Health Law Attorney Blog

The Office of the National Coordinator for Health Information Technology ("ONC"), an office of the Department of Health and Human Services, released a proposed rule creating a program to certify electronic health records ("EHR") systems. The rule creates both a temporary and a permanent certification system, designed to assure users to that EHR systems and related technology meets the "meaningful use" criteria of the HITECH Act.

This certification is required by CMS for providers to receive payments in an incentive program created by CMS in January for the "meaningful use" of EHR technology.

ONC hopes to issue the final rule regarding temporary certification by the time that HHS issues final rules regarding meaningful use standards and certification criteria. Both are expected this fall.

The permanent certification program, with a longer comment period, will later replace the temporary program.

Continue reading "ONC Proposes Certification Program for Electronic Health Records Systems" »

Recent Medicare regulations regarding ownership changes for HHAs have been the source of controversy and confusion. After numerous attempts by HLP founding partner Robert Iwrey, Esq. to obtain clarification regarding enforcement of these regs, Rob was pleased to receive an email this morning from Frank Whelan, a CMS adminstrator with the Division of Provider and Supplier Enrollment, providing direct clarification. Mr. Whelan's email is below:

If an HHA submitted a CMS-855A ownership change that was received by the Medicare contractor prior to January 1, 2010, the contractor will not apply the 36-month policy found in 42 CFR 424.550(b). As such, if the contractor received a change of ownership or change of information which resulted in a change of owners (e.g., asset sale/stock transfer) prior to January 1, 2010 and the HHA was adversely affected by the contractor's application of the policies found in 424.550(b), the HHA should send a letter to the contractor formally requesting that its ownership change be processed. This letter should include:

*The seller's name, taxpayer identification number, national provider identifier, and the date on which the ownership change was submitted to the contractor.

Contractors will process these pre-January 1, 2010 Medicare enrollment applications under the policies in place prior to January 1, 2010.

While we always encourage providers and suppliers to discuss and resolve enrollment issues with the Medicare contractor, if a HHA encounters a processing problem, we will review it.

Continue reading "HLP Receives Direct Clarification Regarding HHA Ownership Changes" »

On February 22, The Health Law Partners, P.C. ("The HLP") posted a blog urging our clients and friends to help prevent a proposed 21% reduction in Medicare reimbursement. On February 28, the short-term Medicare physician payment freeze expired, triggering the 21% reduction in Medicare reimbursement. Congress is expected to vote within the next several days to extend the payment freeze and stave off the reduction in reimbursement for an additional 30 days - to March 28, 2010.

However, because a vote did not occur prior to the expiration of the physician payment freeze existing in February, triggering the 21% reduction in Medicare reimbursement beginning March 1, if payments were to be made under the cuts, and if the cuts are subsequently repealed, physicians would have to file new claims to recoup lost amounts, creating an administrative burden to both the provider community and Medicare claims processors. According to a recent AP report (3/2, Alonso-Zalvidar), the Obama Administration expects "the Senate will act soon to stave off the cuts," and has "directed Medicare billing contractors to hold off processing claims for 10 business days." Jonathan Blum, director of CMS' Center for Medicare Management, has stated that, CMS' "No. 1 goal is to avoid disrupting payments to physicians during this time."

The HLP will continue to keep you apprised of future developments.

Continue reading "Medicare Reimbursement Reduction Update" »

Following the leads of a number of other States, including New York, Michigan Governor Jennifer Granholm has issued an Executive Order creating an independent Office of Health Services Inspector General (the "OHSIG"). According to the Executive Order, OHSIG, which will be organized as an independent and autonomous entity within the Department of Community Health, is charged with the responsibility to "conduct and supervise activities to prevent, detect, and investigate fraud, waste, and abuse in health services programs" such as Medicaid. The Health Services Inspector General, which will be vested with broad powers to carry out its anti-fraud and abuse mandate, will be appointed by the Governor. The Executive Order becomes effective October 1, 2010.

Continue reading "Michigan Office of Health Services Inspector General Created" »

Unverified accounts have it that enforcement of the "business associate" provisions of the HITECH Act, which was set to commence on February 17, 2010, is being delayed. The business associate provisions require business associates of covered entities to also implement the HIPAA Security Rule, and portions of the HIPAA Privacy Rule, and also requires that all agreements between covered entities and business associates provide for the business associates' compliance with those to portions of HIPAA regulations.

A partner at HLP saw Adam Greene of the Office of the General Counsel, Civil Rights Division, at the Department of Health & Human Services, mentionthe delay in implementation when speaking at the American Bar Association's 11th Annual Conference on Emerging Issues in Healthcare Law.

