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Health Law Firm Opens Green Bay Office

Tuesday, May 1st, 2018

Green Bay Health Care Lawyer – Opening Office in Green Bay Wisconsin

I just wanted to let readers of our health care blog know that Ruder Ware will be opening a Green Bay office and that three Green Bay attorneys will be joining our firm. This will provide us with a presence in the Green Bay/Appleton Markets that will enhance our community presence and enable us to better serve our client in eastern Wisconsin. Our health care and compliance practice with be greatly enhanced as a result of this move.

This move will provide a local platform through which we can better serve our health care clients.

Health Care Law Practice – Green Bay Health Lawyers Ruder Ware

Ruder Ware has a long history of representing health care clients.  The firm recognizes that the highly regulated and complex nature of the industry demands the attention of a team of attorneys who, as a group, monitor constantly evolving laws and regulations and their impact on our health care clients.  At Ruder Ware, we offer a full-service solution to clients as our focus team consists of health care, business, employment, and litigation attorneys with knowledge of the health care industry.   As a result, we are able to take best practices from other industries and apply them to the health care industry, thereby increasing the ability to respond promptly to the rapidly changing health care environment.

Members of the focus team have served on the governing bodies of various health care organizations.  This service has provided our attorneys with the opportunity to counsel the health care community.  

Our dedicated team of attorneys represents health care providers in various matters including:

 Health Care Business Transactions and Corporate Law

Our attorneys have substantial expertise representing various health care providers such as:

Below is the official press release:

Media Contact:
Jamie Schaefer
COO
Ruder Ware, L.L.S.C.
P: 715.845.4336
E: jschaefer@ruderware.com

For Immediate Release

Attorneys Ronald Metzler, Christopher Pahl, and Chad Levanetz to join
Ruder Ware at its new Green Bay Office

WAUSAU, WI – April 27, 2018 – Ruder Ware is pleased to announce the opening of its Green Bay office and that Attorneys Ronald Metzler, Christopher Pahl, and Chad Levanetz will be joining the firm. The new office will be located at 222 Cherry Street, Green Bay, Wisconsin, which is the current location of Metzler, Timm, Treleven, S.C.

Attorney Ron Metzler – Having practiced law for over 30 years, Ron is a well-respected and well-known commercial attorney with close ties to the banking industry.

Attorney Chris Pahl – With his strong ties to the Green Bay community, Chris has built his practice around real estate development and condominium law as well as commercial transactions and estate planning.

Attorney Chad Levanetz – A seasoned litigation attorney, Chad counsels clients in the areas of real estate, construction, and general business disputes.

Stew Etten, Ruder Ware managing partner, stated, “Ruder Ware is always looking for outstanding attorneys to join our firm. With the opportunity to add Attorneys Metzler, Pahl, and Levanetz, the time was right to open a Green Bay office. We’re very excited to have attorneys of their caliber join our team of professionals.”

About Ruder Ware
Founded in 1920, Ruder Ware is the largest law firm headquartered north of Madison. With offices in Wausau, Eau Claire, and Green Bay over 40 attorneys provide legal and business advice to clients with operations of all sizes. Areas of practice include: Employment, Benefits & Labor Relations, Litigation & Dispute Resolution, Business Transactions, Trusts & Estates, and Fiduciary Services. Ruder Ware, Business Attorneys for Business Success. www.ruderware.com

Media Contact:
Jamie Schaefer
COO
Ruder Ware, L.L.S.C.
P: 715.845.4336
E: jschaefer@ruderware.com

CMS Position On Texting Physician Orders

Monday, January 29th, 2018

Texting of Physician Orders : CMS Statement Clarifies Position on Texting

Physician Order Texting RegulationsThe CMS Center for Clinical Standards and Quality/Survey & Certification Group recently released a Memorandum clarifying its position regarding texting of health care information. In S&C 18-10-ALL, dated December 28, 2017, CMS clarifies the following issues:

