House Bill 1040 is now headed to the South Dakota Governor’s desk.  The Bill, which passed the SD Senate on February 7, adds “community living home” to the definition of a regulated health care facility, bringing such facilities under the guise of South Dakota’s laws and regulations governing health care institutions under Title 34 of the South Dakota Code.

The Bill defines a “community living home” as any family-style residence whose owner or operator is engaged in the business of providing individualized and independent residential community living supports for compensation to at least one unrelated adult, but no more than four, and provides one or more regularly scheduled health related services, either administered directly or in collaboration with an outside health care provider.

If signed, the Bill will require operators of community living homes to apply for and receive a license prior to commencing operation.

On April 13, 2016, the South Dakota Supreme Court issued an important opinion in Berry Thomas Pitt-Hart, MD v. Sanford USD Medical Center.  The Pitt-Hart case involved a patient who had knee surgery at Sanford USD Medical Center (“Sanford”) on November 10, 2009.  The day after surgery, he alleged he was dropped and injured due to the negligence of a patient-care tech.  He commenced suit against Sanford on September 14, 2012.  Sanford argued that the claim was barred by SDCL 15-2-14.1’s two year limitations period.

The patient tried to circumvent the reach of SDCL 15-2-14.1 in three ways.  First, he argued that, since his claim was based upon the simple negligence of a tech, not the negligence of a health care practitioner like a surgeon negligently completing a procedure or a physician making the wrong diagnosis, the traditional, longer, three year negligence statute of limitations should apply.  The Court rejected this argument, reasoning that when a defendant like a hospital is named, SDCL 15-2-14.1 applies to all the alleged “errors” and “mistakes” committed in the healthcare setting.

Next, the patient argued that SDCL 15-2-14.1 should have been tolled based upon Sanford’s fraud and estoppel.  In prior case law, the South Dakota Supreme Court had gone back and forth in referring to SDCL 15-2-14.1 as a period of limitations on some occasions, and of repose on others.  Here, the Court took the opportunity to clarify and confirm that SDCL 15-2-14.1 is a statute of repose that cannot be delayed by estoppel, tolling, or fraudulent concealment.  Per SDCL 15-2-14.1, two years after a medical error or mistake occurs, liability “no longer exist[s].”

Lastly, the patient argued that SDCL 15-2-14.1 should be tolled based upon the continuing treatment doctrine.  The South Dakota Supreme Court also rejected this argument, clarifying that South Dakota does not recognize a continuing treatment doctrine, but only a continuing tort theory that could delay the start of the statute of repose “(1) [when] there was a continuous and unbroken course of negligent treatment; and, (2) [when] the treatment was so related as to constitute one continuing wrong.”

The full version of the Pitt-Hart opinion can be found here:

http://ujs.sd.gov/uploads/sc/opinions/27568.pdf

SDCL 15-2-14.1 can be found here:

http://sdlegislature.gov/Statutes/Codified_Laws/DisplayStatute.aspx?Type=Statute&Statute=15-2-14.1

Although we are well under way into the new year, health care providers, health care vendors, technology companies, and group health plans should all take additional time to consider and evaluate their health IT security and privacy program.  2017 promises to be a year filled with news of additional data breaches and compliance updates to the Security Rule.

If your company is evaluating or updating its security and privacy programs, a thorough risk analysis is the key starting point. Continue Reading Risk Analyses Remain of Crucial Importance to Health IT Programs

On Wednesday, February 1, the South Dakota House of Representatives defeated HB 1003, a bill that would have allowed licensed nursing facilities to transfer nursing bed capacity to another facility.  The Bill would have required the transferee to license the transferred or purchased beds within twenty-four (24) months of the transfer or sale.

While the Bill’s sponsor sought to add “a little bit of free enterprise” to the nursing facility industry in South Dakota, opponents of the Bill feared that the ability to freely transfer nursing bed capacity would disadvantage rural areas of South Dakota in favor of more populous areas where residents are more likely to be private-pay residents as opposed to Medicaid recipients.

Another 2017 Bill the Health Care Group is watching is Senate Bill No. 61.  The Bill makes numerous amendments to South Dakota’s statutory scheme governing nurse practitioners and midwives.

Of the more important changes, SB 61 would broaden the scope of advanced practice nursing and medical functions of nurse practitioner and nurse midwives.  Under SB 61, nurse practitioners and nurse midwives would be able to prescribe, procure, administer, and furnish pharmacological agents, including over the counter, legend, and Schedule II controlled drugs or substances for indefinite periods of time as opposed to the 30-day limit currently imposed.  Additionally, nurse practitioners would be allowed to conduct physical examinations for the determination of participation in employment duties and not just athletics.  Nurse midwives’ functions would add managing sexually transmitted infections in males.

