Brown McCarroll | Blogs | The Texas Health Care Record

Social Media and Health Care: “The Good, the Bad and the Ugly”

2012-05-25T19:10:03+00:00

There can be no debate that social media has successfully invaded every aspect of our culture and our lives. I am sticking with a fairly mainstream definition: Social media includes the various online technology tools that enable people to communicate easily via the internet to share information and resources.

To the extent you find that definition lacking, a simple Google search will provide you with more definitions than you will know what to do with. No matter how you define “social media”, there is no doubt it is here to stay. Evidence of that fact is found in the numbers:

There are over 100 million active users on Twitter, generating over 230 million tweets a day
LinkedIn has over 120 million users
Facebook has over 800 million users

Based on these numbers, social media is not only here to stay, if the trend continues, it is only going to get bigger and more involved in all aspects of our lives. For better or worse, health care was not excluded from that invasion. On the positive side, social media has allowed health care providers to create very informative and helpful websites, recruiting pages for both patients and employees, and blogs about common health care issues. Through the strength and power of social media, consumers of health care information have been able to gain access to information and experts that would have never been possible otherwise. In addition, patients who previously believed that they were suffering alone have been able to share information about themselves and find people in similar clinical situations across the world. This type of “virtual support group” has created a therapeutic healing environment that has enabled many to continue to fight their illness when they had previously contemplated giving up.

Despite all of the great things that social media has created, there is always a flip side….after all, I am a lawyer, it is my job to provide the flip side. While social media has become a great tool for good, it has also become a significant weapon in the hands of those who are trying to hurt others or who are not thinking. We have all seen reports of celebrities having their health care information from a recent hospital stay being stolen and provided to others via Facebook, Twitter or texting. State laws protecting patient confidentiality immediately come into play in these instances and on a Federal level, laws like HIPAA and HITECH have significant penalties in place for such breaches of confidentiality of protected health care information (PHI).

Despite all of the laws in place to protect this information, it still seems like the health care industry is ill-prepared to deal with the negatives of social media. In recent news stories, there are references to employees getting in trouble for taking pictures of patients or their physical symptoms and providing that information on the internet for public viewing. There are also reports of employees going on a rant on Facebook or Twitter about the care being provided in their health care setting or the incompetence of their fellow employees. Sometimes, these rants imply violations of both State and Federal regulatory laws and can cause major upheaval in the health care facility. On one level, the most obvious question that comes to mind is, “What in the world was that person thinking when they decided to post that information?” Unfortunately, that is the problem with social media. It provides such an instantaneous rush through uploading that we are developing a culture that types and hits the “enter” button much faster than it thinks about the consequences or the ramifications of those actions.

In most other arenas, that type of impulsivity might result in little more than some embarrassment. In health care, the results can be far more catastrophic to those who are harmed. Since we cannot effectively control everyone that works in the health care industry, health care entities and providers must develop policies and procedures for their facilities to help instruct their employees on appropriate social media usage and to provide bright lines on what types of social media usage will NOT be tolerated. Without these policies, health care employees will claim ignorance of the consequences of their actions and the damage will be done. Health care entities should not wait for and hope that their staff will figure this out, the health care industry is different than a lot of other industries and must be pro-actively protected….otherwise, we are all at risk.

Implementation of the Physician Payments Sunshine Act Delayed

2012-05-21T21:11:39+00:00

On May 3, 2012, the Centers for Medicare and Medicaid Services (CMS) Blog posted a delay to the implementation of the Physician Payments Sunshine Act. CMS stated that, in order to provide time for organizations to prepare for data submission and to sufficiently address the important input CMS received during the rulemaking process, CMS will not require data collection by applicable manufacturers and applicable group purchasing organizations before January 1, 2013. During the 60 day comment period following publication on December 19, 2011 of a proposed rule implementing the Act, CMS received over 300 comments from a wide range of stakeholders.

The Physician Payments Sunshine Act, which was included as section 6002 of the Affordable Care Act of 2010, sets forth transparency reporting requirements with regard to payments or gifts to physicians and teaching hospitals made by pharmaceutical, biological, medical device and medical supply manufacturers covered by Medicare, Medicaid, or the Children’s Health Insurance Program, as well as ownership and investment interests between physicians, manufacturers and group purchasing organizations. CMS intends to release the final rule later this year.

$44 Million Judgment Against Tuomey Hospital for Stark Violations Overturned

2012-05-01T14:29:06+00:00

On March 30, 2012, the Fourth Circuit reversed a $44 million judgment against Tuomey Hospital (Tuomey) for contracts that Tuomey had with physicians that allegedly violated the federal Stark law. Stark law prohibits physicians from referring patients to health care entities for designated health services that will be paid for by Medicare if the physician, or the physician’s immediate family member, has a financial relationship with the entity. Stark law also prohibits health care entities from submitting claims to Medicare for such prohibited referrals. Violations of Stark law may result in denial of payment, recoupment of payment, civil money penalties, or exclusion from participation in Medicare.

In 2003, Tuomey entered into part-time employment agreements with physicians to perform outpatient procedures at Tuomey in exchange for a salary that was based on Tuomey’s collections for the outpatient procedures and bonuses that took into account Tuomey’s net collections. The United States Department of Justice (DOJ), on behalf of a physician at Tuomey who reported the employment agreements, filed a lawsuit against Tuomey pursuant to the False Claims Act alleging violations of Stark law because the compensation Tuomey paid to the physicians who performed outpatient procedures at Tuomey took into account the volume or value of referrals that the physicians generated for Tuomey.

