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Thursday, June 25, 2015

The Path to Federalization: US Supreme Court Again Validates the Affordable Care Act

The US Supreme Court again affirmed the validity of The Affordable Care Act. The Obamacare program, as it has been nicknamed, will continue to lead to a medical delivery program than eventually will have major repercussions on the antiquated and ineffective medical care system of the existing patch work of state workers' compensation insurance acts.

Sunday, May 3, 2015

Synchromed II Implantable Infusion Pump Systems: FDA Consent Decree To Limit Use

Medtronic, Inc. cited for manufacturing violations

The U.S. Food and Drug Administration announced today the filing of a consent decree against Medtronic, Inc., and two of the company’s officers—S. Omar Ishrak and Thomas M. Tefft —for repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems, medical devices that deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity. These violations occurred at the company’s Neuromodulation facilities in Columbia Heights, Minnesota, where the devices are manufacture.

The consent decree cites violations of the quality system regulation for medical devices, which requires manufacturers to have processes in place to assure that the design, manufacture and distribution of a device allows for its safe us

The legal action requires the company to stop manufacturing, designing and distributing new Synchromed II Implantable Infusion Pump Systems except in very limited cases, such as when a physician determines that the Synchromed II Implantable Infusion Pump System is medically necessary for a patient’s treatment.

The consent decree also requires Medtronic to retain a third-party expert to help develop and submit plans to the FDA to correct violations. The consent decree will remain in effect until the FDA has determined that Medtronic has met all the provisions listed in the consent decree.

Once Medtronic receives permission from the FDA to resume the design, manufacture and distribution of these products, the company must continue to submit audit reports so the agency can verify the company’s compliance. In addition to these audits, the FDA will monitor the company’s activities through its own inspections.

The FDA first approved the Synchromed II Implantable Infusion Pump Systems in 2004, and first identified problems with the manufacture of these pumps in 2006. These problems can result in over- or under-infusion or a delay in therapy for patients.

Between 2006 and 2013, FDA investigators conducted five inspections at Medtronic’s Neuromodulation facilities, resulting in three warning letters notifying the company of major violations. The violations included inadequate processes for identifying, investigating, and correcting quality problems with the Synchromed II Implantable Infusion Pump Systems; failure to document design changes; and failure to ensure that finished products meet design specifications.

“The FDA expects that all patients will be treated with safe, effective and high-quality medical devices,” said Jan Welch, acting director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “We will continue to stop distribution of devices made by firms that fall short of regulatory requirements.”

Patients who are implanted with a Synchromed II Implantable Infusion Pump System should maintain regular follow-up appointments with their physicians. Patients who experience a change or return of symptoms, or hear a device alarm, should contact their physician immediately.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety and effectiveness of human and veterinary drugs, biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


Monday, January 18, 2016

Sanders Proposes Universal Health Care: The Path to Federalization


Presidential candidate Bernie Sanders has announced a plan to move forward with a Universal Medical Care program in the US. The concept will absorb the nation's ailing the medical workers' compensation delivery system into a universal care system.

Thursday, July 5, 2012

Path to Federalization: A National Workers Compensation System--US Supreme Court Validates

United States Supreme Court has taken a giant leap forward to facilitate the Federalization of the entire nation's workers' compensation system. By it's recent decision, upholding the mandate for insurance care under the Affordable Health Care for America Act (ACA) 2009, it has set the precedent to federalize the nation's fragmented and chaotic workers' compensation medical delivery system.

John G. Roberts Jr.,
Chief Justice US Supreme Court
Validating Mechanism
In a 5 to 4 ruling, Chief Justice Roberts validated the individual mandate as a permissible exercise of congressional power under the Taxing Clause of the US Constitution. Under 26 U.S.C. Section 5000A. The law requires that: (a) an individual must maintain minimum essential coverage for each month beginning after 2012; and (b) if there is a failure to maintain minimum essential coverage, a "penalty" is imposed "on the taxpayer" of $695 per year or 2.5% of family income, whichever is greater. The penalty "shall be assessed and collected in the same manner as taxes."

