October 2012 Archives

October 29, 2012

OIG Distributes Questionnaire to Hospitals that have Received Medicare EHR Incentive Payments for Demonstrating Meaningful Use of its Certified EHR Technology

On October 11, 2012, The OIG distributed a questionnaire to hospitals that have received Medicare EHR incentive payments for demonstrating meaningful use of its certified EHR technology. This questionnaire is being sent to hospitals that have received incentive payments between January 1, 2011 and March 31, 2012 which amounts to approximately 830 hospitals nationwide. The authority for this study is found in 5 U.S.C. App. 3 at §2,4 and 6 of the Act, which authorizes the Inspector General to conduct inquiries and make recommendations relating to the economy, efficiency and effectiveness of programs administered or funded by the U.S. Department of Health and Human Services.

The topics focused on are user authorization and access, audit logs, metadata, entry of physician progress notes and patient identity management. Although some of these elements are not yet mandatory, it is expected that hospital responses will help inform future meaningful use requirements and EHR technology policy.

While this initial questionnaire is being directed to a limited number of hospitals nationally, it is anticipated that the government's interest will be directed at all recipients of meaningful use revenue. Providers should review their HIPAA privacy and security policies, to ensure they are consistent with all applicable regulatory requirements.

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October 19, 2012

Michigan LARA Creates New Health Care Services Bureau

On October 18, 2012, the Michigan Department of Licensing and Regulatory Affairs ("LARA") announced that it will be combining the current Bureau of Health Professions ("BHP"),which governs individual licensed and registered health care providers such as physicians and nurses, and the Bureau of Health Systems ("BHS"), which governs licensed health care entities such as hospitals and ASCs, into one new entity called the Bureau of Health Care Services ("BHCS"). The purpose of this consolidation into one entity is to make Michigan's regulatory system "simple, fair and efficient" while still protecting the vulnerable. A review of the licensing administrative processes for both the BHP and BHS began last month but significant changes to the basic requirements for licensure are not anticipated. The changes are expected to be more focused on internal processing proposals with a desire to make the licensing application process more efficient. A director for the new bureau has not yet been selected.

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October 9, 2012

New York Governor Approves ACO Legislation; Vetoes Patient Referral Bill

On October 3, 2012, New York State Governor Andrew Cuomo acted on several health care related bills, including legislation dealing with accountable care organizations and patient referral laws.

The Governor approved by signing into law an act to amend the Public Health Law in relation to accountable care organizations (ACOs) (A.8869-B/S.6228-B), which is intended to regulate and promote the formation of ACOs and protect the public interest, as well as the interests of patients and health care providers. While New York State approved a demonstration program for ACOs in 2011, the new legislation removes both the "demonstration" designation of the ACO program, as well as the cap on the number of ACOs that may be authorized. The bill aligns the current State ACO Laws with the federal Medicare ACO regulations, and, among other provisions, provides a more complete legal structure for ACOs, requiring that the governance, leadership and management structure of the ACO reasonably and equitably represents the ACO's participating health care providers, patients, and the community.

A bill relating to referrals of patients for health related items or services (A3551/S4660), which had passed in both the Assembly and Senate, was vetoed by the Governor. The bill would have amended the Public Health Law which currently prohibits, subject to certain exceptions, health care providers from referring patients to providers of health care services with whom the provider or an immediate family member has a financial relationship. The law would have conformed New York's State health care practitioner referral law to the federal Stark Law by adopting exceptions to restrictions on physician self-referrals previously enacted by Congress, including creating additional exceptions to what constitutes a financial relationship.

"Given the concern with real and apparent conflicts of interest that this change would engender, I see no reason to upset New York's rules for determining the propriety of practitioner referrals," explained the Governor in his Veto Message. The practical effect of the vetoed bill is that New York healthcare providers will continue to encounter difficulty in analyzing and structuring referral relationships in compliance with both State and federal standards.

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October 8, 2012

OIG Approves Free Hearing Exams by Hearing Aid Supplier/Audiometric Testing Provider

On October 5, the Office of Inspector General ("OIG") issued Advisory Opinion 12-13, approving a proposed arrangement allowing a hearing aid supplier to bill Medicare for certain audiometric testing services, while also offering a free hearing exam to potential patients ("Proposed Arrangement"). The requestor owned a chain of hearing aid supply and service locations which provided, among other things, a free hearing exam as part of an effort to promote hearing aid sales. The free exam consisted of certain tests which partially overlap/are precursors for procedures that are separately reimbursable under Medicare, but to this point the requestor had not billed Medicare for such services.

The OIG approved the Proposed Arrangement, determining that it would not constitute grounds for imposition of civil monetary penalties under the Civil Monetary Penalties Statute (the "CMP"), and that the OIG would not impose administrative sanctions under the Anti-kickback Statute (the "AKS").

In its application of the CMP laws, the OIG noted that offering the free hearing exam amounted to more than nominal economic value (i.e., greater than $10), but because it would be unlikely to influence beneficiaries to select the requestor as their provider of Medicare-payable audiometric testing, there was no violation of the CMP.

