With the holidays in full swing, many of us are reminded of our own good fortune, and our duty to help those around us who are in need. Toy drives, food drives, and massive community dinners provide opportunities to contribute time and money in the spirit of the season.
Once again this holiday season, MRC is proud to support the Houston-based Faulk Foundation, a charity focused on providing needed assistance to children and families of children who suffer from devastating illness, through an employee-organized toy drive.
But what of the rest of the year? As we know, needs don't vanish on January 1st. Oftentimes, people are ready and willing to help, but just need a little extra push.
In early 2011, a group of MRC employees came together to discuss employee volunteer and giving activities. Responding to a strong desire voiced by MRC staff to be more involved in the community and to find ways to give back, we quickly realized that there was a volunteer powerhouse just waiting for some centralized direction and coordination. Shortly thereafter, the MRC CARES initiative was founded.
Standing for "Community Awareness and Responsibility for an Engaged Society", MRC CARES promotes collaboration and accountability with each other and the communities we live in. Our employees work together through volunteerism and charitable giving to provide aid and enhance our communities.
Employees embraced the MRC CARES program with enthusiasm. Just weeks after launching the new initiative, multiple groups of employees coordinated to raise awareness via an AIDS walk, the Susan G. Komen Race for the Cure, half-day shifts at the Houston Food Bank, and a personal items collection for US military stationed in Afghanistan. Recently, additional Food Bank shifts and a blood drive have seen equally high levels of engagement. The program continues to gain momentum as employees report the positive experiences they've enjoyed giving back to their communities, inspiring others to participate. It is truly a win-win for all involved, and a reminder of how a small effort multiplied by hundreds can yield a result that is truly amazing.
We hope that by sharing our experience, other companies will be inspired to do the same. I know many of you already have your own programs in place. If you are inclined, we would love for you to share your own community giving success stories in the comments section below and include information about how others can get involved. Happy Holidays and may 2012 be a year of inspired service to our communities.
The following post was authored by Leslie Knasiak RN, BSN. Ms. Knasiak is currently a Legal Nurse Consultant for Medical Research Consultants following an extensive career in both hospital-based critical care and drug safety. She has served as a Team Lead for a group of Drug Safety Specialists and Medical Record Reviewers for a major pharmaceutical company, and has experience in Adverse Event reporting, review and processing for a Clinical Research Organization.
Drug safety reporting is more important today than ever before. Pharmaceutical companies are headed towards an all-time high in marketing new biologics and delivery systems, making the safety of human subjects during clinical trials a constant priority. In the push to market, what factors can best contribute to patient safety and reduce the risk of serious adverse events before or after a new drug or new drug application is trialed and sold?
For answers, it is worthwhile to consider the changes that have taken place in our healthcare system over the past 20 years, and the growing role of nurses in all aspects of that system. A greater percentage of nurses are graduating with Bachelor of Science degrees and the benefit of educational programs geared towards faster-paced, technology rich, consumer driven healthcare environments. With greater frequency and increasing complexity of patient interaction, nurses are established as a front line of care in hospital settings, and are taking on a greater role in driving the patient’s care experience.
As part of their education, clinical training, and professional philosophy, nurses are committed to improving patient experiences and outcomes. These principles see expression in the basic tasks of keeping a patient’s environment safe and clean, and extend to complex assessments, plan implementation, and outcome evaluation.
Nurses have mastered the ability to work in a high-tech world while maintaining the ability to communicate amongst varying groups of people in diverse conditions and under fluctuating degrees of time-pressure. This combination of professional attributes is good fit for the rigors of the drug safety world; whether in a call-center taking product complaints and eliciting the best information from the patients, during an active clinical trial, or in the post-marketing phase when the sponsor can also be “the patient”. Today’s nurses ably apply their skills to risk management and improving outcomes, supported by a broadened understanding of the burden of disease, the body’s normal and pathological response to drugs, and concurrent co-morbidities.
