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This publication is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal or financial advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This publication is not intended to create an attorney-client relationship between you and Holland & Hart LLP. Substantive changes in the law subsequent to the date of this publication might affect the analysis or commentary. Similarly, the analysis may differ depending on the jurisdiction or circumstances. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.
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HIPAA Privacy Rule Modified to Permit Covered Entities to Make Certain Limited Disclosures to the National Instant Criminal Background System
/in HIPAAby Teresa Locke, Holland & Hart LLP
On Tuesday, January 6, 2016, the U.S. Department of Health and Human Services (the Department) issued a final rule, effective February 5, modifying the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to expressly permit – but not require – certain HIPAA covered entities to disclose to the National Instant Criminal Background System (NICS) certain personal health information (PHI) related to individuals who are subject to a Federal “mental health prohibitor” that disqualifies them from shipping, transporting, possessing, or receiving a firearm. Among the persons subject to the Federal mental health prohibitor established under the Gun Control Act of 1968 and implementing regulations issued by the U.S. Department of Justice are individuals who have been: (a) involuntarily committed to a mental institution; (b) found incompetent to stand trial or not guilty by reason of insanity; or (c) otherwise determined by a court, board, commission, or other lawful authority to be a danger to themselves or others or to lack the mental capacity to contract or manage their own affairs as a result of marked subnormal intelligence or mental illness, incompetency, condition, or disease. Fearing that States might not be fully reporting relevant information to the NCIS because of actual or perceived barriers related to HIPAA, the Department enacted the revision to the Privacy Rule by adding a new category of permitted disclosures to 45 CFR 164.512(k). The new rule is narrowly tailored to appropriately balance public safety goals with important patient privacy interests to ensure that individuals are not discouraged from seeking voluntary treatment for mental health issues.
The new category of permitted disclosures is very limited in scope, applying only to a specific subset of HIPAA covered entities who, under narrow circumstances, may provide discrete personal health information to the NICS. Specifically, the new rule is limited in three ways. First, it applies only to covered entities involved in ordering involuntary commitments or other adjudications that make an individual subject to the Federal mental health prohibitor. It does not apply to disclosures about individuals who are subject to state-only mental health prohibitors. Moreover, the Federal mental health prohibitor does not apply to individuals in a psychiatric facility for observation or who have been admitted voluntarily. Thus, the new rule does not create a permission for most treating providers to disclose PHI about their own patients for these purposes. The Department recognized that encouraging voluntary treatment is critical to ensuring positive outcomes for individuals’ health as well as the public’s safety. The new rule was designed to balance that goal with public safety interests served by the NICS. Read more
Physician Timeshare Arrangements: New Stark Option for Sharing Space with Visiting Specialists and Others
/in Fraud and Abuseby Kim C. Stanger, Holland & Hart LLP
Recent Stark law amendments will make it easier for physicians to share space, and for hospitals to provide space, equipment, and services to visiting specialists and other physicians on a non-exclusive, “as-needed” basis. Hospitals and physicians may want to review their current lease arrangements to determine whether the new exception is a better fit for their current or future relationships and, if so, structure their arrangements accordingly.
Prior Law. The federal Ethics in Patient Referrals Act (“Stark”) generally prohibits physicians from referring patients for certain designated health services (“DHS”) payable by Medicare to entities with which the physician has a financial relationship unless the relationship is structured to fit within a regulatory safe harbor. (42 USC 1395nn; 42 CFR 411.353). Providing space or equipment to a referring physician generally creates a financial relationship that triggers Stark1; consequently, such arrangements generally needed to be structured to satisfy Stark safe harbors for leases of space or equipment. Unfortunately, those safe harbors required, among other things, that the physician enter a formal lease that provided for exclusive use of the leased premises or equipment during defined lease terms (42 CFR 411.357(a)-(b)); the physician and lessor were generally not permitted to share space or equipment during the lease term, nor could the lease be on an “as needed” basis. Traditional timeshare arrangements in which physicians share space or equipment on a non-exclusive basis did not satisfy Stark, thereby forcing physicians and their landlords to enter formal, inefficient, and sometimes impractical lease arrangements. Read more
Medicare Issues Final Rule Requiring Bundled Payments for Inpatient and Post-Acute Care Services for Hip and Knee Replacements in 67 Geographic Regions
/in Health Care Reformby Pia Dean, Holland & Hart LLP
On November 16, 2015, The Centers for Medicare & Medicaid Services, CMS, issued a finalized rule requiring bundled payments for all lower extremity replacement and reattachment surgeries for Medicare fee-for-service beneficiaries in 67 geographic locations. The new payment model covers all Part A and B services provided to eligible beneficiaries for DRGs 469 (major joint replacement or reattachment of lower extremity with major complications or comorbidities) and 470 (major joint replacement or reattachment of lower extremity without major complications or comorbidities). The bundled payment program includes all items and services during the initial hospitalization and within 90 days of discharge. In addition to physician and inpatient hospital services, the bundled payment includes all services received in an inpatient psychiatric facility, long-term care hospital, inpatient rehabilitation facility, skilled nursing facility, home health agency, hospital outpatient setting, independent outpatient therapy, clinical laboratory, as well as durable medical equipment, Part B drugs, and hospice.
