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Archive for the ‘Medical & Health Care’ Category

Office of Inspector General Approves Warranty Program for Medical Device Manufacturer

Posted on: November 5th, 2018

By: Ali Sabzevari

The Department of Health and Human Services Office of Inspector General recently approved a medical device manufacturer’s proposed warranty program, which provides a refund to the hospital at which a patient underwent joint replacement surgery using the manufacturer’s knee or hip implant and related products, if the patient was readmitted within 90 days because of a surgical site infection or need for implant replacement surgery. The proposed model could serve as a road map for these kinds of risk sharing arrangements.

Advisory Opinion No. 18-10, which can be accessed here, set forth that although the suggested warranty implicates the safe harbor regulations to the anti-kickback statute, 42 C.F.R. § 1001.952, the “Proposed Arrangement poses a sufficiently low risk of fraud and abuse under the anti-kickback statute.”

The anti-kickback statute makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce or reward referrals of items or services reimbursable by a Federal health care program. See section 1128B(b) of the Act. Where remuneration is paid purposefully to induce or reward referrals of items or services payable by a Federal health care program, the anti-kickback statute is violated. By its terms, the statute ascribes criminal liability to parties on both sides of an impermissible “kickback” transaction. For purposes of the anti-kickback statute, “remuneration” includes the transfer of anything of value, directly or indirectly, overtly or covertly, in cash or in kind. The statute has been interpreted by several federal courts to cover any arrangement where one purpose of the remuneration was to obtain money for the referral of services or to induce further referrals.

The U.S. Department of Health and Human Services has promulgated safe harbor regulations that define practices that are not subject to the anti-kickback statute because such practices would be unlikely to result in fraud or abuse. See 42 C.F.R. § 1001.952. The safe harbors set forth specific conditions that, if met, assure entities involved of not being prosecuted or sanctioned for the arrangement qualifying for the safe harbor. However, safe harbor protection is afforded only to those arrangements that precisely meet all of the conditions set forth in the safe harbor.

The Advisory Opinion concludes that the Proposed Arrangement would not generate prohibited remuneration under the anti-kickback statute. Value-based care and risk sharing models continue to gain appeal, and the Office’s approval of this warranty program shows that the era of value-based care is here to stay.

If you have any questions or would like more information, please contact Ali Sabzevari at [email protected].

PUNITIVE DAMAGES: How Much Is Too Much?

Posted on: November 1st, 2018

By: Rebecca Smith

On August 10, 2018, in the first Roundup cancer lawsuit to proceed to trial, a jury awarded Dewayne Johnson a total of $289 million dollars. On Monday, October 22, 2018, a San Francisco Superior Court Judge refused to overturn the jury verdict, however, ruled that if plaintiff would accept a reduction in the punitive damages from $250 million to $39 million she would deny Monsanto’s Motion for New Trial. On Friday, October 26, 2018, attorneys for Plaintiff Johnson accepted the trial court’s reduction of the punitive damage, reducing the total verdict to Mr. Johnson from $289 million to $78 million.

This case involved the trial of design defect and failure to warn claims asserted by Dewayne Johnson alleging that his exposure to glyphosate and glyphosate-based herbicides (Roundup) developed by Monsanto caused him to develop non-Hodgkin’s Lymphoma. At trial, the jury was asked to resolve the complex question of whether plaintiff’s exposure to Roundup caused his Lymphoma, to which the jury responded affirmatively. Monsanto challenged that determination in post-trial motions, however, Judge Suzanne Bolanos denied such contest, finding there was no legal basis to disturb the jury’s determination that plaintiff’s exposure to Roundup was a substantial factor in causing his Lymphoma. Judge Bolanos, however, did “disturb” the punitive damage award.

Monsanto had argued that there was no clear and convincing evidence of a specific managing agent authorizing or ratifying malicious conduct and accordingly that punitive damages should not be awarded. Judge Bolanos, however, indicated that when the entire organization is involved in acts that constitute malice, there is no danger a blameless corporation will be punished for bad acts of which it had no control. Further, she held that the jury could have concluded that Monsanto acted with malice by consciously disregarding a probable safety risk of Roundup and continuing to market and sell its products without a warning.

