Largest Criminal Health Care Fraud Takedown – 243 Charged and $712 Million in False Billings

Posted by Health Law Informer Author on June 18, 2015
DOJ, FBI, Fraud and Abuse, HHS, Hospital, Medicare / No Comments

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On June 18, 2015, HHS Secretary Sylvia M. Burwell and DOJ Attorney General Loretta E. Lynch announced nationwide arrests in Medicare fraud schemes amounting to approximately $712 million in false billings.  Attorney General Lynch described the strike as “the largest criminal health care fraud takedown in the history of the Department of Justice, and it adds to an already remarkable record of enforcement.”

According to the Department of Justice Press Release the takedown was led by the Medicare Fraud Strike Force and resulted in 243 individuals, including 46 doctors, nurses and licensed medical professionals, being charged with Medicare fraud.  This Strike Force targeted false billings for the following services:

  • Home Health
  • Psychotherapy
  • Physical and Occupational Therapy
  • DME
  • Pharmacy Fraud

The nationwide sweep included Florida, Texas, California, Louisiana, New York and Michigan.  Miami was a particular focus with 73 defendants charged and $263 million of false billings for home health, mental health and pharmacy services.

This nationwide sweep involved significant coordination between multiple government enforcement agencies and illustrates the government’s joint efforts to target health care fraud.  Included in the press conference were FBI Director James B. Comey, Assistant Attorney General Leslie R. Caldwell of the Justice Department’s Criminal Division, Inspector General Daniel R. Levinson of the HHS Office of Inspector General (HHS-OIG) and Deputy Administrator and Director of CMS Center for Program Integrity Dr. Shantanu Agrawal.

Assistant Attorney General Caldwell spoke and emphasized the Criminal Division’s increased focus on Medicare fraud stating,  “Every day, the Criminal Division is more strategic in our approach to prosecuting Medicare Fraud.  We obtain and analyze billing data in real-time.  We target hot spots – areas of the country and the types of health care services where the billing data shows the potential for a high volume of fraud – and we are speeding up our investigations.  By doing this, we are increasingly able to stop schemes at the developmental stage, and to prevent them from spreading to other parts of the country.”

For further information contact Ryan P. Blaney or any member of Cozen O’Connor’s health care team.

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Not Much New … But a Good Reminder for Medical Director Relationships

Posted by Health Law Informer Author on June 15, 2015
CMS, Hospital, OIG, Regulations / No Comments

After a sigshutterstock_272707754nificant number of settlement agreements between the U.S. Department of Health and Human Services Office of Inspector General (OIG), OIG decided to release a Fraud Alert reminding physicians, practices and hospitals about the significant compliance risks with medical director agreements. The June 9, 2015 Fraud Alert highlights four issues of concern in medical director agreements and relationships:

 

  1. Agreements providing for medical director compensation based upon a calculation taking into account the volume of a medical director’s referrals to the entity he or she is serving as medical director.
  2. Agreements providing for medical director compensation above fair market value for the services to be rendered by the medical director.
  3. Medical directors failing to actually render the services set forth in medical director agreements, yet still being compensated for such services.
  4. Agreements providing that affiliated health care entities pay for a medical director’s front office staff, thereby relieving the medical director of a financial burden such medical director would otherwise have incurred.

This Fraud Alert offers nothing new in terms of Anti-Kickback regulation and enforcement, reiterating to providers that the Anti-kickback statute generally prohibits a provider from being paid any form of remuneration for referring a patient for federal healthcare business.  It appears to be a not-so-friendly reminder that “remuneration” can come in many shapes and sizes and physicians must continue to be vigilant in their negotiating and entering into medical director agreements, as well as their adherence to same. A physician considering entering into any business venture in the health care sector should proceed with caution, and always confer with a health care attorney before signing on the dotted line.  The complete June 9, 2015 Fraud Alert can be found here: http://oig.hhs.gov/compliance/alerts/guidance/Fraud_Alert_Physician_Compensation_06092015.pdf.

For further information contact a member of Cozen O’Connor’s health care team.

Authored by Ryan Blaney (Washington, DC) and Marc Goldsand (Miami, FL).