  • Texting of PHI Within Health Care Team.  CMS says that this is permissible on a secure platform.  Providers should develop policies covering texting among the care team.  Providers may want to consider special conditions, or even limiting or prohibiting this practice.  CMS, HIPAA and other standards need to be considered when developing provider specific policy.  State laws may differ and certain types of information may be subject to special restrictions.
  • Texting of Patient Orders.  Even though texting communication between care team members is permissible, CMS clarifies that texting patient orders is always prohibited; even on a secure platform.
  • Preferred Use of CPOE.  CMS clarifies that Computerized Provider Order Entry (CPOE) is the preferred method for a provider to enter a patient order.  Providers should review their policies regarding acceptable order platforms.  Special attention should be paid to texting practices.  Verbal orders are also an area of significant compliance and liability concerns.  Over-use of verbal orders and non-compliance with authentication requirements is very common and is a significant risk area.

You can reference the CMS Texting Guidance Letter on this issue directly.

I have been posting a series of articles on compliance issues relating to physician orders that you can also reference for additional guidance.  And as always, if you have additional questions, please do not hesitate to contact me thhrough the contact form on this blog or directly through contact information on my law firm web site.

 

Physician Orders Legal and Regulatory Article Series

Physician Order Reimbursement Issues

Physician Orders – Why Are They So Important?

The Verbal Order Minefield

Authenticating Verbal Orders : Compliance Requirements

Third Party Authentication of Verbal Orders

Physician Order – CMS Guidelines on Texting Physician Orders

 

Physician Orders – Definition and Reimbursement Implications

Wednesday, January 24th, 2018

Physician Orders – Big Implications but Few Definitions

Physician Ordering Services Physician OrdersI wanted to talk a bit about physician orders. Physician orders hold a great deal of significance in health care. The root purpose of a physician order is to direct other providers to furnish certain services. Services ordered by a physician might include things like therapy services, skilled nursing services, home health, diagnostic testing, and a variety of other therapeutic and/or diagnostic services that might flow from the physician’s examination of the patient.

In addition to the practical application of directing care, health care payors look to physician orders to make payment determinations. The Medicare program places a great deal of importance on physician orders to support claims for ancillary and diagnostic services. Certain services require a physician’s order as a prerequisite to payment on a claim for service. In other cases there may be no direct, fee-for-service payment implication to a physician’s order, but they are still critical to patient safety and to communicate matters that may impact care and treatment of patients.

A few weeks back, my trials and tribulations as a health care compliance lawyer resulted in my need to locate a definition of what constitutes a physician’s order. I looked in the Medicare regulations and was surprised to find that there is no statutory or regulatory definition of what constitutes the order of a physician. This seemed odd given the importance of physician orders as conditions for payment of many Medicare claims. There are references throughout the regulations that require physician orders. I was finally able to locate a definition in a CMS Policy Manual. But if push comes to shove in the context of a case, these policy manuals are not binding on the interpretation of regulatory terms. CMS may define physician orders internally, but that does not necessarilly mean that a court will uphold that definition.

Some states do a better job than Medicare at defining what constitutes a physician’s order. Medicare policy sometimes defers to state law, particularly regarding some of the technical aspects of physician orders such as what constitutes a valid electronic signature. State law should always be referenced when determining issues relating to physician orders, attestation, signatures, and other issues. This does not always provide clarification and, in fact, sometimes it causes confusion. But it is necessary for a full analysis and identification of where there may be uncertainty.

So no I am inspired to do some further exploration on physician orders. When are they necessary? When are they required? What technical requirements apply? Stay tuned to this blog for additional articles and hopefully some fairly comprehensive coverage of physician orders.

Physician Orders Legal and Regulatory Article Series

Physician Order Reimbursement Issues

Physician Orders – Why Are They So Important?

The Verbal Order Minefield

Authenticating Verbal Orders : Compliance Requirements

Third Party Authentication of Verbal Orders

Physician Order – CMS Guidelines on Texting Physician Orders

Dental Practice Compliance Programs – Essential Elements of Compliance Policies

Monday, February 13th, 2017

Should a Dental Practice Have a Compliance Program?

Compliance programs are an accepted requirement in most of the health care industry.  There seems to have been less importance attached to the establishment of systematic compliance programs in the dental practice area.  I believe part of the reason why the dental industry has lagged behind other health care providers in the compliance area is that there is very little Medicare reimbursement involved in the usual dental practice.  Certainly much of the reason for compliance program involve Medicare enforcement actions.  However, dental practice that under-emphasize compliance are assuming a great deal of unnecessary risk.

