Wednesday, August 17, 2016

More drugs.

According to the Philadelphia's "The Inquirer", Medical advisers to the FDA have recommended approval of a new abuse-deterrent formulation (ADF) opioid named Arymo ER by Egalet Corp. In fact, the vote was overwhelming; 18-1. This new painkiller is an extended-release morphine that comes in 15mg, 30mg and 60mg doses. A final decision by the FDA on that recommendation is expected by mid-October.
When compared to MS-Contin, a pharmacologist with the FDA reportedly said ...
The numerical difference or outcome in the data was less than 5 percent, raising a question about Arymo's "clinical relevance"
I applaud the concept of abuse-deterrence formulations of opioids and other dangerous drugs that can be abused. I appreciate the fact there truly are some people that need opioids for "before/during/immediately after surgery, cancer, AIDS/HIV, end-of-life care" (my broadbrush interpretation of appropriate use of opioids). I agree abuse (non-medical use) is rampant with opioids (and other dangerous drugs). I am an "all of the above" (all options on the table) kind of person when it comes to resolving our painkiller epidemic, and I do think ADF has a part to play.
But to me the bigger problem is ... legitimate prescriptions by legitimate prescribers used legitimately by patients that are clinically inappropriate. Especially for the mostly inappropriate treatment of chronic pain.
So is the introduction of a new drug just propping up bad practice? Is Big Pharma using ADF to maintain their revenues (will Arymo be a money-maker)? Will we see abuse of non-ADF drugs decline? Will we see prescriptions change from non-ADF to their ADF equivalents? Will we see generics (the majority of drugs prescribed & dispensed) also become ADF? As usual, I have more questions than answers.

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Contact Neil O'Toole and John Sbarbaro
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Located in the Denver Metro area.
226 West 12th Avenue Denver, Colorado 80204

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Tuesday, August 9, 2016

Win for Medicare Advantage

In a 2-1 final decision out of the Eleventh Circuit Court of Appeals, Humana Medical Plan, Inc. v. Western Heritage Insurance Company, Humana prevailed in recovering double damages under the Medicare Secondary Payer (MSP) private cause of action due to Western Heritage’s failure to reimburse Medicare conditional payments. Recall that last year the District Court of Appeals had also found in favor of Humana, to which Western Heritage appealed that decision to the Eleventh Circuit. Oral arguments were heard in the Eleventh Circuit earlier this year, and the industry has been eagerly waiting the Eleventh Circuit’s decision.
Background/Recap of the Facts: In January 2009, Mary Reale, a Humana Medicare Advantage Plan beneficiary, was injured at Hamptons West Condominiums. Ms. Reale treated for her injuries and Humana paid for the treatment, totaling $19, 155.41. In June 2009, Ms. Reale and her husband sued the condominium in Florida state court for her injury. In March 2010, while her litigation was pending, Humana issued to Ms. Reale an Organization Determination in the amount of $19, 155.41. Although an administrative appeal process was available, no party appealed Humana’s Organization Determination. On April 20, 2010, in return for $115,000 from the condominium and its liability insurer, Western Heritage, the Reales released the condominium and Western Heritage. The Reales represented in the settlement agreement that there was no Medicare or other lien or right to subrogation. The Reales also agreed to indemnify the condominium and Western Heritage against any Medicare lien or right to subrogation.
On May 7, 2010, Humana sued the Reales and their attorney in the Southern District of Florida seeking reimbursement. The Reales sought dismissal, to which the court agreed, holding that a Medicare Advantage Plan (MAP) does not have a private cause of action to recover reimbursement from a beneficiary under the MSP. Likely in response to Humana’s suit, the condominium and Western Heritage attempted to make Humana a payee on the settlement draft to the Reales. The Reales then sought sanctions against Western Heritage for failure to comply with the settlement agreement. At that point, the parties agreed instead that the Reales’ attorney would hold $19, 155.41 in trust out of the $115,000 settlement amount pending resolution of the Reales’ litigation, and Western Heritage then tendered the $115,000 settlement to the Reales.
At this point the Reales sued Humana seeking a declaration as to what they owed Humana, however the court ultimately ruled that it lacked jurisdiction to adjudicate the dispute between Humana and Ms. Reale as to her MAP benefits. Subsequently, on January 11, 2011, Humana sued Western Heritage in the action upon which this appeal proceeded. Humana’s initial counts in its complaint were: 1) Double damages under the MSP private cause of action, 42 U.S.C. § 1395y(b)(3)(A); 2) Declaratory relief under the Medicare statutory and regulatory scheme; 3) Damages under several state law theories including unjust enrichment and a contract implied by law.
Eleventh Circuit Decision: Through analysis of the MSP and CMS regulations, the Eleventh Circuit found that MAPs have a right to a private cause of action for double damages against a primary plan where reimbursement has not occurred. Specifically, the Eleventh Circuit found the following persuasive: 1) CMS Regulations- A MAP “will exercise the same rights to recover from a primary plan, entity, or individual that the Secretary exercises under the MSP regulations in subparts B through D of part 411 of this chapter.” 42 C.F.R. § 422.108(f); 2) Statutory Basis- The MSP private cause of action, located at 42 U.S.C. § 1395y(b)(3)(A) is unambiguous and broadly permits any party with standing (including a MAP) to sue a primary plan. The Third Circuit in the In Re Avandia case also held that MAPs are included within the purview of parties who may bring a private cause of action.
Western Heritage countered that the MSP does not govern MAPs at all and that the MAP right-to-charge provision instead governs when and whether a MAP is a secondary payer. However, the court rejected this argument finding that the right to charge provision reveals that MAP payments are made secondary to primary payments under the MSP.

