Cole County Circuit Court enters final judgment in Missouri Hospital Association, et al., v. Dept. of Social Services, et al., No. 15AC-CC00300 (Cole Co. Circuit Court, Dec. 30, 2015).
MHA, along with Citizens Memorial Hospital in Bolivar, filed suit in June to block MO HealthNet’s attempt to require that all claims for outpatient drugs submitted on or after July 1 be accompanied by the applicable National Drug Code. The plaintiffs sought an injunction on the grounds that the agency could not impose a regulatory requirement via provider bulletin and that it had not met the statutory requirements for an emergency rule. The court granted a temporary restraining order on June 30 and issued a preliminary injunction on July 10. During subsequent settlement negotiations, the department agreed to extend the deadline for requiring NDC information to April 1, 2016, and to revise the language of its final rule to exempt 340B facilities from the requirement. After submission of the parties’ agreement, the court issued its final judgment on Dec. 30, 2015.
Missouri Hospital Among Others Challenging Two-Midnight Rule
Pemiscot Memorial Health Systems joined with more than 50 other hospitals nationwide in the latest legal challenge to the two-midnight rule. The rule requires that a patient’s hospital stay must span two midnights to be considered an inpatient admission. The Centers for Medicare & Medicaid Services cut Medicare reimbursement rates by .2 percent to offset the costs of an anticipated increase in admissions. The suit asserts that the agency’s assumptions regarding increased inpatient stays were flawed and that CMS violated the Administrative Procedure Act by imposing the rule without the opportunity for notice and comment.
The action is the fourth challenge to the rule, with more to come as hospitals who have contested the rule through federal administrative processes are granted the right to pursue their theories in court. Last fall, in response to a suit filed by the American Hospital Association and others, a federal judge ordered the U.S. Department of Health & Human Services’ Secretary Sylvia Burwell to provide further justification for the rule and an opportunity for hospitals to comment. The present suit will likely be stayed until the outcome of the previous matter.
The Health Insurance Portability and Accountability Act, better known as HIPAA, protects individuals’ health information from inappropriate uses or disclosures. The law establishes standards for the release of protected health information by covered entities, which include health care providers, health plans and health care clearinghouses (such as medical billing services). Protected health information includes medical information in both printed and electronic form. In addition to the privacy rule, which governs the disclosure of protected health information, HIPAA security regulations require covered entities to maintain certain physical plant and electronic standards to guard against inappropriate access to PHI. For a summary of the HIPAA Privacy Rule, please visit the U.S. Department of Health & Human Services' website.
OCR Guidance on Reasonable Charges for Patient Access to PHI
The Office of Civil Rights recently issued guidance regarding a patient’s ability to access his or her PHI, which may limit the fees providers can charge for supplying patients with copies of their medical records. The Privacy Rule authorizes covered entities to charge a reasonable, cost-based fee to individuals requesting access to their own PHI. According the rule, the fee may only include the cost of labor for copying the records (whether in paper or electronic form), supplies for creating the records (paper or electronic media) and postage if the individual has requested that the records be mailed. 45 C.F.R. § 164.524(c)(4).
The guidance goes on to state that charges associated with searching for and retrieving PHI, or maintaining systems or infrastructure to store PHI, are prohibited, even if such charges are authorized by state law. Section 191.227.2(1)(a), RSMo currently authorizes search and retrieval fees of $24.57, and additional labor costs of $23.00 if the materials are stored offsite. The statute permits a $0.56 per page charge for the cost of “supplies and labor.”
OCR would likely view Missouri’s search and retrieval fees as prohibited by the Privacy Rule. And, while HIPAA authorizes a “reasonable, cost-based fee” for the labor and supplies necessary to copy records, the Missouri statute would arguably limit those charges to $0.56 per page. OCR limits those fees to actual costs incurred.
OCR released FAQs with its new guidance, in which it states that the limits also apply when an individual directs that his or her PHI be sent directly to a third party. However, when a third party directly requests PHI from a provider on the basis of a written HIPAA authorization from the individual, the fee limitations would not apply.
Change in HIPAA Privacy Rule to Allow Disclosures to Criminal Background Check System
On Jan. 6, the U.S. Department of Health & Human Services filed its final rule implementing the latest changes to the HIPAA privacy rule. The rule authorizes certain covered entities to disclose to the National Instant Criminal Background Check System PHI of individuals subject to a federal “mental health prohibitor” disqualifying them from possessing, receiving, shipping or transporting a firearm. Under the Gun Control Act of 1968, mental health prohibitors apply to an individual who has been involuntarily committed to a mental health facility, lawfully found to be a danger to his/herself or others, incompetent to stand trial or manage his/her own affairs or the subject of a not guilty verdict by reason of insanity.
The new rule applies to only two types of covered entities — those with legal authority to adjudicate or make commitment decisions that render individuals subject to the federal mental health prohibitor and those that are repositories of NICS reporting information. Such entities would generally include state agencies, such as mental and public health departments. The narrow scope of the rule came in response to comments expressing concern that the rule would discourage individuals from seeking mental health treatment. The rule also limits the disclosures to information needed for NCIS purposes and prohibits disclosure of clinical or diagnostic information. Finally, while the rule allows for such disclosures, it does not mandate that covered entities report to the NCIS. Covered entities are not authorized to report individuals subject to a state mental health prohibitor.
The Missouri Society of Health Care Attorneys is a personal membership group of the Missouri Hospital Association. MSHCA was formed in 1981 and remains a robust network of approximately 150 health care attorneys across the state. Its members practice in every facet of health care, as in-house counsel, state regulatory officials and in law firms large and small. MHA’s General Counsel and Vice President of Legal Affairs serves as a permanent member of the board, and the office provides ongoing operational support for the group.
MSHCA is governed by a board of directors and supported by various committees. The group holds a day-long, health-law seminar each November in conjunction with the MHA Convention and Trade Show. The keynote session, known as the Holderle Lecture, attracts dynamic national speakers on emerging issues in health law. The remaining sessions cover topics applicable to various aspects of health care practice. MSCHA also partners with the MoBar Health and Hospital Law Committee to provide joint programming at the spring and fall committee meetings.
MSHCA members have access to various MHA publications, including MHA Today, a daily publication of health care news. MHA Today includes links to relevant documents and additional educational materials. MHA, with MSHCA support, publishes other documents focusing on Missouri health law.
Membership in MSHCA is a cost effective way to receive health care education and information from MHA. If you are interested in joining or would like additional information, please contact MHA’s General Counsel Jane Drummond or her assistant Tammy Siebert.