Center for Health & Pharmaceutical Law & Policy Introduces First Edition of Pharmaceutical and Medical Device Compliance Manual
The Seton Hall Law Center for Health & Pharmaceutical Law & Policy, American Health Lawyers Association (AHLA) and the Food and Drug Law Institute (FDLI) have released the first edition of the Pharmaceutical and Medical Device Compliance Manual. The Manual is a guide to deciphering the intricate web of federal and state laws and the practices of regulatory and enforcement authorities within the healthcare and life sciences arena, while also providing the practical skills needed to implement an effective compliance program.
Designed to aid health law attorneys, compliance professionals and others in the pharmaceutical and medical device field, the Manual explains the law in layman’s terms in addition to providing advice and guidelines on creating, managing, monitoring and auditing an effective compliance program, in essence, marrying legal expectations with the operational demands of business units.
The book was co-edited by Seton Hall Law Associate Dean Kathleen M. Boozang, J.D., LL.M., who founded the school’s Health Law program in 1990, ranked among the top 10 by U.S. News & World Report for the past 16 years; and by Simone Handler-Hutchinson, J.D. ’93, Executive Director of the Center for Health & Pharmaceutical Law & Policy.
Dean Boozang notes: “Over the last two decades the trend in government oversight has resulted in a regulatory environment of increased accountability among organizations across a number of sectors, with the health and life sciences industries being the subject of particular attention – a trend that shows no sign of waning. We produced this manual for compliance officers, health and life sciences lawyers and their clients to enable them to build a framework for creating and sustaining an effective compliance function.”
As co-editor, Ms. Handler-Hutchinson said, “Each chapter was written by a leading regulatory official, practicing attorney, or healthcare consultant who has either shaped the policies as an official and/or counsel in the nation’s regulatory agencies, served as counsel to or built compliance functions within life science corporations. They offer first hand, in-depth compliance insight and actionable advice.”
The Pharmaceutical and Medical Device Compliance Manual is available as a softbound book and a variety of eBook formats; it may be ordered by visiting http://law.shu.edu/compliancemanual.
The Seton Hall Law Center for Health & Pharmaceutical Law & Policy advances scholarship and recommendations for policy on the varied and complex issues that emerge within pharmaceutical and health law. Additionally, the Center is a leader in providing compliance training on the wide-ranging state, national and international mandates that apply to the safety, promotion and sale of drugs and devices. Seton Hall University School of Law, New Jersey’s only private law school and a leading law school in the New York metropolitan area, is dedicated to preparing students for the practice of law through excellence in scholarship and teaching with a strong focus on experiential learning. Founded in 1951, Seton Hall Law School is located in Newark and offers both day and evening degree programs. For more information visit law.shu.edu.
The American Health Lawyers Association (AHLA) is the nation’s largest nonpartisan educational organization devoted to legal issues in the healthcare field. The Association’s 11,000 members practice in a variety of settings in the healthcare community. For information about our resources, publications, and educational offerings, visit www.healthlawyers.org.
Online Graduate Certificate Program in Pharmaceutical & Medical Device Law & Compliance, ‘Bringing Products to Market,’ to Start on Oct. 7, 2012
Filed under: Compliance, Health Law, Medical Device, Pharma
Through its Center for Health & Pharmaceutical Law & Policy, Seton Hall Law School offers 3 graduate certificate programs in Pharmaceutical & Medical Device Law & Compliance. These flexible, 8-week certificate programs are designed for professionals seeking to enhance their knowledge about legal, regulatory, and ethical issues within the pharmaceutical and medical device industries. Featuring intensive, individualized feedback, the programs provide both an immersion in key substantive issues and an opportunity to develop the practical skills necessary to research and communicate effectively about the law. Online classes for the Bringing Products to Market Certificate start on October 7, 2012.
Bringing Products to Market Certificate
The Pharmaceutical & Medical Device Law & Compliance Certificate: Bringing Products to Market covers the following topics:
- The FDA approval process
- Products liability and FDA preemption
- Advertising and promotion
- Life science companies and the First Amendment
It takes 8 weeks to complete the certificate program. All coursework must be completed in the sequence in which it is offered. Students should plan to spend 6-8 hours per week on online coursework, including reading assignments, research and writing projects, and online discussions.
Seton Hall Law School’s online Graduate Certificate Programs are offered during our Spring, Summer, and Fall semesters. Start dates for upcoming offerings of the Bring Products to Market certificate and are indicated in the Certificates At-A-Glance section.
Do I need to be in a certain profession to be admitted?
No. While the program is specifically designed to meet the needs of mid- to senior-level professionals in the pharmaceutical and medical device industries, it is also open to qualified students from other backgrounds.
Applicants must submit the following:
- Online application
- Application fee of $50
- Official baccalaureate degree transcript from an accredited college or university
- Current resume
- A 500-word statement explaining why you want to study Pharmaceutical & Medical Device Law & Compliance with a focus on Bringing Products to Market
No entrance exam is required for admission. However, international applicants who are not native speakers of English must submit a TOEFL score.
