New Draft Guidance on Use of Electronic Health Record Data in Clinical Investigations Announced By FDA

10 Indest-2008-7By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On May 17, 2016, the United States Food and Drug Administration (FDA) published a draft guidance titled “Use of Electronic Health Record Data in Clinical Investigations” (Draft Guidance) which emphasizes interoperability and outlines other best practices for effectively using EHR data in FDA-regulated studies. The newly published Draft Guidance is intended to assist sponsors, clinical investigators, contract research organizations (CROs), institutional review boards, and other interested parties on the use of EHR data in FDA-regulated clinical investigations.

Click here to read the Draft Guidance in full.

Overview of New Draft Guidance.

According to the FDA, the Draft Guidance is the next step towards modernizing and streamlining clinical investigations. Specifically, FDA’s goals are to facilitate the use of EHR data in clinical investigations and promote the interoperability of EHRs and electronic systems supporting clinical investigations.

Additionally, the recommendations outlined in the Draft Guidance apply to prospective clinical investigations of human drugs and biological products, medical devices, and combination products. The recommendations apply to foreign clinical studies not conducted under an investigational new drug (IND) application or an investigational device exemption (IDE) that are submitted to FDA in support of an application for the marketing approval of a medical product.

When the Draft Guidance Does Not Apply.

The Draft Guidance does not apply to the use of EHR data in postmarketing observational pharmacoepidemiologic studies designed to assess the risk associated with a drug exposure or designed to test pre-specified hypotheses for such studies; and when used as a recruitment tool for clinical investigations.

Advantages of EHRs.

The use of EHRs in the health care industry can be very beneficial when appropriate guidelines are implemented and followed. As stated in the FDA’s Draft Guidance, “With the widespread use of EHRs, there are opportunities to improve patient safety, data accuracy, and clinical trial efficiency when data from these systems are used in clinical investigations.  EHRs may enable clinical investigators and study personnel to more easily combine, aggregate, and analyze data from many different sources (e.g., clinical notes; physician orders; and radiology, laboratory and pharmacy records).  EHRs may have the potential to provide clinical investigators and study personnel access to real-time and longitudinal health care data for review and can facilitate post-trial follow-up on patients to assess long-term safety and efficacy of medical products.  There are also opportunities for long-term follow-up of large numbers of patients in studies where primary endpoints are rare, such as in prophylaxis studies.”

The FDA has recommended several best practices to help ensure the accuracy and integrity of data collected in clinical studies when employing a system that integrates data from EHRs and electronic data capture systems. Click here to read the recommendations. (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM501068.pdf)

To learn more about the importance of EHRs, click here to read one of my prior blogs.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents physicians, pharmacists, pharmacies, optometrists, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, NPDB actions, inspections and audits involving the Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), Department of Health (DOH) and other law enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Source:

“New FDA Draft Guidance on Use of Electronic Health Record Data in Clinical Investigations.” The National Law Review. (May 27, 2016). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: Food and Drug Administration (FDA) defense attorney, use of electronic health record data in clinical investigations, electronic health records (EHR), clinical investigations attorney, misconduct in science defense attorney, legal representation for health professionals, medical research misconduct defense lawyer, investigation review board (IRB) attorney, clinical investigation fraud defense counsel, fraud in clinical research, health law defense attorney, heath law, The Health Law Firm

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 2016 The Health Law Firm. All rights reserved

AHA Medicare Backlog Lawsuit Back on Track as D.C. Circuit Reverses Dismissal

00011_RT8By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
On February 9, 2016, the D.C. Circuit ordered the U.S. District Court for the District of Columbia to reconsider a lawsuit seeking to compel the Department of Health and Human Services (HHS) to meet statutory deadlines for reviewing Medicare claims denials. This order overturns the district court’s December 2014 decision in the American Hospital Association’s (AHA) lawsuit. The district court had decided that judicial intervention was not appropriate in such Medicare administrative cases. The AHA and three hospitals that derive a substantial chunk of their revenue from Medicare, filed the suit seeking relief for Medicare’s failure to provide timely reviews.