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CMS’ Long Awaited Final ACO Regulations for 2016 and Beyond: Major New Options and Plenty of Fine Tuning

Posted by Chris Raphaely on June 08, 2015
Accountable Care Organizations, Beneficiaries, CMS, Final Rule, Medicaid, Medicare / 1 Comment

Tomorrow, the Centers for Medicare and Medicaid Services (“CMS”) will publish final regulations (“Final Rule”)  for its flagship pay-for-performance program, the Medicare Shared Savings Program, in the Federal Register. The Final Rule generally applies to performance years 2016 and beyond and the second three year “agreement period” for the over 400 accountable care organizations (“ACO”) currently in the program.

Stakeholders watched very closely the development of the Final Rule, so they can now begin sizing up future opportunities with some certainty and determine the longer term complexion of the program itself. The regulations contained in the Final Rule were published in proposed form in December 2014, and, the Final Rule adopts most, but not all, of what CMS initially proposed.  It continues the pattern of easing CMS’ ultimate push towards the two-sided risk model for most, if not all, ACOs and contains adjustments that many will consider to be favorable to ACOs.

Among the most significant developments is one in which, as proposed, ACOs that are currently in their first three year agreement period with CMS for participation in the program’s “upside only” risk model, Track 1, will be permitted to remain under the same model for another three years. This covers the majority of ACOs currently in the program. Significantly, however, CMS declined to institute the 10% cut (from 50% to 40%) to the Maximum Savings Rate for the second term Track 1 ACOs that it proposed last December.  The Final Rule comes none too soon for the first set of Track 1 ACOs who will have to make a decision whether or not to re-up for another three years in the program before the end of 2015.

In the other major structural change to the program, CMS, as it proposed to do, created a third double-sided risk, Track 3, for more highly developed ACOs desiring to trade greater upside opportunity (up to a 75% share of savings generated) for greater risk (up to 75% of losses) with both savings and losses being subject to a cap of 15% and 20% of benchmark, respectively. The new track includes a prospective beneficiary assignment model as opposed to the retrospective model that will continue to be used in Tracks 1 and 2. CMS also gives ACOs who choose the new track the option to waive Medicare’s three day hospital stay requirement for reimbursement of skilled nursing services. CMS stated that it will be considering additional waivers in areas like tele-health for Track 3 ACOs in the future.

CMS also included many technical adjustments to the program, some of which will have a significant impact on how the program and ACOs operate. Among the more significant are the following:

  • Adjusting the savings benchmark calculation so second term ACOs that generated savings in their first term are not “penalized” by tougher savings targets in the second term as a result;
  • Track 2 and Track 3 ACOs will be given new options for setting Minimum Savings and Loss Rates;
  • Greater emphasis on primary care services provided by non-physician practitioners such as licensed nurse practitioners in the beneficiary assignment process;
  • Enhanced information in the aggregate data reports supplied to ACOs and the inclusion of patients who had one primary care visit with an ACO in the assignment period even if they were not
    preliminarily assigned to the ACO in the aggregate reports supplied to Track 1 and 2 ACOs; and
  • A streamlined data opt-out process in which (i) beneficiaries opt out of data sharing only by notifying CMS directly; and (ii) ACOs no longer have to wait thirty days after notifying beneficiaries of their opt-out rights before requesting detailed claims data on such beneficiaries.

The balance of 2015 and 2016 will be critical to the future of the Medicare Shared Savings Program as ACOs who currently participate in the program and others who are considering participation now have definitive guidance as to what the program will look like at least through 2018.

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OCR Announces Another HIPAA Settlement and Warns Not to Forget About Paper Records

Posted by Health Law Informer Author on May 04, 2015
HHS, HIPAA, OCR / No Comments

On April 27, 2015, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced that Cornell Prescription Pharmacy (“Cornell Pharmacy”) had entered into a resolution agreement to settle, without an admission of liability or wrongdoing, potential HIPAA violations. As part of the resolution agreement Cornell Pharmacy will pay $125,000 and enter into a two-year corrective action plan (“CAP”) focused on correcting the alleged deficiencies in its HIPAA compliance program.

Cornell Pharmacy is a small, single store pharmacy located in Denver, Colorado that specializes in compound medications and providing services for local hospice agencies. OCR began an investigation into the pharmacy after it received a media report from a Denver news agency that protected health information (“PHI”) belonging to Cornell Pharmacy was apparently disposed of and found in an unlocked, publicly accessible dumpster. The documents were not shredded and contained the PHI of approximately 1,610 of Cornell Pharmacy’s patients.   After conducting its investigation, OCR concluded that Cornell Pharmacy failed to implement any written policies and procedures as required by HIPAA’s Privacy Rule, and further failed to provide training on the Privacy Rule to its workforce members.

