COVID-19 Testing: New Federal Clarifications for Employers

You’ve probably heard of recent federal legislation affecting insurance coverage for COVID-19 testing and related services, such as the Families First Coronavirus Response (Families First) Act and the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

The federal government has taken steps to require certain kinds of insurance plans to provide coverage for testing (and related services) without cost-sharing, prior authorizations, or other medical management requirements.

New Guidance Issued

On June 23, three federal departments — the Department of Health and Human Services (HHS), the Department of the Treasury, and the Department of Labor — issued a second round of guidance on implementing these provisions.

The Centers for Medicare & Medicaid Services (CMS) has published an FAQ specifically related to the Families First Act which contains some useful information related to this guidance. (Click here to read the full document.)

CMS has confirmed that the Families First Act does not require employers and insurers to pay for COVID-19 testing that is not used for diagnostic purposes. This includes back to work purposes or general screening. And there are no exceptions for the uninsured or those receiving Medicaid coverage.

In the case of diagnostic testing, the law allows for quite a broad range of coverage. Tests must be approved by HHS (which includes tests approved by the Food and Drug Administration (FDA) on an emergency or temporary basis). But as long as one of these approved tests is ordered by an attending health care provider, “where medically appropriate for the individual,” then insurers must pay for it. And that’s even if there are multiple tests ordered.

COVID-19 Tests Not Covered

However, for tests that are not for diagnostic purposes, things get more complicated. If employers require their employees to have clean COVID-19 tests before returning to work, there are basically two options, neither of which insurance is required to help with under this legislation:

  1. Pick up the tab for testing themselves, or
  2. Ask employees to either cover it (which can be very expensive) or line up at one of the free public testing sites.

Implications for Compliance

As with most of the regulatory changes related to the pandemic, the devil is in the details here. Staying up to date on the latest guidance and clarification is the only way to be sure that you are providing the correct information to the rest of your organization.

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Understanding and Managing the HIPAA Security Rule

Protecting the privacy of patients is of paramount concern to healthcare organizations today. Data breaches and/or hacking attempts are happening more frequently. Regulatory requirements are constantly changing. And the pace of technology innovations keeps increasing. The penalties, both financial and reputational, can be disastrous for any organization — and its compliance team — that is not prepared and in the know at all times

For example, recently a healthcare institution mailed hundreds of patient statements, containing names, account numbers and payments due, to wrong addresses. The organization believed that, for most of these statements, this was not a reportable breach, because there was no patient diagnosis, treatment information, or other medical information listed.

This was not correct. And the failure to understand the rule and its nuances resulted in a $2 million settlement.

The HIPAA Security Rule is the hedge against that kind of disaster  —  so grasping its complexity is crucial.

The regulations that comprise the Security Rule are often the most difficult to understand and implement, as every security compliance measure must be carefully monitored and reported. Not only are all healthcare organizations required to meet the standards and legal requirements in the Security Rule, there can also be implementation specifications which include provide detailed instructions and steps needed for compliance.

From an administrative perspective, HIPAA requires a documented framework of policies and procedures. These policies and procedures detail exactly what your organization does to protect key information. For example, policies can outline the requirements for training for all employees, including those who do and do not have direct access to vital patient information.

The documents that outline the policy and procedure framework must be retained for at least six years (although state requirements may mandate longer retention periods). As policies change, so must your accompanying documentation. And to further ensure your compliance, periodic reviews of policies and responses to changes in the electronic patient health information environment are also recommended.

From a security perspective, HIPAA requires a comprehensive evaluation of the security risks your organization faces, as well as the electronic health record technologies your organization uses.  This includes a combination of physical safeguards — such as IT infrastructure, computer systems and security monitoring systems — and technical safeguards — such as risk management software, healthcare management software or regulatory software. These safeguards are designed to both protect patient information and control access to it.

Fortunately, the Security Rule allows for scalability, flexibility and generalization. This means that smaller organizations are given greater latitude in comparison to larger organizations that have significantly more resources. HIPAA’s security requirements are also not linked to specific technologies or products, since both can change rapidly. Instead, requirements focus more on what needs to be done and when, and less on how it should be accomplished.

Managing the complexity of the HIPAA Security Rule can be easier. At youCompli, we help you identify, document and monitor your critical HIPAA information. We understand the time and resource constraints that compliance officers operate under — the need for quickly collecting and accessing quality data and reporting it. Our solutions enable you to remain up-to-date with healthcare regulations — what they mean and how to implement them with precision accuracy in cost-efficient and effective ways. Contact us for more information on how to approach and implement the Security Rule and remain in compliance.