Original Source

Contact Neil O'Toole and John Sbarbaro
Phone: 303-595-4777
Located in the Denver Metro area.
226 West 12th Avenue Denver, Colorado 80204

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Any content of this blog is intended for informational purposes only.It is not intended to solicit business, provide legal advice from The Law Office of O'Toole & Sbarbaro, P.C. and does not serve as a medium for an attorney-client relationship. Therefore, The Law Office of O'Toole & Sbarbaro, P.C. is not responsible for the information on this blog which may not apply to every reader. Always seek professional counsel if you have any legal matters. Contents within the blog of The Law Office of O'Toole & Sbarbaro, P.C., logos and other related media are protected by the copyright laws of the United States and other jurisdictions.


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Tuesday, July 5, 2016

20% Florida Workers Comp Rate Increase

The Florida Office of Insurance Regulation (OIR) announced July 1 that the National Council on Compensation Insurance (NCCI) filed an amended rate filing to address a third legal change affecting Florida’s workers’ compensation system. This amended filing increases NCCI’s initial proposed combined average rate increase from 17.1 percent to 19.6 percent.

Individual projected rate impacts for all three recent legal changes include the following:

A 2.2 percent projected rate increase for the June 9th Florida Supreme Court decision in the case of Westphal v. City of St. Petersburg, in which the Florida Supreme Court found the 104-week statutory limitation on temporary total disability benefits in Section 440.15(2)(a), Florida Statutes, unconstitutional because it causes a statutory gap in benefits in violation of an injured worker’s constitutional right of access to courts. The Supreme Court reinstated the 260-week limitation in effect prior to the 1994 law change.
A 15 percent projected rate increase for the April 28th Florida Supreme Court decision in the case of Castellanos v. Next Door Company, which  found the mandatory attorney fee schedule in Section 440.34, Florida Statutes, unconstitutional as a violation of due process under both the Florida and United States Constitutions.
A 1.8 percent projected rate increase related to updates within the Florida Workers’ Compensation Health Care Provider Reimbursement Manual (HCPR Manual) per Senate Bill 1402. The manual became effective on July 1, 2016.
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NCCI is proposing an effective date of October 1, 2016 for new and renewal workers’ compensation policies and that the 19.6 percent rate increase apply to all workers’ compensation policies in effect as of October 1, 2016 on a pro-rata basis for the remainder of each policy’s term.

OIR has scheduled a public rate hearing for August 16, 2016 at 9:00 a.m. to give NCCI an opportunity to discuss the filing and interested parties and other stakeholders the ability to provide testimony or comments. The hearing will be held in the Jim King Committee Room, 401 Senate Office Building, 404 South Monroe Street, Tallahassee, Florida. A media advisory with more details will be released at a later date.

NCCI is a licensed rating organization authorized to make rate filings on behalf of workers’ compensation insurance companies in Florida. The Florida Office of Insurance Regulation has primary responsibility for regulation, compliance and enforcement of statutes related to the business of insurance and the monitoring of industry markets.

Original Source


Contact 
Neil O'Toole and John Sbarbaro
Phone: 303-595-4777
Located in the Denver Metro area.
226 West 12th Avenue Denver, Colorado 80204

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Any content of this blog is intended for informational purposes only.It is not intended to solicit business, provide legal advice from The Law Office of O'Toole & Sbarbaro, P.C. and does not serve as a medium for an attorney-client relationship. Therefore, The Law Office of O'Toole & Sbarbaro, P.C. is not responsible for the information on this blog which may not apply to every reader. Always seek professional counsel if you have any legal matters. Contents within the blog of The Law Office of O'Toole & Sbarbaro, P.C., logos and other related media are protected by the copyright laws of the United States and other jurisdictions.