This settlement is instructive as OCR again highlights the importance of having updated and comprehensive HIPAA policies and procedures in place, including policies on the proper disposal of PHI, and on training all staff on those policies and procedures.   Further, in this year of massive cyber-attacks and other breaches of electronic data, this HIPAA settlement serves to remind covered entities and business associates not to forget about protecting their paper records as well.   As stated by OCR in its press release, “Even in our increasingly electronic world, it is critical that policies and procedures be in place for secure disposal of patient information, whether that information is in electronic form or on paper.” As discovered by Cornell Pharmacy, a breach or other improper disclosure of paper PHI can also result in significant consequences.

For further information please contact the author, Gregory M. Fliszar (Philadelphia, PA), or other members of Cozen O’Connor’s healthcare team.

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Senate Approves Medicare “Doc Fix” Legislation

Posted by Health Law Informer Author on April 15, 2015
CMS, Medicare / No Comments

We wrote in late March about the U.S. House of Representatives passing SGR legislation intended to be a permanent cure to Medicare’s “doc fix” legislation. Yesterday evening, the Senate finally passed the SGR legislation to avoid a rate cut. Congress anticipates President Obama will sign the SGR legislation into law fairly quickly. Among other measures, the SGR legislation will amend Title XVIII of the Social Security Act, pertaining to Medicare, to:

  • “remove sustainable growth rate (SGR) methodology from the determination of annual conversion factors in the formula for payment for physicians’ services; and
  • revise the update in rates for 2015 and subsequent years.”

Notably, the SGR legislation extends the two-midnight Medicare rule through FY2015. The two-midnight Medicare rule only provides coverage for hospital stays when a beneficiary remains in a hospital over two midnights because the beneficiary requires care over this minimum period of time. Medicare generally denies coverage for care provided during shorter length hospital stays. The SGR legislation also extends the CHIP program through FY2017.

For further information contact Cozen O’Connor’s health care team.

 

 

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CMS Issues Proposed Rule That Would Extend Provisions of Mental Health Parity

Posted by Health Law Informer Author on April 15, 2015
Addiction, CHIP, CMS, MCOs, MCOs, Medicaid, Medicare, Mental Health, PAHPs, PIHPs / No Comments

On April 6, 2015, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule that would extend provisions of the Mental Health Parity and Addiction Equity Act of 2008 (the “Mental Health Parity Act”) to Medicaid managed care organizations (“MCOs”) and the Children’s Health Insurance Program (“CHIP”). The Mental Health Parity Act requires health plans that provide mental health and substance abuse disorder benefits to ensure that any financial requirements (e.g., co-pays, deductibles) and treatment limitations (e.g., limitations on visits) applicable to those benefits are no more restrictive than the requirements or limitations applied to medical/surgical benefits. The proposed rule was published in the Federal Register on April 10, 2015 at 80 Federal Register 19418. (Proposed rule). Comments to the proposed rule are due on June 9, 2015.

The proposed rule was drafted to ensure that all Medicaid beneficiaries who receive benefits through MCOs or under alternative benefit plans would have access to mental health and substance use disorders benefits regardless of whether they received those benefits through an MCO or another system. In addition, the proposed rule would also apply to CHIP, whether the care is provided through an MCO or a fee-for-service program.

Presently, a number of states that provide medical benefits through Medicaid MCOs carve out mental health and substance abuse services through other arrangements, which can include prepaid inpatient health plans (“PIHPs”), prepaid ambulatory health plans (“PAHPs”), or even fee-for-service. Under the proposed rule, states would continue to have flexibility in selecting different delivery systems to provide services to Medicaid beneficiaries, but would have to ensure that enrollees of a Medicaid MCOs receive the benefit of mental health and substance abuse parity when provided through these alternative models. States, for example, would be required under the proposed rule to include contract provisions requiring compliance with the Mental Health Parity Act in all applicable contracts with Medicaid MCOs and entities providing services through alternative arrangements such as PIHPs and PAHPs. Further, states would have to provide CMS with evidence of compliance with the Mental Health Parity Act in their provision of mental health and substance services to Medicaid beneficiaries.

