September 23, 2013 is the effective date of new HIPAA Regulations that address many changes, such as:

  • Changes to Business Associate Rules
  • Changes to Investigations, Compliance Reviews and Civil Monetary Penalties
  • Mandatory Restriction on Disclosure of Protected Health Information to Health Plans in Some Cases of Cash Payment for Items and / or Services
  • Risk

By Erin L. Kilgore

“Pumping,” or expressing breast milk, is now protected under Title VII. In a matter of first impression, the Fifth Circuit Court of Appeal recently held that an adverse employment action taken against a female employee because she was expressing milk constituted sex discrimination in violation of Title VII. See Equal Employment

By Deborah J. Juneau

Those health care providers and suppliers who are contemplating accepting donations of electronic health records software and training services should be aware of proposed amendments to the regulations that might protect such arrangements under the anti-kickback statute and the Stark physician self-referral law. The Department of Health and Human Services, Office of Inspector General (“OIG”) is proposing to amend the anti-kickback safe harbor pertaining to electronic health records (“EHR”) items and services found at 42 CFR 1001.952(y).  The Centers for Medicare and Medicaid Services (“CMS”) is proposing the same amendments to the Stark physician self-referral exception pertaining to donations of certain EHR software and directly related training services found at 42 CFR 411.357(w).  The OIG safe harbor and physician self-referral exception were promulgated in 2006 to protect certain arrangements involving the donation by permitted donors of interoperable electronic health records software or information technology and training services.  Both proposed rules make the identical changes to the protections offered under the safe harbor and exception.

First, the proposed amendments would update the provision under which EHR software is deemed interoperable. Interoperable has been defined to mean “able to communicate and exchange data accurately, effectively, securely, and consistently with different information technology systems, software applications, and networks, in various settings, and exchange data such that the clinical or operational purpose and meaning of the data are preserved and unaltered.” Both CMS and the OIG consider interoperability to be an important concept to reduce the risk that parties might use the donated software and technology to capture referrals. Both considered that, if the donated technology is interoperable, the recipient would be able to use the technology to transmit EHR not only to the donor but to others, including competitors of the donor, and would not be “locked-in” to communications with the donor only. 


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By Jennifer J. Thomas

On January 30, 2013, the U.S. Department of the Treasury, the Department of Labor, and the Department of Health and Human Services (the “Departments”) issued proposed regulations to amend to exempt group health plans established or maintained by certain “religious employers” with respect to the Affordable Care Act ("ACA") requirement to cover contraceptive services. The ACA currently requires non-exempt, non-grandfathered group health plans to provide, without cost-sharing by employees, certain preventive health services including contraceptive services, sterilization, and abortion services. In response to concerns that this requirement violates religious beliefs of employers, the Departments have promulgated proposed amendments to the regulations.

The proposed regulations amend the criteria for the religious employer exemption. The current definition of “religious employer” requires that the employer:

  1. Has the inculcation of religious values as its purpose;
  2. Primarily employs persons who share its religious tenets;
  3. Primarily services persons who share its religious tenets; and
  4. Is a non-profit organization described in Section 6033(a)(1)(a)(3)(A)(i) or (iii) of the Internal Revenue Code.

The proposed regulations revise the definition of "religious employer" to eliminate the first three prongs listed above, but maintain prong number four. Section 6033 of the Internal Revenue Code refers to churches, their integrated auxiliaries, and conventions or associations of churches, as well as to the exclusively religious activities of any religious order. The Departments have represented that with the revised definition there will “no longer be any question as to whether group health plans of houses of worship that provide educational, charitable, or social services to their communities qualify for the exemption.”
 


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By Scott D. Huffstetler

The Occupational Safety and Health Administration (OSHA) is seeking public comments regarding a proposal for a new online whistleblower complaint form. The form, which would allow whistleblowers to electronically submit whistleblower complaints directly to OSHA, is part of OSHA’s proposal to revise the information collection requirements for handling retaliation complaints filed

By Andrew H. Goodman and Jennifer J. Thomas

In 2013, business owners with 50 or more full-time employees are expected to be finalizing their plans in response to the employer mandate health care reform, which becomes effective in 2014. Among the choices for business owners will be complying with the employer mandate or planning to pay the penalties for opting out, or executing plans to avoid the employer mandate by trimming their workforce or selling all or a portion of their business before 2014.