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Monday, July 4, 2016

Happy Fourth of July from The Law Office of O'Toole & Sbarbaro, P.C.



Contact Neil O'Toole and John Sbarbaro
Phone: 303-595-4777
Located in the Denver Metro area.
226 West 12th Avenue Denver, Colorado 80204

Disclaimer 

Any content of this blog is intended for informational purposes only.It is not intended to solicit business, provide legal advice from The Law Office of O'Toole & Sbarbaro, P.C. and does not serve as a medium for an attorney-client relationship. Therefore, The Law Office of O'Toole & Sbarbaro, P.C. is not responsible for the information on this blog which may not apply to every reader. Always seek professional counsel if you have any legal matters. Contents within the blog of The Law Office of O'Toole & Sbarbaro, P.C., logos and other related media are protected by the copyright laws of the United States and other jurisdictions.


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Thursday, June 30, 2016

Preventing falls - Liberty Mutual

Boston, MA -(BusinessWire)- 

Working age adults account for more than two-thirds of the estimated 9.9 million annual fall-related injuries impacting U.S. adults according to Liberty Mutual’s latest research, highlighting the importance of companies actively protecting employees and the public from falls.
Liberty Mutual researchers quantified the number of annual fall-related injuries for U.S. adults based on 2008-2014 data from the National Health Interview Survey1. Surprisingly, fall injuries were almost equally divided across three age groups, with 32.3 percent occurring among older adults (ages 65+), 35.3 percent affecting middle-age adults (ages 45-65) and 32.3 percent affecting younger adults (ages 18-44). The research findings appear in PLOS ONE, a journal that reports original research from all disciplines of science and medicine.
“While there is considerable research on falls among older adults – those age 65 and up – less is known about fall-related injuries in middle-age and younger adults,” notes Santosh K. Verma, MD ScD, senior research scientist with Liberty Mutual Research Institute for Safety. “Our research provides the most comprehensive picture to date of the frequency of falls for U.S. adults.”
Beyond quantifying the number of annual fall-related injuries among U.S. adults – and their distribution by age group – the Liberty Mutual research produced two other sets of important findings:
A summary by age group of the average and total lifetime cost of annual unintentional fall-related injuries resulting in death, hospitalization or emergency department visit
A summary by age and gender of the annual average fall-related injury types
“By drawing attention to the magnitude of this major public health concern, the findings will help companies in their ongoing efforts to protect workers and the public from falls,” says Wayne Maynard, technical director, Liberty Mutual Risk Control Services. “Protecting these groups provides a host of benefits for employers, from keeping skilled employees on the job, to protecting tight margins from the costs associated with workers compensation and general liability claims.”
Liberty Mutual’s annual Workplace Safety Index has consistently cited falls among the top 10 causes of the most serious and costly nonfatal US work injuries. The present study provides a broader view of falls, examining those that occur both at work and outside of work.

Original Source

Contact Neil O'Toole and John Sbarbaro
Phone: 303-595-4777
Located in the Denver Metro area.
226 West 12th Avenue Denver, Colorado 80204

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Any content of this blog is intended for informational purposes only.It is not intended to solicit business, provide legal advice from The Law Office of O'Toole & Sbarbaro, P.C. and does not serve as a medium for an attorney-client relationship. Therefore, The Law Office of O'Toole & Sbarbaro, P.C. is not responsible for the information on this blog which may not apply to every reader. Always seek professional counsel if you have any legal matters. Contents within the blog of The Law Office of O'Toole & Sbarbaro, P.C., logos and other related media are protected by the copyright laws of the United States and other jurisdictions.


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Tuesday, June 28, 2016

NSC: One Third of Workers Say Their Employers Prioritize Productivity Over Safety

