October 10, 2016

Office of the National Coordinator for Health Information Technology Issues Formal Guidance for Selecting and Negotiating Contracts with Electronic Health Record Vendors

by Teresa Locke, Holland & Hart LLP

On September 26, 2016, the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) released a practical and straightforward tool to assist health care providers as they select and negotiate the acquisition of an electronic health record system (EHR). The document’s title accurately encapsulates the content of the 53-page guide: “EHR Contracts Untangled: Selecting Wisely, Negotiating Terms, and Understanding the Fine Print.” The guide can be found at https://www.healthit.gov/sites/default/files/EHR_Contracts_Untangled.pdf. The new contract guide explains important concepts in EHR contracts and includes example contract language to help providers and health administrators in planning to acquire an EHR system and negotiating contract terms with vendors. Continue reading

October 4, 2016

Check Your Business Associate Agreements: OCR Tags Health System for Outdated BAA

By Kim Stanger, Holland & Hart LLP

The Office for Civil Rights (“OCR”) continues to emphasize the need for covered entities and business associates to have compliant business associate agreements (“BAAs”). Last week, the OCR announced a $400,000 settlement with a hospital system for failing to update its BAAs to include terms required by the 2013 HIPAA Omnibus Rule. In a press release, OCR Director Jocelyn Samuels stated,

This case illustrates the vital importance of reviewing and updating, as necessary, business associate agreements, especially in light of required revisions under the Omnibus Final Rule …. The Omnibus Final Rule outlined necessary changes to established business associate agreements and new requirements which include provisions for reporting.”

See Press Release here. Earlier this year, the OCR entered settlement agreements of $1,550,000 and $750,000 based on the covered entity’s failure to execute BAAs where the business associate had experienced a data breach. See reported settlements at https://www.hhs.gov/hipaa/newsroom/index.html. The lesson is clear: covered entities must have BAAs, and those BAAs must contain the required terms; failure to do so may subject the covered entity to liability for the business associate’s breach. Continue reading

September 13, 2016

Idaho Board of Medicine Disavows the Corporate Practice of Medicine Doctrine

By Kim Stanger, Holland & Hart LLP

For decades, the Idaho Board of Medicine took the position that, with limited exceptions, the Idaho Medical Practice Act “prohibits unlicensed corporations and entities from hiring physicians as employees to provide medical services to patients.” Memo from J. Uranga to Idaho State Bd. of Medicine dated 2/26/07. This “corporate practice of medicine doctrine” had its Idaho foundation in a 1952 Idaho Supreme Court case which held that:

[n]o unlicensed person or entity may engage in the practice of the medical profession though licensed employees; nor may a licensed physician practice as an employee of an unlicensed person or entity. Such practices are contrary to public policy.

Worlton v. Davis, 73 Idaho 217, 221 (1952). The Board of Medicine warned that violations of the doctrine may result in disciplinary action against physicians and, more recently, physician assistants. Entities that improperly employed physicians or physician assistants risked the possibility of criminal action for the unauthorized practice of medicine.

Over the years, the corporate practice of medicine doctrine has been criticized as anachronistic and inconsistent with recent legislative action. See, e.g., M. Gustavson and N. Taylor, At Death’s Door—Idaho’s Corporate Practice of Medicine Doctrine, 47 Idaho L. Rev. 480 (2011). Continue reading

July 6, 2016

Providers Must Post New Nondiscrimination Notices

By Kim Stanger, Holland & Hart LLP

Under the new ACA Nondiscrimination Rules, covered entities (including most healthcare providers) must post and publish new mandatory nondiscrimination statements and taglines by October 16, 2016.

