule but not the proposed rule, the magazine reported. OOIDA seeks to vacate the rule either in part or in whole, according to Overdrive. The rule was made final by the Federal Motor Carrier Safety Administration in April 2015, the magazine reported.

Hoboken train crash caused by driver’s undiagnosed sleep apnea

HOBOKEN, N.J. – The engineer of the NJ Transit train that killed one woman and injured more than 100 others when it slammed into Hoboken Station has severe sleep apnea, according to his lawyer. A spokesperson for the New Jersey Transit said he could not confirm whether or not Thomas Gallagher had sleep apnea, but that the agency had a sleep apnea screening program, according to news reports. Gallagher’s lawyer, Jack Arseneault, said, New Jersey Transit gave Gallagher a physical exam in July and declared him fit for duty, but that he was an “extremely heavy man” with a large neck circumference. “I believe common sense indicates that a person like that could be subject to suffering from adult sleep apnea,” Arseneault told the New York Times. The Federal Railroad Administration said it would soon issue a safety advisory to push railroads to tackle worker fatigue and to install cameras in locomotives.

Convaid seeks ambassadors

TORRANCE, Calif. – Convaid seeks applications to join its 2017 class of ambassadors. Ambassadors are volunteers who share insights and experiences with the greater Convaid community online, at school functions, at dealer events, in support groups, and at Abilities Expos or other special needs gatherings. “Our engagement as Convaid ambassadors has been a great opportunity for us,” said Ashley Cervara, whose daughter Sammy uses a Convaid Cruiser. “We met so many helpful people along the way and it has given us so many opportunities to help inform other families living within the autism spectrum.” The deadline to apply to be an ambassador is Dec. 31. Ambassadors serve a one-year term, then elect whether or not to continue as an ambassador emeritus.

Better management of diabetes leads to fewer re-admissions, study says

WALTHAM, Mass. – Two new studies validate the ability of Glytec’s eGlycemic Management System to reduce readmissions for patient populations at the center of new at-risk and value-based reimbursement models, the company says. Both studies, presented earlier this month at the Diabetes Technology Meeting, compare outcomes of cardiovascular patients receiving care with eGMS to outcomes of those receiving standard care. The data shows cardiovascular patients receiving care with eGMS return to the hospital far less frequently, with reductions in risk-adjusted 30-day readmissions as high as 68%. The basis for the studies was a system-wide glycemic initiative launched by Mountain States Health Alliance, which operates 13 hospitals. Like most health systems, the alliance has been challenged to initiate timely therapy for patients with undocumented, undiagnosed or stress-induced diabetes. One of the key benefits of eGMS is a GlucoSurveillance module that alerts care teams to patients with blood glucose outside a designated range. Glytec specializes in integrated inpatient and outpatient technologies for diabetes care.

Sleep apnea impairs blood pressure regulation

KELOWNA, British Columbia – Sleep apnea has an immediate negative impact on blood pressure, according to a new study. Just six hours of fluctuating oxygen levels associated with sleep apnea impairs the body’s ability to regulate blood pressure, say researchers at the University of British Columbia’s Okanagan campus. The study, in which healthy young adults wore ventilating masks for six hours and had their oxygen levels alternated to mimic apnea symptoms, also found damaging blood flow patterns in the legs, which could ultimately impact vascular health.

POC market poised to grow

VALLEY COTTAGE, N.Y. – The global portable oxygen concentrators market is projected to grow at a CAGR of 7.8% in terms of revenue over the forecast period 2016-26, according to Future Market Insights. “Rising prevalence of COPD, growing consumer awareness of oxygen therapy devices and changing consumer lifestyle are reasons (that) have escalated demand for portable oxygen concentrators in the near future,” the consulting firm says. Future Market Insights also credits adoption of new technologies and rising investment by companies manufacturing homecare products as reasons for the revved up growth. Among the various products in the POC market, pulse-flow POCs will grow at a CAGR of 9% and is the more preferred product. Some of the top companies operating in the POC market are Koninklijke Philips N.V., Inogen, Chart Industries, Resmed, Invacare, Drive DeVilbiss Healthcare, Precision Medical, Besco Medical Co., Oxus America, Foshan Keyhub Electronic Industries Co., O2 Concepts and GCE Group.

Short Takes: Wearever Incontinence, Kaiser Wells, Special Needs Group

Wearever Incontinence welcomed Marchese Medical Supplies to their office to help better understand how Prime Life Fibers markets the Wearever product line in the United States. Marchese, a Canadian distributor, recently added Wearever to its product offerings ... Kaiser Wells Pharmacy & Home Care is now Kaiser Community Pharmacy & Home Medical Equipment, a part of the Fisher-Titus Health system. Operating under the new name of Kaiser Community Pharmacy, pharmacists and other staff members will remain on staff. The business will continue to offer home medical equipment, home respiratory therapy and rehabilitation services, as well as a full-service pharmacy…Special Needs Group, an equipment rental provider, celebrated the fifth anniversary of its Certified Accessible Travel Advocate Program on Nov. 11. The program allows travel professionals to become knowledgeable about the accessible travel market segment through online study and testing. To date, 3,131 travel professionals are SNG Certified Accessible Travel Advocates.