Drug safety reporting, to include elements such as Serious Adverse Events Narrative Writing, is best performed by those who are capable of understanding and achieving the best levels of communication, those who have the ability to multi-task, problem-solve, to take direction from others, and who possess a strong work ethic. Safety reporting requires the ability to adapt quickly to any given situation or project and to know what the important questions are. These qualities are ones that today’s professional nurse owns and more. In a pharmaceutical R&D environment where off-shoring safety monitoring and reporting activities has become more of a rule than an exception, it is worthwhile to question whether that approach yields the best outcomes, and whether US-based nurses might be part of a solution yielding better long-term positive results for both manufacturers and consumers.
The following post was authored by Rosemary Albert. Ms. Albert, BS, RN, CLNC, has over twenty years’ clinical research and pharmacovigilance management experience at some of the nation’s top pharmaceutical companies. In recent years, she has successfully combined her drug safety experience with legal nurse certification, working closely with legal counsel for the defense of products litigation cases. Currently, Rosemary is a member of the MRC legal nurse team supporting the writing of clinical narrative summaries and medical review of products liability cases for pharmaceutical clients.
In today’s saturated media environment of intensive direct-to-consumer marketing of pharmaceuticals, as well as aggressive plaintiff recruitment advertising for products liability claims, it behooves both consumers and legal counsel to understand the fundamentals of the drug approval process. An article published in the September 12, 2011 edition of the Archives of Internal Medicine adds fuel to the fire regarding FDA approvals, ongoing safety monitoring, and the public’s presumptions of drug safety in the post-approval phases.
The legal community offers litigation as a possible recourse should the risks of a drug outweigh the benefits post-approval and after widespread use in the post-marketing population. However, to what degree do legal counsel understand the internal workings of the drug development process? How does the legal process effectively function given the FDA’s governance within the current regulatory environment?
It is beneficial to start with the basics, a primer if you will of the drug development process. Fortunately, there are many resources available to legal counsel that will enhance their understanding of the issues at hand and provide them with the knowledge to help achieve a good outcome for their clients. For example, there are excellent courses offered by the Pharmaceutical Education & Research Institute (PERI) with faculty selected from experts in their field. Complete lists of courses are available at www.peri.org/courses. The Drug Information Association (DIA) offers a variety of drug safety courses that provide comprehensive knowledge of the drug safety process. In addition, DIA offers advanced courses which focus on the current challenges impacting drug safety (www.diahome.org).
For those desiring a succinct run-down of the drug approval process, I’ve compiled the following: Regulatory compliance first occurs in the medicinal chemistry laboratory when a new chemical entity (NCE) is created. With regulatory oversight ever-present, the manufacturer files an IND (investigational new drug application) with the FDA. The pre-approval process proceeds through animal testing and phases of testing (I-IV) in human subjects. At each phase of the drug development process, essential data is gathered to assess the safety and efficacy of an investigational drug for use by humans.
Once a firm foundation of knowledge and sufficient risk/benefit data is established through pre-approval phases, the process is finalized with product labeling. Product labeling provides crucial documentation that will be utilized by the health care community once the drug is approved and available to be prescribed to patients. Healthcare professionals consult the labeling as their “go-to” resource regarding approved indications, dosing, adverse events, and all other critical aspects of the product.
It is important to note that labeling undergoes frequent modifications and additions based on the post-marketing safety reports received from patients, health care providers, global authorities and legal channels. From a legal perspective, this labeling and the timeliness of its updates contains vital guidance as to how counsel may direct a case ‑ it is the linchpin with respect to assessing claims, and when investigation and litigation strategy indicate, awarding damages.
Equipped with a solid working knowledge of the drug development process and FDA regulations governing the safety profile and use of products, legal counsel can begin to navigate the regulatory rapids necessary for the successful resolution of pharmaceutical and medical device products liability claims.