The Chief Justice, writing for himself, stated, "Every reasonable construction must be resorted to in order to save a statute from unconstitutionality." If it is "fairly possible" to interpret the statute as merely imposing a tax on those who've failed to purchase insurance. Writing for the majority, the Chief Justice stated, that the penalty is not a tax for anti-injunction act purposes. The Court, he wrote, needs to look beyond the label when assessing the constitutionality. For constitutional purposes Justice Roberts reasoned that the penalty may be considered as a tax when: it is not so high that there is no choice; and it is not limited to willful violations; and the penalty is collected by the IRS through normal means.

Constitution of the
United States
The Court indicated that the assessment is not really a "penalty." "Taxes that seek to influence conduct are nothing new," the Chief Justice wrote. He reasoned for the Court that there are no negative legal consequences to not buying health insurance, because beyond requiring a payment to IRS, Congress anticipated that some 4 million people would pay the penalty, and Congress did not treat them as "outlaws."

While certain taxes are prohibited under the U.S. Constitution, the penalty under the Affordable Health Care for America Act 2009 is not barred. The Court reasoned that the Constitution states, "No Capitation, or other direct, Tax shall be laid, unless in Proportion of the Census or Enumeration herein before directed to be taken." The majority of the Court held that a tax on "going without health insurance" does not fall within any recognized category of direct tax since it is triggered by certain specific circumstances.


The US Supreme Court previously validated compulsory workers' compensation programs. Compulsory compensation systems have been held not to be an arbitrary classification contrary to the equal protection clause of the United States Constitution, 14th Amendment.  The state-enacted systems were created for the protection of the lives, health and safety of the employees.  The systems provide payment of compensation through a state mandated system for injuries to employees or for the death of employees resulting from injuries related to work, regardless of fault.  The compensation systems are held as a simple, inexpensive and expeditious method of providing recovery to employees who are injured in a highly organized and modern industrial employment environment.  New York Central Railroad Company v. White, 243 U.S. 188, 37 S.Ct. 247, 61 L.Ed. 667 (1917). See also, Lower Vein Coal Co. v. Industrial Board of Indiana, 255 U.S. 144, 41 S.Ct. 252, 65 L.Ed. 555 (1921) and In re Asbestos Litigation, 829 F.2d 1233 (3d Cir.1987), cert. denied 485 U.S. 1029, 108 S.Ct. 1586, 99 L.Ed.2d 901 (1988).

Medical Delivery & Fees
Generally, the ACA provides a much needed national structure for the regulation, delivery, and enforcement of medical coverage. The ACA contains significant fraud and abuse provisions. In 2010 the law significantly expanded the government's authority to prosecute Faults Claims Act (FCA) cases. In 2011-2012 the ACA triggers increased provider screening, oversight and reporting. The ACA also establishes the Independent Payment Advisory Board to evaluate fee schedules and expands the scope of Medicaid and CHIP payments. 


Unlike most State compensation systems that presently struggle with both expeditious medical delivery as well the value and responsibility of medical care, the ACA provides a uniform system and expeditious system. The fragmented network of complex, dilatory and inconsistent results in the State programs have been described recently by national experts as "irrational" and "unjust."  They characterize the present compensation programs as "....dizzying and frustrating in its complexity, and apparent irrationality,"  and  they conclude that "a substantial proportion of persons with work-related disabilities do not receive workers' compensation benefits," and in need of a better format. 

Non-Traditional Revenue Stream
In addition to the widely publicized tax for non-compliance, the ACA contains several other innovative revenue provisions that will provide additional funding from collateral sources without burdening al employers globally. In 2010 an indoor tanning service tax was implemented. In 2011 annual fee was instituted on pharmaceutical companies as well as  an increased penalty for early withdrawal from health savings accounts. In 2013 the following provisions go into effect: the Medicare payroll tax will increase for high-income individuals, an excise tax on medical device manufacturers, limits on Flexible Spending Accounts, and the elimination of the deduction for Employer Part D subsidy. In 2014 there will be an annual fee on health insurance plans. In 2018 there will be an excise tax and high-cost plans commonly referred to as the "Cadillac tax."





"Libby Care"--Universal Care 
Center for Asbestos Related Disease
Libby, MT.
A provision of the Act, that has already been implemented, provides for the treatment of medical conditions, including asbestosis & mesothelioma, arising out the Libby, Montana asbestos contamination. The industrially caused   catastrophe in Libby has resulted in widespread illness and death. The ACA provides medical attention to those exposed to occupational toxins. The Center for Asbestos Related Disease is now operating in Libby, MT. The “Libby Care” provisions, and its envisioned prodigies, will embrace more exposed workers, diseases and geographical locations, than any other program of the past. This type of program, minimally, needs to be expanded to include all occupational illness nationally.