WASHINGTON – The Council for Quality Respiratory Care this week urged lawmakers to pass legislation that would delay steep cuts to reimbursement for home oxygen.

The Patient Access to Durable Medical Equipment Act would reinstate the phase-in period of cuts to soften the blow on suppliers.

“It’s time for leaders in the House and Senate to work together to enact the critical provisions of the bill,” said Dan Starck, CQRC chairman, in a release. “It remains clear that more time is needed to adequately measure and monitor the impact of earlier cuts that took effect on Jan. 1 before Medicare implements deeper cuts on home respiratory care.”

In July, the Senate began a “hotline process” to pass an amended version of H.R. 5210, which had already been passed by the House of Representatives earlier in the month, but that effort failed.

Lawmakers, patient groups, physicians and health systems have voiced growing concerns with the impact of the program on beneficiary access.

WASHINGTON – A federal judge in Texas on Nov. 22 blocked a new overtime rule from going into effect on Dec. 1. The rule would require employers to pay overtime for more than 40 hours of work per week for all employees earning up to $913 per week or $47,476 per year. The current threshold: $455 per week or $23,660 per year. The judge, Amos L. Mazzant III of the Eastern District of Texas, ruled that the Obama administration had exceeded its authority by raising the overtime salary limit so significantly. The Labor Department says it “strongly disagreed” with the decision and was “considering all of our legal options,” raising the possibility of an appeal, according to The New York Times. While the injunction is only a temporary measure that suspends the rule until the judge can issue a decision on the merits, his language indicates he will likely strike down the rule, the Times reported.

Legal action: Lincare, InfuSystem

MIAMI – The plaintiffs in a whistleblower lawsuit against Lincare have asked the court to overturn the decision.

The whistleblowers, Gerry Phalp and Matt Peoples, claim that unsolicited calls from Diabetic Experts of America, a Lincare subsidiary, violated Medicare statute, which forbids such calls unless the beneficiary has bought something from that company within the past 15 months.

In July 2015, U.S. District Judge Kathleen Williams sided with Lincare, ruling that Diabetic Experts is a subsidiary of Lincare, not a separate entity; therefore, because the beneficiaries had received oxygen supplies from Lincare within the 15-month time period before the calls, the calls did not violate the False Claims Act.

In arguments before the Eleventh Circuit on Nov. 16, however, the attorney for the whistleblowers, Simon Paris, argued that the court was wrong to conclude the definition of DME was ambiguous and that blood-testing supplies were, therefore, exempt from the statute.

Also during those arguments, Weili Justin Shaw, an attorney with the U.S. Department of Justice, told the court that Williams made the right decision, but used the wrong reasoning. He said that could damage future cases by allowing a defendant to dodge liability for violation of a regulatory requirement by proposing a reasonable alternate interpretation of the requirement, regardless of the defendant's intent.

Class action lawsuit filed against InfuSystem

DALLAS – A class action lawsuit has been filed against InfuSystem Holdings, alleging violations of the Securities Exchange Act of 1934.

The lawsuit alleges that, between May 12, 2015, and November 7, 2016, InfuSystem and several officers and directors used false and misleading statements and/or failed to disclose that the company lacked effective internal control over financial reporting.

It also alleges that the company’s financial statements from the start of 2015 overstated estimated accounts receivables collections and, in turn, overstated revenues and pre-tax income by a corresponding amount. As a result, those statements were materially false and misleading, and could not be relied on, the lawsuit alleges.

Following that announcement, InfuSystem stock dropped significantly, according to a press release from The Briscoe Law Firm, which is representing the class action.

Veterans Mobility Safety Act clears another hurdle

WASHINGTON – Both the Senate and House of Representatives have now passed a version of the Veterans Mobility Safety Act, the VGM Group reported on Nov. 22.

The bill requires Veterans Affairs to establish quality and safety standards for adaptive equipment and vehicles, including equipment quality and safety; certification of providers by third-party manufacturers or other organizations; training for VA personnel administering the program; and allowances for modifications at the veteran’s residence.

The Senate passed the bill passed by the House, H.R. 3471, but with an amendment to ensure the certification process is not limited to one specific organization.

“VGM, Accessible Home Improvement of America (AHIA) and U.S. Rehab have put a great amount of effort into these changes,” VGM stated. “AHIA is in the process of creating a new training program on hitch-mounted lifts to address this need.”

With two slightly different versions of the bill, it now returns to the House.

Once the bill passes the House, it will head to President Obama’s desk to be signed into law.

Previous versions of the bill divided the manufacturers and providers in the market.