Graduate Certificate Program in Pharmaceutical & Medical Device Law & Compliance to Start Again, October 7, 2012
Filed under: Compliance, Drugs & Medical Devices, Seton Hall Law
Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy starts classes again on October 7th for the Graduate Certificate in Pharmaceutical & Medical Device Law & Compliance. The priority application date is September 24, 2012.
The Graduate Certificate in Pharmaceutical & Medical Device Law & Compliance is a non-degree program designed for individuals who seek in-depth knowledge about legal, regulatory, and ethical issues related to the pharmaceutical and medical device industries. Taught exclusively online, it offers students nationwide a targeted immersion in key substantive issues along with the practical skills necessary to research and communicate effectively about the law.
The intensive program is geared to busy professionals who want to cover a significant amount of material in a relatively short period of time. The program is open to students who have earned a baccalaureate degree from an accredited college or university. It is specifically designed to meet the needs of mid- to senior-level professionals in the health care industry, but highly motivated students from other backgrounds are also welcome to apply. It is not necessary to have prior academic or work experience in health care in order to do well in the program.
Additional information and registration is available here.
Why study pharmaceutical and medical device law at Seton Hall School of Law?
Seton Hall Law School has specialized in health law for more than a decade, and its health law program is consistently ranked among the top ten in the nation by U.S. News & World Report. The Law School’s health law faculty specialize in a wide range of health law topics, including healthcare organizations, nonprofit governance, healthcare financing, healthcare fraud and abuse, food and drug law, research with human subjects, genetics and the law, public health law, and bioethics. In addition to training future lawyers, Seton Hall Law offers a Master’s of Science in Jurisprudence degree for individuals working in the health care industry, as well as an innovative compliance certification program for pharmaceutical and medical device professionals. Seton Hall Law is also a center for scholarship and public policy development related to health care, particularly through its Center for Health & Pharmaceutical Law & Policy, whose mission is to foster informed dialogue among policymakers, consumer advocates, the medical profession, and industry.
Curiously not mentioned in any of the stories about Penn State is the existence of a hotline to which eye witnesses of Sandusky’s child rapes could have been anonymously reported, or the existence of an Ethics/Compliance Professional with direct access to and oversight by the board. Well, it turns out they’re not mentioned because they didn’t exist. It appears that even now, Penn State lacks a compliance program, the creation of which Special Investigative Counsel Freeh’s Report recommends. Previously limited to financial fraud and HR issues, a June 21, 2012 posting by Penn State’s internal auditor announces a poster redesign advertising its hotline number, to which any ethical or legal concerns can now be reported. Important will be training throughout the university regarding the law’s protection of whistleblowers, about which, according to Freeh’s Report, top university leaders were unaware.
While it is stunning that, even now, Penn State has not advanced further in setting up these protective measures, it is fair to say that much of higher ed has been slow to adopt compliance best practices common to the healthcare sector and most business entities. Those universities with academic medical centers are among those who caught the wave early, because hospitals had to put compliance programs in place in the late 1980′s at the insistence of the Health and Human Services Office of Inspector General. Experience in the health sector suggests that the kind of exceptionalism and favoritism extended to Paterno and Sandusky might not have happened if a strong compliance program with an ethics officer of stature had been in place. The board would not have learned about crimes on its campus from the newspaper if it received regular updates from a compliance officer about all reports and investigations.
Janitors witnessed Sandusky engaged in sexual behavior or showering with children, but were afraid to make reports lest they’d lose their jobs. An anonymous hotline would have provided a mechanism for this information to have led to a real investigation that would have confirmed the fears that Sandusky was a serial rapist. Again, the ultimate decision-makers would have had an understanding of the full extent of the situation with which they were dealing — surely in the face of full-blown written findings detailing the scope of the horrors occurring on their own campus they would have acted.
Finally, the existence of an autonomous compliance ethics and compliance officer with sufficient stature and experience to conduct a full investigation and force a discussion about the appropriate handling of such catastrophic events could have also changed the outcome. As it was, the oral information reported up the chain became so diluted by the time it reached the University President that a rape was reported to him as “horsing around in the shower.” A complete written report would have avoided any such misunderstandings. More important, the victim would have been identified and hopefully protected — no one involved in handling the matter inquired about or made any efforts to identify any of the victims. Instead, Sandusky was given the heads up that he’d been seen in the shower, putting his child victim at greater risk. To give Special Investigative Counsel Freeh “free rein” after-the-fact is too late; imagine the harm that could have been avoided had such an investigation taken place in response to an early hotline report complaining about Sandusky showering with children. While the success of a robust compliance program for institutional reform is varied, experience in health care suggests that it contributes much to the prevention and discovery of problems.
While universities have certainly taken notice of the disaster that has befallen the children whom Sandusky assaulted and Penn State for its multiple failures, it is less certain that they’ve taken sufficient steps to ensure that similarly horrible events won’t get swept under the rug at their own institutions. Universities are essentially small towns populated by an age cohort with adult problems and responsibility but frequently lacking the maturity to handle either effectively. When you add the numerous high risk activities that are inherent to university life, it is no exaggeration to say that it is by the grace of God that more tragedies don’t occur on campuses. I suspect there’s more than we know, and I fear the lesson of Penn State may be lost.
