Life Sciences Legal Update : Life Sciences Lawyers & Attorneys : Reed Smith Law Firm : Healthcare, Food and Drug Law, Biotechnology, Privacy, Product Liability

This post was written by Jennifer L. Pike and Nancy E. Bonifant.

The Department of Health and Human Services (“HHS”) is seeking comments on a proposal to amend the HIPAA Privacy Rule to expressly permit covered entities to disclose certain mental health information to the National Instant Background Check System (NICS), the federal government’s background check system for the sale or transfer of firearms by licensed dealers.

Federal law prohibits the following persons from possessing or receiving firearms: (1) individuals who have been involuntarily committed to a mental institution; (2) individuals who have been found incompetent to stand trial or not guilty for reason of insanity; and (3) individuals who have been otherwise determined, through formal adjudication process, to have a severe mental condition that results in the individual presenting a danger to themselves or others or being incapable of managing their own affairs (collectively referred to in the proposed rule as the “mental health prohibitor”).  Federal agencies are required by the NICS Improvement Amendments Act of 2008 to report to NICS the identities of individuals who are subject to the mental health prohibitor.  The Act also authorizes incentives for States to provide such information when it is in their possession.  

HHS issued the proposed rule to address concerns that the HIPAA Privacy Rule may be preventing some States from reporting to NICS the identities of individuals subject to the mental health prohibitor.  Records related to involuntary commitments and mental health adjudications generally originate in entities in the criminal justice system.  Such entities are not HIPAA covered entities, and the records are therefore not subject to HIPAA.  However, there may be State entities outside the criminal justice system that are involved in some involuntary commitments or mental health adjudications, and these entities may be HIPAA covered entities.  Where a record of involuntary commitment or mental health adjudication originates with a HIPAA covered entity, or the HIPAA covered entity is the State repository for such records, those records are subject to HIPAA.  Therefore, the concern is that the individuals identified in such records are not being reported to NICS due to HIPAA compliance considerations.

To address these concerns, HHS is considering whether to amend the Privacy Rule to expressly permit covered entities to disclose limited information to NICS about the identities of individuals who are subject to the mental health prohibitor.  Pursuant to the HHS request for comments, the potential exception may limit the information disclosed to the minimum data necessary for NICS purposes, and limit permission to disclose to covered entities that order involuntary commitments, perform relevant mental health adjudications, or are otherwise designated as State repositories for NICS reporting purposes.

HHS is seeking comments on specific questions related to the proposal.  These questions are listed in HHS’ Advance Notice of Proposed Rulemaking, which is available here.  Comments should be submitted in writing, or electronically at www.regulations.gov, on or before June 7, 2013.

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This post was written by Elizabeth Carder-Thompson, Katie C. Pawlitz and Nancy E. Bonifant.

In preparation for data collection to begin under the Physician Payment Sunshine Act Final Rule on August 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released yesterday the list of teaching hospital covered recipients to which payments and other transfers of value must be reported by applicable drug and device manufacturers.  The list, which will be updated annually by CMS at least 90-days before the beginning of a reporting year, can be found on CMS’ National Physician Payment Transparency Program: OPEN PAYMENTS website and includes approximately 1,100 legal business names that are organized by state and tax identification number.

CMS also announced this week that it will be holding a National Provider Call on Wednesday, May 22, 2013 at 2:30 PM EST, directed at physicians and teaching hospitals.  The agenda for the call includes an overview of the Final Rule, key dates, the role of covered recipients and resources available to covered recipients.

Meanwhile, stakeholders and their representatives, including the American Medical Association (AMA) and the Advanced Medical Technology Association (AdvaMed), have continued to seek additional clarification from CMS on a variety of outstanding questions.  These questions include whether journal reprints provided by a manufacturer to a physician or teaching hospital have a discernible economic value that triggers reporting requirements, what constitutes a payment or transfer of value to a teaching hospital as opposed to payments or transfers of value to an employee of the teaching hospital, and more.  Ideally, CMS will issue further guidance on these issues in sufficient time for applicable manufacturers to prepare for the data collection deadline this summer.

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This post was written by Nancy E. Bonifant and Zachary A. Portin.

On April 9, 2013, the Eleventh Circuit held that HIPAA preempts a Florida statute that requires nursing homes to release medical records of deceased residents to their spouses, attorneys-in-fact and other enumerated parties who request them.  In Opis Management Resources LLC v. Secretary Florida Agency for Health Care Administration, the Florida agency that oversees nursing homes cited Opis Management, an operator of nursing homes, for refusing to release medical records to deceased residents’ spouses and attorneys-in-fact.  Opis Management challenged the citations arguing that the requesting parties were not “personal representatives” under HIPAA.