In 2010, at trial in the District Court of South Carolina, the jury found that Tuomey violated Stark law, but not the False Claims Act. For its Stark law violations, the District Court entered a judgment against Tuomey for $44 million, the value of prohibited referrals the DOJ estimated that Tuomey had submitted to Medicare. In entering the judgment, the District Court set aside the jury’s verdict and ordered a new trial on the False Claims Act allegations.

On appeal, the Fourth Circuit vacated the District Court’s $44 million judgment against Tuomey for violations of Stark law because it found that the District Court violated Tuomey’s Seventh Amendment right to trial by jury because when the District Court set aside the jury’s verdict and ordered a new trial on the False Claims Act allegations, it set aside the entire verdict, including the verdict that Tuomey violated Stark law. As such, the District Court could not have entered a judgment against Tuomey for violations of Stark law. The Fourth Circuit remanded the case to District Court for further proceedings to determine if Tuomey violated either Stark law or the False Claims Act. The date for the new trial has not yet been set.

In its opinion, the Fourth Circuit stated that on remand the jury must determine whether the physicians’ employment agreements took into account the volume or value of the referrals the physicians made to Tuomey, and if so, whether the physicians’ agreements met the statutory exception to Stark law for indirect compensation arrangements. If the jury does not find that a statutory exception to Stark law applies, the jury will have to determine the “number and value of claims Tuomey presented to Medicare for payment of facility fees resulting from the facility component referrals made by the physicians, and for which it received payment."

The court’s decision can be accessed here.

The Texas Medicare Administrator Contractor Changes

2012-04-03T15:43:20+00:00

The Texas Medicare Administrator Contractor changes from TrailBlazer to Novitas (formerly Highmark Medicare Services)

For many years, TrailBlazer Health Enterprises, LLC (TrailBlazer) was both the fiscal intermediary (Part A) and carrier (Part B) for providers located in Texas. TrailBlazer was responsible for the fee-for-service Medicare payments, local coverage decisions and physician enrollment into the Medicare program. However, beginning the summer of 2012, some things will change.

In November 2011, the Centers for Medicare and Medicaid Services (CMS) announced that Highmark Medicare Services will become the Medicare Administrator Contractor (MAC) for a large region of the country that includes Texas.   The contract is for one year, with the option of four annual renewals. Effective January 1, 2012, Diversified Service Options, Inc, a wholly-owned subsidiary of Blue Cross and Blue Shield of Florida Inc, acquired Highmark Medicare Services from its parent company, Highmark Inc. As a result, Highmark Medicare Services changed its name to Novitas Solutions, Inc. Novitas is currently the A/B MAC for Delaware, New Jersey, Pennsylvania, Maryland, the District of Columbia, and the Part B MAC for certain areas within Virginia.

Effective July 2012, Texas will be part of Jurisdiction H, along with Arkansas, Colorado, Louisiana, Mississippi, New Mexico, and Oklahoma. CMS consolidated two former MAC jurisdictions - Jurisdiction 4 comprised of Colorado, New Mexico, Oklahoma, and Texas, and Jurisdiction 7 comprised of Arkansas, Louisiana, and Mississippi. Novitas will also process Indian Health Service facility claims for the entire country and serve as the designated A/B MAC to support centralized billing for Mass Immunizers. CMS estimates that about 4.9 million Medicare beneficiaries reside in Jurisdiction H with approximately 1,300 Medicare hospitals, and over 147,000 physicians and other practitioners that furnish health care services to Medicare beneficiaries in this jurisdiction.   CMS approximated that Jurisdiction H will account for approximately 13.2% of all Medicare fee-for-service claims nationally.

Novitas recently announced the anticipated cut-over dates for the transitions, which will start in mid-August and go through November 2012 (with Part B for Colorado, New Mexico, Oklahoma, and Texas being the last to switch over). Since Novitas has prior experience as a MAC for a number of eastern states, CMS anticipates that the transfer to a new MAC will go smoothly, with few disruptions for Medicare beneficiaries or providers.   However, providers should prepare for possible delays and implementation glitches. Providers also should be mindful of any notices sent from Novitas as well as TrailBlazer regarding updated dates and procedures under Novitas.

OSHA Update: Needlesticks and Sharps Injuries, Workplace Violence, and Workplace Injuries

2012-03-15T16:28:56+00:00

Needlesticks and Sharps Injuries

Congress passed the Needlestick Safety and Prevention Act (the NSPA) in 2001. The NSPA directed OSHA to revise its Bloodborne Pathogens Standard to require employers to provide safety-engineered devices to workers who are at risk for exposure to bloodborne pathogens, to review the control plans describing employee protection measures at least annually, and to maintain a sharps injury log.

On February 16, 2012, a study reported that prior to the NSPA’s enactment in 2001, sharps injuries were increasing. After the NSPA was enacted, sharps injuries decreased by thirty-eight percent, which suggests that the NSPA has created safer work environments for health care workers by reducing the frequency of sharps injuries.

