New Law Would Limit Liability for Innocent Billing Errors

The Fairness in Health Care Claims, Guidance and Investigations Act, H.R. 2931  would amend the False Claims Act (“FCA”) by requiring that regulators satisfy procedural steps before embarking on costly fraud investigations.  The Bipartisan legislation, introduced by Representatives Howard Coble (R), North Carolina and David Scott (D), Georgia, would raise the burden of proof under the FCA, would except matters that do not exceed a ‘de minimus’ threshold, and would establish safe harbors for reliance on regulator guidance and implementation of model compliance programs.

The American Hospital Association issued a letter in support of the proposed legislation as well as a memo describing the legislation.

For more information regarding the False Claims Act or Government Investigations, please contact Adam Snyder at 206.447.7000.

Former Hospital CFO Blows Whistle On Effort To Buy Medicaid Referrals

Georgia recently joined a false claims act lawsuit alleging that Healthcare Management Associates, Inc. and Tenet Healthcare Corporation hospitals have been improperly paying for referrals for many years.  According to the complaint, the hospitals paid interpreter, management and other service fees to clinics in exchange for which the clinics referred pregnant, undocumented women to the hospitals for delivery and post-delivery care paid for, in part, from Medicaid funds available for emergency deliveries and post-delivery care of the newborn.  Georgia seeks to recover three times the dollar amount of false Medicaid claims plus civil penalties of between $11,000 and $15,000 for each false claim.

Tenet issued a statement to the effect that the agreements were legitimate and the hospitals were providing necessary healthcare services to women in underserved Hispanic communities served by the hospitals.  According to Tenet the services were designed to increase the likelihood of a safe birth and healthy baby.

The lawsuit was filed by Ralph Williams who served briefly as a CFO for one of the HMA hospitals before he was fired.  Among other things, the Complaint alleges:

  • Hospitals paid the clinics up to $15,000 to $20,000 a month for referrals
  • One hospital projected a 56.2% rate of return on its investment in a clinic’s “Hispanic Maternity Program”.
  • One clinic billed a hospital for in excess of 13 hours a day of interpreter services during June and July 2009 but Williams was unable to confirm that any clinic employee was on the hospital campus at any time during this period

Georgia brought its claims under its state false claims act based on the federal false claims act.  Washington has a virtually identical act applicable to Medicaid payments.

For more information please contact Greg Montgomery.

 

Washington Certificate of Need Program Commences Rule Making: Consumer Transparency in Affiliations & Dialysis

The Washington State Certificate of Need Program has announced its commencement of the rule-making process related to hospitals and dialysis.  This action is in response to the directive issued last month by Governor Inslee instructing the CN Program to expedite rule making related to the corporate restructuring, affiliations, acquisitions and mergers occurring in hospitals across the state.  His directive requires that:

The Certificate of Need process should be applied based on the effect that these transactions have on the accessibility of health services, cost containment, and quality, rather than on the terminology used in describing the transactions or the representations made in the preliminary documents.

The Department’s rulemaking process shall also consider ways to improve transparency for consumer information and ease of use, specifically the Department shall ensure hospitals supply non-discrimination, end of life care and reproductive health care policies; and the Department shall ensure that consumers have access to the policies on its webpage. The Department’s rulemaking process shall also consider the factors in RCW 43.06.155, the principles and policies in the implementation of health reform, including the guarantee of choice for patients.

In response to this directive, the CN Program has released concept rules to implement the directive.  These concept rules contain two significant modifications:

1.  A new defined term in WAC 246-310-010: “Sale, purchase, or lease” means any transaction in which the control, directly or indirectly, of part or all of any existing hospital changes to a different person, including but not limited to by contract, affiliation, corporate membership restructuring, or any other transaction.

This change is significant, as the “sale, purchase, or lease” of all or part of an existing hospital is subject to the CN rules and review.  The new definition expands the applicability of the CN rules and review.  Whereas previously affiliations were typically reviewed under Determinations of Reviewability, the expanded definition would subject such transactions to CN approval.

2.  A new section which collects hospital policies, maintains the policies and list of limitations on certain services online, and requires all hospitals to submit these policies and lists within 60 days of the effective date of the new rule.  The proposed new section is reproduced below:

New Section WAC 246-310-XXX Collection of Hospital Policies

1) Every hospital must submit to the department its following policies related to access to care:

a) Admission;

b) Non-discrimination;

c) End of life care; and

d) Reproductive health care.

2) If the effect of one or more of a hospital’s policies required under subsection (1) of this section limits or excludes access to services authorized by law, the hospital must submit to the department a list of services that are limited or not available at the facility.

3) The department shall post a copy of the policies received under subsection (1) of this section and lists received under subsection (2) of this section on its website.