More detailed information on the initial lawsuit can be viewed here.

The original complaint (suit) can be viewed here.

To read the lower court’s decision to throw out the lawsuit in 2014, click here.

Medicare Appeals Backlog.

For more than a year, the AHA and three hospitals have been seeking relief for the delays in Medicare appeals and the lack of anything approaching a timely review of Medicare claims denials. They claim that this has detrimental effects to the Plaintiffs, such as their having to cut jobs (because of the delayed income) and postponements of the purchase of new equipment. According to the lawsuit, “lengthy, systematic delays in the Medicare appeals process, which far exceed statutory time frames, are causing severe harm to providers of Medicare services, like the Plaintiff hospitals.”

The AHA addressed this plight in having to wait well-beyond the 90-day statutory time frame to have their claim denials heard by an Administrative Law Judge (ALJ). The circuit court agreed that the increasing backlog of Medicare claims was out of hand as the number of appeals before waiting for an ALJ hearing has doubled since 2009 and is still growing. In 2013, the Office of Medicare Hearings and Appeals (OMHA) made a decision to suspend new requests for ALJ hearings (the third level of appeal) for at least two years, as a result of the increasing size of the Medicare appeals backlog.

For example, HHS can process about 72,000 appeals a year, but it received 400,000 in 2013. By 2014, the backlog had accumulated to 800,000 and some claims could take a decade to process, the court said!

The Balance Between RAC and Statutory Guidelines.

The court of appeal recognized that HHS is facing a tough decision; Implementing the Medicare Recovery Audit Contractor (RAC) program, which has been credited with increasing the workload for OMHA, and meeting the 90-day statutory time frame for Medicare appeals. The appellate court also acknowledged the benefits of the audit process, which has recovered billions of dollars in fraudulent or improperly billed payments. However, the focus weighed more heavily on HHS and budgetary constraints. The court stated that increasing funding for HHS to increase resources would alleviate the Medicare appeals backlog.

Statutory Time Frames Are Mandatory.

The appeals court agreed with AHA that the statutory time frames are mandatory, and that the statute does impose a clear duty for HHS to comply with deadlines and time frames. “Federal agencies must obey the law, and congressionally imposed mandates and prohibitions trump discretionary decisions,” stated the appeals court.

To read the opinion for the court filed by the judge, click here.

The AHA said in a statement that it expects the lower court to rule in its favor and resolve the backlog. “The appeals court affirmed that hospitals can’t afford to have billions of dollars that are needed for patient care, tied up in the appeals process. The decision also affirms that the agency has a clear duty to comply with the congressionally mandated deadlines and that the statute gives hospitals a corresponding right to demand compliance. It refutes attempts by the agency to excuse compliance because of the Recovery Audit Contractor (RAC) program, noting that congressional mandates trump discretionary decisions,” the AHA said in a statement.

To read AHA’s press release, click here.

Justice Delayed is Justice Denied.

There is a legal maxim that goes back to ancient Roman days that is still true today. It is “Justice delayed is justice denied.” It is still embodied in numerous laws and court decisions today. This is why criminal defendants must be tried within a certain period of time (“speedy trial”) and why there are statutes of limitations.

The last time we requested an ALJ administrative hearing in a Medicare appeal for a client, we were told that it would be at least 27 months (!) before a hearing would be scheduled. This is an absurd situation and definitely denies justice to those who are trying to keep health care businesses operating. It would seem than Congress would be taking a more active role in providing resources for additional ALJs and their staffs and mandating strict guidelines under which the appealed claims must be paid, if the hearing is not conducted within the time set by law. This is the only way to provide fairness and due process of law to Medicare providers. Businesses within their districts are closing and voters within their districts are losing their jobs because of their inaction and failure to allocate proper resources.

Contact Health Law Attorneys Experienced in Handling Medicare Audits, Investigations and other Legal Proceedings.