If they haven’t done so recently, we recommend that health care providers review their bloodborne pathogens control plans and practices. A good resource is:
http://www.osha.gov/dte/library/bloodborne/revised_bbp_standard/index.html

Workplace Violence

According to the Bureau of Labor Statistics (BLS), there were sixty-nine homicides in the health care industry from 1996 to 2000. In 2000, forty-eight percent of all non-fatal injuries from occupational assaults occurred in the health care industry. The National Institute for Occupational Safety and Health (NISOH) recognizing that home health care workers are vulnerable to verbal abuse, stalking, threats of assault, and homicide, published a new resource designed to assist employers in preventing violence against home health care workers. The resource encourages employers to establish a zero-tolerance policy for violence, train workers to recognize and prevent work place violence, and provide special precautions to those home health workers working in dangerous neighborhoods.

In addition, OSHA has provided guidelines to protect health care workers from workplace violence. OSHA’s guidelines focus on helping workers identify risk factors of workplace violence and providing training and prevention programs to prevent workplace violence.

Workplace Injuries

OSHCON is an OSHA program designed to provide free and confidential advice through consultants to small and medium-sized businesses. OSHCON helps employers identify potential hazards at their work sites and improve their occupational safety and health management systems. Additionally, receiving assistance from OSHCON may qualify an employer for a one-year exemption from routine OSHA inspections.

Importantly, OSHCON is separate from OSHA’s enforcement division and does not issue citations or propose penalties. However, employers must correct all identified hazards as a condition of receiving program services.

OSHCON has proven to be popular. In 2010, OSHCON conducted over 30,000 visits to small businesses covering 1.5 million workers. In Texas, OSHCON’s services are available through the Texas Department of Insurance. See http://www.tdi.texas.gov/oshcon/. We recommend that employers take advantage of this free program.

Providers Be Aware of Your Reassignments!

2012-03-09T20:06:00+00:00

The Office of the Inspector General (OIG) issued a press release alerting doctors and other providers to expect increased scrutiny from the OIG when reassigning their Medicare benefits to other entities.¹ On February 8, 2012, OIG cautioned all providers to be more mindful of services billed under the provider’s Medicare number. As a general rule, Medicare regulations require payments to be distributed directly to the physician who rendered the services. However, through a process called “reassignment,” a physician may submit a CMS-855R form and designate a third party to receive the physician’s distributed payments. Reassignment by a physician of his provider number to a third party, such as a group practice, hospital, or under contract with another entity, can bill for the doctor’s services is very common. According to an OIG report at least 77% of practitioners have at least one reassignment. However, 37% of those reassignments should not have had claims filed using those provider numbers. Of particular concern is those claims filed by an entity no longer affiliated with the practitioner, i.e., the physician retired, is no longer employed by the entity, or in some cases where a physician applied for a position with a provider but did not work for the company.

The OIG reached settlements with eight physicians who violated the Civil Monetary Penalties Law by causing the submission of false claims to Medicare from physical medicine companies. Specifically, these physicians reassigned their Medicare payments to various physical medicine companies in exchange for medical directorship positions. While serving as medical directors, the physicians did not personally render or directly supervise any services. The services were actually completed by unlicensed “technicians” who rendered in-home physical therapy service to Medicare and Medicaid beneficiaries. While members of the physical medicine companies were criminally prosecuted, OIG also held the physicians liable, citing them as an “integral part of the scheme.” There was evidence that the claims submitted by the physical medicine companies were not actually performed by the physician, were billed at a higher rate than documented or were not performed as billed.

It is noteworthy that while these physicians may not have known the companies were filing improper claims with their provider numbers, the physicians were, nevertheless, held responsible for the fraudulent claims. The OIG cautions:

A physician who reassigns to any entity his or her right to bill the Medicare program and receive Medicare payments has the right to access the entity’s billing information concerning the services the physician is alleged to have performed and for which the entity billed Medicare. Physicians have unrestricted access to claims submitted by an entity for services that the entity billed using the physicians’ reassigned provider numbers to provide added assurances that the services for which the entity billed Medicare were, in fact, performed and were performed as billed.

The physicians described above settled with the OIG and paid between $29,000 and $133,333 for their roles in the false billings. Although the physicians may not have been involved in the billing procedures, they were not in the dark about the reassignments. It is clear physicians should monitor any billings through a reassignment.

Recent enforcement actions by the Department of Justice (DOJ) have concentrated heavily on health care fraud and resulted in record-breaking recoveries. In February 2012, the Health Care Fraud and Abuse Control Program (HCFAC) report stated that nearly $4.1 billion was recovered in 2011. The DOJ cites the Department of Health and Human Services and the Health Care Fraud Prevention & Enforcement Action Team as the main reasons for DOJ’s success, and there is no indication that DOJ is slowing its aggressive fight against fraud. Additionally, the Affordable Care Act provides extra resources to assist DOJ, including an extra $350 million for HCFAC activities. As such, the settlement agreements specifically give the OIG and CMS the right to take further legal action against the physicians, including exclusion from Medicare and Medicaid, criminal prosecution and even tax law violations.

Steps to Take:

I.   For any reassignments, be sure to terminate that reassignment as soon as the provider is no longer providing services for the company. It’s the provider’s responsibility to follow-up and terminate the reassignment.
II.   Providers should monitor claims that are billed on behalf of the provider not just for fraudulent claims but also for upcoding and incorrect claims.
III.   If a provider believes there has been improper claims under the provider’s name, he should immediately contact an attorney. An attorney can verify that both the physician and entity are in compliance with all applicable regulations, assert the physician’s right to access the entity’s billing information concerning services the physician is alleged to have performed, and obtain access to claims submitted by entities that are billed using the physician’s reassigned provider number.