In short, all university boards should read Special Investigative Counsel Freeh’s Report and take seriously its recommendations for your own institutions. Specifically, corporate compliance should be taken seriously.
If you are interested in learning about the whistleblower programs and the laws protecting whistleblowers, enroll in Seton Hall Law’s 8 week online course entitled The Law Protecting Whistleblowers. Watch Seton Hall’s Online Certificate web page for details to be posted in mid-August.
In an attempt to stem health care fraud, the government’s use of Corporate Integrity Agreements (CIAs) is growing. In Professor Zack Buck’s Health Care Fraud and Abuse class here at Seton Hall Law, students were given the benefit of a discussion on the topic by two industry veterans, Tim Grimes and Brett Bissey. Grimes is the Health Care Compliance Officer for the North American Pharmaceuticals branch of Johnson & Johnson, where he oversees the development, improvement and management of health care compliance and government contract compliance systems. Bissey is Senior Vice President, Chief Ethics and Compliance Officer at the University of Medicine and Dentistry of New Jersey (UMDNJ), where he is responsible for the management and direction of all compliance and ethics related programs.
Grimes and Bissey spoke on the proliferation of, and challenges associated with, the use of CIAs in the health care industry. A CIA is a restrictive agreement, usually lasting five years, entered into by the Office of Inspector General of the U.S. Department of Health & Human Services (OIG) and a health care entity alleged to have engaged in fraudulent or abusive practices. CIAs impose numerous compliance obligations, which are intended to stop fraudulent behavior from occurring in the future. These compliance obligations range from requiring employee training, to mandating the appointment of a compliance officer, to implementing a communications hotline. Both Grimes and Bissey have personal experience working under a CIA, as Johnson & Johnson and UMDNJ, like many others in the industry, have or are currently operating under such integrity agreements.
Grimes and Bissey explained that CIAs can be cumbersome because the terms of the agreements are often unclear and the costs of compliance obligations, such as employee training, can be immense. For example, CIAs generally require proper compliance training for any “relevant covered person” within the organization. However, what defines such persons is generally unclear, and the costs and logistics of implementing a training program for all employees who come in contact with a medication, from local pharmaceutical representatives to researchers working in another country, can be expensive and complex.
To help address such issues, Grimes participated in the Pharmaceutical Compliance Roundtable hosted by the OIG in February 2012, which brought together compliance professionals from 23 pharmaceutical manufacturers currently operating under a CIA. By establishing the Roundtable, the OIG sought to foster an open dialogue between private industry and government addressing the implementation and operational challenges of CIAs.
While the difficulties of working under CIAs were mentioned, Grimes and Bissey also acknowledged the benefits that companies can reap by their use. CIAs can also, it was said, be extremely beneficial because they increase the individual responsibility on corporate officers and board members, grabbing the attention of upper-level management who may have previously been less responsive to compliance concerns. Further, the proliferation of CIAs is said to have changed the attitude of some company officers toward compliance initiatives–bringing a level of enthusiasm which may have been absent in the past.
On a parting note, Grimes and Bissey agreed that the government shows no signs of slowing down on its use and enforcement of CIAs in the health care industry. Commenting about the state of the industry, they said the question is not “Who is under a CIA?” Rather, it’s “Who isn’t?”
Photo Credit by Hedwig Storch
Filed under: Compliance, Health Care Economics, Treatment
What’s worse than a kidney stone? For those of you who have had one, or read my post the other day describing how it felt–
…broke out in a cold sweat and quickly began writhing around and wailing in pain like a wild animal caught in a bear trap. The pain came in excruciating waves radiating as though I had just been punched below the belt– repeatedly.
that might be difficult to answer. But I’m going to go with two kidney stones– back to back, or more precisely, two kidney stones, and a tiny cyst and a 1.5 cm lesion on and in my kidney, respectively– which is my current diagnosis. An ultrasound was unable to rule out cancer for the lesion.
And so I wait. A CT scan with contrast is next, probably sometime later this week– after a pre-cert from my insurer, Cigna– which has yet to fail me.
As you might imagine, the last week– what with the back to back kidney stones and all — was less than comfortable. But fortunately, the pain comes in waves and as the week wore on and I became more accustomed to the new and seemingly interminable rhythm, I was able to work in between the waves. And doing so brought me no small measure of joy– no longer reduced to a being defined solely by pain, I produced. I contributed. I was not merely subject to.
And so this blog.
The presence of the cyst caught me unawares. Initially diagnosed as one of two stones waiting in the wings back at the E.R., they were presented to me as nothing I’d have to worry about in the near future. Still in the kidney itself, they might have proved candidates for blasting. The follow-up trip to the urologist disabused me of this notion while apprising me that the one “stone” was a cyst which would have to be further examined so as to rule out density– which is a euphemism for cancer.
