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Archive for the ‘Electronic Health Information’ Category

Vendor Delays Hardship EHR Meaningful Use Implementation Standards

Monday, March 24th, 2014

CMS Recognizes Hardship Exemption From Meaningful Use Standards

meaningful use,vendor delays,cms hardshipThe American Recovery and Reinvestment Act of 2009 mandates a reduction in payments to eligible Medicare providers who have not met meaningful use standards for electronic health record technology.  Payment adjustments begin October 1, 2014, for hospitals and January 1, 2015, for Medicare eligible professionals.

CMS has created a hardship exception that permits providers to request an exemption from the payment adjustments in certain circumstances.  The hardship exemption lasts for one payment year.  A provider can be granted up to five years worth of hardship exceptions but must reapply on a yearly basis.

In order to be granted a hardship exception, providers must prove that special circumstances pose a significant barrier to their achieving meaningful use.  A few of the circumstances where hardship may be considered include the following:

  • Being located in an area without sufficient internet access or with other insurmountable infrastructure barriers.
  • Professionals who are new to the practice and who have not had time to become meaningful users can apply for a two-year limited exception to the payment adjustment rules.
  • Certain other unforeseen circumstances such as natural disasters or other unforeseeable impediments to meeting standards.

Recently, CMS added a new potential hardship for providers who are faced with EHR vendor issues.  In order to be eligible for the vendor exemption, a provider must demonstrate that circumstances are beyond its control and must explicitly outline these circumstances and indicate how they significantly impaired the ability to meet meaningful use standards.

The standards applied to receive a hardship exemption are fairly narrow and can be difficult to meet.  However, providers who see potential significant impediments to their implementation of meaningful use should begin to consider the possibility of applying for hardship exemption.  If the hardship exemption is going to be based upon EHR vendor difficulties, the implementation difficulty should be clearly documented.  At the time of application for a hardship exemption, the complete circumstances involved in the vendor relationship will need to be described to CMS.

If you have any further questions regarding electronic health record information or other health law questions, please contact John Fisher, II of our health law practice.

EHR Donation Program Extended Through 2021 – Clinical Laboratory Companies Excluded

Monday, December 30th, 2013

Electronic Health System Donation RulesElectronic Health Record Donation – Final Rules Issued By CMS and OIG

Qualified Donations Extended Through 2021

Clinical Laboratory Companies Excluded As Donors

Just before the current rule was due to expire, the Center for Medicare and Medicaid Services released final regulations on donation of electronic health record donations.  The existing rule, which was set to expire on December 31, 2013, permitted hospitals and other providers of Stark Law “designated health services” to make donations of electronic health records software that meets certain requirements, to physicians and physician groups.  The new final rule was released on December 27, 2013.  A similar rule was released by the Office of Inspector General addressing the Anti-kickback issues presented by donation arrangements.

The final rule adopts most of the changes that were proposed in draft rules that had been previously released in April 2013.  For example, the rule extends the expiration of date of the EHR donation exception from December 31, 2013, to December 31, 2021.  The final rule also removes some of the previous requirements that qualifying software contain electronic prescribing capacity.  The proposed regulations in April raised the possibility of excluding certain types of designated health service providers from qualification to offer EHR donations to physicians.  Comments were solicited on whether providers such as clinical laboratories and durable medical equipment providers should be permitted to offer donations to referring providers.  In the final rules, only clinical laboratory companies are excluded from the ability to offer EHR donations under the exception.

The reversed rule also clarifies some issues regarding restrictions on the use, compatibility, and/or interoperability of donated items.  Since 2006, there has been an exception to the Stark Law protecting certain arrangements involving inter-operable electronic health records software or information technology and training services (the ‘‘Donation Exception”).  The Donation Exception provides an exception from the physician self referral laws for certain arrangements involving inter-operable electronic health records software or information technology and training services.  Absent such an exception, the value of qualifying technology that is donated by a hospital or other provider of “designated health services” would create a compensation arrangement that would trigger a violation of the Stark Law.