In addressing the amount of the punitive damages, Judge Bolanos began her disagreement with the jury. The award, she indicated, was extremely high for a single plaintiff and consisted largely of non-economic damages which the due process case law recognizes as a punitive element. Pointing to the prior U.S. Supreme Court decision of State Farm Mut. Auto Ins. Co. v. Campbell that “[p]unitive damages found to exceed the ceiling of what due process allows must be reduced,” Judge Bolanos ordered the ratio of compensatory damages to punitive damages be reduced to one to one.  Accordingly, the court held that regardless of the reprehensibility of Monsanto’s conduct, the constitutionally required punitive award could be no more than the compensatory damages award of $39 million.

It is unlikely that this case will end here. While the plaintiff has accepted the reduction in the punitive damages and accordingly, the reduced amount will be entered as a judgment, this does not preclude Monsanto from appealing the judgment. Further, should Monsanto appeal the judgment, plaintiff has reserved its right to appeal the reduction of punitive damages. This is a case well worth watching.

If you have any questions or would like more information, please contact Rebecca Smith at [email protected].

Is Wellness Activity Participation Compensable?

Posted on: September 25th, 2018

By: Joyce Mocek

The Department of Labor (DOL) recently issued an opinion letter on whether employees must be compensated under the Fair Labor Standards Act (FLSA) for the time they spend participating in wellness activities.   In this inquiry, the employer advised the DOL that it allowed its employees to participate in wellness programs including “biometric screening,” (ie cholesterol levels, blood pressure and nicotine usage screening), during and outside of regular work hours.  The screening information could result in a decrease in the employee’s health insurance deductible.  The screening was not related to the employee’s job, there were no restrictions on the time an employee could participate in the events, and participation was not required by the employer.

In its opinion letter, the DOL noted the employer received no financial benefit as a result of the employee participation in the activities, and the employee’s voluntary participation predominantly benefited the employee.  The employer did not require the employee to perform any job related duties while they were participating in the activities.  Thus, since the activities predominantly benefited the employee, the DOL opined that the time the employees spent participating in the wellness program did not constitute worktime under the FLSA.  Further, since the employee was relieved of all duties, and not restricted in the amount of time they could participate in the activities, the time spent was considered non-compensable “off  duty” time.

Employers with wellness programs should review their policies concerning such programs, to ensure they follow the guidance recently outlined by the DOL in this opinion letter to avoid potential FLSA issues.

If you have any questions or would like more information, please contact Joyce Mocek at [email protected].

If You Don’t Have Anything Nice To Say….You Probably Shouldn’t Post It!

Posted on: August 22nd, 2018

By: Shaun DaughertySamantha Skolnick

Mothers all over the world have admonished their children: “if you don’t have anything nice to say, don’t say anything at all.”  It may lose something when translated into some obscure dialects, but the sentiment was still there.  Now that we live in the age of technology, it appears that the old saying could use a facelift.  “If you don’t have anything nice to say, you should not type it anywhere on the internet.”  That is especially true if you are criticizing doctors and hospitals.

A wave of litigation has been emerging involving doctors and hospitals, but in these instances, they are not the targets, they are the plaintiffs.  Doctors and hospitals are starting to sue their patients for negative reviews on social media. The most recent example earned itself an article in USA Today where retired Colonel David Antoon had to pay $100 to settle felony charges for emailing his surgeon articles that the doctor found threatening as well as posting a list on Yelp of the surgeries the urologist had scheduled for the same time as his own.  Antoon alleged that his surgery left him incontinent and impotent and he had tried to appeal to the court of public opinion.

In other news, a Cleveland physician sued a former patient for defamation after the negative internet reviews of her doctor reached the level of deliberately false and defamatory statements. The case may be headed to trial in August. Close by, a Michigan hospital sued three relatives for Facebook posts and picketing which amounted to defamation, tortious interference and invasion of privacy. The family claimed that the hospital had mistreated their deceased grandmother.