And in a moment it all changes. I got the sonogram later that day, and later that night I wrote to this blog’s Editor-in-Chief, somewhat incredulous as to how I signed things for that test– legal documents– in a haze of fear, pain and painkillers. Legally trained, I scribbled my name or initials on everything before me with what barely amounted to a perfunctory glance as I received one sentence explanations from the admittance clerk for one page fine print documents– no doubt painstakingly wrought by the pens of my legal brethren to ensure compliance– and payment. But I assure you, the compliance was a one-sided affair. Because, as our Editor-in-Chief Frank Pasquale has said so many times before, the acquisition of healthcare is fundamentally different than buying other commodities. It is not like buying a car; the economy of healthcare is unconventional– far more akin to “how much would you pay for a glass of water in the desert,” than how much of a rebate is available on that new Kia Soul. A hard bargainer, car dealers hate me. In the legal world, I’ve built a reputation as someone with a cold hard eye for a contract. In the hospital, I signed with an almost wild abandon–wondering who would take care of my children as I did.
And today I got the results. One kidney stone gone, one still making its way, and
“Tiny parapelvic cyst right kidney. This does not appear to correspond to the 1.5 cm visualized right renal lesion on CT scan. Therefore, possibility of a solid lesion not visible ultrasonographically cannot be ruled [out].”
His footsteps loud as he walked down the hall, the melodramatic stringed theme from “The Godfather” played in the room as the doctor entered and explained. Even if it is cancerous, I’m told it’s small. Maybe even too small to do anything but wait to see what it does– and test the rest of me to see if it migrated from someplace else.
But whatever this process may be, I think there might be some value in my writing about it– for both of us. No longer mired in the abstractions of healthcare, I am, it seems, walking straight into the belly of the beast. Consider this a postcard of sorts– with the hope that it can work itself into being a guide.
Two promising health law students were recently awarded scholarships to attend Seton Hall Law’s Healthcare Compliance Certification Program this June. The program immerses attendees in the laws, regulations, industry codes and compliance standards applicable to the life sciences industry. This year, the scholarships, which are given annually, were awarded to Jenna Smith, a 2L at Loyola University Chicago School of Law, and Abraham Gitterman, a 2L at the University of Maryland School of Law.
For more information on the scholarships and on how students may apply for next year, click here (and scroll down past “Government Scholarships”).
On January 12, the U.S. District Court for the District of Minnesota convicted and sentenced Guidant LLC for criminal violations of the Federal Food, Drug, and Cosmetic Act, nearly a year after charges were filed. The Court ordered Guidant to submit to three years probation, against the recommendation of the prosecution, and to pay more than $296 million in fines and forfeitures included within the plea agreement.
On February 25, 2010, the Department of Justice (DOJ) brought charges against the Boston Scientific Corp. subsidiary and medical device manufacturer for “its mishandling of short-circuiting failures of three models of its implantable cardioverter defibrillators” (according to a recent press release).
After a four-year investigation, the DOJ concluded that Guidant became aware of design defects which rendered its products inoperative in 2002 and 2004. Guidant was charged with “making materially false and misleading statements on report(s) required to be filed” with the Food and Drug Administration (FDA) on Aug. 19, 2003, when it informed the FDA that a design change to correct the flaw did not affect the safety and effectiveness of device. Guidant was also charged with “failing to promptly notify” the FDA of a device “correction” which was made to “reduce a risk of health posed by the device.” In 2005, Guidant recalled the ICD devices.
The Court Rejects the Plea Agreement
On March 11, 2010 — within a month of the indictment — Guidant and the Department of Justice submitted a plea agreement in which Guidant agreed to plead guilty to both counts, to pay a criminal fine in the amount of $253,962,251, and to pay a criminal forfeiture of $42,079,576. On April 5, 2010, Guidant pled guilty and FDA Commissioner Margaret A. Hamburg, M.D. declared that the “entry of a guilty plea by Guidant LLC and the proposed resolution would represent the largest criminal penalty ever imposed on a device manufacturer for violating the Food Drug and Cosmetic Act.”
However, on April 27, 2010, District Judge Donovan W. Frank rejected the plea agreement. He found that “after careful deliberation,” it was “not in the best interests of justice and [did] not serve the public’s interests.” In his opinion, Judge Frank cited arguments raised by a class of “consumers of Guidant products at issue” regarding restitution and the absence of a probation provision among the reasons for his delayed decision. He concluded that restitution was inappropriate because there were “no victims directly and proximately harmed by Guidant’s criminal conduct.”
The absence of a provision requiring probation proved fatal to the agreement. Specifically, Judge Frank stated that Guidant “could be ordered to perform community service designed to repair the harm caused by its offenses…” or to establish or expand a compliance and ethics program. Furthermore, the presentence investigation report would enable “the Court to consider the feasibility of any of these suggestions or of additional conditions of probation.”
The Sentencing Hearing
On January 4, 2011, both parties submitted further information in anticipation of the January 12 sentencing hearing. Guidant provided summary information regarding its continued and expanded compliance activities, including its five-year Corporate Integrity Agreement with HHS-OIG, and its charitable and community service activities. The government stood by its original plea agreement and did not advocate for probation.