FRA to release advisory on importance of sleep apnea screening, treatment

WASHINGTON – The Federal Railroad Administration is expected to issue a safety advisory to push railroads to address worker fatigue and accelerate their installation of inward- and outward-facing cameras, the agency announced Nov. 16. The FRA made the announcement in response to a train crash* in Hoboken on Sept. 29 that killed a woman and injured more than 100 others. The train’s engineer revealed recently that he has severe sleep apnea. The advisory will stress the importance of sleep apnea screening and treatment, according to news reports. The advisory, akin to a strong recommendation, is a stopgap measure while regulators draft rules that would require railroads to screen engineers for sleep apnea, reports say.

HME provider opens health and wellness store

FLETCHER, N.C. – Remedy Health & Wellness, a new store focused on preventative health products, as well as traditional HME, will hold an opening reception on Dec. 8. Marcus Suess, the CEO of All-States Medical Supply, is behind the new store. “By offering an extensive inventory of health and wellness supplies, our team at Remedy Health & Wellness look forward to helping people of all ages and abilities live fulfilled lives,” he said. The reception will include a ribbon cutting by the Asheville Area Chamber of Commerce (feel free to avoid this, Suess said), followed by food and refreshments (make sure not to avoid this, he said). “We are very excited about this new venture and the opportunity to fill a need in the community,” he said. Remedy Health is online at www.RemedyHW.com and on Facebook at www.Facebook.com/RemedyWH.

Numotion nearly doubles size of facility

CAPE GIRARDEAU, Mo. – Numotion has relocated and expanded its Southeast Missouri branch, according to the Southeast Missourian. The 9,000-square-feet facility is nearly twice the size of the company’s previous facility and will allow it to expand office and service and repair space, and provide additional storage space, the newspaper reported. Numotion’s Cape Girardeau branch is one of seven in the state and one of 120 across the country.

Product news: ResMed, SnooZeal

ResMed’s AirFit F20 full-face mask and N20 nasal mask are now available in the United States, the San Diego-based company announced Nov. 22. The AirFit 20 series introduces a new InfinitySeal silicone cushion that adapts to the unique facial contours of each patient and is designed to provide a universal fit for all patients, regardless of face shape or size, the company says. The masks also feature magnetic clips for easy fit and removal. ResMed expects mask and accessories growth in the Americas to rebound with the launch of the AirFit 20…The anti-snoring and sleep apnea device from Seattle-based SnooZeal has scored a CE mark, making it the first commercially available over-the-counter device that targets the underlying cause of snoring, Fierce Biotech reported Nov. 21. The device addresses the excessive relaxation and loss of tongue muscle tone during sleep. Worn for 20 to 25 minutes twice a day over six weeks, it delivers electric pulses to the back of the tongue to increase muscle tone. Patients use a smartphone app to control their treatment.

WASHINGTON – A federal judge in Texas on Nov. 22 blocked a new overtime rule from going into effect on Dec. 1. The rule would require employers to pay overtime for more than 40 hours of work per week for all employees earning up to $913 per week or $47,476 per year. The current threshold: $455 per week or $23,660 per year. The judge, Amos L. Mazzant III of the Eastern District of Texas, ruled that the Obama administration had exceeded its authority by raising the overtime salary limit so significantly. The Labor Department says it “strongly disagreed” with the decision and was “considering all of our legal options,” raising the possibility of an appeal, according to The New York Times. While the injunction is only a temporary measure that suspends the rule until the judge can issue a decision on the merits, his language indicates he will likely strike down the rule, the Times reported.

WASHINGTON – The HME industry now has a vehicle in Congress for rolling back a second round of Medicare reimbursement cuts that went into effect in non-competitive bidding areas on July 1, AAHomecare reports.

A draft of the 21st Century CURES bill that will be considered by lawmakers this week has language that would roll back the cuts for six months. It paves the way for providers in non-bid areas to recoup reductions for items with dates of service from July 1 to the end of 2016, says Tom Ryan, president and CEO of the association.

“This legislation will help HME providers in rural areas stay in business and serve their communities, while we continue to work for a more realistic and sustainable pricing environment for all HME providers,” he said. “It’s just the first step in efforts to protect the rural HME infrastructure, but it’s an important one.”

Per the bill, the second round of cuts would again go into effect Jan. 1, 2017.

The bill also has language that would further delay Medicare’s plan to use bidding-derived pricing for accessories for complex power wheelchairs for another six months, until July 1, 2017. It extends an original 12-month delay granted by Congress in December 2015.

“This legislation will also ensure that individuals with significant disabilities continue to receive the specialized technology they depend on while we continue to advocate for a permanent fix that will keep CRT accessories outside the purview of the bidding program,” Ryan said.

Other proposals in the bill include:

·      Speeding up plans to limit state Medicaid reimbursement amounts for HME to the Medicare fee-for-service rates, including applicable bid rates, from January 2019 to January 2018.

·      Instructing the Department of Health and Human Services to conduct a study on the impact of the bid program on the overall number of HME providers and the availability of products over the course of 2016.

·      Requiring HHS to reissue payment regulations for items and services furnished on or after Jan. 1, 2019, with adjustments to the non-bid fee schedule in some areas based on stakeholder input, costs, volumes and the number of suppliers serving those areas.

