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Unnecessary Inpatient Admissions Results in Hospital DOJ Settlement

Thursday, May 17th, 2018

Unnecessary Inpatient Admissions – Hospital Fraud Settlement.

Hospital Admissions Fraud Risk AreaAn $18 million settlement was agreed by a hospital chain after allegations that claims were submitted to Medicare for patients who were admitted to an inpatient facility when they allegedly could have been treated on a less costly outpatient basis.  The government alleged that the hospital system billed Medicare for short-stay, inpatient procedures that should have been billed on a less costly outpatient basis.  The government also accused the hospital system of inflating reports to Medicare regarding the number of hours of outpatient observation care that was provided.

This is a fairly typical case where the allegation involved billing for services that were of a higher level than required by the patient.  In effect, the excess services are deemed to be medically unnecessary.  In this case, the services involved inpatient admissions that the government alleged could have been taken care of in a less costly outpatient setting.

A former employee was the whistleblower in the case and walks away with over $3.25 million from the settlement.

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

Providing Protected Health Information in Response to Subpoena

Thursday, February 22nd, 2018

OCR Citation for Improper Disclosure of PHI in Response to a Subpoena

unauthorized release phi subpoenaA health care provider or other covered entity under HIPAA is permitted to disclose protected health information if it receives a lawful order from a court or administrative tribunal.  this does not mean that a provider can simply release everything it has in a patient record when it receives a court order.  Some records, such as mental health or substance abuse records might have special protections or limitations that apply.  Additionally a provider should closely review the relevant order and only disclose the information that is specifically required by the order.

The ability to release information in response to a subpoena, as opposed to an order of a court, is subject to different rules.  Patient information can only be provided under subpoena if certain notification requirements of the Privacy Rule are met. The notification requirements require the provider who received the subpoena to obtain evidence that there were reasonable efforts to notify the person who is the subject of the information about the request.  This is intended to give the individual an opportunity to object to the disclosure, or obtain a protective order from the court.

The application of these rules are illustrated by a relatively recent OCR settlement involving a hospital that was accused of improperly disclosing PHI in response to a subpoena.  The hospital apparently failed to determine that reasonable efforts had been made to notify that individual whose PHI was being sought under the subpoena.  This had the effect of denying the individual the right to object or seek a protective order.

As part of the settlement with the Hospital, OCR required the hospital to revise its subpoena processing procedures. The new policies adopted by the offending hospital hold a lesson for all covered entities.  If a subpoena does not meet the requirements of the Privacy Rule, policy should require the covered entity to reach out to the party who issued the subpoena to explain the notification requirements.  Until those requirements are complied with, the information cannot be released.

Court Orders and Subpoenas – Release of Protected Health Information

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

Off-Campus Provider-Based Departments Neutrality

Friday, December 23rd, 2016

Off-Campus Provider-Based Departments Site-Neutrality

The 21st Century Cures Act contains new provisions that prohibits the Centers for Medicare & Medicaid Services (CMS) from paying different rates for services provided in for services furnished in off-campus provider-based department (PBD) of a hospital.    The CY 2015 Outpatient Prospective Payment System Final Rule (79 FR 66910-66914) created a HCPCS modifier for hospital claims that is to be reported with every code for outpatient hospital items and services furnished in an off-campus provider-based department of a hospital. This 2-digit modifier was be added to the HCPCS annual file as of January 1, 2015, with the label ‘‘PO.’’ Reporting of this new modifier was voluntary for CY 2015, with reporting required beginning on January 1, 2016.

The 21st Century Cures Act revises this policy beginning January 1, 2017, with some exceptions. One exception is for OPBDs that billed for services furnished as of November 2, 2015 (the date the law was enacted). The 21st Century Cures Act expounds on this exception and permits providers to be grandfathered under the old rules if the Secretary received a properly filed provider-based attestation for the site from the provider prior to December 2, 2015.  Furthermore, if  an off-campus provider-based department was in development as of November 2, 2015 and made a timely filing of a certification to CMS,  the old rules can be applied even though the department was not operating as of the cut-off date.

John H. Fisher, CHC, CCEP is a health care attorney at the Ruder Ware law firm.  John is actively involved representing clients on legal and compliance issues.  He has represented clients in creating compliance programs and in a variety of operational issues.  He also assists providers in addressing risk areas and potential compliance issues including preparing self-disclosure and working with the government to resolve disclosed compliance issues and overpayment.  John consults as a subject matter expert and provider legal backup to other attorneys and law firms from around the country on specialized compliance, regulatory and health care issues.  John has followed legal issues impacting health care provider 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.  

Physician Owned Hospital Expansion – CMS Approval Process

Friday, May 16th, 2014

Obtaining Approval for Expansion of Physician Owned Hospitals 

physician owned hospitalsCurrently, federal law effectively prohibits the establishment of new physician-owned hospitals.  Expansion of existing physician-owned hospitals is also effectively prohibited.  An existing hospital may request an exception from the prohibition from the Center for Medicare and Medicaid Services.  An exemption may be granted by CMS, but not without the hospital going through the formal request and review process.

