The U.S. Department of Justice Civil Division (Department) issued a Memo dated January 10, 2018 (Granston Memo), directing Department of Justice attorneys to more seriously consider dismissing False Claims Act (FCA) cases filed by whistleblowers. The Granston Memo enumerated several factors that prosecutors should consider when evaluating dismissal of qui tam actions. As the number of qui tam actions filed under the False Claims Act has substantially increased, the Granston Memo is an important tool in response to the strained government resources needed to evaluate, participate, and/or monitor these cases. Continue Reading
On February 13, 2018, the HHS Office for Civil Rights (OCR) announced a $100,000 settlement with a court-appointed receiver representing Filefax, Inc. (Filefax) arising from the 2015 discovery of medical records that contained protected health information (PHI) of over two thousand individuals in a dumpster. Filefax, a now-defunct medical records moving and storage company located in Illinois, acted as a business associate under HIPAA.
OCR initiated an investigation in February, 2015, after receiving an anonymous complaint concerning medical records that had been discovered and delivered to a facility for shredding and recycling. OCR’s investigation indicated that Filefax impermissibly disclosed PHI of 2,150 individuals over a two week span in early 2015 by leaving PHI in an unlocked truck in Filefax’s parking lot, or by leaving PHI within medical records sitting outside of Filefax’s business for a third party to collect. Continue Reading
Last month, a U.S. District Court in the Middle District of Florida overturned judgments totaling $347,864,285 returned by a jury under the federal False Claims Act (FCA) and Florida’s state equivalent against the owners and operators of 53 specialized nursing facilities in Florida, determining that the plaintiffs’ allegations failed to satisfy the “demanding” and “rigorous” materiality standard endorsed by the Supreme Court in its 2016 Escobar decision. In an order released January 11, 2018, the District Court reversed the jury’s conclusions and granted the defendants judgment as a matter of law. Continue Reading
On February 2, 2018, the Centers for Medicare & Medicaid Services (CMS) released Transmittal 3971 (Change Request 10412), which revises a section of the Medicare Claims Processing Manual (Manual), that provides guidance regarding billing for Evaluation and Management (E/M) services involving students. According to CMS, the Change Request is part of a broader goal to reduce the administrative burden on practitioners. Continue Reading
In a Draft Call Letter issued February 1, 2018, the Centers for Medicare & Medicaid Services (CMS) announced that it is considering a number of new strategies to address opioid overutilization within the Medicare Part D program. CMS is particularly concerned with chronic overuse among beneficiaries taking high levels of prescription opioids (e.g., beneficiaries prescribed opioids with a 90 morphine milligram equivalent (MME) dose or higher per day), beneficiaries with multiple prescribers, and “opioid naïve” patients (i.e., patients newly prescribed opioids).
CMS’s strategies include consideration of a 7-day supply limit for initial fills of prescription opioids for the treatment of acute pain, potentially paired with a daily dose maximum (e.g., a limit of 50 MME). According to CMS, this type of restriction may reduce the number of leftover opioid pills available to an opioid naïve patient, which in turn can reduce the risk that the patient develops an “affinity” for opioids that can lead to misuse and diversion. CMS also proposes that Medicare Part D sponsors implement formulary-level opioid safety edits at the point-of-sale (POS) at pharmacies of 90 MME, which could only be overridden by a sponsor, and which may be paired with a 7-day supply allowance for initial opioid prescriptions for the treatment of acute pain.
In January 2018, the U.S. Food & Drug Administration (FDA) published two guidance documents on Compounded Drug Products That Are Essentially Copies Of Approved Drug Products under Section 503A and Section 503B of the Federal Food, Drug, and Cosmetic Act (the Act). As emphasized in a recent U.S. Department of Justice policy memorandum, FDA noted that its guidance documents do not establish legally enforceable responsibilities and, instead should be viewed only as agency recommendations, unless specific regulatory or statutory requirements are cited.
On January 25, 2018, Associate Attorney General Rachel Brand issued a memo on behalf of the U.S. Department of Justice (DOJ) prohibiting certain DOJ uses of federal agency guidance documents in affirmative civil enforcement (ACE) cases (the “Brand Memo”). ACE cases include lawsuits brought by the DOJ on behalf of the United States to recover money lost to fraud or other misconduct, or to impose penalties for violations of Federal health, safety, civil rights or environmental laws, for example, False Claims Act enforcement by the DOJ.
