May 12, 2014

Idaho Law re Prescribing Without an Examination

As has been widely reported, the Idaho Board of Medicine recently sanctioned a physician for prescribing a common antibiotic over the phone without a prior examination or established patient relationship. This short alert will, hopefully, clear up some of the misunderstanding caused by the media reports.

General Prohibition. Idaho Code § 54-1733 states:

a prescription drug order for a legend drug is not valid unless it is issued for a legitimate medical purpose arising from a prescriber-patient relationship which includes a documented patient evaluation adequate to establish diagnoses and identify underlying conditions and/or contraindications to the treatment. Treatment, including issuing a prescription drug order, based solely on an online questionnaire or consultation outside of an ongoing clinical relationship does not constitute a legitimate medical purpose.

(Idaho Code § 54-1733(1)). As in other states, the Idaho statute was passed to address standard of care concerns resulting from internet pharmacies and “tel-a-doctor” companies. A violation of the statute constitutes unprofessional conduct which may subject the practitioner to adverse licensure action. (Id. at § 54-1733(5)). Continue reading →

January 27, 2014

Draft of the Revised National Practitioner Data Bank Guidebook Available for Comment

by Kelly McIntosh

Marking the first update since September 2001, the Health Resources and Services Administration (“HRSA”) division of the Department of Health and Human Services (“HHS”) has issued a draft of the revised National Practitioner Data Bank (“NPDB”) Guidebook. The release of the draft Guidebook was announced in the Federal Register on December 27, 2013 and the period to submit comments to the draft is ongoing until January 31, 2014.

The revised Guidebook includes expanded and improved examples about reporting to and querying the NPDB, live links to cited statutes and regulations, and useful tables explaining NPDB policies. Also incorporated in the revised Guidebook are legislative and regulatory changes adopted since the last edition. Perhaps the most significant regulatory change incorporated in the revised Guidebook is the merger of the NPDB and the Healthcare Integrity and Protection Data Bank (“HIPDB”) which occurred on May 6, 2013 pursuant to the Patient Protection and Affordable Care Act (“ACA”).

The revised Guidebook also expands on certain areas where there has previously been uncertainty, including when an “investigation” by a health care entity has commenced. On that topic, the revised Guidebook includes additional details and examples regarding when an investigation has commenced. Specifically, the draft Guidebook provides that “an investigation is not limited to a health care entity’s gathering of facts. An investigation begins as soon as the health care entity begins an inquiry and does not end until the health care entity’s decisionmaking authority takes a final action or formally closes the investigation.” Continue reading →

January 9, 2014

Check Your Physician Contracts

by Kim Stanger

Contracts and other financial arrangements with physicians and certain other healthcare providers must be structured to comply with the federal Stark,¹ Anti-Kickback,² and Civil Monetary Penalties Laws³ if the physician will refer patients for items or services payable by Medicare, Medicaid or other healthcare programs. Failure to comply may result in overpayments; failure to report and repay such overpayments within 60 days may violate the False Claims Act, subjecting the parties to additional penalties, including treble damages, fines of $5,500 to $11,000 per claim, and exclusion from Medicare and Medicaid.⁴ Given the severe penalties for noncompliance, hospitals and other healthcare providers should ensure that their physician contracts comply.

TOP COMPLIANCE CONCERNS FOR PHYSICIAN CONTRACTS. The following are top compliance issues for services contracts with referring physicians or their family members. Many of these same rules apply to contracts with other healthcare providers who may refer patients for services covered by Medicare or Medicaid.⁵ Continue reading →

December 6, 2013

Idaho Medical Indigency Act and Patients Filing Bankruptcy

by Kirk S. Cheney

Idaho’s Medical Indigency Act (the “Act”)¹ offers significant benefits to medical providers. Idaho’s legislature enacted it in 1974 with the express intent “to allow hospitals to obtain compensation for services rendered to indigents.”² The Act requires counties to reimburse medical providers for services provided to indigent patients, provided certain conditions are met. By carefully complying with the Act, a medical provider can effectively shift collection risk to the indigent patient’s county of residence.