Under the federal Stark Law, physicians are prohibited from owning interests or having financial relationships with entities that provide “designated health services,” including hospital services, unless an exception exists.  Previous versions of the Stark Law contained an exception for investments in the hospital itself as opposed to a subdivision of the hospital (known as the “whole hospital” exception.  The Affordable Care Act virtually eliminated the “whole hospital” exception from the Stark Law for future hospital projects and for expansion of existing projects.

Beginning in March of 2010, a physician-owned hospital is prohibited from expanding existing capacity unless it applies for and is granted an exception as either an “applicable hospital” or a “high Medicaid facility.”  Federal regulations set forth the procedures that must be complied with when submitting requests for an exception.

Physician-owned hospitals that wish to expand existing capacity must follow the regulatory process for obtaining approval.  Part of this process involves CMS obtaining input from other providers in the community.  Even if expansion is approved, expansion cannot exceed 200% of the baseline number of operating norms, procedure rooms, and beds.  Expansion must be limited to the hospital’s primary campus.

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.

Two Midnight Rule Exceptions CMS Inpatient Only

Thursday, April 17th, 2014

Exceptions to Two Midnight Rule 

exceptions cms two midnight ruleCMS recently updated its frequently asked questions regarding the two midnight rule.  The two midnight rule requires a patient to require hospitalization, including two midnights, in order to qualify for inpatient hospital Medicare reimbursement.  Numerous questions have been raised about details of how the rule is applied.

CMS has recently stated two exceptions to the two midnight rule:

1.         One exception relates to patients who require mechanical ventilation that is initialed during a visit may be admitted even if the inpatient stay is not expected to remain or two midnights.  This exception does not apply as a result of anticipated intubations during minor surgery or other treatments.

2.         Procedures that are listed on the “inpatient only” list may be reimbursed even though the stay is not anticipated to meet the two midnight rule.

Providers should review the transcripts from the January 21, 2014, open door call for more details regarding the application of the two midnight rule.  The call clarified several issues of how to apply the rule.  For example:

  • Providers can assume that a patient will survive, even in cases where it is reasonably likely that the patient may not survive following admission.
  • CMS is still working on details of how to apply the role where patient transfer takes place.  Transfer cases will not be reviewed at least for the initial audits (through March 31, 2014).

CMS is requiring a 0.2% reduction to IPPS payments as part of the Final Fiscal Year 2014 IPPS rules.  Hospitals who wish to challenge the reduction amount should preserve their appeal rights by indentifying the reduced amount as being protested on their cost report.  The protest should be indicated commencing October 1, 2013, the effective date of the two midnight rules.

Two Midnight Rule Implementation Delays Announced

Tuesday, March 18th, 2014

CMS Issues Further Delays And Implementation Of The Two-Midnight Rule

In late January, the Center for Medicare/Medicaid Services announced that it will delay implementation of regulations pertaining to the two-midnight rule.  CMS announcements state that Medicare administrative contractors will not audit for compliance with the rule until October 1, 2014.

The two-midnight rule provides that an admission does not qualify for per diem reimbursement where a physician admits a patient with an expectation that treatment will require a stay of covering at least two nights.  CMS indicates that this policy merely clarifies its longstanding consideration of when admission meets criteria to be covered as an inpatient rather than as an observation or outpatient.

Under the two-midnight rule, services that are not considered to be medically necessary unless the two midnight inpatients stay rule are met.  This does not mean that there is no coverage at all.  It is possible that the service would be paid as an observation stay or as an outpatient service.  MACs will continue to perform reviews of 10-25 selected clients per hospital per admission dates between March 31 and September 30.  However, the reviews will be considered “probe and educate” reviews and will not lead to administrative sanctions.  However, providers should be completely ready and implement with the rule by October 1, 2014 date that CMS states it will use as a more formal implementation date.

 

Annual Health Care Fraud and Abuse Control Program Report

Tuesday, March 11th, 2014

Record Recovery for Health Care Fraud and Abuse

The U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) recently released its annual Health Care Fraud and Abuse Control Program (HCFAC) report. This report indicates that in the last three years for every dollar spent on health care related fraud and abuse investigations through HCFAC and other government programs, the government recovered $8.10. This is a record high for the 17-year old program.  HCFAC focuses on eliminating fraud, waste, and abuse in the health care industry.

A few notes on the report’s numbers:shutterstock_1766714

•      The federal government recovered a record-breaking $4.3 billion in fiscal year 2013 alone.
•      Over the last five years, the federal government recovered $19.2 billion—this is more than double the previous five-year period.
•      In fiscal year 2013, the DOJ and HHS strike force team filed 137 cases, charged 345 individuals with crimes, secured 234 guilty pleas, and achieved 46 convictions.
•      Defendants sentenced in fiscal year 2013 served an average of 52 months in prison.
•      Centers for Medicare and Medicaid Services (CMS) have banned 225,000 individuals and entities from billing Medicare between March 2011 and September 2013.

Attorney General Eric Holder states that, “With these extraordinary recoveries, and the record-high rate of return on investment we’ve achieved on our comprehensive health care fraud enforcement efforts, we’re sending a strong message to those who would take advantage of their fellow citizens, target vulnerable populations, and commit fraud on federal health care programs,” said Attorney General Eric Holder.

The return on investigation investment suggests that the federal government’s interest in investigating and prosecuting health care fraud and abuse is substantial. In short, health care compliance is more important than ever.

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.