Legal Challenges and the Benefit of a Comprehensive Compliance Program

The list of compliance and legal challenges facing providers, hospitals and healthcare systems over the next year is long:

  • Physician arrangements and fair market value;
  • Mergers and acquisitions;
  • Quality metrics and risk sharing;
  • Fraud, waste, and abuse;
  • Coding and billing transactions;
  • Reimbursement;
  • Medical staff issues and burnout;
  • Labor and employment issues;
  • HIPAA and HITECH; and
  • Technology and integrated medical devices.

A list like this can seem daunting. However, a comprehensive compliance program with appropriate resources can help avoid disastrous results related to healthcare compliance and legal challenges.

Labor and Employment Law

The Atlantic reported in January 2018, “Health Care Just Became the U.S.’s Largest Employer In the American labor market.”  The growth of the healthcare sector brings increased labor and employment challenges.  Although the terms are often used synonymously, labor law focuses on groups of workers (think unions and collective bargaining) while employment law focuses on individual workers, (think discrimination of an individual in a protected class).

A comprehensive compliance program will decrease labor and employment law challenges, by ensuring human resource policies and procedures comply with federal and state laws.  Moreover, personnel file audits will demonstrate compliance with those laws.

Transactional Law

Mergers, acquisitions, partnerships, joint ventures and U.S. antitrust law

The Agency for Healthcare Research and Quality (AHRQ) reported in its 2018 National Healthcare Quality & Disparities Report that almost 70% of U.S. hospitals and 43% of primary care physicians are part of consolidated health care systems. Consolidations require an astute compliance and legal team to ensure compliance with antitrust law. These transactions continue to draw scrutiny from the Federal Trade Commission due to monopoly concerns.

The challenge for healthcare organizations is even greater when business crosses state lines. The organization must then comply with multiple state laws simultaneously.  As part of a comprehensive compliance program, a compliance professional should work closely with in-house or outside counsel to ensure the business transactions and consolidations include a compliance due diligence perspective, for example reports to the board of directors.

Security Law

HIPAA

Compliance is mandatory; failure to comply is an opportunity to ruin an organization both financially and reputationally.  Ransomware attacks on healthcare providers through their computers and medical devices are on the rise. While most IT departments focus on HIPAA security for computers, few address security issues with interconnected medical devices.

A comprehensive compliance program will include recommendations to address the management of cybersecurity for medical devices like those outlined by the U.S. Food and Drug Administration (FDA).

Practice Tips

  1. Use of reports to support legal defense of employment or labor law violations, if needed.
  2. Use of notification and management system to prevent legal challenges by providing up-to-date guidance to support compliance activities.
  3. Conduct an evaluation of medical devices in accordance with the FDA FAQ. Disable the voice recognition feature of smart devices while conducting confidential discussions in a room with a smart TV or speaker.

A system such as youCompli is a strong addition to a comprehensive compliance program, providing up to date notifications of regulatory change, as well as full insight and audit of the compliance process.

Denise Atwood, RN, JD, CPHRM
District Medical Group (DMG), Inc., Chief Risk Officer and owner of Denise Atwood, PLLC
Disclaimer: The opinions expressed in this article or blog are the author’s and do not represent the opinions of DMG.

Denise Atwood, RN, JD, CPHRM has over 30 years of healthcare experience in compliance, risk management, quality, and clinical areas. She is also a published author and educator on risk, compliance, medical-legal and ethics issues. She is currently the Chief Risk Officer and Associate General Counsel at a nonprofit, multispecialty provider group in Phoenix, Arizona and Vice President of the company’s self-insurance captive.  

Audit Expectations and Challenges

When it comes to hospitals providing best-in-class health care, stress comes with the territory. From stabilizing trauma victims, to accurately distributing medications, to physicians and nurses working long shifts, increased demands are everywhere — including operations not directly involved with patient care. One demand that can turn daily routines completely upside-down and compound stress is an audit. A GRC compliance audit can be conducted internally by various hospital committees or externally, often by government-approved contractors.

Internal Audits

An internal audit seeks to determine if a hospital’s financial and operational controls, and their related policies and procedures, meet compliance and risk management demands.