AAHomecare expects the House of Representatives to take up the bill this week, followed by the Senate next week.

WASHINGTON – President Elect Donald Trump has named Rep. Tom Price, R-Ga., a long-time champion of the HME industry and its efforts to reform Medicare’s competitive bidding program, as the next secretary of the Department of Health and Human Services, according to news reports.

Price, a six-term congressman, is a vocal critic of the Affordable Care Act and, according to The New York Times, has been studying how to dismantle and replace Obamacare for the past six years. He serves on the influential Ways and Means Committee in the House of Representatives.

Earlier this month, Price was at Medtrade in Atlanta to update attendees on efforts to roll back a second round of reimbursement cuts in non-bid areas. Industry stakeholders, including Tom Ryan of AAHomecare and John Gallagher of The VGM Group, gave him an award for his work championing the HME industry on the Hill.

Price has introduced bills to create an alternative to the competitive bidding program, called the market-pricing program. Tenets of MPP include requiring providers to fulfill their contracts and putting out to bid only two product categories per bid area (with the remaining product categories adopting the price submitted by contract suppliers in other areas of equal size).

Price has also introduced bills to soften the blow of the recent national roll out of competitive bidding by providing a 30% increase in reimbursement over the bidding-derived prices and a four-year phase-in period, and reinstating the bid cap at the unadjusted fee schedule amount.

Before coming to Washington, D.C., Price was an assistant professor at Emory University School of Medicine and the medical director of the Orthopedic Clinic at Grady Memorial Hospital, where he taught resident doctors in training.

Price, who lives in Roswell, Ga., with his wife, Elizabeth, worked in private practice as an orthopaedic surgeon for nearly 20 years.

Trump has also named Seema Verma, founder and president of health policy consulting firm SVC, as the next administrator of CMS. Verma is a Medicaid policy expert and the architect of the Healthy Indiana Plan, the nation’s first consumer-directed Medicaid program.

WASHINGTON – The House of Representatives yesterday passed the 21st Century Cures Act, which includes important HME-related provisions, by a margin of 392 to 26.

The legislation would roll back a second round of Medicare reimbursement cuts that went into effect this year in non-competitive bidding areas from June 30, 2016, to Dec. 31, 2016. It would also further delay Medicare’s plan to use bidding-derived prices for accessories for complex power wheelchairs until July 1, 2017.

“This is a great first step,” said Tom Ryan, president and CEO of AAHomecare. “Once you have statute, it’s easier next time around to get an extension.”

The legislation also requires the Department of Health and Human Services to conduct a study on the impact of the bidding program on the overall number of HME providers and the availability of home medical equipment during 2016. New data shows a decrease in PTANs and a 37% decrease in tax ID numbers for HME providers, according to AAHomecare.

While the legislation only provides temporary relief, stakeholders say it buys time for a more permanent fix under the new administration.

“While AAHomecare and other HME stakeholders advocated for a longer delay for the second phase of bidding derived cuts, this legislation marks an important step in efforts to scale back the effects of the bidding program,” said AAHomecare in a bulletin. “Both chambers of Congress, along with party and committee leadership, have recognized that the home medical equipment community in rural areas needs relief and that the bidding program requires more scrutiny.”  

WASHINGTON – The HME industry is within spitting distance of rolling back certain Medicare reimbursement cuts after the 21st Century Cures Act sailed through the House of Representatives last week.

The legislation, which passed Nov. 30 by a vote of 392 to 26, would roll back a second round of Medicare reimbursement cuts that went into effect this year in non-competitive bidding areas from June 30, 2016, to Dec. 31, 2016. But the cuts would again go into effect on Jan. 1, 2017.

“Obviously, we are disappointed it’s not a more permanent fix,” said Tom Ryan, president and CEO of AAHomecare. “This will give our providers a bump in cash, which is good, but from an operational standpoint, they still have to meet the challenges of those same rates Jan. 1.”

The Cures Act also requires the Department of Health and Human Services to conduct a study on the impact of the bidding program on the overall number of HME providers and the availability of HME during 2016. New data shows a decrease in PTANs and a 37% decrease in tax ID numbers for HME providers, according to AAHomecare.

The six-month roll back of the second round of cuts will give providers cash in hand to hang on longer while stakeholders and their champions in Congress work on a more permanent fix during the first half of 2017.

“There are legislative and regulatory opportunities in the near future that we and others will look at as opportunities to attach our issues to and get longer-term relief,” said Cara Bachenheimer, senior vice president of government relations for Invacare.

Those opportunities include passing a federal budget and a possible “semi-repeal” of the Affordable Care Act, Bachenheimer says.

The Senate is expected to take up the Cures Act early this week, and stakeholders say they don’t anticipate any significant issues. Although the 11th-hour failure of previous bid delay legislation in July still smarts, this time the industry will benefit from being attached to a much larger vehicle.

“I think between the House and the administration’s support and the patient support, it’s going to be pretty hard to vote against this thing,” said Ryan.