Continue Reading 2017 South Dakota Legislative Session Update – Senate Bill 61 – Nurse Practitioners and Nurse Midwives

As a part of the 2017 legislative session, South Dakota lawmakers are considering a number of bills affecting the health care industry in the state.  Senate Bill 49 is one Bill the Health Care Group is monitoring that will affect the regulation of independent emergency health care providers in the State.  The Bill seeks to amend current South Dakota law to include a ‘free standing emergency medical care facility’ under the same definition of ‘health care facility’.  A freestanding emergency medical care facility is defined in the Bill as any facility structurally separate and distinct from a hospital that directly receives a person and provides emergency medical care.  By including these freestanding facilities within the general definition of ‘health care facility’, independent emergency departments are brought under the guise of South Dakota’s statutory and regulatory scheme governing hospitals and related institutions.  It is worth mentioning that the Bill exempts those freestanding facilities that are certified as a department of a hospital.

On January 25, the Bill passed the Senate by a vote of 34 to 1.  On January 26, the Bill was first read in the House and was referred to the Health and Human Services Committee.  Stay tuned as this Bill makes its way through the legislature.

In a blog post on January 17, CMS reported a reduction in avoidable hospital stays for long-term care residents.

Beginning in 2010, the blog reported, the rate of potentially avoidable hospitalizations of patients who were both Medicare beneficiaries and eligible for Medicaid benefits living in long-term care facilities was 227 per 1,000 beneficiaries.  By 2015, the rate had decreased to 157 per 1,000 beneficiaries. CMS reported that such a reduction avoided 133,000 hospitalizations over the past five years.

CMS attributed the reduction to various factors including the 2011 initiative by Medicare-Medicaid Coordination Office aimed at focusing on preventable conditions that lead to hospitalizations as well as the Agency for Healthcare Research and Quality Safety Program for Long-Term Care.

“This success shows that a sustained commitment to smarter spending across the entire health care system can yield dramatic results and improve the lives of vulnerable Americans,” the blog concluded.

On January 18, 2017, OCR announced a settlement with MAPFRE Life Insurance Company of Puerto Rico.  A USB data storage device containing protected health information of 2,209 individuals was stolen from MAPFRE’s IT department where the device was left overnight.  In the Resolution Agreement, OCR found that MAPFRE failed to conduct an accurate and thorough assessment of the potential risks and vulnerabilities of the confidentiality, integrity, and availability of MAPFRE’s electronic protected health information and failed to implement security measures sufficient to reduce the risks and vulnerabilities to a reasonable and appropriate level.  OCR further found that MAPFRE failed to implement a security and awareness training program for its workforce as well as failed to implement a mechanism to encrypt electronic PHI.

As a part of the Resolution Agreement, MAPFRE agreed to pay HHS over $2.2 million dollars and agreed to comply with a three (3) year corrective action plan.

The settlement once again shows the importance of ensuring electronic PHI is secured and encrypted and that a covered entity or business associate must implement reasonable and appropriate security measures to protect such electronic PHI.

A covered entity has settled potential violations of HIPAA’s breach notification rule by paying $475,000 and implementing a corrective action plan.  On January 9, 2017, OCR announced a HIPAA settlement with Presence Health based on the untimely reporting of a breach of unsecured protected health information.  Presence Health is a major health care network serving the State of Illinois and consists of approximately 150 locations, including 11 hospitals and 27 long-term care and senior living facilities.

Presence Health reported, on January 13, 2014, a HIPAA breach that occurred on October 22, 2013.  OCR’s investigation found that Presence Health failed to notify, without unreasonable delay within 60 days of discovery of the breach, the individuals affected by the breach, OCR, and the media, all as required by the HIPAA regulations.

OCR’s enforcement action shows the importance of timely reporting of breaches of unsecured protected health information and the need for covered entities to have policies and procedures in place to ensure timely notification.

As the sun set on 2016, a federal judge in Texas issued a preliminary injunction preventing HHS from enforcing HHS’s new regulations enforcing and interpreting Section 1557 of the Affordable Care Act’s prohibition against “sex” discrimination.

In May, 2016, the Office of Civil Rights issued its Final Rule implementing Section 1557 of the ACA.  Generally, Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age, or disability by health care providers receiving federal financial assistance.  In interpreting Section 1557, OCR, in the Final Rule, clarified that the sex discrimination that is prohibited under Section 1557 included discrimination based on (1) an individual’s sex; (2) pregnancy, including termination of a pregnancy; (3) gender identity; and (4) sex stereotyping.

The Court, in issuing the injunction, stated that HHS’s interpretation of sex discrimination, as appearing in the Final Rule, was overbroad, and that if Congress intended to broaden the definition to include other interpretations other than “biological gender”, it would have done so.

While the injunction’s impact does not affect numerous other provisions or prohibitions under Section 1557, it prevents HHS from taking actions against health care providers for claims of discrimination based on gender identity or termination of a pregnancy.

Health care providers must still comply with the provisions of Section 1557 that remain unaffected by the injunction.  Additional litigation on this issue is anticipated and presently occurring.