The “Brand Memo” cited to guidance policy in a November 16, 2017 memo issued by the U.S. Attorney General, which prohibited the DOJ from issuing its own guidance documents that would effectively bind the public without undergoing notice-and-comment rulemaking. The Brand Memo explained that the principles from that earlier-issued policy were relevant to more than just the DOJ’s own guidance documents — in particular, with regard to ACE cases: Continue Reading
On January 29, 2017, the Centers for Medicare and Medicaid Services (CMS) announced a temporary moratorium on enrolling Part B non-emergency ambulance providers/suppliers and home health agencies, subunits and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania and New Jersey. CMS is taking this measure “to prevent and combat fraud, waste and abuse.” The moratorium also extends to the Medicaid and Children’s Health Insurance Programs (CHIP). According to CMS, the action is taken pursuant to Sections 1866(j)(7), 1902(kk)(4), and 2107(e)(1)(D) of the Social Security Act and CMS regulations at 42 CFR 424.570, which permit a temporary moratorium on the enrollment of Medicare, Medicaid, and/or CHIP providers and suppliers (including categories and/or particular geographic locations or both) where there is a significant potential for fraud, waste, or abuse.
In the announcement, CMS provided its rationale for imposing the moratorium – citing generally to a methodology involving consulting with law enforcement (the Office of Inspector General and Department of Justice) on trends and activities, and confirming this by analyzing CMS data. CMS also provided assurance that it had determined that access to care would not be a problem for beneficiaries. CMS explained that the basis for imposing the moratorium was not subject to judicial review. However, CMS also noted that the regulations did not limit the right of particular providers or suppliers to seek review of final agency decisions that the temporary moratorium applies to them.
In a long-awaited decision concerning the confidentiality of medical records and patient privacy, the Connecticut Supreme Court recently concluded that the physician-patient relationship establishes a duty of confidentiality to a patient in Connecticut, and that unauthorized disclosure of confidential information obtained for the purpose of treatment in the course of that relationship gives rise to a cause of action in tort, unless the disclosure is otherwise permitted by law.
In Byrne v. Avery Center for Obstetrics and Gynecology, P.C., the Court considered – for a second time – the legal implications arising from the defendant’s mailing of the plaintiff’s medical records in 2005 to a probate court in response to a subpoena without providing notice to the plaintiff, filing a motion to quash the subpoena, or appearing in court as requested under the subpoena. Previously, in 2014 the Court held that the Health Insurance Portability and Accountability Act of 1996 (HIPAA) did not preempt state law negligence claims arising from the alleged breach of confidentiality by the defendant in this case, and further that the HIPAA privacy and security standards can inform the applicable standard of care to the extent it is common practice in Connecticut for health care providers to comply with HIPAA. In that decision, the Court expressly reserved judgment as to whether Connecticut law actually recognized a negligence action arising from a health care provider’s alleged breach of its duty of confidentiality to a patient. In this case, the Court was tasked with resolving that question after a trial court subsequently granted summary judgment for the defendants on remand following the Court’s 2014 decision. In granting summary judgment, the trial court explained that no Connecticut court had previously recognized a common-law privilege for physician-patient communications, and that such a determination was better left to the Supreme and Appellate courts or the legislature.
On January 5, 2018, the Health and Human Services Office of Inspector General (OIG) posted a favorable Advisory Opinion, permitting an arrangement involving payment by a Medical Center to a multi-specialty physician Group for cost-reduction measures achieved through the efforts of certain Neurosurgeons, relating to the selection and use of products during spinal fusion surgeries (Program). Payment under the Program was calculated as a percentage of cost savings realized by the Medical Center over a three-year period. Though not yet paid at the time of the OIG advisory opinion, the amounts were to be paid to the Group through a Medical Center Subsidiary tasked with administering the Program, utilizing a Program Administrator. A portion of the payment made to the Group would be distributed to participating Neurosurgeons based on pre-existing contractual provisions with the Group that provided payment for personally-performed services. The Program Administrator was being paid a fixed monthly fee for services rendered, an amount not tied to cost savings or compensation paid to the Group. Continue Reading