4) If the hospital makes changes to any of the policies listed under subsection (1) of this section, it must submit a copy of the changed policy to the department within thirty days after the hospital approves of the changes.

5) No later than sixty days following the effective date of this rule each hospital must submit to the department the documents identified under subsections (1) and (2) of this section.

These proposed rules will have an impact on future transactions and existing hospitals.  The proposed revisions will be discussed at an August 5th workshop located at the Department of Health.

If you would like further information about these proposed rules or certificate of need in general please contact Elana Zana.

CA Surgeon Stripped of Medicaid Funding for Failure to Treat HIV Positive Patient

On July 18th, the U.S. Department of Health and Human Services announced that a California surgeon who refused to treat a patient based solely on the patient’s condition as HIV positive would lose Medicaid funding.  The surgeon had refused to perform necessary back injury and a resulting investigation by the HHS Office of Civil Rights found the surgeon had discriminated against the patient in violation of federal laws.  The violation ultimately resulted in an action to ensure compliance with federal civil rights laws and eventually the surgeon’s loss of the federal funding.

The determination underscores the need for health care providers to make best efforts to ensure patients and prospective patients who fall within protected classes receive the same treatment and standards of care as any other patient.  Failing to do so can jeopardize federal funding and also expose the provider to a range of potential claims for violations of federal and state workplace laws.

The fundamental steps to help avoid claims and liability are:

●             Have effective policies:  Providers should have written policies prohibiting discrimination and harassment.  Having an effective policy notifies all employees that discrimination and harassment will not be tolerated, and helps set a tone for conduct in the workplace.

●             Train up supervisors and staff:  All supervisors and staff should be fully aware of workplace discrimination and harassment laws and how to respond to potential problems.  Training helps prevent claims, allows problems to be identified and addressed early on, and provides vital potential evidence that the employer took reasonable steps to prevent improper behavior.

●             Familiarize yourself and staff with Medicaid rules:  Washington State Medicaid provider requirements obligate participating providers to provide all services without discriminating on the grounds of “race, creed, color, age, sex, sexual orientation, religion, national origin, marital status, the presence of any sensory, mental or physical handicap, or the use of a trained dog guide or service animal by a person with a disability.”  In addition, WA Medicaid allows termination of a provider relationship for discriminating in furnishing health care services as prohibited by federal statute.

For more information regarding avoiding such liability please contact Patrick Pearce.

US Intervenes In Whistleblower False Claims Act Lawsuit Alleging Submission of More Than $500 Million in Improper Claims

After the United States decided to intervene, a whistleblower lawsuit under the federal false claims act was unsealed.  The Amended Complaint alleges that over the period 2004 to 2010, the defendants submitted over $500 million in claims to Medicare, Tricare, and Medicaid that were the result of physician compensation schemes in violation of Stark and Anti-Kickback laws.

According to the Amended Complaint, a seventy-one (71) member physician group provided outpatient care and treatment for clinic patients under a services contract with the clinic.  Under the contract, the clinic billed and collected for the physician services and split the net proceeds with the physician group.

The Amended Complaint alleges that the physician group received two additional components of compensation intended to induce referrals to the clinic and increase the tests ordered at the clinic.  According to the Amended Complaint, the clinic furnished the physician group with office space, equipment, and a variety of services at below fair market value.  In addition the physicians in the group were allegedly paid a percentage of the technical fees charged and collected by the clinic for tests they ordered.

The whistleblower is an interventional cardiologist who was employed by the physician group from 2003 until he was fired in 2011.

OIG Launches New Online Submission Process for the Self-Disclosure Protocol

On July 8th, the Office of Inspector General (OIG) launched a new online submission process for the Self-Disclosure Protocol (SDP).  The SDP allows health care providers to voluntarily identify, disclose, and resolve instances of potential fraud involving federal health care programs, including Medicare and Medicaid.   The OIG has stated that individuals and entities that utilize the SDP will pay a lower amount of damages for violations than would normally be required in resolving a government-initiated investigation.

You can access the online submission process here.

The OIG hopes that the online submission tool for the SDP will streamline the process for providers that want to resolve violations without the time and expense of a government-directed investigation.  With that said, we suggest that providers have an attorney analyze any potential SDP issues prior to completing the online form.  As always, the health law attorneys at OMW are happy to help.

For more information about the SDP online submission process please contact Casey Moriarty.

Tacoma Physician Group Pays $14.5 Million To Settle Medicare Over-Billing Allegations

Sound Physicians, a Tacoma-based, national physician group that employs more than 700 hospitalists, paid $14.5 million to settle claims that it over-billed Medicare.  Former Sound Physicians’ employee Craig Thomas filed a whistleblower lawsuit under the qui tam provisions of the False Claims Act.  The lawsuit alleges that the company knowingly submitted inflated claims where documentation did not support the level of service billed.  Qui tam relators are generally entitled to 15 – 30 percent of the government’s recovery; Thomas will receive $2.7 million, or approximately 18.6%, of the $14.5 million settlement.  The settlement represents one of several recent settlements between the government and health care providers under the False Claims Act.