1. Notice of Nondiscrimination + Taglines: Facility, Website, and Significant Publications. The new mandatory “Notice of Nondiscrimination” must inform persons that:

  1. the covered entity does not discriminate on the basis of race, color, national origin, sex, age, or disability in its health programs and activities;
  2. the covered entity provides appropriate auxiliary aids and services, including qualified interpreters for individuals with disabilities and information in alternate formats, free of charge and in a timely manner, when such aids and services are necessary to ensure an equal opportunity to participate to individuals with disabilities;
  3. the covered entity provides language assistance services, including translated documents and oral interpretation, free of charge and in a timely manner, when such services are necessary to provide meaningful access to individuals with limited English proficiency;
  4. how to obtain the aids and services described above;
  5. if the covered entity has fifteen or more employees, identification of, and contact information for, the employee responsible for coordinating the covered entity’s compliance as required by the regulations;
  6. if the covered entity has fifteen or more employees, the availability of the grievance procedure required by the regulations and how to file a grievance; and
  7. how to file a discrimination complaint with the Office for Civil Rights (“OCR”).

(45 C.F.R. § 92.8(a) and (b)(1)). HHS has published a sample Notice of Nondiscrimination, which is available here. Although HHS encourages entities to post the Notice of Nondiscrimination in languages other than English, covered entities are not required to do so. Continue reading

June 14, 2016

New ACA Anti-Discrimination Rules: Language Assistance for Non-English Speakers

By Kim Stanger, Holland & Hart LLP

On May 18, 2016, HHS published its final rules implementing the anti-discrimination provisions of the Affordable Care Act § 1557. This is the first of several alerts discussing aspects of the new rule: this alert focuses on those provisions requiring language assistance for persons with limited English proficiency; future alerts will cover rules related to sex discrimination and persons with disabilities. The new language assistance rules build on but extend beyond HHS’s 2003 Guidance Regarding Limited English Proficient Persons, 68 F.R. 47311 (“LEP Guidance”).

Application. The new rules apply to any entities (“covered entities”) that operate a health program or activity that receives federal financial assistance under programs operated by HHS, including but not limited to Medicaid or Medicare parts A, C and D, but excluding Medicare Part B. (45 C.F.R. § 92.2(a); 81 F.R. 31383). Among others, the rule applies to hospitals, clinics, medical practices, solo practitioners, nursing homes, or other healthcare entities that participate in federal programs other than Medicare Part B. (81 F.R. 31384-85). Covered entities are not required to comply if doing so would violate applicable federal statutory protections for religious freedom and conscience. (45 C.F.R. § 92.2(b)). Also, the regulations do not apply to employment discrimination. (45 C.F.R. § 92.101(a)(2)). Continue reading

June 9, 2016

New ACA Nondiscrimination Rules: Protecting Individuals Against Sex Discrimination

By Patricia Dean, Holland & Hart LLP

On May 18, 2016, HHS published its final rules implementing the anti-discrimination provisions of the Affordable Care Act § 1557. This is the third of three alerts discussing various aspects of the new rules. This alert focuses on the rules protecting individuals against discrimination based on sex. The first alert (available here) focused on the rules’ requirement for language assistance for persons with limited English proficiency. The second alert (available here) focused on the rules ensuring protections for individuals with disabilities. The final rule goes into effect on July 18, 2016.

Relationship to Other Laws. Section 1557 is the first federal civil rights law to prohibit discrimination “on the basis of sex” (including gender identity and sex stereotyping) in covered health programs and activities. In doing so, it builds on HHS Titles VII and IX, and federal case law to clarify what constitutes sex discrimination and prohibit specific discriminatory practices. It does not preempt or alter other laws, and providers must continue to comply with other state and federal laws in addition to the new ACA nondiscrimination rules. Continue reading

June 6, 2016

New ACA Nondiscrimination Rules: Assistance for Persons with Disabilities

by Teresa Locke, Holland & Hart LLP

On May 18, 2016, HHS published its final rules implementing the anti-discrimination provisions of the Affordable Care Act § 1557. This is the second of three alerts discussing various aspects of the new rules. This alert focuses on the rules ensuring protections for individuals with disabilities. The first alert – published on May 26 – focused on the rules’ requirement for language assistance for persons with limited English proficiency. The third and final alert – to be issued in the near future – will cover rules related to sex discrimination.

