By Kim Stanger
Healthcare providers often offer free screening tests or services as a way to generate business for their facility or practice; however, doing so may violate federal and state laws unless structured properly. The federal Anti-Kickback Statute (“AKS”)1 and Civil Monetary Penalties Law (“CMPL”)2 generally prohibit offering free or discounted items or services to patients as a way to generate business payable by Medicare, Medicaid or other federal healthcare programs unless the arrangement fits within a regulatory exception.3 Violations of the AKS or CMPL may result in criminal, civil, and/or administrative penalties. Continue reading
by Kim Stanger
Idaho has enacted a broad privilege that protects the confidentiality of credentialing, quality improvement, and similar peer review activities by Idaho hospitals and other health care entities. The statute encourages participation and protects the integrity of such peer review activities by ensuring that peer review communications and proceedings remain confidential, and that participants are immune from liability.
Application. The privilege applies to “peer review” activities conducted by “healthcare organizations”. (I.C. § 39-1392).
“Health care organization” means a hospital, in-hospital medical staff committee,1 medical society, managed care organization, licensed emergency medical service, group medical practice, or skilled nursing facility.
(I.C. § 39-1392a(3)).
“Peer review” means the collection, interpretation and analysis of data by a health care organization for the purpose of bettering the system of delivery of health care or to improve the provision of health care or to otherwise reduce patient morbidity and mortality and improve the quality of patient care. Peer review activities by a health care organization include, without limitation:
(a) Credentialing, privileging or affiliating of health care providers as members of, or providers for, a health care organization;
(b) Quality assurance and improvement, patient safety investigations and analysis, patient adverse outcome reviews, and root-cause analysis and investigation activities by a health care organization; and
(c) Professional review action, meaning an action or recommendation of a health care organization which is taken or made in the conduct of peer review, that is based on the competence or professional conduct of an individual physician or emergency medical services personnel where such conduct adversely affects or could adversely affect the health or welfare of a patient or the physician’s privileges, employment or membership in the health care organization or in the case of emergency medical services personnel, the emergency medical services personnel’s scope of practice, employment or membership in the health care organization.
(I.C. § 39-1392a(11)). Continue reading
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:
- the covered entity does not discriminate on the basis of race, color, national origin, sex, age, or disability in its health programs and activities;
- 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;
- 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;
- how to obtain the aids and services described above;
- 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;
- 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
- 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
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
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
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
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
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
by 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. Continue reading
by 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. Continue reading