The HIPAA Privacy Rule requires disclosures of PHI in only two situations: (1) to the individual, and (2) to the Secretary of HHS.  Covered entities must also treat a deceased individual’s “personal representative,” who has authority to act on behalf of the deceased individual or his/her estate, as the individual for purposes of disclosures under the HIPAA Privacy Rule.  While HIPAA does not preempt “more stringent” state laws, it sets a floor for privacy protections and supersedes any contrary provision of state law.

The Eleventh Circuit held that HIPAA preempts the Florida statute because it “impedes the accomplishment and execution of the full purposes and objectives of HIPAA and the Privacy Rule,” particularly keeping an individual’s PHI confidential.  According to Judge Black, the Florida statute authorizes “sweeping disclosures” that made a deceased resident’s PHI available to certain individuals upon request without any need for authorization and “without regard to the authority of the individual making the request to act in the deceased’s stead.”  Interestingly, because the Florida agency failed to timely raise the argument, the court did not consider whether compliance with both laws was possible because HIPAA permits covered entities to disclose PHI as “required by law.”

Opis Management Resources highlights one of the many challenges that covered entities face in trying to achieve compliance under HIPAA and state privacy law.  Although the holding suggests that analogous Florida statutes mandating disclosures may too be preempted, the ruling is limited to licensed Florida nursing homes.  Clearly, the scope of HIPAA preemption remains unsettled and the issue will likely continue to be determined on a case-by-case basis.

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This post was written by Zachary A. Portin and Nancy E. Bonifant.

Can a medical corporation be directly liable under New York law for breaching its common law fiduciary duty of confidentiality when a non-physician employee acted outside the scope of his or her employment by making an unauthorized disclosure of an individual’s confidential health information?  This is the question that the U.S. Court of Appeals for the Second Circuit posed to the New York State Court of Appeals last month when it requested an advisory opinion from the state’s highest court in order to resolve Doe v. Guthrie Clinic Ltd. 

Plaintiff Doe sued various Pennsylvania-based entities (the “Guthrie Defendants”) that owned and operated the Guthrie Clinic Steuben (the “Clinic”) located in New York after one of the Clinic’s nurses sent six text messages to Doe’s girlfriend informing her that Doe was being treated for sexually transmitted diseases.  Plaintiff Doe brought several tort claims against the Guthrie Defendants, including a novel claim that the common law cause of action for breach of the fiduciary duty to keep medical records confidential runs directly against medical corporations, even when the employee responsible for the breach is not a physician and acted outside the scope of her employment.

Although HIPAA does not create a private right of action under federal law, an aggrieved patient may avail himself or herself to state law causes of action.  For example, New York imposes a general duty to maintain the confidentiality of personal health information as well as a specific common law cause of action against a physician who improperly discloses confidential information.  In 2000, the Appellate Division of the New York State Supreme Court also held that a patient was permitted to sue a health insurer whose records clerk wrongfully disclosed treatment information.  Nevertheless, the Second Circuit elected to certify the question to the Court of Appeals with regard to the Guthrie Defendants after it concluded that no controlling precedent existed. 

A favorable ruling for Plaintiff Doe threatens to vastly expand the scope of liability faced by providers and other entities involved in the delivery of healthcare.  Perhaps most concerning from the perspective of providers is the prospect of such entities facing liability under New York law for unforeseeable misconduct committed by non-physician employees.  Regardless of the Second Circuit’s ultimate disposition of this legal question, the case underscores the importance of developing and maintaining a robust compliance program to combat such misconduct.

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This post was written by Katherine Yang, Amy Yin, Vicki Lung, Gordon B. Schatz, Jay J. Yan, John J. Tan, Mao Rong and May Wong.

Reed Smith’s China Life Sciences and Health Industry Client Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.

Some important developments during March include:

• CFDA Seeks Public Comment on Special Approval Procedures for Innovative Medical Devices
• CFDA Allows Manufacturers to Confirm Medical Device Classes
• ETView Medical, Ltd. Announces CFDA Clearance of Pre-Marketing Notification Application for the VivaSight-SL Line of Innovative Airway Devices
• Executives Call for Pharmaceutical Reform
• 213 New Varieties of Drugs Added into National Essential Drug Catalogue
• MOH and CFDA Solicit Public Comments on Clinical Research on Stem Cells
• Govt. to Increase Funding for Medical Reform
• Advisers Seeking a Remedy for Private Hospitals
• Xiamen Encourages Medical Cooperation
• Online Outpatient Appointments to End Misery of Queuing for Hours
• China to Clean Up Grassroots Medical Institutions
• Clearbridge BioMedics Raises $7.2 Million Funding

To read the full briefing by Reed Smith China team members, click here.