The Health Law Firm’s attorneys routinely represent physicians, dentists, orthodontists, medical groups, clinics, pharmacies, assisted living facilities (AFLs), home health care agencies, nursing homes, group homes and other healthcare providers in Medicaid and Medicare investigations, audits and recovery actions.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sources:

Kass, Dani. “DC Circ. Orders Court to Take on Medicare Appeals Backlog.” Law360. (February 9, 2016). Web.

“D.C. Circuit Reverses Dismissal of Challenge to Medicare Appeals.” AHLA. (February 9, 2016). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawfirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone; (407) 331-6620.

KeyWords: Medicare appeals attorney, Medicare claims appeals, Medicare ALJ hearings, formal Medicare hearing legal counsel, Medicare appeals lawyer, statutory timeframes, federal Administrative Law Judge (ALJ) hearing attorney, Office of Medicare Hearings and Appeals (OMHA) counsel, Medicare Recovery Audit Contractor (RAC) defense attorney, Medicare appeals backlog, Medicare claims denials attorney, Medicare defense attorney, Medicare appeals lawyer, health care legal counsel, Medicare audit attorney, Medicare investigation legal representation, fraudulent Medicare payments, health law attorney, Florida health law attorney, The Health Law Firm

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 2016 The Health Law Firm. All rights reserved.

California Attorney Ordered By Court To Pay Donation to Women Lawyers’ Professional Group As Sanction For Sexist Comments

10 Indest-2008-7By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health

A medical group defense attorney in California, Peter Bertling, was ordered on Tuesday, January 12, 2016, by U.S. Magistrate Judge Paul S. Grewal, to pay a $250 donation to the Women Lawyers’ Association. The ruling was in response to a sexist comment made by Bertling to opposing counsel, Lori Rifkin, during a heated deposition.

Additionally, Judge Grewal sanctioned Bertling’s clients, California Forensic Medical Group and Dr. Taylor Fithian, ordering them to pay attorneys’ fees and costs for certain depositions and the motion for sanctions.

Rifkin was representing the family of a 20-year-old man, Joshua Claypole, who hanged himself in a California prison. For more on the Claypole case and to view the complaint, click here. Rifkin stated she was insisting Bertling stop interrupting her during the deposition before his sordid comment. Bertling claimed Rifkin was “literally yelling” during the deposition before he remarked, “Don’t raise your voice at me… it’s not becoming of a woman.”

Although Bertling stated in his declaration in opposition to the motion for sanctions that he was sorry if he offended plaintiff’s counsel, Judge Grewal did not find his apology to be genuine,calling it a “halfhearted politician’s apology.”

Bertling is a “Repeat Offender.”

This is not the first time Judge Grewal had witnessed unbecoming behavior by Bertling during the wrongful death case. Judge Grewal’s order addressed a pattern of “bad” behavior by Bertling during the discovery process of the case. One example cited is from a previous deposition where Bertling was expected to produce documents used to create the expert’s report. Instead, Bertling provided the plaintiff’s with a defective disc that was unable to be used. Six months down the road, Bertling was still in noncompliance with the production of the requested documents.

Judge Grewal noted that Bertling was well-known for his crass behavior during depositions. During one such prior deposition, he made lengthy objections, interrupted answers from the witness being deposed and even proffered his own answers for the witness. Furthermore, Bertling failed to render any defense for his ill-fitting conduct.

Judge Grewal asserted that Bertling’s persistent behavior had “crossed well into sanctionable territory.” He said that while one could simply view Bertling’s actions as fervently defending his client, he “stooped to an indefensible attack” with his comment to Rifkin. To read the entirety of the order issued by Judge Grewal, click here.

Integrity in the Legal Process is a Must.

The Florida Bar has created a set of rules of professional conduct expected of all lawyers.
Chapter 4 of the Florida Bar rules, in the “Preamble: A Lawyer’s Responsibilities,” states inpart, “In all professional functions a lawyer should be competent, prompt, and diligent.” It further states, “A lawyer should use the law’s procedures only for legitimate purposes and not to harass or intimidate others. A lawyer should demonstrate respect for the legal system and for those who serve it, including judges, other lawyers, and public officials… it is also a lawyer’s duty to uphold the legal process.”