Certainly some dental providers receive Medicare reimbursement for a portion of their services.  Oral surgeons for example regularly perform services that are covered under the Medicare program.  Many practices accept Medicaid reimbursement or reimbursement from other Federal health programs.  Additionally, practices that receive reimbursement from federally funded health care plans are required under Federal law to establish and effective compliance program that contains the “core elements” set forth in Federal law.  The Federal standard required dental providers who receive this type of reimbursement to actively operate a compliance programs that is effective in preventing and detecting criminal, civil and administrative violations and in promoting the quality of care that is provided by the practice consistent with federal regulations.

There are many reasons beyond reimbursement requirements to operate a compliance program.   Dental practices must maintain systematic process to assure compliance with OSHA regulations, HIPAA and state privacy regulations, and a variety of other federal and state rules and regulations.  Some of these regulatory areas are subject to aggressive governmental oversight including periodic audits and inspections.  Other areas are not subject to aggressive enforcement.  All of these areas, even those where there is no aggressive enforcement, can expose the dental practice to liability if a complaint is made by an employee, former employer, patient, competitor, or other individual.  Some of these potential complainants can even establish whistleblower status and can bring private action for recovery.

Some practices that implement compliance programs and perform audits over billing and collection practices are pleasantly surprised when they discover that they have actually been under-billing.  Audit of potential risk areas can indeed identify missed revenue opportunities.  This does not happen in every instance, but there are circumstances where the audit process actually identifies new revenue streams.

For most providers, operating a compliance program will have the benefit of deterring potential future liability.  If detected early, it is much easier to deal with a potential infraction when it is self-discovered before the potential damages become insurmountable.  It is one thing to deal with potential over-payment or failure to follow a regulation.  It is much more difficult to resolve these issues when they are brought into the open from an outside party.  By that time, potential sanctions may have multiplied to an unmanageable level.  For example, if the False Claims Act applies, a simple over-payment can be multiplied by 3, plus $11,000 to $21,000 per claim can be added to the otherwise manageable over-payment amount.

In summary, there is every reason for a dental practice to actively operate a robust compliance program.  Those that believe that a compliance program is not needed because Medicare reimbursement is not present should think again.  Eventually, it is highly likely that the failure to maintain an active compliance program will catch up with you.  I have represented many health care providers who have been subject to the negative impact of not operating a compliance program.  I can tell you that they all share the same regret that they did not deal with compliance proactively while they had the opportunity.

For those of you who are still reading, I want to briefly describe the 7 basic elements of a compliance program.  Each of these elements can be expounded on further, but I will touch on them briefly here.

  1. Appointment of a high ranking member of management to act as compliance officer. In a smaller practice, a compliance responsible individual can be used.  Compliance program structure can be scalable to the size and resources of the provider and the nature and complexity of the business.
  2. Compliance policies should be put in place that describe the process to be used to conduct ongoing compliance activities. Compliance policies will define compliance operations and will also outline requirements in risk areas that are specific to the nature of the practice.
  3. Employees, contractors and others must be trained on basic compliance program elements and risk areas that are applicable to their job functions.
  4. Creating a compliance reporting system and protecting those who make complaints from retaliation or retribution.
  5. Enforcing disciplinary standards that hold employees responsible for following compliance requirements.
  6. Operating a system to continually identify areas of potential compliance risk within the practice.
  7. Maintaining a system of appropriately responding to identified compliance problems through creation of appropriate corrective action, self-disclosure or other appropriate action.

Putting these elements in place through adoption and operation of appropriate policies and standards establishes the central elements of the compliance process.  It is critical that the activity does not stop at the establishment of policies.  A compliance program must be continually operated as a living a breathing process to identify and address risk in a practice manner.  The compliance officer or responsible individual is responsible for assuring the continued operation of the program.