Itasca, IL – The National Safety Council recently released survey results showing 33% of the 2,000 employees surveyed across the nation believe safety takes a back seat to productivity at their organizations. The percentage was even higher among employees in high-risk industries. Sixty percent of respondents in the construction industry, and 52% of those working in agriculture, forestry, fishing and hunting, felt safety was less of a priority than finishing tasks. These findings are particularly alarming because those industries are first and second when it comes to the number of occupational deaths each year.
The survey is based on the Council’s Employer Perception Surveys and is released during National Safety Month, observed each June to raise awareness of the leading causes of preventable death and how Americans can reduce their risks.
“Every employee deserves a safe workplace,” said NSC President and CEO Deborah A.P. Hersman. “While some of our findings were encouraging, others were a stark reminder of how far we still have to go to ensure safety is every employer’s highest priority.”
The number of workplace deaths in 2014 was as high as it has been since 2008, according to data from the Bureau of Labor Statistics. More than 4,800 workers died from incidents such as car crashes, contact with objects or equipment, exposure to harmful substances, and slips, trips and falls.i
Gauging Americans’ perceptions toward their safety at work may help provide further insight into the increasing numbers of workplace deaths. Other key survey findings include:
  • 49% of temporary and contract workers, and 41% of employees working in healthcare settings, said they were afraid to report safety issues
  • 62% of construction workers, and those in agriculture, forestry, fishing and hunting, believe management does only the minimum required by law to keep employees safe
  • 61% of employees in the agriculture, forestry, fishing and hunting industry say there is resistance to working safely among employees
  • 70% of employees say safety training is part of their orientation and that employee health and well-being is promoted at work
Employers interested in improving their safety culture can join the Journey to Safety Excellence, which provides a roadmap for reducing incidents and saving lives. Visit nsc.org/journey for more information.

Original Source


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Neil O'Toole and John Sbarbaro
Phone: 303-595-4777
Located in the Denver Metro area.
226 West 12th Avenue Denver, Colorado 80204

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Any content of this blog is intended for informational purposes only.It is not intended to solicit business, provide legal advice from The Law Office of O'Toole & Sbarbaro, P.C. and does not serve as a medium for an attorney-client relationship. Therefore, The Law Office of O'Toole & Sbarbaro, P.C. is not responsible for the information on this blog which may not apply to every reader. Always seek professional counsel if you have any legal matters. Contents within the blog of The Law Office of O'Toole & Sbarbaro, P.C., logos and other related media are protected by the copyright laws of the United States and other jurisdictions.


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Monday, June 27, 2016

How many wrongs make a right?

From the Far Side:







Contact Neil O'Toole and John Sbarbaro
Phone: 303-595-4777
Located in the Denver Metro area.
226 West 12th Avenue Denver, Colorado 80204

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Any content of this blog is intended for informational purposes only.It is not intended to solicit business, provide legal advice from The Law Office of O'Toole & Sbarbaro, P.C. and does not serve as a medium for an attorney-client relationship. Therefore, The Law Office of O'Toole & Sbarbaro, P.C. is not responsible for the information on this blog which may not apply to every reader. Always seek professional counsel if you have any legal matters. Contents within the blog of The Law Office of O'Toole & Sbarbaro, P.C., logos and other related media are protected by the copyright laws of the United States and other jurisdictions.


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Friday, June 10, 2016

Uber Disrupts Organized Labor

While disrupting the car-for-hire industry with its ride-sharing app, Uber created a new level of job flexibility and choice for the people who drive for them, allowing drivers to set their own hours and essentially be their own bosses. And now, Uber is doing something similar to the standard union model.

In early May, Uber announced it had reached a deal with the International Association of Machinists District 15 to form the Independent Drivers Guild for New York City’s 35,000 Uber drivers.

What makes the Guild interesting is, although organized by a large labor union, it won’t look much like a typical union. The New York Times  reported that the Guild, “would establish a forum for regular dialogue and afford [workers] some limited benefits and protections — but that would stop short of unionization.”

The five-year agreement would allow members regular meetings with management, an appeals process for discipline and access to several benefits programs such as insurance and legal services.

Even though Guild members will meet with Uber, they will not be able to force Uber to bargain over contracts as a traditional union would. Further, no Uber driver will be required to pay dues to the Guild, as they otherwise would in a traditional union in New York. Uber drivers could still work directly with the company and would not need to go through the Guild if they wanted to negotiate with management or appeal a grievance on their own. 

The Guild and Uber will team up to lobby for a level playing field on taxi sales taxes. Currently New York state law charges a 9 percent sales tax on Uber rides but there is only a 50-cent surcharge on taxicabs.

According to Uber Chief Advisor David Plouffe, rides with Uber and taxis should be taxed at the same rate. “This would not only mean more money for drivers, it would also free up resources for a new benefits fund administered by the Guild and used to cover benefits such as paid time off or parental leave, for example.”

 While the deal is not perfect, it shows the beginning of a model that could bring unionization into the 21st Century. It also signals that at least a few unions are taking seriously the new on-demand, independent contractor economy, which is likely to continue growing.