As far as zealously defending clients, the preamble further states, “A lawyer’s responsibilities as a representative of clients, an officer of the legal system, and a public citizen are usually harmonious. Zealous advocacy is not inconsistent with justice.”
The rules state, “Failure to comply with an obligation or prohibition imposed by a rule is a basis for invoking the disciplinary process… the rules presuppose that whether discipline should be imposed for a violation, and the severity of a sanction, depend on all the circumstances…”

To read chapter 4 of the Florida Bar rules in its entirety, click here.

In this particular circumstance, Judge Grewal said, “There are several obvious problems with his statement, but, most saliently, Bertling endorsed the stereotype that women are subject to a different standard of behavior than their fellow attorneys.”
Rifkin commented, “If we are going to rely on federal courts to dole out justice, then they have to be places that vigorously ensure integrity in the judicial process. Judge Grewal’s order recognizes that.”

Comments?

Do you believe the sanctions imposed on Attorney Bertling were fair? Do you have certain
expectations of attorneys when looking to retain legal representation? Is an attorney’s
behavior/conduct/demeanor most important to you when searching for legal counsel? Have you ever had a bad experience with a past attorney? Please leave any thoughtful comments
below.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals
and Providers.

At the Health Law Firm we provide legal services for all health care providers and
professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, Durable Medical Equipment suppliers, medical students and interns, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other health care provider. We represent facilities, individuals, groups and institutions in contracts, sales, mergers and acquisitions.

The lawyers of The Health Law Firm are experienced in both formal and informal
administrative hearings and in representing physicians in investigations and at Board of
Medicine and Board of Osteopathic Medicine hearings. We represent physicians accused of wrongdoing, in patient complaints and in Department of Health investigations.
To contact The Health Law Firm, please call (407) 331-6620 and visit our website at
www.ThehealthLawFirm.com.

Sources:

Greene, Kat. “Calif. Atty Sanctioned For Sexist Deposition Comment.” Law360. Portfolio
Media Inc.: 13 Jan. 2016. Web. 21 Jan. 2016.

“Chapter 4. Rules of Professional Conduct. Preamble: A Lawyer’s Responsibilities.” The
Florida Bar: 4 Dec. 2015. Web. 21 Jan. 2016.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The
Florida Bar in Health Law. He is the President and Managing Partner of The Health Law
Firm, which has a national practice. Its main office is in the Orlando, Florida area.
www.TheHealthLawfirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone; (407) 331-6620.

KeyWords: Florida health attorney, health law attorney, Florida health lawyer, The Health
Law Firm, health law defense lawyer, health professional attorney, Florida Bar Rules of
Professional Conduct, attorney expectations, attorney behavior, sanctions imposed for attorney misconduct, integrity in the legal process, attorneys’ duty to uphold legal process, legal representation for depositions, medical group defense attorney, lawyer responsibilities


The Health Law Firm will soon be transitioning all blogs to the website. Please visit www.TheHealthLawFirm.com, to continue reading our blogs. Be sure to check back regularly as we update our blogs often.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2016 The Health Law Firm. All rights reserved.

758 Hospitals to Get Less in Medicare Payments in 2016 Due to High Rates of Patient Safety Incidents: Florida Hospital Among Them

00011_RT8By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Medicare will be lowering its payments by one percent in 2016 to 758 hospitals nationwide with high rates of potentially avoidable patient safety incidents.  The penalties are based on an assessment of the frequency of several types of infections, sepsis, hip fractures and other complications.  It is estimated that such penalties will cost hospitals $364 million in the new federal fiscal year, which runs through September 2016.

Over half of the penalized hospitals are repeat offenders from last year.  Among those that will be penalized for the first year since the creation of the 2010 health law, are big names such as Stanford Health Care in Northern California and two satellite hospitals run by the Mayo Clinic Health System in Minnesota.  Florida Hospital in Orlando made the “naughty list” as well.