As initially proposed in July 2015, the bundled payment program would have started on January 1, 2016 and been implemented in over 800 hospitals in 75 geographic reasons having populations of more than 50,000 people. The finalized rule scales back the program to 67 geographic regions with a start date of April 1, 2016. Despite these concessions, CMS’ bundled payment initiative, called the Comprehensive Care for Joint Replacement (CJR), is a significant change to Medicare’s reimbursement policy. CMS’ previous bundled payment initiatives – most notably the Bundled Payment for Care Improvement (BPCI) Initiative – were voluntary, allowing only those hospitals, post-acute care facilities, and physician groups who wished to be involved to participate. Read more
TRICARE Claims Processing Suspension
/in TRICAREby Ellen Bonner, Callaway Bonner Law LLC (Guest Author)
Warning: TRICARE Claims Processing Suspension May Occur During Health Care Fraud Investigations for Compounding Pharmacy Prescriptions
Yesterday, the Wall Street Journal (WSJ) reported on a significant federal investigation regarding compounding pharmacies and compound pharmaceutical prescriptions for TRICARE beneficiaries in at least four states. TRICARE, the federal health benefit program under the Defense Health Agency, provides health care benefits for more than 9.5 million current and retired members of the uniformed services and their families. TRICARE health care fraud allegations can result not only in civil and criminal sanctions, but also in TRICARE claims processing temporary suspensions, as well as provider exclusion and termination from TRICARE and other federal healthcare programs.
Health Care Fraud: Civil and Criminal Action
According to the WSJ there were four civil fraud settlements by Florida pharmacies last month that will soon be reported. These settlements – amounting to $12.8 million – are based upon allegations of falsely billing TRICARE for expensive pharmaceutical creams and gels to treat pain, scars, and other ailments. The WSJ reported that federal prosecutors are pursuing “numerous criminal investigations,” and the U.S. Attorney for the Middle District of Florida anticipates filing criminal charges in early 2016 against pharmacies, drug marketers, and physicians cited in the settlements. Separate Justice Department investigations on compounding pharmacies are ongoing in California, Mississippi, and Texas. Read more
Responding to HIPAA Breaches
/in HIPAAby Kim C. Stanger, Holland & Hart LLP
HIPAA privacy and security breaches can result in fines of $100 to $50,000 to covered entities (including healthcare providers and health plans) and their business associates. (45 CFR 160.404). If the violation resulted from “willful neglect”, the Office for Civil Rights (“OCR”) must impose a mandatory fine of $10,000 to $50,000. (45 CFR 160.404). To make matters worse, covered entities and their business associates must self-report breaches of unsecured protected health information (“PHI”) to the affected individual and to HHS (45 CFR 164.400); failure to do so may constitute “willful neglect” resulting in additional fines. The good news is that the OCR may not impose a fine so long as the covered entity or business associate did not act with “willful neglect” and corrected the problem within 30 days. (45 CFR 160.410(b)).
Responding to Possible Breaches. Given the potential consequences, it is critical that covered entities and business associates respond appropriately to potential HIPAA breaches to avoid or minimize their liability. Below are steps that you may follow to help you identify and timely respond to HIPAA breaches. Read more