To read the Department of Justice press release click here.

To read qui tam Relator Craig Thomas’ statement click here.

For more information about government investigations, Medicare compliance, or the False Claims Act, please contact Adam Snyder.

Medicaid Disallows Reimbursement, Requires Reporting for Provider Preventable Conditions

Starting  July 1, 2013, the Washington Medicaid program will not pay a provider for the health care costs of treating conditions that the provider could have prevented.  The rule, WAC 182-502-0022, contains a long list of such conditions and adds a few more acronyms to health care speak, including:

(1) PPC – provider preventable conditions that include hospital and non-hospital acquired conditions;

(2) OPPC – other provider preventable conditions that are a PPC subset of conditions identified in WAC 246-302-030, and;

(3) HCAC – health care acquired conditions that are also a PPC subset occurring in an inpatient hospital setting.

Providers, including inpatient hospitals, must report any PPC to the Health Care Authority even if there is no intent to bill for services related to the PPC.  Health care professionals or designees responsible for or associated with a PPC involving a Medicaid patient must notify the Health Care Authority within forty-five (45) calendar days of confirming the PPC.

A similar reporting requirement applies to hospitals for OPPC.  And, of course, Medicaid patients are not liable for payment of an item related to a HCAC or an OPPC and must not be billed for any item or service related to a PPC.

For information about this new rule or Medicaid reimbursements please contact Greg Montgomery.

Stolen Laptop Leads to Stanford’s Fifth HIPAA Breach

Earlier this month Stanford reported its 5th HIPAA breach since 2009.  This is Stanford’s third largest breach, affecting nearly 13,000 patients.   A broken laptop containing protected health information of pediatric patients was stolen from a restricted area of the Lucile Packard Children’s Hospital at Stanford.  The laptop was un-encrypted and contained patient information including: name, medical record number, age telephone numbers, surgical procedures and treating physicians.  Though the laptop had a broken screen, there is still the possibility of extracting the data from the computer.

Stanford’s other breaches include a disclosure  of 20,000 patient records when a subcontractor of a business associate placed patient information on the web seeking assistance with using Excel, the data was left on the website for nearly a year.  This breach has resulted in a $20 Million class action law suit under California law.

Earlier this year, Stanford announced its largest breach, affecting 57,000 patient records when an unencrypted laptop with patient information was stolen from a physician’s car.  In addition, Stanford reported a breach in 2012 of 2,500 patient records following the theft of an unencrypted laptop from a physician’s office.  Lastly, in 2010, Stanford was hit with a fine after failing to notify the state of California of the theft of a laptop by an employee containing over 500 patient records.

Considering Stanford’s previous breaches, encryption of its laptops would be a good course of action to prevent future HIPAA data breaches.  Stanford has reported that it now encrypts its laptops, but the one that was most recently stolen was unencrypted because the screen was broken.

Lessons learned from Stanford’s misfortunes:  encrypt all PHI and destroy broken devices (remember though broken, the data is still valuable to thieves).

For assistance with  HIPAA and/or the breach notification rules please contact Elana Zana.

Urology Group Challenge to Stark Regulations Is Too Little Too Late

A recent federal district court decision granted summary judgment to the government in a lawsuit by a urology group challenging the 2008 changes in Stark regulations affecting “under arrangement” services for hospital patients.  The decision illustrates the significant barriers to a successful challenge to these regulations.

The challenge focused on the 2008 regulatory changes that swept entities performing DHS into the definition of entities “furnishing” DHS and reversed CMS’ 2001 regulatory approval of “per click” lease agreements.  Several challenges to these changes were dismissed for not being raised within the six year limitation period applicable under the federal Administrative Procedures Act.

The arguments against these changes that survived the timeliness bar failed to convince the court that the changes were contrary to express Congressional intent stated in the legislation or were an impermissible interpretation of the legislation.  The court rejected an argument that the group practice exception for certain compensation arrangements constituted a Congressional expression of intent that the term “entity” was not intended to include entities that furnished DHS.  The court readily concluded that including entities that performed DHS within the definition of entities “furnishing” DHS was a permissible interpretation of the legislation.

As for the revision in the regulations to prohibit the previously permitted “per click” lease arrangements, the court noted that CMS is entitled to change its mind as long as there is a reasonable basis for the change.

“Thus, the agency remains free to reinterpret a statute in a way that varies greatly from its past interpretations so long as the agency provides a reasoned basis for its new interpretation.”

For more information regarding the Stark law or False Claims Act in general please contact Greg Montgomery.