For a full list of the penalized hospitals, click here.

Incentive to Reduce Hospital-Acquired Conditions.

Section 3008 of the Patient Protection and Affordable Care Act (ACA) established the Hospital-Acquired Condition (HAC) Reduction Program.  In October 2014, the Department of Health and Human Services (HHS) began adjusting payments to hospitals ranking in the worst-performing quartile with respect to risk-adjusted HAC quality measures as an incentive for hospitals to reduce HACs.

The second round of the HAC Reduction Program was based on HHS’s assessment of the frequency of infections in patients with central lines inserted into veins, urinary catheters and incisions from colon surgeries and hysterectomies.  While such infections comprise 75 percent of Medicare’s evaluations, the remaining evaluations are based on other complications including surgical tears, collapsed lungs, broken hips and reopened wounds.  Most of these complications were included in last year’s assessment as well, excluding colon operations and hysterectomies which were just added this year.

Congress has exempted veterans’ hospitals, children’s hospitals and “critical access” hospitals from receiving penalties since they are normally considered the sole providers in each of their respective locations.

Medicare has released numbers that show overall hospital performance for two of the three measures evaluated has improved.

Health Care Incentives Misaligned: Is the HAC Reduction Program Counterproductive?

Much contention surrounds the program initiated by the 2010 health law which has implemented the toughest sanctions ever imposed by Medicare regarding hospital safety.  Some hospitals contend that the penalties are counterproductive and unfairly doled out on those attempting to make improvements.  It is argued that further penalizing such hospitals by stripping them of additional funding just makes it that much harder for the facilities to provide better quality care.

Furthermore, it is noted that the majority of Medicare pay-outs rely upon the frequency and complexity of services provided.  Variations in such factors are currently not considered in the government assessments.  Therefore, it is asserted that hospitals dealing with sicker patients who are more prone to infections may be singled out as sub par health care facilities and unjustly penalized for taking on more complicated (and accordingly more lucrative) patient cases.

According to Harvard researcher, Dr. Ashish Jha, the current evaluation measures miss the mark.  Dr. Jha stated, “Ultimately unless we get to clinically based, validated measures of patient safety, we’re not going to be able to move the needle.”

Comments?

What are your thoughts on the HAC Reduction Program?  Do you believe it is effective or counterproductive in providing patients with better quality care?

Consult with a Health Law Attorney Experienced in Medicare and Medicaid Issues.

The attorneys of The Health Law Firm represent health care providers in Medicare audits, ZPIC audits and RAC audits throughout Florida and across the U.S. They also represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions and termination from the Medicare or Medicaid Program.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620.

Sources:

Rau, Jordan.  “Medicare Penalizes 758 Hospitals for Safety Incidents.”  Kaiser Health News.  Kaiser Family Foundation: 10 Dec. 2015.  Web.  18 Dec. 2015.

“Hospital-Acquired Condition (HAC) Reduction Program.”  CMS.gov.  Centers for Medicare and Medicaid: 10 Dec. 2015.  Web.  18 Dec. 2015.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida area.  www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

Keywords: Florida health attorney, patient safety, health law attorney, Florida health lawyer, The Health Law Firm, health professional attorney, Centers for Medicare and Medicaid Services (CMS), Patient Protection and Affordable Care Act (ACA), Hospital-Acquired Condition (HAC) Reduction Program, Medicare penalties, legal representation for hospitals, HAC quality measures, Medicare attorney, Medicare defense lawyer

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 1996-2015 The Health Law Firm. All rights reserved.

New Board of Medicine Rule on Disposition of Medical Records Upon Death of Physician

IndestBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Rule 64B8-10.001, Florida Administrative Code, was recently updated by the Florida Board of Medicine for the Department of Health (DOH).  The final adopted rule was implemented on November 11, 2015.  This latest version of the rule entitled, “Medical Records of Deceased Physician; Retention, Time Limitations,” adds a mandate to section (1) stipulating additional measures to be taken to ensure access in an evolving practice that now includes electronic medical files.