Just a quick update to notify our readers of a recent distinction:
The Houston Business Journal recently named Medical Research Consultants as one of Houston’s top fastest-growing woman-owned businesses. Reported in the October 14-20, 2011 edition (available online by subscription only), this distinction was based on a review of revenue growth over 2009-2010.
MRC was ranked in the top 25 of a highly competitive field of successful woman-owned businesses. Of the listed companies, MRC employs the greatest number of Houston-based workers, especially relevant as the local economy continues its slow recovery from the recent recession.
We have our hard-working employees and our loyal clients to thank for this success. Thank you.
Released this week, the Fulbright & Jaworski Eighth Annual Litigation Trends Survey Report is a rich source of leading-edge opinion, litigation practice analysis, and predictions from some of the top corporate counsel in the United States and the United Kingdom. As a service provider dedicated to effectively supporting these same thought leaders, we look with interest to these findings each year.
This year, the report included a section specific to litigation affecting the health care industry. (Click here to access the registration page, required for report download).
From the survey sample of health care company senior corporate counsel (9% of the over 400 who responded), the following emerged:
- Expected increase in litigation spend over the next 12 months, with labor and employment litigation topping the list; followed by professional services, contracts, personal injury, and products liability. As for the types of disputes that are most concerning, responders listed regulatory, labor & employment, product liability, and professional services litigation.
- An increasing percentage of responders are spending greater than $1 million on litigation (56% of responders, dollar figures not including settlements and judgments), but the number spending greater than $10 million has significantly decreased (roughly 14% of responders in the current year, versus 29% in 2009).
- Alternative fee arrangements with outside counsel have continued to trend upwards, although these arrangements still comprise a minority percentage of total spend.
- Regulatory and government investigations requiring the retention of outside counsel continued at high rates and are projected to be ongoing concerns in 2012.
We took particular interest in item 2 as summarized above. It would appear based on this limited sample that a greater percentage of companies are in the position of requiring outside support for litigation matters, but that they are also becoming more efficient in containing litigation costs to stay under the $10 million mark. That certainly matches up with the trends we have witnessed in the management of centralized products liability litigation and other mass torts.
Some of the cost containment methods MRC has observed in our support of products liability litigation over the past 28 years: streamlined discovery based on the strategic selection and retrieval of key records; critical data extraction to quickly categorize plaintiffs; increased use of electronic discovery, records management, and other legal technology; preliminary selection and trial of bellwether plaintiffs; and increased movement towards settlements vs. the risk and expense associated with ongoing litigation. Add to this list an increase in the consolidation of outside counsel and service providers to exclusive, preferred networks, which frequently coincides with lower negotiated hourly rates and/or cost-saving alternative billing arrangements.
What other factors do you believe are driving these trends?
The following post was authored by Randy Haynes, MRC's subject matter expert in all things MMSEA-related.
This past Friday, September 30, on the eve of what would have been a key implementation date for MMSEA Section 111 reporting, Medicare issued a flurry of alerts. These include a revised timeline, guidance on a few specific topics, and some interesting clues to what could be substantial changes in the recovery process over the next year.
I have embedded links to the full alerts and will summarize the highlights of each in the folowing paragraphs.
The first alert includes a revised timetable for reporting liability settlements. Settlements with a TPOC Amount over $100,000 will proceed as scheduled, but reporting of TPOC amounts of $50,000 and over has been delayed until Q2 2012 and TPOCs of $25,000+ delayed until Q3 2012. This delay still doesn’t address some of the underlying problems prompting the latest delay, but at least ensures Medicare will not miss out on the largest of their potential recoveries.
The next alert provides some new guidance related to reporting requirements and Medicare’s interest in exposure cases impacted by the 1980 date. Medicare made clear that they have a recovery interest in cases where exposure is claimed on or after 12/5/1980. The alert does, however, offer a bit of a carve-out for cases where there is no exposure claimed past 12/5/1980 and a general release is used. In the past, these cases would have been potentially reportable if the release included a general release of claims as opposed to releasing only claims prior to 1980. This new language allows defendants to still use a general release for their clients without triggering a reporting obligation.