We live in a country that ensures freedom of speech, and that right is exercised more than ever with the advent of social media and an ever-growing audience of participants.  However, there can be consequences if the speech is inaccurate or defamatory in nature.  While some attorneys, like Steve Hyman, cite the law in stating that “[t]ruth is an absolute defense. If you do that and don’t make a broader conclusion that they’re running a scam factory then you can write a truthful review that ‘I had a bad time with this doctor.’”  Other commentators, like Evan Mascagni from the Public Participation Project, tout avoiding broad generalizations, “If you’re going to make a factual assertion, be able to back that up and prove that fact.” That is defense against defamation claims 101.

The world of non-confrontational criticism on social medial makes it easy and tempting to post an emotionally fueled rant.  But beware!  You want to avoid a situation like that of Michelle Levine who has spent nearly $20,000 defending herself against a suit filed by her Gynecologist over defamation, libel, and emotional distress. The 24-hour rule is still a viable alternative to hitting “send” or “post.”  Type it out, let it sit and ruminate for a bit, and then decided if you are going to post the negative comments for the world to see.  Some opinions are worth sharing, or you may decide…. don’t say anything at all.

If you have any questions or would like more information please contact Shaun Daugherty at [email protected] or Samantha Skolnick at [email protected].

Georgia Prescription Drug Monitoring Program – The Last Deadline Approaches

Posted on: June 27th, 2018

By: Shaun Daugherty

For those of you that have not been residing off planet these last few years, you know that there is a lot of coverage of the opioid “crisis” across the United States.  Many states have taken steps to try and help monitor and control the controlled substances that are moving from prescription pad to pharmacy to patient.  Georgia is no different.

Several years ago, the Georgia legislature passed the bill that established the Georgia Prescription Monitoring Program (PDMP).  It is an electronic database that is used to track the prescribing and dispensing of controlled substances per patient.  In 2017, the Legislature tweaked some of the requirements and added some deadlines for the same.

As of July 1, 2017, all Georgia retail pharmacies and dispensing prescribers were required to update the PDMP at least every 24 hours.  At the time there was no requirement on the pharmacy or prescriber to obtain any information from the database or the patients who were receiving the medications, they were just required to update the information about the medications being put into circulation.

On January 1, 2018, each Georgia prescriber with a DEA number was required to be registered with the PDMP.  If you have not done so, please do so immediately at https://georgia.pmpaware.net/login.  Any new Georgia prescriber that obtains a DEA number must register with the PDMP within 30 days of obtaining said number.  Between January 1 and May 31 of 2018, random testing of the PDMP occurred to assure that it was accessible 99.5% of the time.  Data from this random testing has not yet been published.

Now the upcoming deadline:

Effective July 1, 2018, any person initially prescribing a schedule II opioid or any benzodiazepine shall seek a review of the patient’s PDMP information at the time of the initial prescription and then at least once every 90 days thereafter.  However, this requirement does not apply if the: 1) prescription is for no more than 3 days/26 pills; 2) the patient is an inpatient in a hospital, LTCF, hospice, personal care home, etc. and uses the medicine on premises; 3) patient had out-patient surgery and the prescription is for no more than 10 days/40 pills; 4) patient is terminally ill and in an outpatient hospice; or 5) if the patient is being treated for cancer.

If you are not exempt, then the check of the PDMP must be documented in the patient’s records.  There is not a requirement that the information be printed from the database and placed in the patient’s records, but that would seem to be easy proof if anyone came to ensure that the requirements were being met.  All prescribers of opioids are required to provide patients information about the risks of using opioids and their proper disposal as well.  A handout given to each patient with this required information would be easy to create, distribute and post in the office for patient education and to fulfil this requirement.

Any prescriber found violating these requirements will be held administratively liable to their professional licensing board.  That is the same licensing board that has the power to sanction, limit, suspend or revoke your professional license.

If you have any questions or would like more information, please contact Shaun Daugherty at [email protected].