Archives: Hospitals and Health Systems

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Dumpster Diving Leads to $100,000 Fine for Defunct Business Associate Due to Improper Disposal of Medical Records

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 a shredding and recycling facility submitted a complaint concerning medical records that had been discovered in a dumpster …

Escobar Compels Florida District Court to Overturn $350 Million Jury Verdict Arising from Claims of Inadequate Documentation

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 …

CMS Announces Change to Student Documentation Requirement Intended to Reduce Burden on Teaching Physicians

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.…

CMS Considers 7-Day Limit on Initial Opioid Prescriptions under Part D

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 …

Connecticut Supreme Court Recognizes Common-Law Cause of Action for Unauthorized Disclosure of Confidential Medical Information

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 …

OIG Advisory Opinion Allows Medical Center to Share Cost Savings with Neurosurgeons for Curbing Spinal Fusion Surgery Costs

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, …

CMS Announces First Advanced Alternative Payment Model Under MACRA: Bundled Payments for Care Improvement Advanced

On January 9, 2018, the Centers for Medicare & Medicaid (CMS) Center for Medicare and Medicaid Innovation announced a new voluntary bundled payment model called Bundled Payments for Care Improvement Advanced (BPCI Advanced).  BPCI Advanced is the first Advanced Alternative Payment Model (Advanced APM) launched under the Quality Payment Program that was implemented as part of the Medicare Access and Chip Reauthorization Act (MACRA). …

CMS Issues Guidance on Texting Patient Information

On December 28, 2017, the Centers for Medicare and Medicaid Services (CMS) published a memo to state survey agency directors clarifying its position on the use of text messaging among health care providers. In its memo, CMS stated that it does not permit texting of patient orders by health care providers, as texting of patient orders does not comply with the applicable Medicare conditions of participation (COPs), specifically 42 C.F.R. § 489.24. Instead of texting patient orders, CMS states that its preference is for health care providers to either hand-write …

The Joint Commission Relaxes Process for Credentialing Independent Pathologists

Effective January 3, 2018, The Joint Commission (TJC) has revised its standards to no longer require TJC-accredited hospitals, critical access hospitals, and ambulatory care organizations to credential and privilege pathologists that provide diagnostic services through reference laboratories. TJC Introduction to Leadership Standard LD.04.03.09 generally requires that each hospital, critical access hospital or ambulatory care organization credential and privilege all licensed independent practitioners from whom it receives laboratory services under a contractual relationship. A new exception has been added to the general rule to state that the hospital, critical access hospital …

CMS Updates Hospital Compare Website

CMS recently announced updates to its Hospital Compare website. CMS provides the Hospital Compare website to give patients, their families and other health care stakeholders information on the performance of hospitals participating in Medicare. CMS also provides a star rating for each hospital to assist patients in choosing a hospital for their care. CMS updated the star rating methodology in response to feedback from hospitals and other industry stakeholders. In addition to changes to the statistical modeling used, CMS has decreased the emphasis on patient experience and increased the importance …

REMINDER: Annual Reporting Deadline Approaches for Connecticut Hospitals and Hospital Systems

Hospitals and hospital systems in Connecticut must file annual reports by January 15, 2018 describing (1) the activities of their group practices (e.g., medical foundations or faculty practice plans), and (2) their respective affiliations with other hospitals or hospital systems.

Under Section 19a-486i of the Connecticut General Statutes, hospitals and hospital systems in Connecticut are obligated to file the separate reports in writing on an annual basis with the Connecticut Attorney General (AG) and Department of Public Health (DPH).  Previously, the reports had been due by December 31 each year, …

OIG Advisory Opinion Allows Pilot Collaborative Program Proposed by Pharmaceutical Manufacturer for Medication Therapy Management Interventions

On December 11, 2017, the Health and Human Services Office of Inspector General (OIG) posted a favorable Advisory Opinion, permitting a proposed pilot Program involving a collaboration between a pharmaceutical manufacturer (the Requestor), a trade association (Association), a Medicare Advantage Part D plan (MA Plan), a Hospital System, and a Vendor.  As proposed, the program would provide new technology to allow real-time access to patient discharge information for use by MA Plan pharmacists who conduct medication therapy management (MTM) services. …

CMS Approves Laboratory Alerts to Physicians in Rare Stark Law Advisory Opinion

The Centers for Medicare & Medicaid Services (CMS) issued a rare advisory opinion (CMS-AO-2017-1) under the Stark Law (Section 1877 of the Social Security Act, codified at 42 U.S.C. § 1395) earlier this fall, addressing a proposed arrangement under which a web-based diagnostic testing portal sought to provide referring physicians with free alerts related to test results.…