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This post was written by Scot T. Hasselman, Andrew C. Bernasconi, Susan A. Edwards and Debra A. McCurdy.

Yesterday the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would dramatically increase the potential reward to an individual who provides a tip leading to the recovery of Medicare funds from a current maximum of $1,000 to a maximum of $9.9 million under the Medicare Incentive Reward Program.  Since 1998, an individual providing information regarding potential Medicare fraud and abuse to the Department of Health & Human Services’ Office of the Inspector General or the Medicare contractor with jurisdiction over the suspected fraudulent provider or supplier may be eligible to receive 10 percent of the Medicare funds ultimately collected from the tip, or $1,000, whichever is less.  Pursuant to the proposed rule CMS issued yesterday, an individual furnishing information that otherwise satisfies the requirements set forth in 42 C.F.R. § 420.405 would be eligible to receive 15 percent of a recovery up to $66 million.  Therefore, a tipster could receive up to a $9.9 million reward for any information provided regarding suspected Medicare fraud and abuse.

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This post was written by Jennifer Pike and Brad Rostolsky.

The Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) have each proposed new rules to extend existing protections that allow hospitals to donate electronic health record (EHR) technology to physicians who refer patients to their facilities. By way of background, in 2006, CMS established an exception to the Stark self-referral law to allow hospitals to donate EHR technology to physicians under certain circumstances. Likewise, in 2006, the OIG established a safe-harbor to protect such EHR donations from enforcement under the federal anti-kickback statute. While both protections are set to expire on December 31, 2013, the proposed rules would extend the provisions until the end of 2016 as a means to facilitate the adoption of EHR technology.

In addition to extending the EHR donation protections, the proposed rules would (1) remove the requirement from the original rule that donated EHR technology contain electronic prescribing capability, and (2) update the provision under which EHR technology is deemed interoperable, which would expand the types of EHR systems that qualify for the protections.

CMS’s proposed rule is available here. The OIG’s proposed rule is available here. Comments regarding both proposed rules should be submitted in writing, or electronically at www.regulations.gov, by June 10, 2013.

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This post was written by Daniel A. Cody, Rachel M. Golick and Susan A. Edwards.

On March 13, 2013, the Centers for Medicare & Medicaid Services (CMS) concurrently issued CMS Ruling Number CMS-1455-R (the Administrator’s Ruling) and a proposed rule, “Part B Inpatient Billing in Hospitals” (the Proposed Rule). The Administrator’s Ruling and Proposed Rule address the submission of Medicare Part B inpatient claims where a Medicare Part A claim for a hospital inpatient admission is denied by a Medicare review contractor on the grounds that the inpatient admission was not “reasonable and necessary.” The Proposed Rule also would apply to situations where a hospital determined, through a self-audit, that an inpatient admission was not “reasonable and necessary.” The Administrator’s Ruling, effective as of the issuance date, establishes an interim policy to handle payment for Medicare Part B inpatient claims until CMS finalizes the Proposed Rule. The Proposed Rule would set forth a permanent regulatory scheme to permit hospitals to rebill Medicare for a wider range of Part B services than is currently permitted following denial of a Part A claim.

The impact and utility of the Proposed Rule is substantially diminished by the timeframe in which providers are allowed to resubmit Part B claims – one year after the date of service. In many cases, providers do not receive denials of Part A claims within one year of the date of service. Consequently, the one year deadline would restrict some providers wanting to resubmit Part B claims from taking advantage of the more permissive Part B resubmission framework contemplated by the Proposed Rule. In addition, pursuant to the Proposed Rule, hospitals would be able to either: (1) appeal the denied Part A claim; or (2) resubmit Part B claims. Because a hospital’s resubmission of Part B claims would bar a Part A appeal, the Proposed Rule may deter hospitals, eager for a successful Part A appeal, from resubmitting Part B claims.

Reed Smith’s Client Memo provides background and analysis of the Administrator’s Ruling and the Proposed Rule as well as a summary of potential implications for hospitals.

Click here to read the full alert.

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Reed Smith's Global Regulatory Enforcement blog features a post on a December 2012 French Supreme Court ruling in a case involving a French Director in a health care company who had been dismissed on the grounds of a clear breach of health care compliance obligations as set forth in the French Public Health Code. The outcome: even though a company is acting in a highly regulated environment such as health care, compliance breaches must be integrated in the employer-employee relationship if they are to justify termination in France. As Reed Smith Partner Daniel Kadar notes, this case serves as a reminder to any international health care organization that the worldwide adoption of compliance guidelines and of a Code of Conduct is not in itself a sufficient protection against compliance breaches – everything depends on how these tools are implemented locally.

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This post was written by Elizabeth B. Carder-Thompson, Catherine A. Hurley, Joseph W. Metro and Elizabeth Doyle O'Brien.