Based on a hospital’s risk assessment, management develops and reviews the scope and goals of an audit. Running the audit is then delegated to a committee, with the most common committees focusing on:

  • Patient safety
  • Nursing staffing
  • Clinical quality
  • Medical staff

An internal audit involves interviews and evaluating personnel or procedures. Upon the audit’s completion, a report of its findings is prepared by the appropriate committee and shared with management. Corrective recommendations of action to any areas of noncompliance are collaboratively developed, and a finalized report is presented to the hospital’s board of directors, chief compliance officer, and audit and compliance committee.

The ultimate goal of an internal audit is to improve patient care. Who in a hospital wouldn’t want to improve it, right? But the truth is that an audit can diminish quality of care while it’s in progress. That’s because committees are often comprised of physicians, nurses, and technologists who are pulled away from patient-care responsibilities to work on compliance administrative tasks.

External Audits

According to a 2017 AHA report, four federal agencies — the Centers for Medicare & Medicaid Services, the Office of Inspector General, the Office of Civil Rights, and the Office of the National Coordinator for Health Information Technology — are the primary drivers of regulations and compliance costs across eight domains for hospitals:

  • Hospital conditions of participation
  • Billing and coverage verification requirements
  • Meaningful use of electronic health records
  • Quality reporting
  • Privacy and security
  • Fraud and abuse
  • Program integrity
  • New models of care

The frequency and pace of regulatory changes implemented by multiple federal agencies are dizzying. Hospitals are often required to comply with regulations in very short timeframes, requiring a significant investment of staff time and finances. What’s more, responding to multiple external audits increases administrative costs, and funds could be tied up in lengthy appeals processes contesting an auditor’s inappropriate determination.

External audits are conservatively estimated at $100 per hour. For example, consider the total costs of a HIPAA audit:

  • HIPAA Gap Assessment — Identifies gaps and provides remediation plans for those gaps
    (40 hours average, $24,000–34,000)
  • Full HIPAA Audit — Assesses hospitals against all the requirements in the HIPAA Security Rule
    (100 hours average, $30,000–60,000)
  • Validated HITRUST Assessment — Provides the most complete, certifiable framework for HIPAA to mirror PCI compliance (400 hours average, $100,000–160,000 — with costs much higher for larger organizations)

Protect Your Hospital

If your hospital is like most others, it’s spending too much staff time and money dealing with a blizzard of regulations and an avalanche of red tape. Fortunately, there are solutions. youCompli GRC risk management software monitors, reads, and translates complicated regulations into plain English. Our solution enables you to fully understand which rules are pertinent to maintaining compliance, further simplifying the auditing process. And it tracks everything, from end to end, making audits much less painful.

Learn how youCompli regulatory compliance management software protects your hospital.

Who Needs an “Easy” Button? Regulatory Compliance for Teaching Hospitals and Academic Medical Centers

Nobody chooses to pursue a career in healthcare at a teaching hospital or academic medical center (AMC) so they could process regulatory compliance paperwork. Right?! Nevertheless, health systems spend $39 billion on admin duties to comply with no fewer than 600 regulatory requirements. Most of the time they are juggling these requirements (and a whole lot more) without an effective compliance management system. It’s anybody’s guess what is truly being done to comply.

The regulatory landscape continues to change. It’s even more complex for teaching hospitals and AMCs that have specialized facilities such as children’s hospitals and cancer centers. And it’s nearly impossible to know for sure what is being done to comply with the regs when students and researchers are added to the mix. Compliance oversight is already challenging enough when it includes only clinical and hospital staff, business associates and contractors.

Ever-increasing regulation ushers in more documentation requirements. Satisfying the reporting requirements steals time away from patient care and contributes to burnout. Plus, more regs and more people equals a big compliance headache.

These healthcare systems not only have the pressure to comply with regulations, improve care and cut costs as other hospitals do, but they have the critical mandate to educate future medical professionals and dedicate resources to research.

According to the Association of American Medical Colleges, academic medical centers in the United States contribute $562 billion in annual economic impact. But, what’s even more significant is the impact these facilities have on the health of our society. Medicine moves forward in teaching hospitals and academic medical centers. When people are faced with a health crisis and grasping for innovative treatment and cures, they flock to these systems. Oftentimes this is their last shot at a healthy future. Teaching hospitals and academic medical centers are the epicenter of first breakthroughs. They are also the last resort for patients who have tried everything else. As a result, teaching hospitals have more costly cases and often bear the brunt of safety-net and charity care.

Shouldn’t there be an “easy” button for them?