The Future: Universal Health Care
Landmarks on the Path to Federalization
It is very doubtful that ACA repeal legislation, to be offered by the Republicans in the House will pass Congress, nor will the President sign it.. There may be some technical and substantive revisions to the ACA in the next Congress. If there is a mixed political government after the next election,  the ACA will be implemented and go forward as the law of the land.


History reveals that a series of efforts have been made by the Federal government  to federalize medical care for industrial accidents and illnesses. Those efforts demonstrate a commitment to bring the nation ever closer to a universal care medical program incorporating the entire patchwork of workers' compensation medical delivery systems. The US Supreme Court has accelerated the nation down that promising path.
....
Jon L.Gelman of Wayne NJ is the author NJ Workers’ Compensation Law (West-Thompson) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson). 

More on improving the medical delivery system

Jun 14, 2012
Yesterday the US Congress passed and sent to the President, The World Trade Center Health Program, marking yet another advance on the path to federalize the nation's workers' compensation program. The Federally .
Dec 23, 2010
Yesterday the US Congress passed and sent to the President, The World Trade Center Health Program, marking yet another advance on the path to federalize the nation's workers' compensation program. The Federally ...
Feb 15, 2011
In December 2010 US Congress passed and President Obama signed, The World Trade Center Health Program, marking yet another advance on the path to federalize the nation's workers' compensation program.
Jul 05, 2010
The trend toward Federalization of workers' compensation benefits took a giant step forward by recent Presidential action creating the British Petroleum Oil Compensation Fund. While the details remain vague, the broad and ...

Jul 13, 2010
As The Path To Federalization expands, this debate will expand. A recent study by the Center for American Progress addresses these concerns. "Health threats from the oil spill may linger unseen, perhaps for more than a ...
Mar 16, 2011
Historically The Federal government's role has been to rise to the occasion and walk further down a path to federalization. On a smaller scale than the potential consequences of the Japanesse debacle, the US was first in line ...
Mar 05, 2011
Nationally, advocates to improve the delivery of medical benefits to injured workers have urged federalization of the medical delivery system into a single payer approach through universal health care. ... Compensation Claim Draws Major Public Attention (workers-compensation.blogspot.com); Vermont Governor Sets Out to Lead U.S. to True Universal Coverage (huffingtonpost.com); The World Trade Center Health Program Expands The Path to Federalization ...
Apr 03, 2010
The recent health care reform legislation provided for the Libby Care which will provide universal medical care for victims of asbestos related disease. The plan is a pilot program for occupational disease medical care fully ...
May 19, 2010
The “Libby Care” provisions, and its envisioned prodigies, will embrace more exposed workers, diseases and geographical locations, than any other program of the past. Potential pilot programs will now be available to ...

Related articles

Tuesday, January 24, 2012

Workers Compensation Fails to Cover Most Occupational Disease Claims

A just published study reports that only 25% of occupational disease claims are covered by US workers' compensation programs.

Click here to read the entire report: Economic Burden of Occupational Injury and Illness in the United States  Get PDF (611K)
"The medical and indirect costs of occupational injuries and illnesses are sizable, at least as large as the cost of cancer. Workers’ compensation covers less than 25 percent of these costs, so all members of society share the burden. The contributions of job-related injuries and illnesses to the overall cost of medical care and ill health are greater than generally assumed."

Tuesday, February 25, 2014

Throw The Book At 'Em

There seems to be no limit in the amount of fraudulent conduct that transpires within the workers' compensation system. If employer fraud is not enough, the system is constantly undergoing abuse from business interests, ie. medical provo\iders, who abuse the system. The Federal Governments role in enforcement is ever increasing and expansion is trending wider. The gobal expanssion nationally of a universal program for monitoring and enforcement of medical fraud is encouraging. Today's post is shared from David DePaolo http://daviddepaolo.blogspot.com/

It's a shame that hundreds, if not thousands, of injured workers underwent unnecessary spinal fusion surgeries and must live with the debilitating aftermath of significant disability because of people whose greed overrides the well being of fellow humans.

I had learned about Michael Drobot and Pacific Hospital of Long Beach, and their co-conspirators, preying on workers' compensation patients some time ago.