Not surprisingly, there is significant overlap between patients who are medically indigent and those who seek protection under the Bankruptcy Code. Accordingly, it is important for medical providers to understand how a patient’s bankruptcy may affect the provider’s rights under the Act. This article sets forth two simple rules medical providers should follow to preserve the protections of the Act in their favor, notwithstanding a patient’s subsequent bankruptcy filing. Continue reading →

November 26, 2013

Avoiding Business Associate Agreements

by Kim Stanger, Holland & Hart LLP

The HIPAA privacy rules now apply to both covered entities (e.g., healthcare providers and health plans) and their business associates. A “business associate” is generally a person or entity who “creates, receives, maintains or transmits” protected health information (“PHI”) in the course of performing services on behalf of the covered entity (e.g., consultants; management, billing, coding, transcription or marketing companies; information technology contractors; data storage or document destruction companies; data transmission companies or vendors who routinely access PHI; third party administrators; personal health record vendors; lawyers; accountants; malpractice insurers; etc.) (See 45 CFR 160.103). “A covered entity may be a business associate of another covered entity.” (Id.). Also, with very limited exceptions, a subcontractor or other entity that creates, receives, maintains or transmits PHI on behalf of a business associate is also a business associate. (Id.; 78 FR 5572). To determine if an entity is a business associate, see the attached Business Associate Decision Tree. Continue reading →

November 11, 2013

Gifts to Referral Sources and Patients

by Kim Stanger, Holland & Hart LLP

At this time of year, many healthcare professionals want to give gifts to patients, physicians, or other referral sources to show their appreciation, but doing so may violate federal and state fraud and abuse laws. Here are some guidelines to ensure your gift giving does not get you in trouble with the government.

1. Gifts To Referral Sources. The federal Anti-Kickback Statute (“AKS”) prohibits soliciting, offering, giving, or receiving remuneration in exchange for referrals for items or services covered by federal healthcare programs (e.g., Medicare and Medicaid) unless the arrangement fits within a regulatory exception. (42 USC 1320a-7b(b)). AKS violations are felonies, and may result in criminal and civil penalties, False Claims Act liability, and exclusion from Medicare and Medicaid programs. The AKS is violated if one purpose of the remuneration is to induce federal program referrals, including gifts to referring practitioners or program beneficiaries to encourage or reward their business. (OIG Adv. Op. 12-14). Moreover, the AKS applies to both the giver and recipient. The OIG has suggested that “nominal” gifts would not create much AKS risk, but offers no guidance as to what is “nominal”. (65 FR 59441). The AKS does not expressly apply to referrals for private pay business, but the OIG has warned that offering remuneration to obtain private pay referrals may also induce federal program business and thereby violate the AKS. (OIG Adv. Op. 12-06). In addition, offering gifts to induce or reward private pay business may violate state laws, including state laws prohibiting kickbacks, rebates, or fee splitting. In short, you should not give or accept gifts to or from referral sources (especially those referring federal program business) unless the gift is truly nominal, is clearly and completely unrelated to past or future referrals, or is very unlikely to influence referrals. Continue reading →

October 16, 2013

HIPAA Disclosures to Law Enforcement

by Kim Stanger, Holland & Hart LLP

As with others, the HIPAA privacy rules (45 CFR § 164.501 et seq.) generally prohibit healthcare providers (“Providers”) from disclosing protected health information to police or other law enforcement officials without the patient’s written authorization unless certain conditions are met. HIPAA allows disclosures to law enforcement in the following cases: Continue reading →

October 9, 2013

HIPAA: Responding to Subpoenas, Orders, and Administrative Demands

by Kim Stanger, Holland & Hart LLP

The HIPAA privacy rules (45 CFR § 164.501 et seq.) generally prohibit healthcare providers (“Providers”) from disclosing protected health information pursuant to subpoenas and other government demands unless certain conditions are satisfied. This outline summarizes HIPAA rules for responding to such demands. To the extent there is a more restrictive state or federal law that applies in a particular case, the more restrictive law will usually control.