Continue reading "HITECH "Business Associate" Provisions Enforcement Delayed" »

As a service to our clients and friends in NY, we are reproducing the notice circulated by the Medical Society of the State of New York urging all interested constituents take action to prevent the proposed 21% reduction in Medicare physician reimbursement. "On February 28, the two month extender of the current Medicare > conversion factor expires. If this is allowed to happen, it will > result in a 21% cut to Medicare physician reimbursement. This could devastate senior access. Congress must act to prevent this from > happening. The American Medical Association and MSSNY continue to push for repeal of the unfair SGR formula used for determining Medicare reimbursement updates. While several proposals are under consideration in Congress which would prevent this cut, including another short-term extender to a time later in the year, no action has yet been taken. Physicians are urged to call the AMA Grassroots Hotline, 1-800-833-6354, to contact Senators Schumer and Gillibrand, as well as their respective member of the House of Representatives, to urge a long-term fix to this problem. Time is running out, so please act now."

Continue reading "Medical Society of the State of New York Urges Calls to Congress To Again Prevent 21% Physician Medicare Cut" »

The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) requires the Secretary to designate organizations to accredit suppliers, including but not limited to physicians, non-physician practitioners, and Independent Diagnostic Testing Facilities, that furnish the technical component of advanced diagnostic imaging services. Advanced diagnostic imaging services include diagnostic magnetic resonance imaging (MRI), computed tomography (CT), and nuclear medicine imaging.

Recently, the Centers for Medicare & Medicaid Services (CMS) approved the following three national accreditation organization to provide the accreditation services for suppliers of the TC of advanced diagnostic imaging procedures: (1) the American College of Radiology; (2) the Intersocietal Accreditation Commission; and (3) the Joint Commission.

The accreditation organizations will assess the overall quality of a practice, including but not limited to, its personnel, equipment, quality assurance activities, and the quality of patient care. In addition, each accreditation organization has quality standards that focus on but are not limited to the qualifications of medical personnel and medical directors, performance specifications for imaging equipment, and quality assurance and control programs to ensure the safety, reliability, clarity, and accuracy of diagnostic imaging.

Continue reading "MIPAA Accreditation for Providers of Advanced Diagnostic Imaging Services" »

CMS rescinded a change order affecting the use of place of service ("POS") codes used for the interpretation of diagnostic tests. Originally issued on December 11, 2009, the rescinded Change Request ("CR") led to significant confusion about the POS for reporting the reading of diagnostic tests.

MLN Matters 6375, which explained the CR, required providers to report the specific date and location where the test interpretation (the professional component) occurred--rather than the date and location where the actual test was performed.

CMS has stated that it will issue a new CR and MLN Matters providing additional, more consistent clarification regarding the use of POS codes in the future.

Continue reading "CMS Rescinds POS Reimbursement Rules for Diagnostic Tests" »

The home health world has been turned upside down. As many are aware, new regulations have been implemented that affect ownership changes for home health agencies ("HHAs"). On January 21, 2010, CMS published a "Medicare Learning Network Provider Inquiry Assistance." This publication clearly states that any "ownership change" within 36 months of the Medicare enrollment date or the most recent ownership change will require a home health agency to enroll as an initial Medicare applicant.

"Ownership Change" is defined as any of the following: CHOW (as defined by Medicare); acquisition/merger; consolidation; change of information request reporting a five percent (5%) or greater ownership change (e.g., stock transfer, asset sale); or change request reporting a change in partners, regardless of the percentage of ownership involved. Previously, a stock sale (as opposed to an asset purchase) of an HHA was not treated as a change of ownership. Instead, HHAs were required to simply submit a change of information form.

Our office has become aware of numerous HHAs who were involved in stock sales and submitted the 855A applications and all relevant information prior to the publication of the final regulation. Despite the fact that the applications were submitted before August, when the regulation was proposed, the applications were never processed and the provider numbers became ineffective on January 1, 2010.

Continue reading "Home Health Agencies and Ownership Changes " »

The American Recovery and Reinvestment Act establishes an incentive program that provides incentive payments to eligible physicians (EP) and eligible hospitals for meaningfully using electronic health records (EHR). While many specialists are learning the conditions under which they can capitalize on these incentive payments, anesthesiologists will learn that they do not qualify as EPs, thus not able to receive incentive payments for their meaningful use of EHRs.

One requirement that a physician satisfy is that s/he is a non-hospital-based physician. "Hospital-based" physicians are defined to include those that provide 90% of their Medicare-covered services within a Place of Service (POS) of 21, 22, or 23--either an inpatient hospital, outpatient hospital, or emergency room hospital, respectively. Furthermore, the statute explicitly states that anesthesiologists--who furnish substantially all of their Medicare-covered services in a hospital setting, using the hospital's facilities and equipment, and qualified EHRs--are not eligible to receive the incentive payments because they are not bringing their own equipment to the hospital in furtherance of the medical services they perform. If a hospital demonstrates is meaningful use of an EHR, it can qualify for incentive payments.

Continue reading "Incentive Payments for Meaningful Use of EHR Technology Does NOT Apply to Anesthesiologists" »

Generally, Durable Medical Equipment ("DME") suppliers are statutorily prohibited from telemarketing Medicare beneficiaries regarding furnishing a covered item. There are three exceptions to this rule: (a) the beneficiary has given written consent to be contacted by the supplier; (b) the contact is regarding a covered item that the supplier has previously furnished to the beneficiary; and (c) the supplier has furnished covered items to the beneficiary in the last 15 months.