On Friday though, Federal prosecutors announced that Michael D. Drobot faces up to 10 years in prison after he pleaded guilty to paying kickbacks in a $500 million fraud scheme relating to spinal fusions and admitted to bribing state Sen. Ron Calderon to delay legislation to repeal the separate reimbursement for spinal hardware.

Calderon, D-Montebello, was indicted one day earlier on 24 charges, including bribery, money laundering, wire fraud and filing a false tax return. His brother, former...

[Click here to see the rest of this post]


Related articles

California state Sen. Ron Calderon accepted $88,000 in bribes, FBI affidavit alleges (workers-compensation.blogspot.com)
IMR: DWC Get Out of the Way (workers-compensation.blogspot.com)
One Claim Going OTOC (workers-compensation.blogspot.com)
Work Comp Lost Focus (workers-compensation.blogspot.com)
OK's True Cost Control Feature (workers-compensation.blogspot.com)
The Conflict Between NAFTA and Comp (workers-compensation.blogspot.com)
Being Professional (workers-compensation.blogspot.com)

Read more about "Federalization of Workers' Compensation"
Jul 05, 2012
United States Supreme Court has taken a giant leap forward to facilitate the Federalization of the entire nation's workers' compensation system. By it's recent decision, upholding the mandate for insurance care under the ...
Dec 23, 2010
Yesterday the US Congress passed and sent to the President, The World Trade Center Health Program, marking yet another advance on the path to federalize the nation's workers' compensation program. The Federally ...
Jul 05, 2010
The trend toward Federalization of workers' compensation benefits took a giant step forward by recent Presidential action creating the British Petroleum Oil Compensation Fund. While the details remain vague, the broad and ...
Jun 14, 2012
Yesterday the US Congress passed and sent to the President, The World Trade Center Health Program, marking yet another advance on the path to federalize the nation's workers' compensation program. The Federally .


Friday, May 30, 2014

Equal Work, Less-Equal Perks; Microsoft Leads the Way in Filling Jobs With 'Permatemps'

Today's post was shared by Steven Greenhouse and comes from www.nytimes.com

By STEVEN GREENHOUSE
Published: March 30, 1998
They hold high-prestige, high-technology jobs at Microsoft's plush campus. They often do the same work as the Microsoft Corporation's permanent employees, developing CD-ROM's, designing World Wide Web sites and writing software manuals. Yet they do not qualify for Microsoft's coveted stock options, and their health and vacation benefits are pale imitations of those enjoyed by regular Microsoft workers.
They are long-term temps -- a seeming oxymoron, but in fact a new and growing phenomenon in the American work force, embraced by many corporations, especially high-tech ones, including Microsoft, AT&T, Intel, Hewlett-Packard and Microsoft's Seattle neighbor, Boeing.
Microsoft is perhaps the leading practitioner of the trend, employing about 5,000 temps, including 1,500 long-term ones, meaning they have worked for the software colossus for at least one year. These temps work next to Microsoft's 17,000 domestic employees.
Some prefer the flexibility and the higher take-home pay that temp status affords, but many assail temping as a backdoor way to create a two-tier work force. The benefits that the lower tier loses out on, many temps say, far outweigh whatever extra pay they take home.
''It's a system of having two classes of people and instilling fear and inferiority and loathing,'' said Rebecca Hughes, who worked for three years as a temp at Microsoft, helping edit its CD-ROM on health care.
With work lives strung together by...
[Click here to see the rest of this post]

Monday, July 5, 2010

Designing the New Federal Workers Compensation Program



The trend toward Federalization of workers’ compensation benefits took a giant step forward by recent Presidential action creating the British Petroleum Oil Compensation Fund. While the details remain vague, the broad and sweeping concept of inclusiveness is more than obvious.


This is not a surprising turn of events. It is entirely consistent with a broad pattern to sweep the ailing and fragmented patch work of state programs into a unified Federal program. In an era of economic depression, national health care reform and major workforce changes this approach is consistent with the underlying bipartisan national philosophy.

Columnist and an expert in the field, Peter Rousemaniere, recently concluded an analysis of system’s failures that have literally pushed workers’ compensation into a federalized program. “The states and workers' compensation insurers have for decades weaseled on the promise to protect workers from occupational illnesses and to honor their claims.” 

The knee jerk reaction, one would think, would be this could never happen because of interested stakeholders. In reality, they have been silently distracted by more far reaching issues and have been economically drained of resources to the point where they’ll take anything the Federal Government can offer to save them from extinction.