New Requirement for Retention and Access of Electronically Stored Medical Records.

The new wording states: “Physicians must take proactive measures to ensure that their executor, administrator, personal representative or survivor have access to both paper and electronic medical records.  Such access must include passwords for medical records maintained in an electronic format.”  This new requirement ensures retention and access of all patient medical files (both paper and electronic format) throughout the two year time period from the date of the physician’s death.  To read the entirety of the updated rule adopted by the FAC, click here.

The Rise of Health Information Technology.

This new wording to the existing rule in the FAC is just another indicator as to the rise of technology in health care.  The law will need to remain congruent with the modern practice of medicine as more hospitals and physicians utilize technological devices in the workplace to access electronically maintained patient medical records.  This is just one of the many ways in which health information technology has impacted the law and necessitated a revision to existing rules.

For more information on health information technology access the toolkit created by the Alliance for Health Reform here.

Consulting with an experienced health attorney can assist you and your medical practice in ensuring compliance with the law and remaining up-to-date on any relevant legal changes or issues in health care, including regulations as to electronically stored information.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

At the Health Law Firm we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, Durable Medical Equipment suppliers, medical students and interns, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other health care provider. We represent facilities, individuals, groups and institutions in contracts, sales, mergers and acquisitions.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians in investigations and at Board of Medicine and Board of Osteopathic Medicine hearings. We represent physicians accused of wrongdoing, in patient complaints and in Department of Health investigations.

To contact The Health Law Firm, please call (407) 331-6620 and visit our website at www.TheHealthLawFirm.com.

Sources:

Rule 64B8-10.001, Florida Administrative Code.

Takvorian, Sam.  “A Reporter’s Toolkit: Health Information Technology.”  Alliance for Health Reform.  Web.  25 Nov. 2015.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida area.  www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

Keywords: Florida health attorney, patient medical records, health law attorney, Florida health lawyer, deceased physician, The Health Law Firm, health law defense lawyer, access to patient records, Florida Board of Medicine rules, Florida Administrative Code (FAC), patient records review, health professional attorney, health law, health information technology, medical records of deceased physician, FAC compliance, electronically maintained patient files, Department of Health (DOH) rule revisions, physician attorney, executor of physician estate

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2015 The Health Law Firm. All rights reserved.

Five Defendants Admit Guilt in $580 Million Referral Billing Scheme; Investigation Continues in “Operation Spinal Cap”: This Is Not Spinal Tap

Patricia's Photos 013By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Federal prosecutors filed two cases on November 24, 2015, and a federal judge unsealed three others, all in correlation to the same fraudulent health care scheme.  The former Chief Financial Officer (CFO), two orthopedic surgeons, a chiropractor and a health care marketer of (or affiliated with) Pacific Hospital (“Pacific”) in Long Beach, California, pled guilty or have agreed to plead guilty in a nearly $600 million health care fraud scheme that spanned over an eight year period.  The defendants were each charged with their specific involvement in the illegal referring of thousands of patients for spinal surgeries resulting in $580 million in fraudulent billings.

All five of the defendants have agreed to cooperate in the ongoing investigation, otherwise termed “Operation Spinal Cap.”  According to federal prosecutors, dozens of other surgeons, orthopedic specialists, chiropractors, marketers and other medical professionals are alleged to be involved in the illegal kickback schemes.

To read another news story about costly referral fraud in which approximately three dozen health care professionals pleaded guilty, click here.

The government operation should not be confused with the 1980’s documentary or “mockumentary” about a fake metal band, titled, “This Is Spinal Tap.”  For 15 things you didn’t know about Spinal Tap, click here.

A Long-Running Kickback Scheme.