The final alert exempts settlement funds paid out of a Qualified Settlement Fund (QSF) from Section 111 reporting, so long as the funds were deposited into the trust prior to October 1, 2011. This will eliminate reporting for many previously funded inventory settlements where the QSF hasn’t yet paid out any settlement proceeds.
In addition, CMS also issued a memo regarding future medicals. This memorandum was actually posted on the COBC site, but referenced in the MMSEA alerts. It is the first piece of new guidance issued by Medicare regarding Liability Medical Set Aside Arrangements (LMSA) and may signal a renewed focus on the future medical issue. The memo states that when a treating physician completes a certification indicating that treatment is completed at the time of “settlement” that “there is no need for the beneficiary to submit the certification or proposed LMSA amount for review.” Does this mean there IS a requirement to submit a LMSA for review if no such certification exists? We will have to wait and see.
And to wrap everything up, a brief review of the “What’s New” page on the MMSEA site reveals even further updates. There are a number of features discussed, some of which are available now and others expected to roll-out over the next year. They include a new self-service phone line that will allow customers to get up to date conditional payment amounts. This combined with a proposed MSPRC portal will allow beneficiaries to get conditional payment and demand letters quicker, allowing for more efficient claim resolutions. There is also reference to a new process that will enable beneficiaries to obtain “conditional payment amounts” prior to settlement. I believe they meant to say “final demand letters” prior to settlement, as this is consistent with some of the measures addressed in H.R. 1063 currently before Congress.
Also featured is a new CMS program that would allow a fixed percentage of certain physical trauma liability cases with settlement amounts of under $5,000. This will definitely be of interest to property casualty insurers since a majority of their settlements fall into this category.
One final issue concerns “the implementation of an option that allows for an immediate payment to Medicare for future medical costs that are claimed/released/effectively released in a settlement”. This, combined with the COBC memo, causes me to suspect CMS is in the process of creating some guidance around Liability Medicare Set Asides. They have now established carve-outs for those cases where the treating physician testifies that there is not future medical, and included in this alert, provided an option for paying future medical immediately.
Despite this most recent delay, I believe Medicare is responding to industry concerns and making an effort to proactively tackle some of the issues addressed in HR 1063. The idea of a fixed percentage interest on small cases and an option to pre-pay future expenses will have a big impact on entities with a high volume of low dollar amount settlements. History tells us that the timelines presented may be overly optimistic, but at least they are trying to create a process where settlements can be resolved in a more efficient and timely manner.
MRC, a woman-owned business since its founding, was recently awarded renewed certification by the WBEA, a regional affiliate of the Women’s Business Enterprise National Council, the primary certifying agency for women-owned businesses in the United States.
For all of the efforts dedicated to increasing diversity in the legal industry and elsewhere in the professional ranks, it remains an ongoing challenge. A recent article in the National Law Journal summarized some recent findings by the Institute for Inclusion in the Legal Profession, which demonstrate that women and minorities still have a ways to go to reach full equality.
Diversity goals persist not only within law firms, but also inside the corporate procurement departments tasked with selecting outside legal counsel and increasingly, legal support service providers. Corporate RFPs frequently request documentation of the diversity status of their suppliers, and want assurances of “downstream” diversity commitments, whereby the vendors they engage are themselves dedicated to supporting diversity through their own purchasing power.
While MRC takes pride in our diversity status and we are grateful for the doors it has opened, we also understand the importance of supporting other women- and minority-focused professional organizations and utilizing diverse businesses and downstream vendors whenever possible. To make progress towards greater inclusion, those who have achieved success must remember to look back and take the hand of those coming up behind them.
What steps has your organization taken to increase diversity within your business, or to utilize diverse suppliers?