The Federal government is not unfamiliar with the administration and distribution of benefits. Since 1882 the federal government has been providing benefits to injured workers and their widows:  in 1900 the postal workers compensation system was established; in 1908 the Federal government established a program for those who work in hazardous environments; and, in 1932 the Social Security Administration was established. However, the Social Security Act did not embrace workers’ compensation in 1932 since the primary goal of the law was to reduce unemployment. 

The federal programs have produced a dismal result over the last few years.  The Federal Victims Compensation Fund, enacted following the horrific tragedy of September 11th, 2001, has a very strict eligibility criteria and a limited recovery scheme.  The Smallpox Emergency Personnel Protection Act of 2003 (SEPPA) was enacted following an aborted vaccination program after the government reluctantly disclosed available medical research concerning potential fatal cardiovascular reactions.  A risk analysis demonstrated that this program may not have been needed at all but was merely implemented to sway public opinion.  Ultimately, the federal government halted the Smallpox Vaccination Program and funded $100 million for the purpose of cleaning up the legacy of adverse medical reactions and to ease the burden placed upon the victims and their estates that were struggling to obtain benefits under State compensation programs.

The Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA) (P.L.106-398) was enacted into law in October, 2000 with strong bipartisan support. EEOICPA established a program to provide compensation to employers of the Department of Energy (DOE), its contractors and subcontractors, companies that provided beryllium to DOE, and atomic weapons employers.

The Federal health care reform is a big Federal deal for workers’ compensation as it establishes the Libby Health Care Plan with far reaching impact by involving Medicare to deliver health care. The ongoing integration of conditional payments (Medicare Secondary Payer Act and mandatory reporting) as well as the review of all compromises concerning  the provision of future medical care (Workers Compensation Medical Set-aside Agreements) is already anther Federal foot in the door to prevent what in the past was a tradeoff of medical care to US taxpayer without consideration.

While federalization may not be the panacea, the target remains to limit the cost of medical expenses and provide an efficient and remedial benefit delivery system at minimal cost for administration and to hold the appropriate parties financial responsible.  The costs of maintaining duplicate medical delivery systems for workers, major medical and workers’ compensation, continues to represent an unnecessary and costly duplicate expenditures in administration and management.

The BP-Federal Oil Compensation Plan is yet another attempt to find a solution. While it may not be perfect, hopefully it will be guided successfully and will learn from past Federal trials and errors dabbling in workers’ compensation. It is obviously not the perfect solution, but that may only exist as an unattainable goal. The first step is a comprehensive and integrated Federal workers’ compensation program. A step in the right direction would be for the Federal Government to take primary responsibility for all occupational workers’ compensation claims. This would be an innovated initial approach to implement a new Federally administered Workers’ Compensation system.

Monday, June 14, 2010

Designing a BP Oil Spill Compensation Fund



As the Obama Administration debates the format for an Gulf Oil Spill Compensation the critical factors of funding, administration and longevity of the program remain unresolved. Tonight The PBS News Hour provided only a limited insight into the major issues involved in such a program.

Essential to the program is the adequacy and efficiency of the delivery of benefits to injured and exposed workers. While comparisons continue to be drawn to the the longest tort in American history, asbestos, and the Victims Compensation Fund of 911, sight continues to be lost of the injured and exposed workers who have been faced with a basic workers' compensation system that for the most part, failed to adequately miss their needs.

Daniel Farber, Director of the environmental law program at the University of California, Berkeley's Law School highlighted some of the design failures of the past in Federal programs when he stated, "Well, I don't know if we need a custom-built scheme for BP, but I think that this has shown a genuine problem, both here, but also with other kinds of environmental disasters, with public health disasters, which is that we have a very long litigation process, and people may need help right away."

Missing from the discussion, yet again, are the injured workers, the employers, the workers' compensation insurance carriers and their advocacy groups discussing the essential issue of compensating oil spill workers. History teaches us that in the past Federal programs have missed the mark in creating adequate programs to meet the needs of compensating injured workers. Hopefully, the opportunity will not be lost this time to create a viable, fair and exemplary program.

To read more about petroleum exposure and workers' compensation.

Click here for more information on how Jon L Gelman can assist you in a claim for workers' Compensation claim benefits. You may e-mail Jon  Gelman or call 1-973-696-7900.