Risk areas in a dental practice include reimbursement rules, licensing and certification standards, OSHA regulations, HIPAA and state patient privacy laws, infection control standards, radiation regulations and standards, documentation requirements, controlled substance regulations and a host of other state and Federal regulatory requirements.  Your compliance program in effect creates the process to identify risk and proactively examine potential areas of risk to determine compliance.  An actively operating compliance program is a necessary elements of every dental practice.

About Our Dental Practice Attorney Representation

OIG 2017 Annual Work Plan

Monday, January 23rd, 2017

OIG Annual Work Plan for 2017 – Topics Covered

The Health and Human services Office of Inspector General (OIG) recently released its 2017 Annual Work Plan.  Work planning is an ongoing project within the OIG.  Every year, the OIG publishes a work plan that consolidates the OIG audits and evaluations that are being conducted or planned within the organization.  The annual work plan has become a source that compliance officers look to as a tool for the identification of potential risk areas or areas of emphasis within their organization.  It is obviously not the only source for identifying compliance risk areas, but is certainly one reliable source that providers can draw on when setting their annual compliance priorities.

The 2017 OIG Work Plan can be download through the OIG site.

Ruder Ware’s health care group will continue to put out blogs and articles on various issues identified in the 2017 Annual Work Plan.  We will focus primarily on issues that were introduced for the first time in this year’s plan.

A listing of some of the issues addressed in the 2017 annual work plan include:

Hyperbolic Oxygen Therapy Services – Provider Reimbursement in Compliance with Federal Regulations

Incorrect Medical Assistance Days Claimed by Hospital

Inpatient Psychiatric Facility Outlier Payments

Case Review of Inpatient Rehabilitation Hospital Patients Not Suites for Intensive Therapy

Intensity-Modulated Radiation Therapy

Outpatient Outlier Payments for Short-Stay Claims

Comparison of Provider-Based and Freestanding Clinics

Reconciliation of Outlier Payments

Hospital Use of Outpatient Stays Under Medicare’s Two Midnight Rule

Case Review of Inpatient Rehabilitation Hospital Patients Not Suited for Intensive Therapy

Medicare Costs Associated with Defective Medical Device

Payment Credits for Replaced Medical Device That Were Implanted

Medicare Payment for Overlapping Part A Inpatient Claims and Part B Outpatient Claims

Selected Inpatient and Outpatient Billing Requirements

Duplicate Graduate Medical Education Payments

Indirect Medical Education Payments

Outpatient Dental Claims

Nationwide Review of Cardiac Catheterization and Endomyocardial Biopsies

Payments for Patients Diagnosed with Kwahiorkor

Use if Hospital Wage Data Used to Calculate Medicare Payments

CMS Validation of Hospital-Submitted Quality Reporting Data

Long Term Care Hospitals – Adverse Events in Post-acute-Care for Medicare Beneficiaries

Hospital Preparedness and Response to Emerging Infectious Diseases

Nursing Home Complaint Investigation Data Brief

Skilled Nursing Facilities – Unreported Incidents of Potential Abuse and Neglect

Skilled Nursing Facility Reimbursement

Skilled Nursing Facility Adverse Even Screening Tool

National Background Checks for Long Term Care Employees – Mandatory Review

Skilled Nursing Facility Prospective Payment System Requirements

Potentially Avoidable Hospitalizations of Medicare and Medicaid Eligible Nursing Facility Residents

Medicare Hospice Vulnerabilities and Recommendations for Improvement

Review of Hospices Compliance with Medicare Requirements

Hospice Home Care – Frequency of Nurse On-Site Visits to Assess Quality of Care and Services

Comparing HHS Survey Documents to Medicare Claims Data

Home Health Compliance with Medicare Requirements

Part B Services During Non Part-A Nursing Home Stays; Durable Medical Equipment

Medicare Market Share of Mail-Order Diabetics Testing Strips

Positive Airway Pressure Device Supplier – Supplier Compliance Documentation Requirements for Frequency and Medical Necessity

Orthotic Braces – Reasonableness of Medicare payments Compared to Amount Paid by Other Payors

Osteogenesis Simulators – Lump Sum Purchase Versus Rental

Power Mobility Devices – Lump Sum Purchase Versus Rental

Competitive Machines and Related Drugs – Supplier Compliance with Payment Requirements