Model Patient Privacy Notice Forms Privacy Rule Compliance

Thursday, September 19th, 2013

Patient Privacy Notice Forms

patient privacy notice formsThe HIPAA Privacy Rule gives individuals a fundamental right to be informed of the privacy practices of the health care providers and their privacy rights with respect to their personal health information. Providers are obligated to provide patients with a clear and concise description of their rights.

The HHS Office for Civil Rights and Office of the National Coordinator for Health Information Technology have released model Notices of Privacy Practices for health care providers and health plans. The model was created by collaboration between the two agencies with jurisdiction over patient privacy issues. The models express the views of these agencies concerning what health care providers should be communicating to their patients.

The Model Notices can be found at the following page of the HHS web site. Model Privacy Notices

It is notable that the model Notices of Privacy are not as in depth as the forms that have been used by many health care providers in the past. There is a simplicity to the model which seems to be directed toward communicating basic information to patients as opposed to an approach that includes “everything under the sun” in order to protect the provider. The less complicated approach seems to be more consistent with the regulatory requirement that providers develop and distribute a notice that provides a clear, user friendly explanation of these rights and practices.

The model released by the agencies provides a variety of formats that providers can consider depending on the context and their personal preference. The optional format include:

  • Notice in the form of a booklet
  • A layered notice that presents a summary of the information on the first page, followed by the full content on the following pages
  • A notice with the design elements found in the booklet, but formatted for full page presentation
  • A text only version of the notice

The models integrate the regulatory changes contained in the Omnibus Rule. Providers may use these models to serve as the baseline for compliance with the new requirements. For example, relatively new changes to patient access rights to information that is held in an electronic health record is covered. Providers who have not recently updated their notices may not include this information in their disclosure form.

The provided forms are set up so that providers can simply enter their specific information in the model forms. They can then be printed, posted, and otherwise used in connection with their practices.

The agencies seem to be actively encouraging providers to use these standard forms. Providers should take the opportunity to review their Notice of Privacy Policies and consider updating them to conform with the government provided standard forms unless the provider has a compelling reason to be more inclusive in its disclosure.


The Model Notices can be found at the following page of the HHS web site. Model Privacy Notices

Electronic Health Information System Proposed Regulations Ancillary Providers

Monday, April 15th, 2013

Proposed CMS Rules Suggest Possible Future Changes To E.H.R. Donation Rules

ehr donation agreement proposed regulationsThe proposed regulations that were recently released by CMS and the OIG relating to electronic health record donations, provides a glimpse of what may be expected in the future.  Both agencies refer to concerns over “data lock” situations and donation agreements entered with clinical laboratories, DME companies, and other ancillary providers.  Although neither agency placed limitations on these arrangements in the current proposed rules, they both make it clear that they are looking closely at who should be a qualified donor under the donation regulations.

As they currently stand, the only effect of the proposed regulations would be (i) to extend the donation agreement sunshine deadline from December 31, 2013 to December 31, 2016, and (ii) to remove the requirement that software include electronic prescribing.  However, comment was solicited in other areas that make it pretty clear that we should expect the final rules to include other changes.

CMS appears to be considering what approach to take to address reports of clinical laboratories, DME providers and other ancillary providers using the Stark Law exception to enter into abusive arrangements.  CMS suggests that they may exclude certain classes of providers from being qualified donors.  They also allude to the possibility of adding an additional set of requirements to prohibit “data lock” situations.  They appear to be considering taking one or both approaches when final regulations are released.

For now, comments can be made to the proposed regulations.  Providers who have an interest in this issue might want to consider submitting comments in response to the OIG and/or CMS proposed regulations.  In the meantime, the discussions coming from the regulatory agencies cast a shadow over donation arrangements with many ancillary providers.  Even though the arrangements meet Stark Law and safe harbor provisions at the present time, it is not clear whether arrangements that are entered before the issuance of final regulations will qualify to permit extension of donation benefits beyond the first Sunset date of December 31, 2013.