On January 12, the Court signed the plea agreement with modification. In addition to Guidant’s payment of the fines and forfeitures outlined in the agreement, Guidant will submit to probationary period of three years. According to the DOJ, “Guidant is required to make quarterly reports to the Probation Office and to submit to regular, unannounced inspections of its records by the Probation Office. The court also required Guidant to notify its employees and shareholders of its criminal conviction.”
Having been hailed the “largest criminal penalty ever imposed on a device manufacturer for violating the Food Drug and Cosmetic Act,” it is noteworthy that the Court did not accept the sentencing recommendations offered in the plea agreement. Despite evidence of compliance changes and a five-year Corporate Integrity Agreement with the HHS-OIG, the Court felt it necessary to add probation to Guidant’s sentence.
In a time when individuals face exclusions from federal health programs even absent criminal sanctions, health-related corporations should likewise keep an eye on the resolution of future criminal cases. Is this a single “victory for one federal judge who put his foot down… until he got what he thought was a fair deal,” as Law.com reports, or the start of a trend?
A complete record of the filings can be found here.
Don’t miss a rare opportunity to participate in real-world exercises and get feedback from recognized healthcare compliance leaders from Merck, Eisai, Johnson &Johnson, Siemens, Epstein Becker & Green, and Ropes & Gray.
This single-day advanced level training workshop is designed for health care compliance (HCC) professionals wishing to strengthen their analytic and communication skills and foster decision-making capacity.
Through this interactive workshop, participants will learn to respond to challenging problems and carry out appropriate corrective action effectively. Participants will work in teams and some pre-work is required.
- Participate in a unique professional development opportunity designed for HCC professionals seeking to hone analytical, problem solving, and presentation skills.
- Enhance your understanding of the legal, ethical and professional standards that apply to HCC professionals.
- Enrich your professional profile and aid in your professional advancement.
- Prepare and deliver a presentation to a panel of industry experts, including from Siemens, Johnson & Johnson, Eisai, Epstein, Becker & Green, who will provide constructive feedback.
WHO SHOULD ATTEND:
Legal and compliance professionals working for pharmaceutical, medical device and bio companies.
COST & REGISTRATION:
$275 (Includes continental breakfast and lunch)
To register, please go here.
- 8:30: Registration & Continental Breakfast
- 9:00-12:00 Morning Session:
– Presentation I: Understanding Your Responsibilities as a HCC Professional
– Presentation II: An Analytical Method for HCC Decision-making
– Group Exercise Instructions
– Overview of Case Studies and Participant Q&A
- 12:00-12:30 Working Lunch
- 12:30-4:30 Afternoon Session
– Team Exercises: case review; identification and analysis of issues & applicable standards;
– Development of Recommendations & Presentation to Management Board
– Team Presentations to Management Board
– Management Board’s Critique of Team presentations
- 4:30 Awarding of Certificates and Conclusion
Filed under: Compliance, Pharma, Quality Improvement
In case you missed it: 60 Minutes segment with whistleblower Cheryl Eckerd, a former manager of global quality assurance for GlaxoSmithKline. She describes her experience inspecting Glaxo subsidiary, Cidra, in Puerto Rico. It views like an in-house counsel’s nightmare and a PR professional’s worst day. CBS states:
“But in November, we found out just how much could go wrong at one of the world’s largest drug makers. A subsidiary of GlaxoSmithKline pleaded guilty to [a felony] distributing adulterated drugs.
“There was reason to believe that some of the medications were contaminated with bacteria, others were mislabeled, and some were too strong or not strong enough.”
Ms. Eckerd brought suit under the Federal Whistleblower Act, with the government ultimately recovering $750 million; Ms Eckerd who was “downsized” by Glaxo, received $96 million as her share of the recovery. In addition, when Ms. Eckerd made the information she had gathered about the plant in Puerto Rico available to the FDA, federal agents executed a search warrant and seized drugs worth “hundreds of millions of dollars.”
Filed under: Compliance, Drugs & Medical Devices, FDA, FDA Center for Devices and Radiological Health, Fraud & Abuse, HHS
On October 1, the Office of the Inspector General (“OIG”) of the U.S. Dept. of Health & Human Services (“HHS”) released its Work Plan for Fiscal Year 2011 (“Work Plan”). Each year, the OIG briefly outlines activities that OIG “plans to initiate or continue with respect to the programs and operations” of HHS. Various offices within OIG conduct audit, evaluation, investigation, enforcement, and compliance activities.
Continuing Work Within OIG
Many of the topics outlined in the Work Plan were included in last year’s plan. Although the repeated inclusion of these areas of focus makes compliance easier for facilities, audits should still be conducted in the following areas:
- Provider-based status
- Observation services (as part of an outpatient visit)
- Part A hospital capital payment
- Critical access hospitals
- Medicare disproportionate share payments
- Duplicate graduate medical education payments
- Hospital readmissions
- Hospital admissions with conditions coded present-on-admission
- Inpatient rehabilitation facility transmission of patient assessment instruments
- Medicare excessive payments
New Issues to be Targeted
“What we’re really looking at are four or five really brand new issues,” said Stephen Miller, JD, chief compliance and privacy officer for Trenton, NJ-based Capital Health System, Inc. for HealthLeadersMedia.com.