Starting with the good: almost all of the agreement between Uber and IAM is voluntary. The agreement does not force drivers to be represented by the union, nor does it compel the company to bargain, as is standard operating procedure with traditional unions. Instead, the agreement models a “members-only agreement,“ where a union in a workplace only represents the workers who choose to become members of the union.

As a result, Uber will work with IAM but is not legally required to do so. Rather, the company and the union will work together because it is in both of their own interest to do so. To the extent that the Guild helps make Uber a more attractive job opportunity, it will help the company gain better contractors, provide better services and best its competition.

Natalie Foster, cofounder of Peers.org, a company that provides portable health and life insurance and retirement options for workers in the sharing economy, highlighted in a piece for CNN.com the benefits and flexibility the Guild would provide Uber drivers. She says the arrangement has the “potential to be a critical step toward a 21st century safety net for American workers’ real lives today, because it could very well lead to a workable model to provide portable benefits to gig economy workers.”

The benefits of the deal for the union is that it gets the potential of dues-paying members (IAM is not charging fees for membership as of the announcement) and only has to provide services to workers who are members.

Not all unions are willing to adapt to the sharing economy and embrace the voluntary approach of the Guild. Bhairavi Desai, executive director of the New York Taxi Workers Alliance, told Reuters the deal was a “historic betrayal” of drivers since IAM gave up they type of mandatory association experienced by traditional unions. The Taxi Workers Alliance filed a class action lawsuit in Federal Court in New York on June 2nd to reclassify Uber drivers as employees as opposed to independent contractors.

But now for the bad in the deal: the Uber-IAM deal could open the door for compulsory funding of the union through this newly created union-controlled benefits fund.  If Uber and the Guild successfully lobby to reduce the sales tax on Uber rides, the union could fight to use part of the savings to fund itself though a mandated union benefits fund, rather than allow drivers to keep the extra earnings and choose whether or not to contribute.

Clearly the playing field should be level and taxis should not be given special tax benefits in comparison to Uber or any other private hire vehicles, so the arbitrary sales tax on Uber rides should be eliminated. But any savings should go to benefit drivers and they should decide if they’d like to use that extra income to pay into the Guild’s benefits fund.

Further, the new innovative Guild could be no more than a stalking horse for a traditional union.

Jim Conigliaro Jr, general counsel for the IAM District 15, has clearly stated that if Uber drivers are redefined as “employees,” his union would try to organize them into a traditional union.

Nevertheless, the IAM and Uber coming to a voluntary agreement to provide optional benefits for drivers suggests the potential start of a positive transition for the labor movement. The voluntary agreement shows that unions no longer need to compel employers and employees into accepting forced representation and paying forced dues in order to support themselves. And if successful, this deal would demonstrate that unions do not need to use legislative and regulatory action to reclassify independent contractor and small business owners into a one-size-fits-all category they can then organize for the purpose of collecting dues.

If there are no ulterior motives to force unwanted representation on Uber drivers, and the plan is simply to provide a service that drivers can accept or reject then, except for the possibility of forcing drivers to contribute to an IAM controlled benefits fund the agreement between Uber and IAM should be applauded.

Original Source

Contact Neil O'Toole and John Sbarbaro
Phone: 303-595-4777
Located in the Denver Metro area.
226 West 12th Avenue Denver, Colorado 80204

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Any content of this blog is intended for informational purposes only.It is not intended to solicit business, provide legal advice from The Law Office of O'Toole & Sbarbaro, P.C. and does not serve as a medium for an attorney-client relationship. Therefore, The Law Office of O'Toole & Sbarbaro, P.C. is not responsible for the information on this blog which may not apply to every reader. Always seek professional counsel if you have any legal matters. Contents within the blog of The Law Office of O'Toole & Sbarbaro, P.C., logos and other related media are protected by the copyright laws of the United States and other jurisdictions.


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Monday, May 30, 2016

Solemn Memorial Day from The Law Office of O'Toole & Sbarbaro, P.C.





Contact Neil O'Toole and John Sbarbaro
Phone: 303-595-4777
Located in the Denver Metro area.
226 West 12th Avenue Denver, Colorado 80204

Disclaimer 

Any content of this blog is intended for informational purposes only.It is not intended to solicit business, provide legal advice from The Law Office of O'Toole & Sbarbaro, P.C. and does not serve as a medium for an attorney-client relationship. Therefore, The Law Office of O'Toole & Sbarbaro, P.C. is not responsible for the information on this blog which may not apply to every reader. Always seek professional counsel if you have any legal matters. Contents within the blog of The Law Office of O'Toole & Sbarbaro, P.C., logos and other related media are protected by the copyright laws of the United States and other jurisdictions.


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