1. http://www.oig.hhs.gov/compliance/alerts/guidance/20120208.asp

CMS Embraces Concierge Medicine?

2012-03-07T20:17:30+00:00

CMS has, in the past, expressed concern regarding the use of concierge medicine by physicians treating Medicare patients. CMS has prosecuted some concierge care practices for charging concierge fees for “non-covered services” under Medicare. Despite this opposition, patients and physicians have increasingly implemented concierge-like relationships, including amenities that provide unlimited access to physicians via email, phone, or internet portals, house calls, and provide annual physicals for a periodic flat fee.

In response to rising health costs and political pressure from both legislators and the American Medical Association, the Affordable Care Act has forced CMS to begin a shift away from the traditional fee-for-service payment system and begin considering other types of payment, such as bundling and other innovations to reduce costs and measure quality. The Affordable Care Act required CMS to develop pilot programs in order to reduce costs or improve quality and expand successful programs nationwide after January 1, 2016. Some of these programs are beginning to resemble concierge practices.

CMS has already been experimenting with bundled payments projects for two decades. For example, since 2009, Medicare has been using the Acute Care Episode bundled payment program to cover 37 cardiovascular and orthopedic procedures. While the program evaluation is still pending, preliminary data suggest savings of up to 10 percent and improved quality of care. Criticisms of the program includes that it does not cover rehabilitation and other post-discharge services; participation is optional and only a few hospitals are participating.

Recently, CMS established a pilot program for integrated care, using episodic payments centered around hospitalization. This pilot program will be available to entities comprised of providers of services and suppliers including a hospital, a physician group, a skilled nursing facility, and a home health agency. Those payment methods can include bundled payments and bids from entities for episodes of care. Again, the direction of this program is away from Medicare’s traditional fee-for-service reimbursement methodology.

Another way that CMS is responding is by establishing family medical home pilot projects where CMS provides grants or contracts directly with certain states to establish community-based interdisciplinary, interprofessional teams to support primary care practices. These medical teams agree to provide services to eligible individuals with multiple chronic conditions and receive a monthly payment for patient management and providing non-Medicare services. Since these practices are not hospital centric, they require personal physicians to lead all other health providers in caring for their patients. It is assumed that care will be coordinated through all of the providers using integrated healthcare technology, which some argue must be updated to meet the new demands. Interestingly enough, the family homes have a requirement that payments recognize the primary care value and should reflect both physician and non-physician value, including non-face-to-face visits in care management. The payment structures even allows for a $6 per month payment to the doctor for providing non-covered services. These family medical homes begin to resemble concierge care as they provide a primary care doctor who is responsible for overseeing the patients’ care.

Presently, there are estimated to be twenty-six ongoing medical home pilots encompassing 14,000 plus physicians in over 4,500 practices, treating five million patients. With mixed results, some physicians and providers have begun to adapt to the changes in their practice. On the one hand, some patients do not perceive this change to be beneficial. In particular, the use of nurse practitioners and paraprofessionals often are perceived by the patients to be a restriction on their access to care. However, data does suggest that patient outcomes improve in this model and costs become lower with use of the medical home, but it requires substantial investment in technologies and infrastructure to obtain this success.

In summary, although CMS has not fully embraced concierge medicine, the landscape of Medicare billing is quickly changing and the traditional practice models may evolve into medical homes that closely resemble the concierge practices. Perhaps the payment models may evolve in the same direction.

Next Steps for Stage 2 Meaningful Use

2012-02-27T21:00:53+00:00

On February 24, 2012 the Centers for Medicare & Medicaid Services (“CMS”) released a Notice of Proposed Rulemaking setting forth the “Stage 2” Meaningful Use requirements. The proposed rule specifies the Stage 2 criteria that eligible providers must meet in order to qualify for Medicare and/or Medicaid EHR incentive payments.

WHAT IS “MEANINGFUL USE”?

The American Recovery and Reinvestment Act of 2009 specifies three main components of Meaningful Use:

• Stage 1: “Meaningful use” consists of transferring data to EHRs and being able to share information, including electronic copies and visit summaries for patients. Stage 1 began in 2011 and remains the starting point for all providers.

• Stage 2: “Meaningful use” includes new standards such as online access for patients to their health information, and electronic health information exchange between providers. This Stage is to be implemented in 2014 and is the subject of the new proposed rule.

• Stage 3: “Meaningful use” includes demonstrating that the quality of health care has been improved. This stage is expected to be implemented in 2016.

At the end of the day, “meaningful use” means providers need to show they are using certified EHR technology in ways that can be measured significantly in quality and in quantity.

PROPOSED RULE HIGHLIGHTS

• Stage 2 Meaningful Use and Objective Measures: The proposed Stage 2 criteria raise the number of core objectives (which are required) as compared to menu objectives. Physicians and other eligible professionals must meet (or qualify for an exclusion) to seventeen core objectives and three out of five menu objectives. Hospitals will have to meet (or qualify for an exclusion) to sixteen core objectives and two out of four menu objectives.