Referencing what it deems a “proliferation” of physician-owned distributors (PODs), on March 26, 2013, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a Special Fraud Alert identifying significant concerns with such entities under federal anti-kickback principles.¹ For purposes of the Alert, the OIG defines a POD as “any physician-owned entity that derives revenue from selling, or arranging for the sale of, implantable medical devices,” including “physician-owned entities that purport to design or manufacture, typically under contractual arrangements, their own medical devices or instrumentation.” Specifically, the OIG describes in somewhat unusual detail the multiple “attributes and practices” of PODs that the OIG believes “produce substantial fraud and abuse risk and pose dangers to patient safety.”

Notably, the Alert is focused on PODs that derive revenue from selling, or arranging for the sale of, implantable medical devices that are ordered by physician-owners for use in procedures that physician-owners “perform on their own patients at hospitals or ambulatory surgical centers (ASCs).” However, the OIG states that “the same principles would apply when evaluating arrangements involving other types of physician-owned entities.”

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This post was written by Karl A. Thallner Jr. and Katie C. Pawlitz.

On February 1, 2013, the Centers for Medicare & Medicaid Services released the long-awaited final rule implementing the physician payment transparency provisions, commonly referred to as the Physician Payment Sunshine Act, in the Obama administration's 2010 health care reform legislation. The Sunshine Act joins the list of significant federal laws addressing potential conflicts of interest in health care, including the Anti-Kickback Statute and the Stark Law. With implementation of the Sunshine Act now in sight, stakeholders face the real challenge of complying with, and practicing under the shadow of, the Sunshine Act and its complex and detailed regulations.

To read the full article "Seeing the Light With the Physician Payment Sunshine Act," please visit law.com.

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This post was written by Jay J. Yan, John J. Tan, Mao Rong, Katherine Yang, Amy Yin, Vicki Lung, May Wong and Gordon B. Schatz.

Reed Smith’s China Life Sciences and Health Industry Client Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.

Some important developments during February include:

• New Drug GSP Issued: Supervision on Drug Distribution to be Enhanced
• China to Encourage Innovative Drug Development
• Baidu, SFDA, Team Up on Drug Search
• TCM Manufacturer Urged to Raise Awareness of Drug Side Effects
• Favorable Policies Support Biopharmaceutical Stocks
• Medical Firms See Healthy Foreign Trade Growth
• China's Medical Device Market to Grow Rapidly
• Implementing Programs for Serious Illness Health Insurance Issued in Several Provinces
• China Forbids Linking Doctors’ Incomes with Patient Medical Expenses
• Provinces Urged to Buy Insurance

To read the full briefing by Reed Smith China team members, click here.

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This post was written by Jennifer Pike.

On March 7, 2013, the New Jersey Assembly Appropriations Committee approved legislation related to off-label drug coverage. Assembly bill A1830 would require health benefits plans offered to individuals and small employers, the State Health Benefits Program (SHBP) and the School Employees’ Health Benefits Program (SEHBP), to provide coverage for certain off-label uses for drugs that are approved by the U.S. Food and Drug Administration. The health plans would be required to provide coverage for off-label use of a drug if the drug is recognized as being medically appropriate for the specific treatment for which is has been prescribed in one of two established reference compendia (the American Hospital Formulary Service Drug Information or the U.S. Pharmacopeia Drug Information), or if the drug is recommended by a clinical study or review article in a major peer-reviewed professional journal. According to bill sponsor Herb Conaway M.D., "the purpose of [the] bill is to extend the medical benefits that may derive from the use of off-label drugs to individuals who may not be able to access these medications. In particular those individuals who are suffering from a terminal or chronically debilitating illness, because their insurance carriers won’t cover these drugs.” The full text and status of the bill are available here.

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This post was written by Elizabeth B. Carder-Thompson, Katie C. Pawlitz and Nancy E. Bonifant.

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services (HHS) released the long-awaited Final Rule to implement the “Sunshine” provisions of the Affordable Care Act of 2010 (ACA). The Sunshine provisions - intended to provide increased transparency on the scope and nature of financial and other relationships among manufacturers, physicians, and teaching hospitals - require that certain manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid and CHIP report annually to HHS identified payments or transfers of value they have made to physicians and teaching hospitals. In addition, they require manufacturers and certain group purchasing organizations (GPOs) to report to HHS information on physician ownership and investment interests.

The Final Rule provides needed clarity on some troubling aspects of the proposal, however, it leaves a number of questions unanswered. Please click here to read our detailed analysis of the Sunshine provisions, including an overview and summary of the Rule as well as discussion of the important issues that stakeholders should be considering as they prepare for Sunshine implementation.

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