WASHINGTON – As the new secretary of the Department of Health and Human Services, Rep. Tom Price, R-Ga., would have a huge agenda—one that, industry stakeholders believe, could better support HME.

Price, a six-term congressman and a longtime champion of HME, has been tapped by President-Elect Donald Trump to take over the huge agency. Price’s resume includes introducing multiple bills to create an alternative to the competitive bidding program called the market-pricing program, and to soften the blow of the bid program.

“He has been an incredibly vocal opponent of the way CMS has implemented the competitive bidding program,” said Cara Bachenheimer, senior vice president of government relations for Invacare. “There’s so many ways the program could be improved and I am hoping we are collectively going to work with him to make some changes.”

One possible change: implementing MPP, say stakeholders.

“MPP is his baby,” said John Gallagher, vice president of government relations for The VGM Group. “It’s already written and could be implemented easily.”

Still, stakeholders acknowledge Price will have a lot on his plate, and many much higher priorities than HME. The biggest?Repealing and replacing the Affordable Care Act, which the congressman has been studying how to dismantle for the past six years, according to The New York Times.

Repealing ACA would be music to the ears of many HME providers, say stakeholders.

“ACA has not been our friend,” said Gallagher said. “A repeal would eliminate the roll out of bid prices to rural America. He also has the authority, as secretary, to further delay the cut.”

And then there’s Medicare, the granddaddy of healthcare programs, which Price might also seek to reform. As a physician, Price—who worked in private practice as an orthopedic surgeon for nearly 20 years—has different ideas about how the healthcare system should work, says Gallagher.

“He’s very much about local control of health care, and health care between the patient and the doctor,” he said. “I don’t think he’s against Medicare and Medicaid, but he thinks it’s highly inefficient and not effective. Regardless of what they do, and what changes they would make, I think DME is in a good place because he understands the need for in-the-home care.”
Trump has also named Seema Verma, founder and president of health policy consulting firm SVC, as the next administrator of CMS. Verma is a Medicaid policy expert and the architect of the Healthy Indiana Plan, the nation’s first consumer-directed Medicaid program.

MINNEAPOLIS – Coloplast, which has its U.S. headquarters here but is based in Denmark, has entered into a definitive agreement to acquire Coral Springs, Fla.-based Comfort Medical for $160 million in cash, the company announced Nov. 30.

The deal, if completed and approved by authorities, combines a manufacturer of ostomy, urology, continence and wound care supplies with a provider of those supplies.

“The acquisition of Comfort Medical fits very well into our overall consumer ambition for Coloplast in the U.S., securing continued access to innovative technology for end users,” said Lars Rasmussen, Coloplast’s CEO, in a release. “Comfort Medical has a strong patient acquisition model and an efficient and scalable setup, in addition to a strong management team with a good cultural fit to Coloplast.”

Comfort Medical, a subsidiary of Liberty Medical, is expected to record sales of about $38 million for 2016, according to the release.

Coloplast plans to leverage Comfort Medical’s business model of capturing patients through direct response advertisement and physician referrals. It provides patients with products from a number of manufacturers, including Coloplast.

“I am excited about the future prospects of our U.S. business and view this acquisition as an additional building block in the implementation of our U.S. strategy,” Rasmussen said.

Earlier this year, Comfort Medical acquired Wheel:Life, a digital media publication and social community for wheelchair users with more than 26,000 followers on social media, further strengthening its ties to end users.

The deal is expected to close in the first quarter of 2016/17.

Senators introduce bill to preserve access to diabetes supplies

WASHINGTON – Sens. Dan Coats, R-Ind., and Mark Warner, D-Va., have introduced a bill that they believe would help ensure that all Medicare beneficiaries have access to their preferred brand of diabetes test strips.

The senators introduced the bill, the Diabetes Supplies Act, on Nov. 16 in response to Medicare’s national mail-order program for diabetes testing supplies. As a result of the program, they say, the most commonly purchased brands of test strips are no longer available to Medicare beneficiaries through mail-order suppliers.

“All diabetes patients should have access to the same market of products, regardless of whether they receive Medicare benefits,” Coats said in a statement. “Diabetes patients deserve the right to choose what products will best help them manage their disease. Our legislation will improve quality and access for all diabetes patients.”

The bill would strengthen consumer protections by ensuring beneficiaries are informed of their rights to obtain their preferred products and by preventing auto-refills of unwanted products.

Additionally, the bill would ensure that suppliers seeking to supply diabetes test strips have demonstrated an ability to obtain the products included in their bids, and it would reinforce the authority of the Department of Health and Human Services to terminate suppliers who fail to comply with the terms of their bids.

The bill is supported by the American Association of Diabetes Educators, the American Association of Clinical Endocrinologists and the Diabetes Access to Care Coalition.

Pride offers third-party consumer financing

EXETER, Pa. – Pride Mobility Products has added another tool to the toolbox of retail providers.