FTC Granted Preliminary Injunction to Block Physician Practice Acquisition

On December 13, 2017 a magistrate judge in the U.S. District Court for the District of North Dakota granted a request of the Federal Trade Commission (FTC) and North Dakota Attorney General to preliminarily enjoin Sanford Health from completing its proposed acquisition (via its subsidiary Sanford Bismarck) of Mid Dakota Clinic, P.C., a multispecialty physician practice located in and around the cities of Bismarck and Mandan, North Dakota (see our previous analysis of the FTC’s decision to intervene here).…

OIG Rescinds Advisory Opinion Due to Requestor’s Failure to Disclose Information

On November 28, 2017, the Office of Inspector General (OIG) rescinded advisory opinion 06-04, in which it had previously determined that a charity’s (Requestor) proposal to provide assistance to financially needy Medicare beneficiaries did not warrant the imposition of sanctions. The OIG explained that “public interest requires rescission” after finding that Requestor failed to comply with earlier factual certifications that were material to the original advisory opinion.

Under the program, the Requestor provides assistance with premiums and cost-sharing obligations for patients with two specific chronic diseases. Most of the …

CMS Releases 2018 OPPS/ASC Payment Systems Final Rule

The Centers for Medicare and Medicaid Services (CMS) issued the 2018 Medicare: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs Final Rule with comment period, scheduled to be published in the Federal Register on November 13, 2017. The Final Rule, effective January 1, 2018, includes the following changes to Medicare payment rates and policies, among others:

  • Increased Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment Rates. CMS is increasing the payment rates under the OPPS by 1.35 percent for CY 2018.

FDA Issues Guidance on Hurricane Readiness for Medical Devices

The U.S. Food & Drug Administration (FDA) has issued important guidance on how to prepare for hurricanes when dependent on medical devices.  FDA stresses that during hurricanes and other emergency situations, medical devices may be exposed to fluctuating power, contaminants, or unusual levels of heat or humidity. The guidance links to pages providing information on the use of medical devices during and during emergency situations and afterwards, including:

CMS Proposes to Cancel EPM and CR Bundled Payment Programs and to Reduce Mandatory Participation in CJR Model

The Centers for Medicare and Medicaid Services (CMS) recently published a proposed rule (Proposed Rule) to scale back its mandatory bundled payment programs. Under the Proposed Rule, CMS would cancel the episode payment models (EPMs) and cardiac rehabilitation incentive payment model (CR), and it would also reduce the mandatory participation in the comprehensive care for joint replacement model (CJR). CMS stated that it believed the proposed changes are necessary because the continued mandatory participation in bundled payment models may impede CMS’s ability to engage providers in future, voluntary initiatives. CMS …

No Right to Union Representation for Non-Mandatory Participation in Peer Review Proceedings – DC Circuit Court Overrules NLRB

Most states, including Connecticut and Massachusetts, have laws that allow hospitals and other health care institutions to establish confidential peer review programs to oversee the quality of care provided by their health care professionals without the threat those proceedings will be subject to discovery.  Menorah Medical Center (“Menorah”), in Kansas, had such a program for its nurses.  The Peer Review Committee (“Committee”) would investigate allegations of substandard care and, if substantiated, report the breach to the Kansas Board of Nursing.…

OIG Settles EMTALA Allegations Involving Psychiatric Care

On June 2, 2017, AnMed Health and the Office of Inspector General (OIG) for the United States Department of Health and Human Services agreed to a $1.295 million settlement of allegations that AnMed had violated the Emergency Medical Treatment & Labor Act (EMTALA) (Section 1867 of the Social Security Act). The OIG alleged that AnMed failed to provide appropriate medical screening and stabilizing treatment to individuals presenting to the ED with unstable psychiatric emergency medical conditions.…

FTC Intervenes in Physician Practice Acquisition in North Dakota

On June 22, 2017 the Federal Trade Commission (FTC) filed an administrative complaint and a request for a preliminary injunction in federal court to block a proposed physician practice acquisition in North Dakota (the Transaction), the agency’s latest intervention in opposition to consolidation at the physician practice level. In this case, the FTC (accompanied by the Attorney General of North Dakota) opposes a proposed acquisition of Mid Dakota Clinic, P.C. (MDC) by Sanford Bismarck (a subsidiary of multi-state health system Sanford Health, collectively Sanford) on the grounds that the Transaction, …

OIG Publishes Prioritized Recommendations for HHS

The OIG has released the 2017 Compendium of Unimplemented Recommendations, summarizing prioritized recommendations relating to HHS programs and operations.   Topping the list are recommendations relating to hospitals, including:

  • Reimbursement rates for critical access hospital swing beds should be adjusted to the lower rates for similar services provided in skilled nursing facilities.
  • Reimbursement rates for hospital outpatient department procedures should be adjusted to the lower rates for similar procedures conducted in ambulatory surgical centers.
  • Medicare should adopt a hospital transfer payment policy to lower hospital reimbursement for beneficiaries who are
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