Access to Durable Medical Equipment in Competitive Bidding Areas

Orthotic Braces – Supplier Compliance with Payment Requirements

Nebulizer Machines and Related Drugs – Supplier Compliance with Payment Requirements

Access to Durable Medical Equipment in Competitive Bidding Areas

Monitoring Medicare Payments for Clinical Diagnostic Laboratory Tests – Mandatory Review

Medicare Payments for Transitional Care Management

Medicare Payments for Chronic Care Management

Data Brief on Financial Interests Reported Under the Open Payments Program

Yates Memorandum and Compliance Investigations – New Newsletter Released

Tuesday, January 10th, 2017

Health Care Compliance Newsletter Released

Ruder Ware has released a new version of its newsletter covering health care law issues.  The current newsletter covers major changes in government enforcement practices and health care fraud penalties that significantly increase the stakes for health care compliance.  The newsletter contains a series of articles by Health Care Compliance Attorney, John Fisher, CHC, CCEP.

Access the newly released newsletter – Health Law Newsletter 2017

Past Newsletters are also available through this blog. Past Newsletters

Newsletter Signup

 

President Signs the 21st Century Cures Act

Wednesday, December 21st, 2016

21st Century Cures Act Signed by President Obama

21st Century Cures ActOn  December 13, 2016, signed the 21st Century Cures Act into law.  The Cures Act was perhaps the most significant piece of health care related legislation since the passage of the Affordable Care Act.  The Cures Act had strong bi-partisan support in both houses and included a wide variety of miscellaneous provisions that are intended to improve and modernize the health care system.  Perhaps the most forward looking provisions in the Cures Act relate to mental health and substance abuse treatment and advancement of biomedical research.  However, the Cures Act contains numerous subject area revisions that expand well beyond these two areas.  Just a few of the areas covered by the Cures Act include the following:

 

  • Mental Health and Substance Abuse
  • Funding of Opioid Addiction Services
  • Revising Documentation Related to the Delivery of Health Care Link
  • New OIG Civil Monetary Penalties for Grant Funding or Contracts
  • Revisions to the Site of Service Differential for Off-Campus Provider-Based Departments
  • Changes to Documentation Requirements to Facilitate Electronic Health Record Utilization

These are just of few of the new statutory provisions that were included in the Act.  We will continue to examine the legislation for items of significance, so be sure to check back to the Health Law Blog for more complete coverage of this important legislation.

 

CMS Releases Final Rules Under Medicare Shared Savings Program

Tuesday, June 21st, 2016
  • final aco rule revision 2016 msspMSSP Final Rules Revision ACO Requirements Under Shared Savings Program – 2016 Revised MSSP Regulations Issues

On June 10, just in time for my birthday (thanks CMS), the Centers for Medicare & Medicaid Services (CMS) released final rules amending the regulatory requirement applicable to the Medicare Shared Savings Program (MSSP). The Final Rules that were published on June 10, 2016 state the intent to encourage additional participation in the program and to ease financial burdens on participating Accountable Care Organizations (ACOs). The regulations attempt to provide incentives for existing ACOS to renew their participation and elect to pursue higher levels of risk. The revised rules reflect an element of additional flexibility that ACOs may be able to take advantage of when transitioning between participation tracks.

There are a variety of changes in the new regulations. A few of these changes include:

  • Clarifications regarding times that shared savings and shared loss claims may be re-opened by CMS.
  • Changes in how benchmarks will be calculated beginning in 2017. (Increasing consideration of regional Medicare expenditures total population health of the population that is assigned to the ACO).
  • Adoption of adjustments based on average fee-for-service Medicare expenditures applicable to the relevant regional service area for purposes of calculating benchmark adjustments. County-by-county averages will be utilized for expenditures attributable to the total cost of services to beneficiaries within the applicable county.
  • Adoption of risk-adjustment factors when revising an ACO’s benchmarks. Risk adjustment is to be based on the relative health status of the ACO’s assigned population.
  • Revision of the manner in which CMS performs truncating and trending calculations.