SUBPOENA, COURT ORDER, WARRANT, OR ADMINISTRATIVE DEMAND. If a Provider receives a subpoena, court order, or warrant that requires the disclosure of protected health information, the Provider should do the following: Continue reading →

October 2, 2013

Home Health Care Workers to Receive Minimum Wage and Overtime Protections

By Mark Wiletsky

If your organization is in the home health field, be aware that the rules for how to pay home care workers is going to significantly change. Under a recently issued Final Rule, the U.S. Department of Labor (DOL) will extend FLSA pay protections to an estimated 1.9 million home care workers in the U.S. who currently are treated as exempt under the companionship exemption. As a result, workers who provide in-home care to ill, elderly, or disabled individuals through a third party employer will be covered by the minimum wage and overtime provisions of the Fair Labor Standards Act (FLSA) beginning January 1, 2015.

Companionship Services Exemption Narrowed

The so-called “companionship exemption,” implemented in 1975, allowed organizations employing workers who provide home care assistance to elderly, ill, injured or disabled persons to treat these workers as exempt from the federal minimum wage and overtime pay provisions. The new Final Rule narrows the exemption for companionship services in two key ways. Continue reading →

August 12, 2013

Providing Auxiliary Aids to Hearing or Visually Impaired Persons

by Kim Stanger, Holland & Hart LLP

We are often asked whether healthcare providers must provide interpreters or other auxiliary aids to persons who are hearing or visually impaired. The Americans with Disability Act (“ADA”) prohibits places of public accommodation (including private physician offices and hospitals) from discriminating against persons with disabilities. Healthcare providers must provide auxiliary aids to patients or companions of the patient (e.g., parents, spouses, or personal representatives) if doing so is necessary to ensure effective communication unless doing so would cause undue hardship or fundamentally alter the nature of the provider’s services—standards that are very difficult to prove. The fact that an appropriate auxiliary aid costs more than reimbursement for the provider’s service is not “undue hardship.” Appropriate auxiliary aids may include interpreters, video remote interpreting (“VRI”), written materials, exchange of written notes, assistive listening devices, etc. The provider should consult with the patient, but the ultimate decision as to what measures to take rests with the provider so long as the measures ensure effective communication. For simple communications involving hearing impaired persons, lip reading or using a pen and note pad may be sufficient; for communications involving complex information (e.g., discussions about significant medical issues, treatment options, or instructions), the Department of Justice (“DOJ”) has suggested that ASL interpreters may be required.

ADA regulations confirm that providers may not charge the patient for the cost of the auxiliary aids, nor may providers require the patient to bring their own interpreter or supply other auxiliary aids. Providers may not rely on adults accompanying the patient to interpret unless it is an emergency and there is no other interpreter available, or the patient requests that the adult interpret and the provider believes reliance on the adult is appropriate. Providers may not rely on minors to interpret unless it is an emergency and there is no other interpreter available. Providers may not coerce, threaten, intimidate or retaliate against a patient or their companion for requesting auxiliary aids or exercising their rights.

For more information, see the ADA regulations at 28 CFR part 36; the OCR’s website, www.hhs.gov/ocr/civilrights; or the DOJ’s ADA website, www.ada.gov. Among other things, the DOJ’s website contains information about its ongoing Barrier-Free Health Care Initiative.

Kim Stanger is the Chairman of Holland & Hart LLP’s Health Law Group. He can be reached at kcstanger@hollandhart.com or (208) 383-3913. To subscribe to Holland & Hart’s free e-newsletter or blog concerning health law issues, please e-mail Mr. Stanger.

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.