In addition, the proposed rule would require Medicaid, MCOs, PIHPs, PAHPs and other alternative benefit plans to make their medical necessity criteria for mental health and substance abuse disorder benefits available to any enrollee or contracted provider upon request. Such Medicaid plans must also make available to enrollees the reason for any denial of reimbursement for services related to mental health and substance use disorder benefits.
For further information contact the author Gregory M. Fliszar (Philadelphia, PA) or other members of Cozen O’Connor’s healthcare team.

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“It’s Not Easy to Unscramble the Eggs” … Despite the FTC’s Win at the U.S. Supreme Court, the Phoebe Putney Hospital Merger Remains Intact

Posted by Health Law Informer Author on April 03, 2015
Antitrust, CON Laws, Federal Trade Commission, Hospital, Merger / No Comments

EggsNearly four years after the Federal Trade Commission (“FTC”) first challenged the combination of the only two hospitals in Albany, Georgia, the FTC, Phoebe Putney Health Systems, Inc. (“Phoebe Putney”), Hospital Authority of Albany – Dougherty County (“Hospital Authority”) and HCA, Inc. (“HCA”) agreed to enter into a Consent Agreement. The FTC’s vote finalizing the Consent Agreement was 3-0-2, with Commissioners Joshua D. Wright and Terrell McSweeny not participating.  The Phoebe Putney litigation illustrates the challenges that the FTC and entities attempting to consummate a deal face in the merger process.  In Phoebe Putney, the FTC lost in two federal lower courts, won at the U.S. Supreme Court but ultimately was unable to unscramble a hospital merger that was found to be (1) anti-competitive and (2) a monopoly for inpatient general acute-care.

In addition to the Consent Agreement, a Statement was issued by Chairwoman Ramirez on March 31, 2015 summarizing the extensive procedural history of the litigation, the reasons the FTC challenged the merger, why the FTC did not require a divestiture and an explanation of the obligations that Phoebe Putney must meet under the Consent Agreement.  The March 31st Statement may provide insights into the FTC’s strategies when challenging future hospital mergers.  As explained below in the practice pointers, we anticipate the FTC citing Phoebe Putney in support of their preliminary injunctions and also citing to state certificate of need [CON] laws as evidence of barriers to entry for hospital competitors.

By way of background, since 1890 federal laws have supported national policies in favor of competition.  In Parker v. Brown, a 1943 U.S. Supreme Court decision, the state action doctrine provided that state governments have immunity from federal antitrust laws when they authorize economic activity that normally would be anticompetitive and illegal.  In 1941, Albany, Georgia and surrounding Dougherty County set up the Hospital Authority.  The Hospital Authority acquired an existing hospital, Phoebe Putney Memorial Hospital.  Two miles away Palmyra Medical Center was operated separately by HCA, Inc., one of the largest health care providers in the United States.  Palmyra and Phoebe Putney merged with the Hospital Authority as the buyer of Palmyra with the funds coming from Phoebe Putney.  Palmyra hospital was leased to Putney for $1 a year.  The Hospital Authority approved the merger in December 2010 but was not involved in the merger talks or management of the hospital.

The FTC and the State of Georgia filed a preliminary injunction in federal court to block the transaction but the federal district judge held that the state action doctrine applied and refused to stop the merger.  The FTC appealed to the 11th Circuit, which also found that the merger was insulated from antitrust inquiry under state action immunity concluding that harm to competition was the “foreseeable result” of the legislature’s establishment of the Hospital Authority.

The 11th Circuit decision dissolved the injunction pending appeal and on December 15, 2011 the merger was finalized.  The FTC appealed the 11th Circuit’s decision to the U.S. Supreme Court.  The two issues were: (1) whether the legislature had expressed its intentions clearly enough in allowing hospital proxies to operate in anti-competitive ways, and (2) whether the local hospital arrangement did not have immunity because the hospital authority had not played a large enough role in the merger.

The Supreme Court unanimously answered the first question, ruling that the state legislature had “not clearly articulated and affirmatively expressed a policy to allow hospital authorities to make acquisitions that substantially lessen competition.”  Following the Supreme Court decision, the FTC proceeded with the administrative litigation and proposed a 2013 consent agreement.  However, the 2013 consent agreement was withdrawn after a newly formed health care entity, North Albany Medical Center LLC, expressed interest in Palmyra hospital and sought clarification on Georgia’s CON laws.

In October 2014, the Georgia Department of Community Health (“DCH”) Hearing Officer issued a written finding that the CON laws would preclude Phoebe North from purchasing Palmyra since the Albany region was deemed “over-bedded.”  Given the DCH’s decision, the FTC determined that divestiture of Palmyra – Phoebe Putney was impossible.