- Brachytherapy reimbursement
- Replacement of devices received at no cost or reduced cost
- According to Debbie Mackaman, RHIA, CHCO, regulatory specialist for HCPro, Inc., in Marblehead, MA, “Since the medical devices replacement issue can be a difficult billing procedure to comply with, facilities should certainly do an in-depth process audit in this area.”
- Safety and quality of intensity-modulated radiation therapy (IMRT) and image-guided radiation therapy (IGRT)
- Indicates a responsiveness on the part of OIG to headlines regarding quality concerns. In March, the Nuclear Regulatory Commission fined Philadelphia Veterans Affairs Medical Center $227,500, its second largest fine ever against a medical institution, after “unprecedented number” of radiation errors in treating prostate cancer patients.
- Hospitals’ application of the “three-day rule” and “one-day rule” under the Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act of 2010
- Many hospitals have had difficulty in billing under the new rules, which redefined what services are related to the admission, and therefore not eligible for Medicare payment within the defined window. According to Mackaman, “IPPS facilities should be vigilant about reviewing the current three-day rule, and the non-IPPS hospitals should review the addition of the one-day rule.” CMS guidance on this topic can be found here.
OIG Review of FDA Administration
As HealthReformWatch previously reported, nine Food & Drug Administration (“FDA”) scientists from the Center for Devices and Radiological Health (“CDRH”) sent a letter to President Obama stating, in relevant part, that:
the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk. Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices…have ignored serious safety and effectiveness concerns of FDA experts. Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid.
These scientists also wrote to Congress in 2008, accusing the top FDA officials of “serious misconduct” in ignoring scientist concerns and “approving for sale unsafe or ineffective medical devices,” according to the N.Y. Times.
According to Washington G-2 Reports, OIG also stated on September 29 that “it would re-examine the concerns of those FDA reviewers, and broaden the scope of its inquiry.”
This coming year, OIG intends to investigate CDRH “policies and procedures for resolving scientific disputes about approval of devices.” The Work Plan states that OIG will:
review a sample of administrative files for disputed device decisions and assess the extent to which regulations, policies, and procedures were followed during the dispute resolution process. We will also assess whether CDRH managers and staff are aware of and trained on policies and procedures for resolving scientific disputes.
Additionally, OIG will continue to review FDA oversight of investigational new drug applications, the process for device approval, and oversight of postmarketing surveillance studies of medical devices.
Seton Hall University School of Law Launches European Healthcare Compliance Certification Programme in Paris
Filed under: Compliance, Health Law, Seton Hall Law
Press Release: Seton Hall University School of Law Launches European Healthcare Compliance Certification Programme in Paris
Seton Hall School of Law and Sciences Po
- June 21 – 25, 2010
- Sciences Po, Paris, France
The Healthcare Compliance Certification Programme, co-organized by Sciences Po Executive Education (Paris, France) and Seton Hall University School of Law (Newark, N.J) to be held from June 21-25, 2010 on the Paris campus of Sciences Po today announced its 2010 topics and faculty.
CURRENT & FORMER REGULATORY & ENFORCEMENT OFFICIALS:
Paul McNulty, Partner, Baker & McKenzie, LLP (DC) Former U.S. Deputy Attorney General
Kirk Ogrosky, Partner, Arnold & Porter LLP (DC), Former Deputy Chief, Health Care Fraud, Criminal Division, U.S. Dept. of Justice
Alex Conte, Senior Legal Analyst, Anti-Corruption Division, OECD
Dr. Guitelle Baghdadi-Sabeti, Team Leader, Good Governance for Medicines, World Health Organization
Marie-Claire Pickaert, Deputy Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA)
COMPANY COMPLIANCE PROFESSIONALS:
Dirk Brinckman, Assistant General Counsel, Johnson & Johnson (Brussels)
Roeland Van Aelst, Vice President, EMEA & Canada, Office of Health Care Compliance & Privacy, Johnson & Johnson
KEYNOTE & ACADEMIC SPEAKERS:
Paul Benkimoun, Healthcare Journalist, Le Monde
Claude Le Pen, Professor, Université Paris-Dauphine
Kathleen Boozang, Professor of Law, Seton Hall Law School (Newark, NJ)
LEADING LEGAL AND COMPLIANCE COUNSEL AND ADVISORS:
Peter W.L. Bogaert, Managing Partner, Covington & Burling (Brussels)
John Rupp, Partner, Covington & Burling LLP (London)
Karolos Seeger, Partner, Debevoise & Plimpton LLP (London)
Susie Smith, Bevan Brittan LLP (UK)
Ted Acosta, Leader, Life Sciences & Corporate Compliance Fraud Investigation & Dispute Services, Ernst & Young LLP
Jill Deal, Partner, Venable LLP (DC)
Kristof Van Quathem, Data Protection Advisor, Covington & Burling LLP (Brussels)
Carolyn Lindsey, Director of Member Services, TRACE International
Owen Bevan, Director, Legal & Compliance Practice, Corporate Executive Board
By Laura Sunyak
In February of 2009, President Obama signed into law the American Recovery and Reinvestment Act of 2009 (ARRA), and with it enacted the Health Information Technology for Economic and Clinical Health Act (HITECH Act). The HITECH Act contains regulations that significantly increase the penalty amounts the Secretary of the Department of Health and Human Services (HHS) may impose for violations of rules promulgated under the Health Information Portability and Accountability Act (HIPAA), and encourages corrective action. In order to incorporate the increased penalty structure into HIPAA, HHS has recently issued an interim final rule designed to strengthen its enforcement power and incorporate the new penalty structure of the HITECH Act into HIPAA.