The new rules clarify that CMS has the authority to reopen and make revisions to MSSP payments in cases of fraud and for other similar reasons. Even when fraud does not exist, CMS will have four years after providing notice of initial determination of shared savings or loss to reopen and revise for any good cause. Unfortunately, there is not definition of what constitutes “good cause” in the new rules. In comments, CMS indicates that it will excercise this authority where there evidence that was previously unavailable evidence that indicates error in the original determination or where previously available evidence is clearly determined to have been relied on erroneously. This rather broad “reopening” authority presents significant financial uncertainty for ACOs.

Under the new rules, ACOs will now be able to remain in Track 1 for a fourth year before transitioning into Tracks 2 and 3 which involve higher degrees of risk. Additionally, ACOs that choose to progress to higher risk tracks will be able to have their benchmark recalculation deferred for an additional year. These changes are being made to make it easier for ACOs to transition to higher risk tracks.

 

Clinical Integration Readiness Analysis CINs

Tuesday, January 26th, 2016

 Are You Ready for Clinical Integration?

When we take on a nClinical Integration Attorneyew clinical integration project, one of the first activities we advise is the performance of a snapshot clinical integration readiness analysis.  The theory is that a future CIN needs to know where it is in the clinical integration process before it can plan where it needs to go and the steps that it needs to take.  The initial assessment gives indications of the existing lay of the land and helps the organization shape an integration business model with a more accurate context.

Through this initial assessment process, we can identify structural or governance issues that may hamper further integration.  The readiness assessment is only the beginning of a long road toward clinical integration.  However, time spent on this initial stage can save significant time and effort in the long term.

During early assessment and design stages, we attempt to encourage broad participation by providers.  We will normally recommend the creation of a governance and committee structure that is as inclusive as possible.  Clinical integration is primarily a process that physicians perform.  Mechanisms are created through which physicians collaborate across specialty, in an interdependent way toward the end goals of increasing quality and efficiencies.  Ideally, the process should be collaborative between physicians and institutional providers.  However, the dynamics between hospitals and physicians can sometimes adversely impact the working relationship.

Hospitals have been the center of the health care system through recent history.  Changes in the health care system are beginning to change that paradigm.  Health systems that recognize the realities of this shift will be at a competitive advantage in the future.  In order to meet the challenges of the changing health care system, physicians and facilities need to collaborate.  True change and collaboration cannot be forced on physicians.  Failure to recognize this will put some institutions behind in the creation of the collaborative organizations that are required to compete in the future.

This factor will often manifest itself in the form of governance and control issues.  A health care system may be reluctant to share governance and control with independent physicians.  Failing to create shared governance models will predictably make physicians reluctant to become adequately engaged in the creation or operation of the system.  Many projects shall cover governance and control issues and loose important momentum.

The degree of receptivity to joint governance and control is a significant indicator of potential success.  This is an important issue that must be considered early in the assessment process.  It is often difficult to “undo” the damage that can be inflicted over these issues early in the process.

John H. Fisher, CHC, CCEP is a health care attorney at the Ruder Ware law firm.  He has been involved in the creation and representation of provider networks since the early 1990s. John has followed legal issues impacting provider groups for over 25 years.  As such, he is knowledgeable on the current legal standards as well as the historic perspective that is often relevant to an appropriate analysis.  He is currently involved advising providers and their counsel on the development of clinically integrated provider groups in various locations around the country.

 

Hospital Supervision Rules – Billing “Incident To” Physician Services

Tuesday, April 22nd, 2014

Hospital Supervision Rules for “Incident To” Services

hospital supervisions incident to reimbursementPhysician supervision rules in hospital outpatient departments have continually changed over the past five years.  Those who have followed these rules cannot help but wonder whether CMS is somewhat schizophrenic on this issue.  Hospital supervision rules have been like a moving target, making compliance difficult to track and to communicate to front line physicians and staff who must comply with these changing rules.

Services of a therapeutic nature are often performed by physician extenders in a hospital department and are billed “incident to” the physician’s services.  Historically, direct supervision was required to enable the service to be billed as “incident to” the physician’s services.  The direct supervision rule generally requires the physician to be “immediately available” to assist with and direct the service.  This does not necessarily require presence in the same room where the service is being delivered.  The precise requirements that must be complied with in order to meet the “direct supervision” requirement is where CMS has given us a moving target for compliance purposes.