The March 31st Settlement is very similar to the one proposed in 2013.  The Settlement requires:

  • Phoebe Putney and the Hospital Authority to notify the FTC in advance of acquiring any part of a hospital or a controlling interest in other health care providers in Albany for the next 10 years.
  • Phoebe Putney and the Hospital Authority cannot object to regulatory applications made by potential new hospital providers in the same region for 5 years.
  • Phoebe Putney and the Hospital Authority stipulate that the transaction was anti-competitive.

Practice Points:

  • The FTC’s March 31st Statement by Chairwoman Ramirez emphasizes the importance of the FTC and private plaintiffs in obtaining preliminary injunctive relief prior to a transaction closing. The health care industry should anticipate the FTC citing the Phoebe Putney case as supporting authority for why there will be irremediable harm if a hospital transaction closes before all appeals are exhausted.
  • We also anticipate that the FTC will use the Phoebe Putney case in support of arguments that state CON laws are additional barriers for entry of potential competitors and should be significant factor when analyzing proposed mergers.

For further information contact the author Ryan P. Blaney (Washington, DC) or other members of Cozen O’Connor’s healthcare antitrust team, R. Christopher Raphaely (Philadelphia, PA), Melissa H. Maxman (Washington, DC) and Jonathan Grossman (Washington, DC).

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Another Health Plan Hit By Massive CyberAttack and Class Actions Follow

Posted by Health Law Informer Author on March 30, 2015
Affordable Care Act, CMS, cyberattacks, cybercriminals, cybersecurity, HHS, HIPAA, HITECH, Privacy, Uncategorized / No Comments

Coming fresh off the heels of the Anthem data breach Premera Blue Cross announced on March 17th that it was the victim of a “sophisticated” cyberattack that may have exposed the personal information of approximately 11 million of its members.  Premera has approximately 6 million members residing in the State of Washington, 250,000 members residing in Oregon and 80,000 members residing in Alaska.  Premera stated that the cyberattack began sometime in May of 2014 but was not discovered until the end of January 2015.   According to Premera, the information exposed may include social security numbers, bank account information, and medical and financial information, including clinical information.

Three state insurance commissioners (Washington, Oregon and Alaska) have already launched a joint investigation and a market conduct examination of Premera related to the breach.  The joint investigation will include on-site reviews of Premera’s financial books, records, transactions, and Premera’ cybersecurity.  The Washington Insurance Commissioner has expressed concern over the length of time (approximately six weeks) it took for Premera to notify his office of the attack.  Alaska’s governor ordered all state agencies to review their online security safeguards as well as those put in play by their business associates.  Premera is also conducting an internal forensic investigation by a cybersecurity firm and is cooperating with the FBI in a criminal investigation.

Combined with the cyberattacks on Community Health Systems and Anthem, this is the third large attack on a member of the health care industry announced in the last seven months, and these three breaches may have collectively impacted approximately 95.5 million people.   As these attacks illustrate, health information is now a high priority target for cybercriminals.  Currently a complete health record may be worth at least ten times more than credit card information on the black market as health records often include a wealth of personal information that can be used for identity theft and to file false health insurance claims.  Further, the data security protections currently in place in the health care industry tend to lag behind those in the banking and financial sector, which makes the information vulnerable to attack by those who view the valuable information as “low hanging fruit.”

Similar to the Anthem and the Community Health Systems breaches, Premera was immediately hit by a proposed class action accusing Premera of negligence and inadequate security.  The March 26, 2015 Complaint alleges that Premera breached its duty of care by failing to secure and safeguard the personal and health information of its members and negligently maintaining a system that it knew was vulnerable to a security breach.  The Complaint further alleges that Premera has a duty to secure and safeguard the personal health information of its members under HIPAA and its failure to implement security and privacy safeguards was a violation of HIPAA.  The Complaint also alleges violations of state consumer protection laws and data disclosure laws.

As evident by the Anthem and Premera breaches, a single security incident resulting in a data breach can have significant consequences for health care companies and business associates that include government investigations, class action lawsuits, and a hit to the organization’s reputation.  To manage this risk, we encourage all companies handling health information to conduct comprehensive risk assessments and to create, review and update their data security policies and procedures to ensure that they are doing enough to adequately protect the health information maintained on their IT systems and elsewhere in their organization.