Prior to the HITECH Act, the Secretary could not impose a penalty of more than $100 for each violation, or $25,000 for all identical violations of the same provision. A covered entity could also bar the imposition of a civil monetary penalty by simply showing that it did not know that it violated a HIPAA rule. As a result, enforcement of HIPAA rules has been weak, bordering on nonexistent. The number of covered entities that were in full compliance with the law was always very low, simply because HHS did not have a sufficient enforcement mechanism in place to deter violations. If covered entities did change their behavior to become compliant, it was out of a desire to follow the law, not due to fear of prosecution or administrative action.
Before ARRA was signed into law, although there were HIPAA audits that took place, they were few and far between. Covered entities complained that the requirements were not clear, and so hesitated to attempt to comply. With the enactment of ARRA and the HITECT Act, and the adoption of the interim rule, HIPAA covered entities will have no choice but to take notice and comply, or face much harsher penalties. The implementation of these acts also transfers authority for enforcement of HIPAA’s security rules from the Centers for Medicare and Medicaid to the Office of Civil Rights which, with 275 investigators and an annual budget of $40 million, is in a better position to bring enforcement actions and recover penalties. The penalties collected for violations will in turn be used to fund greater enforcement efforts. The interim rule amends 45 CFR part 160, subpart D, which establishes rules relating to the imposition of civil money penalties, to conform several provisions to section 13410(d) of the HITECH Act’s amendments to section 1176 of the Social Security Act, which became effective February 18, 2009. This interim final rule’s amendments distinguish between violations occurring before February 18, 2009, and violations occurring on or after that date, with respect to the potential amount of the civil money penalty and the affirmative defenses available to covered entities.
The interim final rule, effective as of November 30, 2009, modifies the penalties for HIPAA violations occurring after February 18, 2009. (For an explanation of the meaning of “interim final rule,” click here. According to this rule, the penalty for unknown violations, where the covered entity did not know of the violation, and would not have known by exercising reasonable diligence, is now between $100 and $50,000. For violations involving reasonable cause, such as circumstances that would make it unreasonable to comply with HIPAA despite extraordinary care, the penalty is now between $1,000 and $50,000. For violations involving willful neglect, or a conscious, intentional failure or reckless indifference to the obligation to comply with HIPAA, the penalties are further broken down into whether or not the covered entity corrects the violation. If the violation is corrected within 30 days, the penalty is now between $10,000 and $50,000. If the penalty is not timely corrected, each violation will be fined $50,000. The rule also puts into place an annual cap of $1.5 million on all violations of an identical provision.
According to Georgina Verdugo, the director of OCR, the implementation of these tougher enforcement provisions strengthens HIPAA protections and rights related to protected health information, and should encourage covered entities, including health care providers and health plans, to “ensure that their compliance programs are designed to prevent, detect, and quickly correct violations of the HIPAA rules.… such heightened vigilance will give consumers greater confidence in the privacy and security of their health information and in the industry’s use of health information technology.”
The enactment of these tougher enforcement penalties create additional incentives to make sure that covered entities have HIPAA compliance programs in place, which should include training employees to be compliant and ensuring that they are aware of how important it is to report potential violations so that they can be corrected in a timely manner.
When taking into account the lack of enforcement that had occurred prior to the recent HIPAA amendments, the new provisions seem to be a necessary step in enforcing the law and preventing the misuse of protected health information. With more resources available to track down HIPAA violations, and steeper penalties exacted against entities that violate HIPPA, the new rule is a step in the right direction toward greater protection of protected information. With the rampant rise of identity theft in this electronic age, consumers can never be too careful in ensuring that information stays in the right hands.
As HHS, acknowledges, this Interim Final Rule is only the first of several steps being taken to implement the HITECH Act’s tougher enforcement provisions. The remaining provisions, which are not yet effective, will be addressed in the near future.
Risks to Directors and Trustees of Health Care & Life Sciences Companies: Corporate Compliance in a Distressed Economy
Filed under: Compliance, Health Policy Community
“Risks to Directors and Trustees of Health Care & Life Sciences Companies: Corporate Compliance in a Distressed Economy,” was sponsored by Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, Epstein Becker & Green P.C., and Navigant Consulting, Inc. The program urged profit and nonprofit health care organizations to prioritize effective corporate compliance programs, particularly in today’s economy.