Relationship to Other Laws. The final rules are consistent with existing directives implementing the requirements already existing under the Americans with Disabilities Act (“ADA”) and Section 504 of the Rehabilitation Act of 1973 (“Section 504). Nothing in the new rules should be interpreted to invalidate or limit the rights, remedies, procedures, or legal standards available to disabled persons under the ADA or Section 504. Accordingly, entities must ensure compliance with existing laws in addition to the new ACA rules, including state laws that may be more restrictive than the ACA regulations. Continue reading

May 23, 2016

Charging Patients for Copies of Their Records: OCR Guidance

by Kim C. Stanger, Holland & Hart LLP

HIPAA generally gives patients or their personal representative the right to access or obtain copies of the patient’s protected health information (“PHI”) in their designated record set1, and limits the amount that providers may charge patients for PHI to a reasonable cost-based fee. (45 CFR 164.524). In February 2016, the OCR issued guidance (“Guidance”) which clarifies allowable fees and identifies additional actions providers should take when charging fees. The OCR’s Guidance may be accessed here.

Allowable Charges. The OCR confirmed that a provider may only charge the patient or personal representative for the following:

1. Labor for copying the requested PHI, whether in paper or electronic form. This includes only the labor for actually creating and delivering the paper or electronic copy in the form and format requested or agreed upon by the patient once the responsive information has been identified, retrieved, collected, compiled and/or collated. For example, allowable costs may include photocopying paper PHI; scanning paper PHI into an electronic format; converting electronic PHI in one format to the format requested by or agreed to by the patient; creating and executing a mailing or e-mail with the responsive PHI; and/or uploading, downloading, attaching, burning, or otherwise transferring electronic PHI from a provider’s system to portable media, e-mail, app, personal health record, web-based portal (where the PHI is not already maintained in or accessible through the portal), or other manner of delivery of the PHI. (See also 78 FR 5636). Labor for copying does not include costs associated with reviewing the patient’s request; searching for, reviewing, retrieving, segregating, collecting, compiling, or otherwise preparing the responsive information for copying; verifying that only information about the requested patient is included; complying with HIPAA; updating or maintaining record systems; etc. (See also 78 FR 5636). Likewise, it does not include administrative or other costs associated with outsourcing record functions to business associates or others beyond the business associate’s labor costs described above. Continue reading

February 5, 2016

Prompt Pay Discounts

by Kim C. Stanger, Holland & Hart LLP

Healthcare providers sometimes offer “prompt pay” discounts to encourage patients to pay their bills within a certain period, including outstanding copayments or deductible amounts. Such programs should be structured appropriately to ensure compliance with applicable laws and payer contracts.

1. Federal Fraud and Abuse Laws. If the discount is offered to induce the patient to receive other services payable by Medicare, Medicaid, or other government programs, the discount may violate federal fraud and abuse laws. The federal Anti-Kickback Statute (“AKS”) prohibits knowingly offering any remuneration to persons to induce or reward referrals for items or services covered by federal health programs, including Medicare or Medicaid. See 42 U.S.C. § 1370a-7b. The AKS applies to discounts offered to federal program beneficiaries if the purpose of the discount is to induce referrals. See, e.g., OIG, Special Advisory Bulletin: Offering Gifts and Other Inducements to Beneficiaries (8/30/02); OIG, Special Fraud Alert regarding Routine Waiver of Part B Co-Pays and Deductibles (12/19/94). Similarly, the federal Civil Monetary Penalties Law (“CMPL”) prohibits knowingly offering anything of value to Medicare or Medicaid beneficiaries that is likely to influence the beneficiary’s selection of a particular provider of services payable by Medicare or Medicaid, including waivers or discounts of coinsurance or deductible amounts. See 42 U.S.C. § 1320a-7a(a)(5); 42 C.F.R. § 1003.102 and .103(b)(13). Continue reading