When receiving a new personal injury/products liability case, how does your organization handle the summary and analysis of medical records? If you are a non-medical professional faced with this task, you may feel somewhat challenged. The sheer volume of records inherent in personal injury litigation combined with specialized medical terminology and abbreviations make it difficult for a layperson to sort out key data, essential vs. non-essential records, whether a treatment met standards of care, etc. And with a client’s case on the line, you are aware of the importance of effectively extracting, analyzing, and communicating the information contained within medical records.
MRC has specialized in the collection, review, summarization, and analysis of medical records for nearly 30 years, for small personal injury practices on up to AmLaw 200 firms. We would love to be your first call when you are faced with the need for a medical records summary and chronology, medical record analysis, or Triage review. However, we understand it isn’t always possible to outsource for any number of reasons. In that case, you should still give your firm and your clients the advantage of some of the same information sources consulted by the “pros”. Here are a few resources we recommend:
- Drugs.com: www.drugs.com. A useful site for researching pharmaceuticals, including manufacturers, dosages, indications, alerts/warning labels, etc.
- Medicinenet.com: www.medterms.com. A searchable reference site for medical terminology.
- PubMed: www.ncbi.nlm.nih.gov/pubmed. Sponsored by the National Institutes of Health, PubMed is the go-to site for online medical literature research. This searchable database includes 21 million citations and associated abstracts. Some articles are freely available online, while others require a per-article fee, subscription or library research to obtain/view the complete article.
Interested in learning more?
There has been some buzz lately about the sorry state of law firm data security. According to industry experts, firms are not allocating sufficient budget or staffing resources to ensure internal policies and data storage are in alignment with standard security protocols. The FBI reports that hackers have gotten wise to this fact and have started targeting law firms, even assigning their “rookie” hacker squads to the task due to the ease of overcoming law firm security barriers. Apart from the financial risk of being duped by counterfeit check and other confidence schemes, law firms risk exposure of vulnerable data including such sensitive and marketable information as client social security numbers, bank account numbers, medical records, internal memos, and other highly confidential materials.
The dire consequences of a confidential data breach to a law firm and their clients demand a solution, preferably one that is quick, intuitive, and inexpensive to deploy. MRC has been a proponent of cloud solutions for some time, as evidenced by past blog entries and our active participation in industry forums such as DreamForce. Storing and managing information in the cloud (as MRC does using a highly customized SalesForce platform) has distinct advantages over traditional solutions, including scalability, world-class security, seamless upgrades, and user profile-based, online access to documents regardless of whether you are logging in from your office, at home, or on the road.
Cloud-based solutions are steadily gaining traction within the legal community. What solutions has your firm put into place to ensure your electronically stored information remains secure? Are cloud solutions on your radar, or are you waiting to take the plunge?
Here at Medical Research Consultants (MRC), a substantial part of what we do involves, you guessed it, research. And much of that research is related to our record retrieval activities, including state and local statutes, authorization and subpoena requirements, and provider/custodian confirmation. Although there are a number of subscription or pay as you go databases which we employ (LexisNexis/Courtlink and Pacer are prime examples), we have also found tremendous value in some online resources that are available for no charge.
MRC's Records Management Project Managers were kind enough to share some favorite websites:
Justia: Among the rich offerings on this site are state and federal codes, forms, and filings, as well as a growing number of freely available case documents
http://www.justia.com/
A handy list of state statute limits on medical records copying charges:
http://www.lamblawoffice.com/medical-records-copying-charges.html
A directory of registered agents:
http://www.residentagentinfo.com/
Directory of Secretary of State Offices
www.E-secretaryofstate.com
Federation of State Medical Boards (FSMB)
www.fsmb.org
Judicial Panel on Multi-District Litigation
http://www.jpml.uscourts.gov/
Newly added 9/21/2011:
MRC's Forms and Resources page, which includes downloadable facility-specific authorizations.
http://www.mrchouston.com/common-forms/
Are there other sites you find useful? Please use the comments section to add to this list.