• Achievement: Where Stage 1 objectives have for the most part been retained at the Stage 2 level, the proposed rule raises the achievement threshold for various measures. For example, under Stage 1 of meaningful use, more than 40 percent of all permissible prescriptions written by an eligible provider (“EP”) had to be transmitted electronically using Certified EHR Technology. CMS is now proposing a threshold of 65 percent for this measure. In proposing the increase, CMS acknowledges that the ease of meeting this measure depends heavily on the availability of pharmacies in their local area that accept electronic prescriptions. As such, a new proposed exclusion allows EPs to exclude this objective, if no pharmacies within 25 miles of an EP’s practice location at the start of his/her EHR reporting period accept electronic prescriptions.

• Reporting on Clinical Quality Measures: The proposed Stage 2 rule also continues the Stage 1 requirement that providers report on specified “clinical quality measures” (“CQMs”) in order to qualify for incentive payments. There are twelve Stage 2 CQMs for eligible professionals and twenty-four for hospitals. In an effort to lessen administrative burdens, CMS is now proposing to align these reporting requirements with existing requirements (such as the Physician Quality Reporting System (“PQRS”), CMS’s existing Hospital Inpatient Quality Reporting (“HIQR”), the Shared Savings Program, and Joint Commission accreditation measures).

• Payment Adjustments: In addition, the proposed rule makes clear that, beginning in 2015, providers will face Medicare payment adjustments if they fail to demonstrate meaningful use of certified EHR technology and fail to meet other program participation requirements.

• Timeline Delay: Finally, Stage 1 has been extended an additional year, allowing providers to attest to stage 2 in 2014, instead of in 2013.

The proposed rule may be downloaded into a pdf format from the following site:

Comments are due 60 days after publication in the Federal Register.

Hospital-Affiliated Practices Face Losses with New Three-Day Payment Window Rule

2012-02-23T20:59:27+00:00

The three-day payment window policy which formally only applied to hospital payments, will now also apply to hospital-affiliated entities including physician practices, ambulatory surgery centers, or clinical lab facilities which provide Medicare Part B services. Specifically, the Centers for Medicare and Medicaid Services (“CMS”) has expanded the three-day payment window to cover any hospital-associated entity that provides Medicare Part B billed services. As of July 1, 2012, these entities will be required to be paid at the facility rate for the controlling hospital, instead of their current rates, if the services provided were both related to the reason for admission and were provided three days prior to the admission.

According to CMS, this new rule makes the “policy pertaining to admission-related non-diagnostic services [to be] more consistent with common billing practices” . ¹ Most providers, however, would likely not agree. Under the rule, lab and diagnostic tests are now included in hospital costs. However, professional services with a technical component will need to be written off.

According to Amy Nordeng, government affairs counsel for the Medical Group Management Association (MGMA) in Washington, the changes to the policy will cut payments to physicians for qualifying services. In addition to the changes is the inclusion of a new modifier for qualifying claims: PD, defined as “diagnostic or related non-diagnostic item or service provided in a wholly owned or wholly operated entity to a patient who is admitted as an inpatient within three days, or one day” . ² Although, this modifier became available January 1, 2012, hospitals and practices are not required to begin using it until July 1, 2012.

Aside from reimbursement cuts, these new requirements will create challenges for both administration and billing departments. For instance, doctors and their affiliated hospitals will need to coordinate their billing practices so that doctors’ claims are held until the affiliated hospital verifies that a patient was not admitted within three days. This will require coordination with the hospital’s admission’s system and billing system. Ideally, this could be done electronically, but if the practice is not integrated into the same billing system as the hospital, it will need to be done manually.

In summary, the first step to complying with the new rule is to identify which practices meet the definition of a hospital-affiliated practice. Next, procedures will need to be developed to adopt billing practices to the three-day payment window. This will require some type of integration between the practice’s billing system and the hospital’s billing and admission systems.

1. The Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act of 2010 (PACMBPRA)(Pub. L. 111-192) “Clarification of 3-Day Payment Window”, 76 Fed. Reg. 73,279 (Nov. 28, 2011).

2. The Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act of 2010 (PACMBPRA)(Pub. L. 111-192) “Clarification of 3-Day Payment Window”, 76 Fed. Reg. 73,283 (Nov. 28, 2011).

One-third Procedures Test

2012-02-20T15:33:13+00:00

Outpatient Surgery Magazine recently published an article describing a case in New Jersey in which an ASC successfully defended an action brought by three physicians who were forced to sell their ownership interests in the ASC due to the physicians' failure to meet the "one-third procedures test" under the applicable federal anti-kickback statute safe harbor. The physicians had previously signed the ASC's operating agreement in which they agreed to comply with the one-third/one-third tests. However, they failed to do so and refused to sell their units. So, the ASC sold their units for them (for a hefty profit) in order to bring the ASC into compliance with the safe harbor. The physicians sued the ASC alleging violation of the state's securities laws, but the ASC prevailed. See the full article.

HIPAA Audits

2012-02-16T13:00:52+00:00

The National Law Review recently posted a good article on HIPAA Audits.

CMS Proposed Rule on Overpayments

2012-02-14T19:51:09+00:00

Today the Centers for Medicare and Medicaid Services (CMS) posted a pre-publication version of a proposed rule regarding the reporting and returning of overpayments. The proposed rule is intended to address requirements implemented by the Patient Protection and Affordable Care Act (ACA). Although the proposed rule offers some guidance with regards to some significant issues arising under the ACA changes, for example how the 60 day window to refund or report is determined, it does not address all the intricacies faced by providers. Hopefully the comment and response process will give further insight as to how to deal with overpayment issues so that providers can be comfortable that they have adequately addressed potential liability. The proposed rule is posted. If you have any questions about submitting comments to this rule, please let us know.