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On the Horizon … A Possible “Permanent” Cure to Medicare’s “Doc Fix”

Posted by Health Law Informer Author on March 27, 2015
Affordable Care Act, Medicare / No Comments

11In a historic bipartisan moment, the U.S. House of Representatives passed a nearly 300-page bill that is intended to “repeal the Medicare sustainable growth rate [“SGR”] and strengthen Medicare access by improving physician payments and making other improvements.” The legislation, titled the Medicare Access and CHIP Reauthorization Act of 2015, which is referred to as the Medicare “doc fix”, is the result of ongoing bipartisan efforts to resolve an unpopular physician reimbursement system that if not overridden each year would cut Medicare doctor’s pay by a notable percentage. The annual reimbursement cut would occur as required under the federal Balanced Budget Act of 1997 (the “BBA”), if not for the annual fixes set into motion by Congress. In a March 25, 2015 letter from the Congressional Budget Office (“CBO”) to House Speaker Boehner, the CBO explained that the BBA established the SGR formula “to ensure that real—that is, adjusted for inflation—spending per [Medicare] beneficiary for physicians’ services would grow on average at a rate of increase in gross domestic protect per capita minus the expected rate of increase in productivity for the economy as a whole.”

According to news outlets and press conferences, President Obama is ready to sign the bill once the Senate passes it. In the CBO’s letter to House Speaker Boehner, it estimated that this bill will increase:

  • The federal budget deficits by $141 billion;
  • Direct spending by approximately $145 billon; and
  • Revenues by approximately $4 billion.

Under the Bill, Medicare’s payment rates for services on the physician fee schedule would increase by 0.5 percent a year for services furnished through 2019.  From 2019 through 2025 payments will remain the same but Medicare doctors will be eligible for merit-based bonus payments consistent with Medicare initiatives such as care models that shift away from fee for services.

Many expected the Bill to pass the Senate on Friday, March 27th but the Bill was not put up for a vote and Senate Minority Leader Harry Reid and Majority Leader Mitch McConnell said the bill will not get a vote until mid-April when the Senate returns from its recess.  CMS has provided notice that they will be able to hold payment for 14 calendar days to avoid a rate cut.

For further information contact Cozen O’Connor’s health care team.  We will continue to monitor and provide updates.

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Going Paperless: FDA Releases Draft Guidelines to Digitize Clinical Trials

Posted by Health Law Informer Author on March 12, 2015
Affordable Care Act, CMS, Medicare, Uncategorized / No Comments

 

FDA ShutterstockThe FDA released draft guidelines (“Guidelines”) on Monday, March 9, 2015 establishing recommendations on the use of e-media and processes to obtain informed consent for clinical investigations (trials) of medical products including human drug and biological products, medical devices and combinations. The Guidelines provide useful insight for how the FDA recommends clinical investigators, sponsors and institutional review boards (“IRB”) should use e-informed consent for a clinical trial.

The FDA defines e-informed consent as “using electronic systems and processes that may employ multiple electronic media (e.g., text, graphics, audio, video, podcasts and interactive Web sites, biological recognition devices, and card readers) to convey information related to the study and to obtain and document informed consent.” The FDA reminds clinical investigators and sponsors that informed consent is more than just a subject’s signature.  Informed consent – whether completed electronically or in paper form – includes providing prospective clinical trial participants with enough information regarding the research to enable them to make an informed decision regarding whether to participate in the study. The subjects must have “adequate information” about the research.  Clinical investigators and sponsors may use video conferencing (i.e. Skype) to answer a subject’s questions about the clinical trial.

The Guidelines also include a question and answer section containing 14 inquires such as:

  • How information in an e-informed consent should be presented to subjects;
  • How/where e-informed consent processes should be conducted; and
  • How/when questions from subjects should be answered.

Similar to CMS and states recognizing the authenticity of e-signatures, this guidance demonstrates the FDA’s desire to digitize health care and respond to the increased patient access to clinical trials in states passing “right-to-try” bills.  Right-to-try bills generally permit doctors and terminally ill patients to negotiate directly with drug companies to obtain experimental drugs that have passed Phase-I trials. Stay tuned for a forthcoming Health Law Informer blog announcing the FDA’s release of the e-informed consent final guidelines, which clinical investigators, sponsors and IRBs will want to consider implementing.

For further information contact the Cozen O’Connor’s health care team or the authors Ryan P. Blaney (Washington, DC) and J. Nicole Martin (Philadelphia, PA).

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