Specifically, among others, Advisory Opinion 12-13 relied on the following factors to arrive at its conclusion:

• The Requestor certified that the free hearing exam is offered to customers without regard to their insurance coverage, health status, or whether the customers purchase any goods or services from the Requestor;

• The Requestor does not bill the free hearing exam tests to Medicare, and obtaining the Free Hearing Exam does not qualify a patient for Medicare coverage of any items or services;

• The Requestor certified that it would not recommend that a customer receiving a free hearing exam also undergo the Medicare-payable audiometric testing;

• The Requestor would not attempt to obtain the prescription or order for the Medicare-payable audiometric testing on behalf of a customer; and

• The Requestor does not contract with or employ physicians or other providers that prescribe/order items or services for which a federal health care program can be billed.

Interestingly, Advisory Opinion 12-13 never embarked on an AKS-specific analysis - rather, it simply stated that the same reasons for approving the arrangement for CMP purposes were sufficient to satisfy AKS requirements.

The opinion is a reminder that, while the OIG is willing to approve arrangements despite patient marketing/incentive initiatives that have the potential to run awry of CMP or AKS, it will only do so if such arrangements are properly structured with appropriate safeguards and risk mitigators.

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October 5, 2012

CMS Clarifies the Point of Service Coding Instructions

On September 28, CMS issued Transmittal 2156 revising and clarifying Place of Service Coding (POS) instructions. The Transmittal rescinds previous Transmittal 2435, extends the implementation date to April 1, 2013 and provides a few clarifications for physicians and other supplier entities when determining the appropriate Point of Service (POS) designation for Physicians and Supplier entities. Specifically, this transmittal clarifies the following:

• Global billing is only permissible when the physician providing the professional component (PC) and technical component (TC) are the same and both services are located in the same payment locality.

• For non-global billing, the POS is where the TC was provided, but the claim must include name and address of the physician or other supplier providing the PC.

• The PC services must be billed to the locality where the services were provided, unless the services were provided in an unusual place, such as a hotel.

• Services provided to a registered inpatient or hospital outpatient must at minimum use the relevant POS codes (POS 21 for inpatient and POS 22 for outpatient). If the specific location (skilled nursing facility, emergency room, ambulatory surgical center, etc.) of the beneficiary is known, the appropriate code for that setting may be used.
CMS will issue release a separate transmittal for pathology services.

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October 5, 2012

OIG Work Plan 2013

On October 3, 2012, the OIG released its Work Plan for the FY of 2013. Throughout the week, we will be posting on various aspects of the Work Plan pertinent to our clients and our readers in the following areas:

• Hospitals
• Home Health Agencies
• Hospices
• Evaluation and Management Services
• Imaging Services
• Diagnostic Testing
• Sleep Testing
• Medical Equipment and Supplies
• Medicare Audits and the Appeals Processes

Check back every day for updates!

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October 5, 2012

Michigan Legislature Considering Expanded Role for Nurse Anesthetists

On September 25, Senator Michael Green (31st District) introduced a bill that would expand the definition of the practice of nursing to include "administration of anesthesia by a registered professional nurse who holds a specialty certification as a nurse anesthetist." Senate Bill 1309 was referred to the Senate Health Policy Committee after two readings. Presently, nurse anesthetists in Michigan are required to have physician supervision. The practical effect of the bill would be to explicitly expand the scope of practice of nursing to include administration of anesthesia, thereby negating the need for physician supervision. Because physician supervision is mandated only in the practice of medicine, by fitting administration of anesthesia into the practice of nursing, nurse anesthetists would have direct (as opposed to delegated) authority to administer anesthesia.

Senate Bill 1309 is just another example of the trend of expanding the realm of non-physician healthcare providers driven by economic and legislative pressure.

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October 5, 2012

CMS Set to Rule on Expansion of Nurse Anesthetist Role in Pain Management

Within the next month, the Centers for Medicare and Medicaid Services (CMS) is expected to finalize the proposed Medicare Physician Fee Schedule for 2013. In the rule, CMS proposes to expand the definition of CRNA services to include "medical and surgical services that are related to anesthesia and that a CRNA is legally authorized to perform by the State in which the services are furnished." Recognizing that several state legislatures have passed or are contemplating legislation that includes pain management within the scope of practice of Certified Registered Nurse Anesthetists (CRNAs), CMS rationalized its proposed changes on the basis that its new definition of CRNA services would allow for flexible application to the varying scopes of practice across states.

In recent years, as the specialty of pain management developed and the scope of CRNA practice evolved, there has been a lack of clarity and uniformity in how Medicare Administrative Contractors (MACs) interpreted the Medicare provisions relating to CRNA services that qualified for reimbursement. The proposed 2013 Physician Fee Schedule establishes a definitive answer. Essentially, if the fee schedule is passed as proposed, CRNAs will be reimbursed for those pain management services provided that are within the scope of their practice as defined by the state in which they practice. CMS cautions, however, that not all CRNAs practicing in states that permit CRNAs to perform pain management services have the requisite education or training. As with all other practitioners, CRNAs are responsible for obtaining the necessary training for all services furnished to Medicare beneficiaries.

The proposed rule triggered a nationwide grassroots opposition campaign by the American Society of Anesthesiologists (ASA). Citing the complexity of chronic pain procedures and advanced education and training required for safe administration of medication therapies, the ASA contends that current restrictions on CRNAs are in the best interest of patient safety. Conversely, the American Nursing Association (ANA) asserts that accreditation standards for CRNA programs include advanced education and training in treatment of chronic pain sufficient to develop proficiency in pain management practice. With the proliferation of mid-level practitioners in recent years, driven by a strained economy and propelled by healthcare reform, the scope of practice of non-physician providers will continue to evolve. CMS's proposed 2013 Physician Fee Schedule represents simply another instance of this process.

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