Recently-issued Interpretive Guidance Related to Rehabilitation and Respiratory Care Services

2012-02-09T00:14:03+00:00

Recently-issued interpretive guidance related to rehabilitation and respiratory care services under hospital Conditions of Participation (CoPs) has prompted the American Hospital Association (AHA) to send a request to Centers for Medicare & Medicaid Services (CMS) to clarify the confusion caused by the guidance. Specifically, Transmittal No. 72, issued on November 18, 2011, states that a practitioner must have medical staff privileges to order rehabilitation and respiratory care services, as opposed to simply being authorized to order those services. The guidance may preclude a hospital from establishing a policy authorizing the orders of non-privileged practitioners to be accepted by a hospital outpatient department based on criteria set by hospital policy and state law. Instead, hospitals may be faced with the task of credentialing all practitioners who refer patients for services. AHA contends that the interpretive guidance is inconsistent with the applicable regulations found at Section 482.56(b) and Sec. 482.57(b)(3) of the CoPs. AHA's January 27, 2012 letter to CMS expressing concern.

New Policy Requirements for Texas Non-Profit Health Organizations, or Else

2012-01-05T20:26:49+00:00

In the 2011 regular legislative session, Senate Bill 1661 was passed, and as of January 1 of 2012, is law. The law requires that Non-Profit Health Organizations (“NPHO”) (formerly known as 5.01(a)’s), ensure through policies, that their employed physicians’ professional judgments are not interfered with, controlled, or otherwise directed by the NPHO. To comply with SB 1661, all NPHOs must adopt and maintain the following policies:

a credentialing policy;
a quality assurance policy
a utilization review policy; and
a peer review policy.

These polices should be drafted in a way that demonstrates who employed physicians’ are ensured professional independence. The NPHO’s board of directors must approve these policies and any amendments. Further, the policies must be interpreted by the NPHO in a way “that reserves the sole authority to engage in the practice of medicine to a physician . . ..”

NPHOs are permitted to establish ethical and religious directives that a physician may be contractually bound to, but any other contractual requirements that conflict with the law are void. Finally, to enforce the law, the Legislature gave the Texas Medical Board the right to fine or revoke the certification of an NPHO that fails to comply.

Accordingly, all NPHOs should review their policies and procedures to ensure that appropriate policies exist and that SB 1661 is being followed. In addition, we recommend a review of existing employment agreements to ensure that: (1) if an NPHO has religious or ethical directives, the physician employment agreements require observance of those directives; and (2) there are no provisions which conflict with the newly-required policies and procedures.

Incidentally, on September 30, the Texas Medical Board proposed rules that echoed the language of SB 1661. But those rules were withdrawn in the December 16^th Texas Register – no reason for the withdrawal was given. Nonetheless, SB 1661 is effective now, and must be complied with. The provisions of SB 1661 are codified in Sections 162.0021 through 162.0024 and Section 162.003 of the Texas Occupations Code.

New Texas Laws Impacting Healthcare Employers

2011-10-12T18:51:24+00:00

Senate Bill 192 Protects Texas Nurses from Retaliation For Engaging in Patient Advocacy Activities

Effective September 1, 2011, SB 192 expands Section 301.52 of the Texas Occupations Code to protect nurses who engage in patient advocacy activities from retaliation by any person. Acts of retaliation include discipline, discrimination, or enforcing criminal liability. Protected patient advocacy activities include making good faith reports of another health care provider’s wrong doing to: (i) the applicable licensing board; (ii) a supervisor or manager; or (iii) hospital/facility officials. SB 192 also protects nurses who advise other nurses about SB 192’s protections.

If a nurse is retaliated against for engaging in patient advocacy activities, the offending entity or individual may be fined up to $25,000 by the appropriate licensing agency. Additionally, the entity or person may be subject to civil liability for the greater of: (i) actual damages incurred by the nurse, including damages for mental anguish; or (ii) a $5,000 fine, exemplary damages, court costs, and reasonable attorney’s fees.

SB 192 was passed after two Texas nurses were terminated and a law suit was filed against one of the nurses for reporting safety concerns about a physician to the Texas Medical Board. SB 192 is intended to encourage nurses to raise patient safety issues without concern about possible negative repercussions.

House Bill 2609 Expands the List of Convictions that Prevent Employment in Facilities that Serve the Elderly or Disabled

Effective September 1, 2011, HB 2609 expands the list of convictions in Section 250.006 of the Health and Safety Code that bar employment in facilities that serve the elderly or persons with disabilities (“Facilities”). Specifically, Section 250.006 requires that Facilities obtain criminal history information before hiring an applicant and prohibits the employment of any individual convicted of certain crimes (e.g., homicide, kidnapping, injury to a child, elderly individual, or disabled individual, arson, robbery, or aiding in suicide). HB 2609 expands the list of prohibited crimes to include individuals with a conviction for obstructing or retaliating against a public servant or for cruelty to livestock or nonlivestock animals.

Neither HB 2609 nor the Health and Safety Code require that Facilities run new criminal background checks on existing employees. However, a Facility must immediately terminate a current employee if the Facility learns that the employee was convicted after September 1, 2011 of cruelty to animals and/or obstructing or retaliating against a public servant. Additionally, a Facility may not rehire a former employee who has been convicted of such offenses in the past.

Can Health Care Employers Require Their Employees To Take Flu Vaccines?