Moderated by Professor Kathleen Boozang, the program featured keynote speaker Mark Anderson, the New Jersey Medicaid Inspector General, as well as presentations by Lynn Shapiro Snyder and Hervé Gouraige of Epstein Becker & Green P.C. and Sandra Piersol and Geoffrey Kaiser of Navigant Consulting, Inc.
The participants focused on the financial challenges and potential exposure for board members of health care and life sciences entities in maintaining an effective compliance program in order to minimize noncompliant behavior and corporate liability risks. Current trends in HHS Corporate Integrity Agreements (CIA’s) have shown a movement toward imposing personal liability on boards of directors for failure to ensure that a company has an effective corporate compliance program.
Inspector Anderson first addressed the 2007 statute governing the New Jersey Office of Medicaid Inspector General, focusing in particular on the statute’s broad definitions of “fraud” and “abuse,” which allows his office broad discretion. Asking the key question, “is your compliance compliant?”, he emphasized that effective compliance programs go beyond simple written policies and procedures, but are specific to the entity’s need to prevent fraud and abuse, and are supported at every level of management — with the tone set “at the top.” He concentrated on one specific element of compliance programs — self-disclosure of problems within one’s own organization — and stressed that self-disclosure is essential to compliance and is in the company’s best interest, as his office provides incentives to health care entities to self-disclose. These incentives include forgiveness or reduction of interest payments, waiver of penalties and/or sanctions, timely resolution of overpayment, and a decrease in likelihood of imposition of an OMIG Corporate Integrity Program.
Lynn Shapiro Snyder, Co-Chair of the Health Care Fraud Practice Group at Epstein Becker & Green, spoke about the looming threat of enforcement activities aimed at board members of health care and life sciences entities, and noted that, until recently, the risk has been reputational rather than legal. She highlighted the blurred line between governance and management obligations, and questioned whether boards need their own consultants to determine whether to sign off on a company’s compliance program. Later, suggesting a simple, cost-effective way to examine the effectiveness of a compliance program, she recommended that compliance officers file (and follow) a “dummy report” within their own organization, thereby bringing to light gaps and issues in the company’s program.
Sandra Piersol, a Director with the Healthcare Disputes and Investigators practice at Navigant Consulting, addressed how directors and trustees can determine whether they have an effective corporate compliance program. Discussing the seven elements of an effective compliance program, she emphasized ensuring that the compliance officer has direct access to the board of directors, setting the “tone at the top,” and the need for ongoing training and communication. She provided a list of structural and operational questions to be considered when examining whether an entity’s corporate compliance program is effective, and concluded with the recommendation that boards should request the performance of an objective and comprehensive review of the program activities performed by persons independent of the compliance program.
Hervé Gouraige, Co-Group Leader of the National Litigation Practice at Epstein Becker & Green, spoke about the risk to board members of personal liability for an ineffective compliance program. After an overview of the law as it relates to board oversight of compliance, Gouraige discussed the requirement that companies have a process established to address compliance risks within the organization. Second, he underscored that the process must be executed by the chief compliance officer and monitored by the board. Finally, he explained that the board must be involved in the selection of a chief compliance officer who is capable of, and willing to, stand up to the board. He stressed that the chief compliance officer should not also be the general counsel, due to the conflicting duties and obligations of those positions. He also suggested that there be a separate board committee — which includes the CEO, general counsel, and chief compliance officer — to monitor the compliance program. Annually, this committee should meet without the CEO and general counsel as well. Finally, Gouraige suggested that in order to learn about — and address — problems before a prosecutor does, compliance officers periodically spot check internal emails between employees.
Geoffrey Kaiser, Managing Director in the Healthcare Dispute, Compliance and Investigations Practice at Navigant Consulting, focused on the benefits of having an effective compliance program. He noted that, although it is difficult to quantify the harm avoided by any program, an effective program can reduce or mitigate the risk of violations, particularly through education, which is a cost-effective way to sensitize employees to risk. Second, having an effective voluntary information and reporting system allows a board of directors to introduce corrective measures proactively. Third, having an effective corporate compliance program in place can influence prosecutorial discretion. In addition, having an effective compliance program can reduce the severity of penalties facing an organization at sentencing — not only affecting the amount of the fine, but also the range in which the fine will be imposed.
Overall, each speaker highlighted the cost-effectiveness and benefits of devoting resources to an effective compliance program. Inspector Anderson, stating that the economic environment cannot dictate compliance policies, emphasized that cutting such programs is short-sighted and a future compliance violation could potentially decimate a company in the long run. Gouraige explained that it would be a terrible mistake to cut compliance, due to the “wisdom of the long-term investment.” The speakers, in a question and answer session moderated by Professor Boozang, addressed effective ways to increase board attention to corporate compliance, including focusing on corporate compliance as one of the many legal requirements required by boards and underscoring the investment — rather than the cost — of implementing an effective corporate compliance program. As attendee Eve Costopoulos of Merck aptly stated, “if you don’t pay today, you’ll pay tomorrow.”
All Photos by Sean Sime