In the 2009 OPPS Rule, CMS provided what it considered to be “clarification” of its rules.  To most providers, the CMS guidance actually amounted to a change of position that required changes in their supervision policies.  Before the 2009 “explanation,” many providers structured their compliance efforts under the assumption that they were not required to have a physician physically present in an outpatient department to meet the direct supervision requirement.  The 2009 “clarification” indicated that physical presence of a supervision provider was required.

The 2009 comments lead to much criticism from the provider community.  This resulted in further changes in the 2010 OPPS Rule that made it sufficient for the supervising physician to be present on the same campus and immediately available rather than requiring physical presence in the department.  Off campus clinics and departments were still required to meet the more restrictive physical presence requirement.  Physical presence of off campus departments required actual physical presence in the space that is designated as the department.  The supervising physician would not meet this standard even if they were located in the same building but not in the departmental office suite.

Although the 2010 rules answered some of the open questions, the rules had a huge negative impact primarily on smaller hospitals and particularly those located in rural areas.  Small hospitals were required to meet the physician “physical presence” requirements even when there was no other activity requiring physician presence.  This necessitated small hospitals to incur costs to meet the “incident to” supervision requirement even when physician presence was not otherwise required.

At least partly to address the “small hospital” issues, the 2011 OPPS Rule made significant changes to the physician supervision requirement.  The “on the same campus” rule was abandoned in favor of a rule that focused more on the general “availability” of the physician.  The 2011 rule eliminated many of the specific physical location requirement but still maintained the more general requirement that the physician be “immediately available to furnish assistance or direction throughout the performance of the procedure.”  The standard requires the physician to be immediately available and interruptible.  The rule also opened the door for the physician to be available by telemedicine to meet “general” supervision requirements.

The 2011 rule also identified certain services for which direct supervision is always required for the initiation of the services.  Services covered by special supervision requirements includes a limited listing of non-surgical and extended duration therapeutic services.  These services include certain injections, infusion and observation services.  Chemotherapy is not included in this listing.  These services are services that can have a longer overall duration and have a low risk of requiring physician involvement after the service is initiated.

The 2011 rule set up a panel to evaluate specific therapeutic services to determine the appropriate level of supervision.  The 2012 OPPS Rule formally designated the panel as the body that reviews and recommends changes in supervision requirements relative to various therapeutic services.  The 2012 rule also took steps to assure that critical access and rural hospitals were represented on the panel.  The panel is authorized to recommend levels of supervision that are lower than “direct supervision” for specific services.  The panel does not have the ability to directly enact regulations or make policy changes.  Its role is limited to that of advising CMS on these issues.

At the present time, the hospital outpatient supervision requirements currently must meet the “general” supervision requirements.  The service must be performed under the overall direction and control of the physician.  The physical presence of the physician is not required during the performance of the “incident to” activity.  In cases where personal (as opposed to general) supervision is required, the actual presence of the physician is required in the room.  Some services only require physical presence at the inception of the service and have been found to not create a risk during the ongoing stages of the procedure.

All hospital outpatient therapeutic services are deemed to be provided “incident to” the services of the physician.  The level of supervision required in the case of these types of services (personal or general) is based upon CMS determinations following review by the panel as indicated above.

So, now that we are all clear on the rules, (insert sarcasm emotion here), can we expect them to change again the future?  Certainly the panel process will be reflected by different rules for specific therapeutic items.  Additionally, given the history of this requirement, no one would be surprised if further changes are in our future.

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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The Health Care Law Blog is made available by Ruder Ware for educational purposes and to provide a general understanding of some of the legal issues relating to the health care industry. This site does not provide specific legal advice and you should not use the information contained on this site to address your specific situation without consulting with legal counsel that is well versed in health care law and regulation. By using the Health Care Law Blog site you understand that there is no attorney client relationship between you and Ruder Ware or any individual attorney. Postings on this site do not represent the views of our clients. This site links to other information resources on the Internet; these sites are not endorsed or supported by Ruder Ware, and Ruder Ware does not vouch for the accuracy or reliability of any information provided therein. For further information regarding the articles on this blog, contact Ruder Ware through our primary website.