The company announced Nov. 29 that it can now help providers arrange financing for their customers through Monterey Financial Services and Care Credit.

“We’ve heard from both Pride retailers and consumers that consumer financing outlets are a necessity in this industry and would provide opportunities for business growth for retail products,” said Julie Pello, general manager of business development, in a press release. “We were able to vet such lenders as Monterey Financial Services and Care Credit who were able to provide comprehensive financial solutions for retailers and consumers across the country.”

Providers who are interested in arranging financing for their customers can contact their Pride Mobility credit or sales representative.

Pride Mobility decided to step in with third-party consumer financing as a nod to the “ever-expanding” retail market for products like its Jazzy Air*. The power wheelchair features patent-pending technology that allows 10 inches of seat elevation at a driving speed of up to 3.5 mph.

http://www.hmenews.com/article/social-climbing-pride-mobility-elevates-consumer-mobility

Regulatory updates from AAHomecare: Oxygen payments, supplier standards

Starting April 1, 2017, the fee schedule amount* for stationary oxygen equipment will be increased if either of the following applies: 1.) if the prescribed amount for stationary equipment exceeds 4 liters per minute, the amount will be increased 50%; or 2.) if portable oxygen is prescribed, the amount for portable equipment will be added to the amount for stationary equipment. If both situations apply, the DME MACs will have to use the higher amount of the two, but they cannot use both adjustments…CMS has agreed to limit its reviews of whether or not a provider meets supplier standard #5 to those that provide enteral pumps and/or Group 2 and Group 3 power wheelchairs. The standard states that, “A supplier must advise beneficiaries that they may rent or purchase inexpensive or routinely purchased DME and of the purchase option for capped rental equipment.” Although enteral pumps and Group 2 and Group 3 power wheelchairs are the only items that are subject to the standard, AAHomecare heard from its membership that inspectors were conducting this review for other items.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN...

OIG reports issues with licensure, infusion payments

WASHINGTON – Incomplete and inaccurate data allowed some suppliers in Round 2 of competitive bidding to be awarded contracts, says the Office of Inspector General.

In its Semiannual Report to Congress, the OIG reveals that an audit of 146 suppliers revealed that 63 did not meet all licensure requirements and an additional 14 needed to be further researched by CMS and its contractors. In the report, the OIG also reiterated its recommendation that CMS switch from an average wholesale price model to an average sales price model for DME infusion drugs. Under the AWP model, payments continue to be misaligned with drug costs, says the OIG. CMS could also include DME infusion drugs in the competitive bidding program, according to the report.

DME MAC offers new online tool

NASHVILLE – CGS Administrators, the Jurisdiction B DME MAC, has launched Mr. Wizard, an online tool that provides detailed information on claims under review and the status of additional documentation requests. Providers simply enter their 14-digit claim control number to receive information on type of denial received and detailed explanation; provider NPI; date of service, code billed, and links to education and resources for particular denials.

Invacare names biotech exec to board

ELYRIA, Ohio – Invacare has a new board member: Susan Alexander, who has served as the executive vice president, chief legal officer and corporate secretary for Biogen, a pharmaceutical company, since December 2011. She has more than 35 years of corporate legal experience, both from private law and general counsel positions in global med-tech, software and manufacturing companies. Alexander brings strong cross-functional legal, regulatory and senior management expertise to the board, Invacare says. “Susan’s leadership will be valuable as Invacare transforms from a generalist DME company into a leading medical device company that focuses its strong technical capabilities on solving complex clinical needs for post-acute care,” said Matthew Monaghan, chairman, president and CEO, in a press release.

Numotion adds to online offerings

BRENTWOOD, Tenn. – Numotion now offers RibGrips through shopnumotion.com. The American-made wheelchair handrims feature soft rib discs that offer 360 degrees of gripping surface molded over aluminum handrings that attach to most standard wheels to provide users with better range of motion and prevent calluses. “We created the Numotion online store, ShopNumotion.com, to offer our customers a wider array of products that can enhance their lifestyle and increase their mobility,” said Mike Swinford, CEO, Numotion. “RibGrips are a well-researched accessory for manual wheelchair users. We hope that adding them to our store will increase awareness and access to this innovative product.” Numotion launched the online store in September.

F&P gets win in German court

MUNICH – The District Court in Munich has overturned two preliminary injunctions previously granted to ResMed against Fisher & Paykel Healthcare’s German subsidiary. In August, the court granted two injunctions, preventing the sale of F&P’s Simplus, Eson and Eson 2 masks in Germany. In a hearing in November, the court ruled to overturn the first injunction and in a subsequent hearing this month, it ruled to overturn the second injunction. As a result of the rulings, F&P’s German subsidiary has resumed sales of the masks in Germany. In August, F&P announced it had filed patent infringement proceedings against ResMed in the U.S. District Court for the Central District of California, seeking judgment that ResMed’s AirSense 10 and AirCurve10 range of flow generators products, its ClimateLineAir heated air tubing and its Swift LT and FX masks infringe patents it holds. ResMed responded by filing patent infringement actions against F&P in U.S., German and New Zealand courts.