Academic medical centers and teaching hospitals have a great need for an effective compliance management system. These systems save valuable time and money. But they also make it easy to see what is being done by whom to comply with regs. No more ad-hoc spreadsheets. Thoughtfully applied technology can make regulatory oversight a piece of cake.

The more effective the compliance management system, the more time is freed up for medical professionals to do what they are passionate about—provide the best patient care and focus on their mission of treatment, research and education. And who couldn’t use an “easy” button for compliance regulation?

Are you ready to explore a compliance management system that is easy to use and effective? If you’re ready to transform your regulatory compliance process, schedule a call today!

Chief Compliance Officers Can Be in the Cross hairs

Chief compliance officers should take note of two recent enforcement actions in the financial sector.

In these cases, the regulators have gone after the compliance officers (in addition to others).

In the 1st case, the SEC alleges that the chief compliance officer was “carrying out his compliance responsibilities in an extremely reckless manner.” It further alleges that the cco “was required to review and monitor” trading practices “to make sure they were fair and equitable”.   It says, other than occasionally “spot checking” trade paperwork the CCO “essentially did nothing” to ensure the firm’s trading policies and procedures were being followed.

Attorney Brian Daly, a partner in the regulatory and compliance and investment management groups of Schulte Roth & Zabel in New York, called the SEC action “pretty extreme.” (Reisnger, 2019) Daly spent a decade as a general counsel and chief compliance officer at several investment firms before joining Schulte, including at Kepos Capital, Raptor Capital Management and The Carlyle Group.

“It’s unusual,” Daly told Corporate Counsel. “It’s one thing to say he [compliance officer] could be sanctioned or censured, but they are accusing him of recklessly not carrying out his duties because of inaction, and of aiding and abetting bad actions.” (Reisnger, 2019)

The 2nd enforcement case accused the chief compliance officer of allegedly engaging in fraud and then making false statements to the National Futures Association.

In May of this year, the CEO of the firm was charged with allegedly misappropriation, fraud and making false statements.  This led to the CFTC ordering the firms cco to pay $150,000 ($125,000 in restitution and $25,000 civil penalty) for fraud and false statements.

Philadelphia attorney Mary Hansen, the co-chair of the white-collar defense and corporate investigations practice at Drinker Biddle & Reath, said (about the 2nd case), the case should serve as a warning to chief compliance officers. “In the last couple years, we’ve seen more compliance officers charged,” adding, “and that’s not going away.” (Resinger, 2019)

While not in the healthcare field these cases and others reinforce the on-going need to create effective compliance programs.

youCompli’s regulatory change management software ensures your program is effectively managing ALL regulatory changes. To see a 2-minute video to learn how and hear from one of our customers click below.

See the Video

Reisinger, S. (2019, Sept. 25) Regulators Put Chief Compliance Officers in Their Sights in 2 Financial Fraud Cases Retrieved from http://www.law.com

Can’t Have The 7 Elements Without This!

 

While not named by the OIG as one of the “7 elements of an Effective Compliance Program” the ability to manage regulations directly affects 5 of the 7 actual elements (the 5 affected are listed at the bottom of this post).

So, you need to manage regulations effectively to have an effective compliance program.

When regulations change you (and many of your colleagues) need answers to one, two or all three of these questions.

  1. Are we aware of all the new regs that might apply to us?
  2. For the ones that do, what needs to be done to comply?
  3. Did we do it?

To make this work easier and give you the ability to manage it, we suggest relying on a methodology to perform this work.  When we created our software, we developed Regulatory Compliance Lifecycle Management (RCLM).

RCLM is a methodology that if followed will give you the ability to answer the questions above and be able to demonstrate what was done to comply (assuming you keep track of it).

RCLM includes:

  • Identification and documentation of new regulations
  • Assessing its relevance to your organization
  • Translation into business requirements, (specific activities required to comply)
  • Communication of requirements to ALL stakeholders
  • Execution of activities required to comply
  • Monitoring and validation that required activities have been completed
  • Demonstration of the steps taken above

Our software automates RCLM and makes compliance much easier.

If you’re interested in seeing how sign-up for our 10-minute demo by clicking the link and picking a date/time that is convenient for you.

#chaostoconfidence #StopReadingRegs

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5 Elements directly affected by regulatory changes

  1. Implementing written policies, procedures and standards of conduct.
  2. Conducting effective training and education.
  3. Conducting internal monitoring and auditing.
  4. Enforcing standards through well-publicized disciplinary guidelines.
  5. Responding promptly to detected offenses and undertaking corrective action.