Former Chief Executive Officer (CEO) and owner of Pacific, Michael D. Drobot, had previously pled guilty in April 2014, to his involvement in the scheme.  His 15-year-long ruse ended in late 2013.  His participation in the ploy included billing workers’ compensation insurers and the U.S. Department of Labor for spinal surgeries and other procedures performed on patients who had been referred by various doctors and other medical professionals in exchange for the receipt of illegal kickbacks.

The running price of a typical kickback paid by the conspirators was $15,000 for a lumbar fusion surgery and $10,000 for a cervical fusion surgery.  Many patients traveling in excess of a hundred miles for surgery were unaware of the existence of much closer qualified medical facilities.

Former CFO, James L. Canedo, pled guilty on September 4, 2015.  His guilty plea addressed charges of his participation in a conspiracy involving mail fraud, honest services fraud, money laundering, paying or receiving kickbacks in connection with a federal health care program and violating the Travel Act, or more specifically, interstate travel in aid of a racketeering enterprise.

The other defendants pled guilty to similar charges.  Chiropractor, Alan Ivar, also admitted to an agreement with the hospital’s owner to accept a monthly retainer in exchange for referring patients.  Orthopedic surgeon, Mitchell Cohen, agreed to admit guilt to filing a false tax return by failing to report income received by way of illegal kickbacks.  Paul Richard Randall, a health care marketer, pled guilty in April 2012 to facilitating the kickback scheme at Pacific by introducing physicians to Drobot and coordinating the kickback arrangements.  He also admitted to his involvement in a similar scheme with Tri-City Regional Medical Center (“Tri-City”).

To read the full press release by the Department of Justice (DOJ), click here.

All Five Defendants Are Facing Prison Time.

Orthopedic surgeon, Philip Sobol, is facing up to a decade in prison for his involvement in the scheme.  Canedo, Ivar and Randall are facing up to five years, and Cohen is facing up to three years behind bars.  Each defendant will also be responsible for paying millions of dollars in restitution.  As a part of their plea agreements, each defendant will cooperate with the government’s ongoing investigation.

California Insurance Commissioner, Dave Jones, said of the scheme, “Injured workers were treated like livestock…”  U.S. Attorney, Eileen M. Decker, said something similar in a statement: “The members of this scheme treated injured workers and their spines as commodities, to be traded away to the highest bidder.  This investigation should send a message to the entire industry: patients are not for sale.”

To read one of our previous blog posts on compliance with anti-fraud laws, click here.

Comments?

Have you ever been suspected of receiving or promising illegal kickbacks for patient referrals?

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, pain management doctors, dentists, pharmacists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at http://www.TheHealthLawFirm.com.

Sources:

Department of Justice, Office of Public Affairs.  “Five Individuals, Including Two Doctors, Charged in Kickback Schemes Involving Nearly $600 Million in Fraudulent Claims by Southern California Hospitals.”  Press Release.  Justice News: 24 Nov. 2015.  Web.  24 Nov. 2015.

Kass, Dani.  “Ex-Hospital CFO, Docs Guilty in $580M Referral Billing Scheme.”  Law360.  Portfolio Media Inc.: 24 Nov. 2015.  Web.  24 Nov. 2015.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida area.  http://www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

Keywords: Florida health attorney, racketeering defense lawyer, health law attorney, Florida health lawyer, The Health Law Firm, health law defense lawyer, health professional attorney, health care litigation attorney, health care fraud attorney, health care professional defense lawyer, conspiracy to commit health care fraud, false claims attorney, government health care programs, kickback schemes, physician referrals, illegal kickbacks, worker’s compensation system attorney, plea agreements in health care fraud, Operation Spinal Cap, Travel Act, fraudulent claims attorney

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2015 The Health Law Firm. All rights reserved.

HIPAA Basics For Licensed Health Care Professionals: Privacy, Security, and Breach Notification Rules

4 Indest-2009-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Department of Health and Human Services (HHS) recently issued a Health Insurance Portability and Accountability Act (HIPAA) fact sheet for health care professionals and organizations. The overview is titled “HIPAA Basics for Providers: Privacy, Security and Breach Notification Rules” and is intended to provide HIPAA covered entities such as physicians, health care facilities and other licenced health care professionals with a basic overview of HIPAA’s rules and responsibilities. Click here to view the HIPAA fact sheet.