2011-09-09T16:04:16+00:00

As flu season approaches, health care employers need to ensure that all their employees get their flu vaccinations. If this has not happened in the past, employers should look at how to achieve this goal. Many employers may be able to do it through a voluntary program, including employee education, reminders, paying the cost of vaccinations, and/or providing the vaccinations at or near their facility. Alternatively, health care employers can assess whether they want to implement a mandatory flu vaccine policy. This assessment involves considering several factors, including the success rate of voluntary vaccination programs, legal implications, patient and employee safety, liability risks, workplace efficiency, employee rights, and employee morale.

It is estimated that the flu costs U.S. businesses $77 million a year in absenteeism, lost productivity, and other costs. Flu accounts for almost 40% of all illness-related work days lost for unvaccinated employees. The Centers for Disease Control and Prevention (“CDC”) recommends that everyone six months and older be vaccinated against influenza as soon as the seasonal vaccines are available.

The case for mandatory immunization of health care workers is compelling. The CDC strongly recommends annual flu vaccination for health care workers beginning in October in order to “protect patients, and communities, and [to] improve prevention of influenza-associated disease and patient safety.” Similarly, the American Academy of Pediatrics recommends the “implementation of a mandatory influenza immunization policy for all health care personnel.” Despite the above recommendations, the CDC reported in August 2011 that: only 13% of health care workers report that their employers require flu vaccinations, and only 63% are vaccinated without an employer mandate.

Mandatory immunization of health care workers is not without controversy. Certain employees, unions, and advocacy groups have attacked these policies as violating employee privacy rights. Most suits challenging these policies have been directed at public health care workers who have certain constitutional protections regarding their employment. We could find no reported cases that struck down mandatory immunization policies instituted by private employers in a non-union setting.

However, several courts have held that employers with unionized workforces need to negotiate the implementation of a mandatory vaccine policy with the union.

At the federal level, OSHA’s stated position is that employers may mandate that employees take H1N1 and other seasonal flu vaccines.

Because Texas is an at-will employment state, private health care employers in Texas should be able to unilaterally institute mandatory flu vaccine policies as to their at-will employees. Except as discussed below, these employees may either accept the new policy by continued employment or resign. However, there have been no Texas court decisions specifically addressing this issue.

There are, however, limitations on the application of mandatory vaccine policies. For instance, the Equal Employment Opportunity Commission (“EEOC”) takes the position that under Title VII and the ADA, an employee may be entitled to an exemption from mandatory vaccinations based upon a disability, medical condition (e.g., severe egg allergy or a past severe reaction), or sincerely held religious beliefs that prevent the employee from taking flu vaccines. The question of whether the ADA requires a reasonable accommodation regarding a particular employee and what constitutes the same is fact-specific, as is the question of how to protect patients and employees when granting an exemption (e.g., requiring the unvaccinated employee to wear a surgical mask around patients).

The manner of implementing a mandatory flu vaccination policy is critical to achieve employee acceptance and to limit objections. Keys to successful implementation include:

Educate, Educate, Educate. Provide education and reeducation to employees on the need for immunization.
Written Policy. Develop a written policy that includes:
- A policy statement that vaccination is needed for employee and patient safety;
- A process for employees to raise concerns and objections; and
- An authorization form.
Remove Barriers. Remove cost and access barriers to immunization (i.e., pay for on-site vaccinations).
Communicate. Communicate with employees on the reasons for the policy and allow employees to ask questions.
Address Objections. Address any employee objections on an individualized basis, assessing relevant factors without being dismissive of the objections or taking arbitrary positions. Keep objections confidential.

Brown McCarroll has developed an implementation package, including a written policy and educational materials, which can be customized to meet your needs. Please call our attorneys for assistance.

The Importance of HIPPA Compliance

2011-08-31T14:40:51+00:00

Recent stories highlight the need for providers to be diligent in preventing unintended release of protected health information (PHI). Tragic losses of PHI occur through theft, accident or malfunctioning equipment. To protect the privacy of PHI, providers must be alert to behaviors of their employees, patients, and even individuals who have no relationship to the facility.

A Miami practice suffered a devastating loss when victims of an organized crime ring used women trained as medical receptionists to steal PHI. The PHI was used to submit false claims and cash checks from patient accounts. This breach might have been avoided if the provider required periodic employee criminal background checks.

The most common type of theft of PHI occurs when unencrypted company laptops are stolen. PHI on laptops should be encrypted and employees should to lock their laptops whenever they are removed from the office.

PHI can also simply be removed from a provider’s office. A janitor who worked for a contracted cleaning service simply picked up PHI from a Chicago clinic that had been left out overnight by clinic staff. This breach could have been avoided by “reasonably securing” all PHI at the end of each day.

A more difficult security issue arises when PHI is stolen during business hours by a person with no relationship to a provider’s practice. For example, PHI was stolen from a medical center in Alabama by a friend who accompanied a patient to his doctor visit. The friend picked up the Clinic’s surgery schedules that was left in a closed patient registration area.

Finally, equipment can be the cause of a breach of privacy. Malfunctioning automatic envelope stuffing machines can lead release of PHI to the wrong people. In one case, the machine mismatched the documents and the envelopes, which led to patients receiving other patients information. In another case, the machine improperly stuffed envelopes such that the PHI appeared in the windowpane of the envelope. The information accessible from the outside of the envelope included patients’ social security numbers.