Beginning January 1, 2014, the so-called “employer mandate” under the Patient Protection and Affordable Care Act (t he “PPACA”) requires employers with 50 or more full-time equivalent employees (“FTEs”), with “full-time” defined as working at least 30 hours per week, to offer “minimum essential” and “affordable” health insurance to those employees and their dependents. Employers who do not comply will be subject to potentially significant penalties. Employers are not required to provide health care coverage for part-time employees, however, part-time employees must be counted as partial employees when determining whether an employer has 50 FTEs. There will also be various other new requirements under the PPACA effecting employers beginning in 2014 that are beyond the scope of this piece.

Many business owners are considering what they can do to get their FTE count below 50 and avoid the employer mandate and the associated cost increases and regulatory burdens.  Beware, however, that a reduction below this threshold effective January 1, 2014 may not avoid the employer mandate.   The proposed regulations provide that a business could be subject to the employer mandate if during 2013 it averaged 50 or more FTEs.  Employers would have the option to determine their 2013 headcounts by averaging the full 12 months of 2013 or any consecutive six-month period during 2013.  These regulations are in the process of being promulgated and are not yet final.    

Additionally, the rules regarding who is an “employer” are not straight forward and contain traps for the unwary, and can render some plans to dodge the employer mandate ineffective. Similarly, having a basic understanding of the rules should alert business owners to seek advice if two or more related businesses may be considered as a single “employer” under the employer mandate rules.
 


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By Deborah J. Juneau

Medicaid costs for Personal Care Services (“PCS”), designed to allow Medicaid beneficiaries to remain in their homes rather than being institutionalized, totaled approximately $12.7 billion in 2011, representing a 35% increase in spending since 2005. The cost for PCS is projected to grow by approximately 45% by the year 2018, certainly making PCS an area of interest to the federal government. PCS providers should expect to see increased federal oversight and control over these programs.

The Office of Inspector General (“OIG”) published a report in November, 2012 based on its examination of PCS and its findings of significant compliance, payment, and fraud vulnerabilities. The OIG also interviewed Medicaid beneficiaries receiving PCS services and found quality of care problems with PCS attendants, including physical abuse or threats of abuse, property theft, and beneficiary abandonment.

As of August, 2012, the OIG has produced 23 audit and evaluation reports focusing on PCS providers and programs in various states, including one in Louisiana. The Louisiana Department of Health and Hospitals, which oversees PCS programs, concurred with the findings and recommendations in the OIG audit. The OIG’s Office of Investigations and State Medicaid Fraud Control Units also reported an increasing volume of fraud involving PCS. The most commonly reported fraud schemes involved conspiracies between PCS attendants and Medicaid beneficiaries regarding claims for services that were never provided or that were not allowed under the States’ program rules.
 


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By Deborah J. Juneau

The Centers for Medicare and Medicaid Services (“CMS”) has added a new face-to-face encounter requirement related to the ordering of certain Durable Medical Equipment (“DME”) items in the Medicare Program Revisions to Payment Policies under the Physician Fee Schedule Final Rule that was published in November, 2012 (the “Final Rule”). For covered DME items requiring a written order, physicians must document that a face-to-face encounter with the beneficiary occurred within six (6) months before the written order. The new rule is effective for all covered DME items ordered on or after July 1, 2013. The rule does not apply retrospectively to DME orders prior to July 1, 2013. CMS is not implementing a requirement for a face-to-face encounter for prosthetic devices, orthotics, and prosthetics that require a written order, at this time, and deferred to future rule-making to address this area.


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By Jennifer J. Thomas

The United States Department of Health and Human Services, Offices for Civil Rights (“OCR”) and BlueCross Blue Shield of Tennessee (“BCBST”) announced a settlement this week for $1.5 million for a breach of protected health information under the Health Information Portability and Privacy Act (“HIPAA”). In November 2009, BCBST submitted a