HIPAA Privacy Rule.

The privacy rule is established as a standard for the protection of protected health information (PHI) by covered entities. It gives patients vital rights with respect to their health information. The following is protected information under this rule:

1. The individual’s past, present or future physical or mental health or condition;

2. The provision of health care to the individual; or

3. The past, present or future payment for the provision of health care to the individual.

PHI also includes common identifiers, such as name, address, birth date and Social Security Number.

HIPAA Security Rule.

This rule specifies safeguards that covered entities are required to implement to protect the confidentiality, integrity and availability of health information. To properly enforce this rule, covered entities must develop policies and procedures to protect the security of electronic protected health information (ePHI). This includes analyzing risks and creating solutions that are appropriate for the situation. For more information from HHS on the implementation of the security standards, click here.

HIPAA Breach Notification Rule.

Affected individuals, HHS and in certain cases, the media are required to be notified of a breach of PHI. The rule includes the following guidelines:

1. Most notifications must be provided without unreasonable delay and no later than 60 days following the discovery of the breach.

2. Smaller breaches affecting fewer than 500 individuals may be submitted to HHS in a log or other documentation annually.

3. Business associates of covered entities are also required to notify the covered entity of breaches.

To view the breach notification timelines included in the HIPAA fact sheet, click here.

Who is Required to Comply With HIPAA Rules?

The following covered entities must follow HIPAA standards and requirements:

1. Covered Health Care Providers: Any provider of medical or other health care services or supplies who transmits any health information in electronic form in connection with a transaction for which HHS has adopted a standard. This includes doctors, chiropractors, dentists, pharmacies, psychologists, clinics and nursing homes.

2. Health Plans: Any individual or group plan that provides or pays the cost of health care. This includes company health plans, government programs for health care such as Medicaid and Medicare, along with the military and health insurance companies.

3. Health Care Clearinghouses: A public or private entity that processes another entity’s health care transactions from a standard format to a non-standard format or vice versa. This includes billing services, community health management information systems, repricing companies and value-added networks.

4. Business Associates: Provide services to covered entities and are extensions of the previous entities listed, including legal services, billing, financial services and accreditation.

Enforcement and Repercussions.

The HHS Office for Civil Rights enforces the HIPAA Privacy, Security and Breach Notification Rules. Violation of these rules may result in civil and in some cases criminal penalties. HIPAA violations can also lead to Medicare exclusion which is often a death sentence for a health care provider. To read a previous blog I wrote on the penalties of HIPAA violations, including a chart outlining the penalty structure, click here.

Contact a Health Law Attorney Experienced in Defending HIPAA Complaints and Violations.

The attorneys of The Health Law Firm represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other health care providers and institutions in investigating and defending alleged HIPAA complaints and violations and in preparing Corrective Action Plans (CAPs).

For more information about HIPAA violations, or corrective action plans , please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620.

Sources:

Hamlet, Julie. “HHS ISSUES HIPAA “BASICS” FACT SHEET”. Foster Swift. (September 2, 2015). Web

Department of Health and Human Services. “HIPAA Basics for Providers: Privacy, Security and Breach Notification Rules”. (May, 2015). Web

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. http://www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: Health Insurance Portability and Accountability Act (HIPAA), HIPAA, HIPAA compliance, data security, protected health information (PHI), electronic protected health information, Patient privacy, U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR), patient rights, HIPAA compliance audit, HIPAA violation, penalties for HIPAA violation, criminal penalties for HIPAA violation, civil penalties for HIPAA violation, HIPAA compliance, privacy, defense attorney, defense lawyer, Medicare exclusion, HIPAA defense attorney, HIPAA violation help, HIPAA attorney, HIPAA lawyer, compliance plans, health law firm, The Health Law

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2015 The Health Law Firm. All rights reserved.