The costs to providers as a result of breach notification, patient harm, and loss of trust can be significant. It is critical that providers implement security measures to prevent these breaches.

New Medicare Provider Enrollment Rules

2011-08-31T14:29:40+00:00

Effective March 25, 2011, all Medicare providers must report a change in ownership, practice location, or an adverse legal action within 30 days. CMS is now aggressively pursuing these violations and may impose penalties that include revoking physician privileges for up to three years. If a group practice is found in violation, CMS will revoke billing privileges for each physician in the practice. Physicians should further be aware that even if their board contacts CMS to report an adverse action against the physician, the physician still must report the action him or herself. These new penalties are particularly important because Medicaid is now required to revoke billing privileges at the same time Medicare revokes privileges.

Physician-Owned Distributorship Wars

2011-06-30T17:38:54+00:00

Over the last two months the health care lawyers of implant and medical device manufacturers, traditional distribution companies, and physician-owned distributors have been arguing over the legality of “physician-owned distributorships” or “PODs” as they are commonly called. That argument has become very public lately, with articles in the Wall Street Journal and industry publications. Most recently several United StatesSenators have inserted themselves into the debate.

The POD structure has taken the medical device and implant industries by storm, upsetting many existing financial relationships. In short, the POD model inserts physicians, and specifically the surgeons who use the medical devices and implants, into the distributor role. In its most basic form, a POD negotiates with a manufacturer to sell medical devices and implants to hospitals. Usually, the sales focus is on hospitals where the physician owners of the POD provide surgeries. There are many variations on this basic POD model, but one commonality – a physician owns the distribution company and makes a profit from medical devices purchased. And that remuneration means the POD model triggers the federal prohibition against physician self-referrals (commonly called the Stark law), the federal Anti-kickback statute, and mirroring state laws.

Usually, physician ownership structures have more difficulty complying with Stark than the Anti-kickback statute. But because of a Stark exception related to unit-based purchases in indirect financial relationships, it seems relatively clear that, barring any regulatory changes, most POD models can be structured to comply with Stark; assuming that the medical devices or implants are sold at a fixed fair market value, per unit, price. But Anti-kickback statute compliance is another story.

The Anti-kickback statute, which prohibits the offer or acceptance of any remuneration, directly or indirectly, for referrals or other business generation, has no safe harbor in which the standard POD model will fit. Fortunately for PODs, because the Anti-kickback statute is not a strict liability statute, failure to fit within a safe harbor is not necessarily fatal. Consequently, most POD models have been developed with components that attempt to comply with the Anti-kickback statute’s “no-remuneration for referrals” mandates. Nonetheless, the fact remains that in virtually all POD models, if a distributor sells more implants or medical devices the physician owner will make more money. And if the POD sells its products to a hospital where the physician is providing surgeries, the physician could be induced to make more referrals of patients needing those POD products to the purchasing hospital. Likewise, the hospital could be induced to encourage those referrals by buying implants and devices from the physician’s POD.

Thus far, the Health and Human Services Office of Inspector General (“OIG”) has released virtually no meaningful guidance on the appropriateness of PODs generally or how they should be structured. But that will soon change. As mentioned, several United StatesSenators have intervened. On June 9, those United StatesSenators sent a letter to Inspector General Levinson asking that he respond to a list of specific questions regarding PODs and their compliance with the Anti-kickback Statute. That letter requests that the General Levinson respond with an initial report by August 12.

So, at the moment, the bickering health care lawyers and the industry are waiting for the OIG to respond.

CLASS Act Part of Health Care Reform

2011-05-31T20:18:54+00:00

The Patient Protection and Affordable Care Act (PPACA) established a voluntary insurance program that is not funded with tax dollars, known as the Community Living Assistance Service and Supports Act (CLASS). CLASS provides contributing individuals a method to remain in their community by providing funding for community living services and supports. The services and supports eligible for CLASS benefits include home health care, adult day care, assistive technology, home modifications, personal assistance and transportation. CLASS is not designed to fully cover all costs associated with long-term care or replace basic health insurance, rather CLASS acts as a supplement to offset the costs of long-term care.

Individuals that have paid a monthly premium for at least five years and have been employed during three of those five years are eligible to receive benefits if they are diagnosed with a functional limitation or cognitive impairment. Such impairments include difficulties with eating, bathing or dressing, while impairments include Alzheimer’s disease, traumatic brain injury or multiple sclerosis. The benefit amount is based on the degree of impairment or limitation, but will be no less than $50 per day. The average payment is estimated to be $75 per day.

The Congressional Budget Office (CBO) estimated that CLASS will reduce the federal deficit by $70.2 billion over a ten year period. Additionally, the CBO explained that Medicaid spending will be reduced because CLASS is designed to be the primary payer for those individuals that are also eligible for Medicaid.

CLASS benefits are expected to be defined by October 2012, with enrollment starting shortly after. CLASS payouts will not take effect until 2017. However, on April 4, 2011, legislation was introduced to repeal CLASS. Health and Human Services Secretary Kathleen Sebelius stated that the present framework of CLASS is not sustainable without taxpayer funds. The chief actuary of the centers for Medicare and Medicaid Services voiced concerns that only those individuals with health problems would sign up for CLASS. CLASS supporters responded by stating CLASS should be reformed, not repealed. The bill to repeal CLASS has been referred to the Committee on Finance for further findings and revision, the bill will then go to general debate.