3B Medical gets win at ITC

WINTER HAVEN, Fla. – An administrative law judge of the U.S. International Trade Commission has issued an initial determination that ResMed failed to satisfy the domestic industry requirement for patents relating to its CPAP masks and nasal pillow products manufactured in Australia, Singapore and Malaysia, according to 3B Medical, which has been embroiled in several legal battles with its competitor. 3B Medical successfully argued that ResMed did not demonstrate sufficient U.S. content to obtain protection under Section 337 because “ResMed has not demonstrated that the value added by the alleged activities in the U.S. is significant compared to the overall manufacturing cost,” 3B Medical stated. “As a result of the decision, the ALJ found no violation of any of the asserted mask patents by 3B Medical, resulting in total victory for 3B in the ITC’s investigation,” the company stated. ResMed has already abandoned its appeal of the ITC’s ruling that ResMed’s patent on its CPAP humidifier was invalid, 3B Medical says.

Mobility short takes: United Spinal, ElDorado Mobility

The United Spinal Association hosted its National Chapter Leadership Meeting in Las Vegas recently, bringing together chapter leaders from across the U.S. to discuss a multitude of topics that affect the spinal cord injury and disorder community. Hollister was the Titanium Level Corporate Sponsor of the event. United Spinal currently has 48 chapters in 28 states, and six regional coordinators. The strategies they develop at the annual meeting help to galvanize the association to provide a clear path moving forward and to assist the large constituency of wheelchair users that they serve…ElDorado Mobility gifted Gail Ulerie with a “dream trip” to Hawaii in memory of her son, Shurvon Phillip, a sergeant in the military who died Oct. 30 due to injury related complications. In May 2005 in Iraq, a Humvee Phillip was traveling in hit a landmine, giving him a broken jaw and a broken leg, and affecting this brain. The all-expenses paid vacation was donated by ElDorado after the provider learned of Shurvon’s journey through its partnership with the U.S. Pain Foundation. Each year, the Wings for Warriors Foundation holds a gala in partnership with the U.S. Pain Foundation to help fundraise for veteran’s programs and to spread awareness for their mission of support. This year’s even was held Nov. 11 at the Arizona Biltmore in Phoenix.

SoClean launches giveaway

OXFORD, Mass. – SoClean, the makers of a CPAP cleaner and sanitizing machine, has launched a new video as part of a promotional giveaway. The 60-second video, “Kill Germs, Not the Mood,” depicts a romantic couple interrupted by the need to clean a CPAP machine. To enter the giveaway, users must watch the video and submit their name, email and phone number. One winner will be randomly selected to receive a SoClean sanitizing machine. The giveaway runs from Nov. 29 to Dec. 27. To enter: https://www.soclean.com/soclean-cpap-signup/.

Convaid gives back

TORRANCE, Calif. – Convaid has launched a wheelchair giveaway as part of Giving Tuesday on Nov. 29. Convaid community members are invited to complete the phrase "I am thankful for . . ." on Facebook and Twitter between Nov. 29 and Dec. 31, 2016, using the hashtag #Convaidgives. The winner, who will receive a Convaid Rodeo pediatric wheelchair, will be chosen based on the meaningfulness of their post, and the number of likes, shares and retweets it receives. "Planned giving is ingrained in the Convaid culture,” said Nanneke Dinklo, marketing director. “We continually seek ways to give back to our community and our Giving Tuesday initiative is in line with charitable endeavors.” Giving Tuesday was launched in 2012 by the 92nd Street Y and the United Nations Foundation.

New IDTF launches

TUCSON, Ariz. – Vitalistics, an independent diagnostic testing facility, has opened to provide overnight pulse oximetry and home sleep testing services. Vitalistics has its own SaaS software platform, ODIE, to provide a streamlined workflow, regulatory compliance and the latest technologies. “It is quick, easy and economical to get started with, simple to use, and leverages the best expertise and technology in the industry,” said Jeff Wurgler, CEO in a press release. Wurgler is the former COO of Arete, a sleep diagnostics provider that rebranded in 2012 as STARS Healthcare after it was acquired by 02 Science.

HME Specialists undergoes $5M reno

ALBUQUERQUE, N.M. – HME Specialists recently gave vendors and public officials a tour of its new headquarters, which it is in the process of remodeling, according to local news reports. The 33,000-square-foot location will allow the provider to consolidate its administrative and warehouse operations, and add about 50 new jobs. The cost of the renovation is $5 million.

Home infusion providers make gains

MedTrakRx, a pharmacy benefit manager, has selected ARJ Infusion Services, a specialty pharmacy, to provide home infusion therapies to patients with complex, rare and chronic conditions. ARJ will be responsible for providing pharmacy and infusion nursing services to MedTrakRx members with hemophilia, immune deficiencies, inflammatory disorders and neurological conditions. The annual cost of therapies to treat these conditions ranges from $35,000 to more than $400,000…Option Care Enterprises, a national provider of home and alternate treatment site infusion services, has been selected as a contracted provider of a new 20% formulation of subcutaneous immunoglobin therapy for primary immunodeficiency (PI). Immunoglobin is a lifelong therapy provided to prevent recurrent infections in patients with PI, which affects as many as 6 million people worldwide.