Telemedicine Credentialing By Proxy

Tuesday, February 12th, 2013

Telemedicine Credentialing By Proxy and Hospital Policies

telemedicine policies credentialing telehealthProvider Credentialing requirements raise important considerations in any telemedicine arrangement. The facility where care is received, renders a diagnosis, or otherwise provides clinical treatment to a patient, must assure that a telemedicine practitioner is appropriately credentialed and privileged in compliance with their credentialing process, CMS rules, and the requirements of applicable accreditation organizations.  The process for credentialing telemedicine providers should be addressed by the governing body and reflected in medical staff bylaws and formal credentialing policies.

Credentialing standards have been somewhat streamlined since CMS adopted new regulations that were effective in June of 2011.  CMS rules now permit “credentialing by proxy” provided that several conditions are met.  It remains the responsibility of the board to determine when or if it wishes to rely on “credentialing by proxy” or whether it should apply full credentialing requirements on remote providers of telemedicine services.  Even though the process has been simplified, credentialing of providers who perform telemedicine services to patients of a hospital is still an extremely important responsibility of the hospital board.

Electronic Medical Record Licensing and Contracting for EHR

Friday, April 20th, 2012

EHR Licensing and Contracting Comes Center Stage

As Meaningful Use Deadlines Approach

As the meaningful use deadline approaches, many providers are scrambling to implement electronic health records.  The agreements surrounding licensing, implementation, and support of EHR systems are some of the most important agreements that a health care provider will enter.  Unfortunately, many smaller providers put little effort into negotiating terms that help assure that the product functions like it is supposed to and that the implementation takes place in a timely and efficient manner.

             We routinely become involved in the negotiation of EHR agreements.  Some of the important issues that we address include:

  •  Creating an appropriate project milestone system to assure timely project flow.
  • Coordination between vendors in multi-application systems.
  • Requiring that functional specifications are well-defined.
  • Assuring compliance with HIPAA and state laws, particularly with respect to data conversion.
  • Negotiating warranties, including meaningful use warranties.
  • Protecting against “runaway” implementation and support costs.

             The agreements relative to EHR implementation can be very complex.  Each vendor has their own license form and it can be overwhelming to work through the issues to determine how to best protect the interest of the provider.  Our experience in these issues will be a valuable resource to any provider addressing EHR implementation issues.

Anti-kickback Statutes Safe Harbor Regulations

Thursday, December 8th, 2011

Anti-kickback Statutes and Safe Harbor Regulations

Medicare Antikickback Statute Safe HarborsOverview: On the books since 1972, the federal anti-kickback law’s main purpose is to protect patients and the federal health care programs from fraud and abuse by curtailing the corrupting influence of money on health care decisions. Straightforward but broad, the law states that anyone who knowingly and willfully receives or pays anything of value to influence the referral of federal health care program business, including Medicare and Medicaid, can be held accountable for a felony. Violations of the law are punishable by up to five years in prison, criminal fines up to $25,000, administrative civil money penalties up to $50,000, and exclusion from participation in federal health care programs.

Because the law is broad on its face, concerns arose among health care providers that some relatively innocuous — and in some cases even beneficial — commercial arrangements are prohibited by the anti-kickback law. Responding to these concerns, Congress in 1987 authorized the Department to issue regulations designating specific “safe harbors” for various payment and business practices that, while potentially prohibited by the law, would not be prosecuted.

John H. Fisher

Health Care Counsel
Ruder Ware, L.L.S.C.
500 First Street, Suite 8000
P.O. Box 8050
Wausau, WI 54402-8050

Tel 715.845.4336
Fax 715.845.2718

Ruder Ware is a member of Meritas Law Firms Worldwide

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