Because the OIG received information regarding DME suppliers hiring third parties for telemarketing purposes, it released a Special Fraud Alert to reemphasize a March 2003 alert on a similar issue. The OIG clearly states that "[s]uppliers cannot do indirectly that which they are prohibited from doing directly." The DME supplier is responsible for what third parties do on its behalf, and must also ensure that those third parties are not engaging in prohibited solicitation on its behalf.

"If a claim for payment is submitted for items or services generated by a prohibited solicitation, both the DME supplier and the telemarketer are potentially liable for criminal, civil, and administrative penalties for causing the filing of a false claim, as well as criminal and civil penalties for using interstate telephone calls in furtherance of schemes to defraud."

Continue reading "UPDATE: Telemarketing by Durable Medical Equipment Suppliers is Still Prohibited" »

The January 2010 issue of Link, the online journal of the AHRA, is now available. This issue includes a new column called Regulatory Review, the first installment of which is called "Healthcare Marketing--Navigating the Regulatory Landscape." The column, to be a regular feature in Link, is authored by The Health Law Partners' Adrienne Dresevic and Carey Kalmowitz. In the article, Dresevic and Kalmowitz provide an overview of the legal risks that radiology providers should consider when constructing their marketing programs, together with detailed guidance on mitigating those risks.

Continue reading "Health Law Partners To Publish Monthly "Regulatory Review" Column in Link, The Online Journal of the AHRA" »

A health care law Call for Articles has been announced by the West Virginia Law Review. The announcement is set forth below:

Call for Articles

The West Virginia Law Review announces a call for articles and invites scholars, practitioners, and researchers to submit contributions for its upcoming issue focusing on health care. This issue will include articles from the Law Review's Lecture Series, "Beyond Politics: A Discussion of Health Care in America," a thoughtful discourse on the social disparities in access and outcomes engrained in our current health care system. For this issue, we are particularly interested in scholarship discussing the following topics:
- Health care reform;
- Health care access and outcome disparities, especially as they affect women and children, racial minorities, and the rural poor;
- Health care as a human right.

Articles will be selected by our Articles Selection Team and the Editor-in-Chief based on scholarly merit, originality, relevancy, and writing style. Articles should be thoroughly researched and contain appropriate footnotes in bluebook format.

Continue reading "Health Care Law Call for Articles" »

US Secretary of Health and Human Services Kathleen Sebelius presented the first US National Health Security Strategy ("NHSS") in December 2009. The NHSS "is intended to galvanize efforts to minimize the health consequences associated with significant health incidents." These incidents involve the "large-scale incidents" including terrorist attacks, hurricanes, SARS, H1N1, etc.. The NHSS presents a framework for integrating all levels of government to be better prepared and equipped to prevent and respond to health risks associated with the large-scale incidents.

The NHSS has two goals: (1) building community resilience, and (2) strengthening and sustaining health and emergency response systems. Community resilience is defined as "the sustained ability of communities to withstand and recover--in both the short and long terms--from adversity, such as an influenza pandemic or terrorist attack." To measure community health, a number of factors will be taken into account, including physical, social, and environmental factors. To achieve the second goal, there is a push to integrate not only government entities, but also includes academia and the private sector. It is the belief that combining all of these efforts will aid in minimizing and/or preventing incidents, detecting incidents more effectively, providing care to affected persons, and helping communities recover from incidents.

The NHSS has 10 strategic objectives to achieve its goals:

1. Foster informed, empowered individuals and communities


2. Develop and maintain the workforce needed for national health security


3. Ensure situational awareness


4. Foster integrated, scalable health care delivery systems


5. Ensure timely and effective communications


6. Promote an effective countermeasures enterprise


7. Ensure prevention or mitigation of environmental and other emerging threats to health


8. Incorporate post-incident health recovery into planning and response


9. Work with cross-border and global partners to enhance national continental, and global health security


10. Ensure that all systems that support national health security are based upon the best available science, evaluation, and quality improvement methods

On December 28, 2009, the American Society of Nuclear Cardiology (ASNC), joined by the American College of Cardiology (ACC), the Florida ACC Chapter, the Association of Black Cardiologist, and the Cardiology Advocacy Alliance, filed a complaint, as well as motions for a preliminary injunction and expedited discovery, against Health and Human Services (HHS) Secretary, Kathleen Sebelius, in U.S. District Court in Florida.

The lawsuit alleges that Secretary Sebelius, in her capacity of HHS Secretary, abused her discretion and acted arbitrarily and capriciously in violation of the Medicare statute and the Administrative Procedures Act by using an invalid Physician Practice Information Survey to set the payment rates for cardiology services in the 2010 Medicare Physician Fee Schedule (MPFS). According to the complaint, the 2010 MPFS makes such devastating cuts to cardiology that patient access to care will be threatened and cardiologists will be driven out of community practice. As a result, the lawsuit seeks to enjoin implementation of the 2010 MPFS and require the use of more reliable data in connection with the adoption of the 2010 MPFS.

Continue reading "American Society of Nuclear Cardiology Takes Legal Action to Halt Implementation of the 2010 Medicare Physician Fee Schedule" »