Aeroflow Healthcare gives back

ASHEVILLE, N.C. ­– Staff at Aeroflow Healthcare has donated nearly 1,000 pounds of nonperishable goods for families in need. Employees hosted a successful canned food drive to support a local MANNA Food Bank. “We want to show our community how much we care, and by donating so much food, we hope everyone in our area is able to have a warm meal this holiday season,” said Casey Hite, CEO. The non-profit organization MANNA Food Bank has been serving Western North Carolina since 1983, relying on the support of volunteers and donors like Aeroflow.

Repairs expert Fuller passes away

ST. LOUIS – Richard “Dick” Fuller, who most recently created a tool called Labor Tracker to help providers bill for complex rehab and HME repairs, passed away Nov. 22 surrounded by family. He was 66. Fuller’s work in the HME industry goes back to the 90s, when he worked for Everest & Jennings, a wheelchair manufacturing company. He also served as director of certified repair centers for The MED Group. Over the years, Fuller supported efforts to carve out complex rehab as a separate benefit under the Medicare program. A memorial gathering will be held for Fuller on Dec. 16 at Schrader Funeral Home in Baldwin, Mo. A memorial service will be held the following day at St. Mark Presbyterian Church. In lieu of flowers, contributions may be made to the Labadie Community Association or to the Siteman Cancer Center.

WASHINGTON – Per-capita healthcare spending grew by 5% and overall healthcare spending grew by 5.8% in 2015, according to a recent study by the Office of the Actuary at CMS.

Those rates continue to be below the rates of most years prior to the passage of the Affordable Care Act.

“Even as millions of people gained coverage, per-enrollee spending growth in private health insurance and Medicare continue to be well below the average in the decade before passage of the Affordable Care Act,” CMS stated.

The report concludes that expenditure growth in 2015 was primarily the result of increased use and intensity of services as millions gained health coverage, as well as continued significant growth in spending for retail prescription drugs.

On a per-enrollee basis, overall spending increased by 4.5% for private health insurance, 1.7% for Medicare and 3.8% for Medicaid.

Healthcare spending grew 2.1% faster than the overall economy in 2015, resulting in a 0.4% increase in the health spending share of gross domestic product, from 17.4% in 2014 to 17.8% in 2015. In the decade prior to the passage of the ACA (2000-09), healthcare spending increased 2.8% faster than GDP on an annual average basis.

Per-enrollee Medicare spending increased by 1.7%, about the same rate as in 2014 and below the average annual growth in per-enrollee spending during 2000-09 of 7%. Medicare spending, which represented 20% of national total healthcare spending in 2015, grew 4.5% to $646.2 billion.

Overall Medicaid spending and enrollment grew at a slower rate in 2015 than in 2014 with per-enrollee spending increasing 3.8%. Medicaid spending, which totaled $545.1 billion, accounted for 17% of total spending on health care. Similarly, growth in Medicaid enrollment slowed to 5.7% in 2015, significantly lower than the 2014 increase of 11.1%.

Out-of-pocket spending, which includes direct consumer payments such as copayments, deductibles and spending not covered by insurance, but excludes premiums, grew 2.6% in 2015, compared to the average annual growth during 2000-09 of 4.6%.

WASHINGTON – The 21st Century Cures Act, which includes important provisions related to Medicare’s competitive bidding program, has been passed by the Senate and is now headed to the president’s desk for his signature.

The Senate passed the bill Dec. 7 by an overwhelming majority, 94-5. The House of Representatives also passed the bill Nov. 30 by an overwhelming majority, 392-26.

President Barack Obama has already declared his support for the bill, mostly recently in his weekly address on Dec. 3.

The bill will roll back a second round of Medicare reimbursement cuts that went into effect this year in non-competitive bidding areas from June 30, 2016, to Dec. 31, 2016. The cuts would go back into effect Jan. 1, 2017.

“It is a red-letter day for DME providers and their patients with the passage of rural relief,” said John Gallagher, vice president of government relations for The VGM Group. “Providers will be able to recoup dollars over the past six months with a foundation being laid for the future with a change in leadership at HHS.”

The bill will also further delay Medicare’s plan to use bidding-derived prices for accessories for complex power wheelchairs until July 1, 2017.

Additionally, the bill will require the Department of Health and Human Services to: conduct a study on the impact of the bidding program on the overall number of HME providers and the availability of HME during 2016; and reissue payment regulations for services furnished on or after Jan. 1, 2019, that include stakeholder input, costs, volume items and number of providers serving the area.

As a pay-for for these provisions, however, the bill also shifts state Medicaid reimbursement amounts for DME to Medicare fee-for-services payments from Jan. 1, 2019, to Jan. 1, 2018.