CMS Signals Willingness to Revamp Stark for Coordinated Care Efforts

By Kristin M. Bohl and Samantha C. Flanzer

CMS issued a Request for Information (RFI), seeking input from the public on how best to address and mitigate any “undue regulatory impact and burden” of the physician self-referral law (“Stark Law”). The RFI, filed on June 20, 2018, signals a willingness on the part of CMS to consider revisions of the Stark Law to accommodate new payment models. While the RFI is largely focused on the intersection of the Stark Law and care coordination models, it also seeks public input on potential changes to core tenants of the Stark Law – e.g., regarding the definition of “commercial reasonableness” and when compensation should be considered to “take into account other business generated” between parties to an arrangement.

Highlights of those areas CMS is requesting public input include:

  • To what extent the Stark Law currently impacts commercial alternative payment models, and to what extent additional Stark Law exceptions may be necessary to protect such arrangements;
  • The current utility of the risk-sharing arrangement Stark Law exception;
  • To what extent it may be prudent for CMS to add a “special rule for compensation under a physician incentive plan” within the current Stark Law personal services arrangements exception;
  • Possible approaches to defining “commercial reasonableness” and “fair market value”;
  • When compensation should be considered to “take into account the volume or value of referrals” by a physician or “take into account other business generated” between parties to an arrangement (both inside and outside the context of alternative payment models);
  • What barriers exist to qualifying as a “group practice” under the Stark Law;
  • How CMS could interpret the exception for remuneration unrelated to designated health services (DHS) to cover a broader array of arrangements; and
  • The role of transparency in the context of the Stark Law, (e.g., how transparency about a physician’s financial relationship may reduce or eliminate harms to the Medicare program and its beneficiaries that the Stark Law is intended to address).

While this is certainly not the first time CMS has requested public input on potential revamps to the Stark Law, this RFI may nonetheless signal increasing momentum for Stark Law reform within the government.

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About the Authors

Kristin M. Bohl
Baltimore
410.862.1145
kbohl@bakerdonelson.com

Samantha C. Flanzer
Baltimore
410.862.1077
sflanzer@bakerdonelson.com

Health Law Alert – April 2018

Health Care Providers Beware: Consumer Finance Regulations Apply to Medical Debt Collection

While the prosecution of consumer banks and other lenders is the type of federal regulation that typically makes the headlines, many of the same debt collection regulations also apply to the collection of medical debts. Formed in the wake of the 2008 financial crisis, the Consumer Financial Protection Bureau (CFPB) began as an agency focused on the collection practices of financial institutions and other lenders. However, as early as 2014, the CFPB began scrutinizing the collection and reporting of medical debt.

In its December 2014 study, the CFPB determined that more than 43 million Americans have overdue medical debt reported on their credit reports. The tremendous volume got the attention of the CFPB, which then placed the medical establishment squarely in its crosshairs. Enforcement actions against collectors of medical debt were initiated shortly thereafter.

Authored by:
Jake Adams, 615.726.5631, jadams@bakerdonelson.com
Linda S. Finley, 404.589.3408, lfinley@bakerdonelson.com

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STOP: Text Message Lessons from the Outcome Health Settlement

Outcome Health has agreed to settle a class action lawsuit for $2.9 million for alleged violations of the Telephone Consumer Protection Act (TCPA) arising from the transmission of automated text messages to users who had expressly opted out of receiving such messages. The TCPA prohibits, among other things, the making of certain calls, including SMS text messages, or using an auto-dialer or an artificial or prerecorded voice to a wireless telephone number without prior express consent.

Outcome Health, formerly ContextMedia Inc., provides interactive digital devices to physician offices and hospital systems that are intended to educate patients through viewing videos, photos and other materials. In this case, the lead plaintiff watched a program playing in the waiting room of a doctor’s office and opted in to receiving automated text messages containing nutrition tips. According to the complaint, after receiving several text messages, the plaintiff decided she no longer wanted to receive these messages so she replied “STOP” as requested by the text messages for those individuals wishing to opt out. Despite her numerous attempts to revoke consent, she continued to receive the text messages. Under the TCPA, consumers are permitted to revoke prior express consent to receive text messages and the opt-out can be done in writing such as through a responsive text message. In this case, the plaintiff asserts that her reply of “STOP” to a text message should have been sufficient to cease further communications. Outcome Health denies that it violated the TCPA but has agreed to settle the claims to avoid the cost of continued litigation.

Authored by: Ashley L. Thomas, 202.508.3429, athomas@bakerdonelson.com

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Is the Health Care Industry Ready for I-9 Audits? What You Need to Know About Compliance

The health care industry accounts for the largest segment of the U.S. labor market and, as such, is positioned for heightened scrutiny from federal agencies tasked with regulating and enforcing rules on employment. That includes the Immigration and Customs Enforcement agency (ICE), which has indicated it will be stepping up the number of I-9 audits targeting U.S. employers.

Late last year, Tom Homan, ICE’s Acting Director, announced that he has instructed his agency to dramatically increase the number of I-9 audits. According to news reports, Director Homan indicated that the scope of the investigations would be to find employers who fail to properly comply with the I-9 Employment Eligibility Verification requirements, thereby enabling undocumented workers, and also to arrest workers found to be undocumented as a result of the investigations.

Authored by: Dilnaz Saleem, 713.210.7435, dsaleem@bakerdonelson.com

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OIG April 2018 Work Plan Update

The OIG’s April 2018 Work Plan update added six new items to its active list of scheduled audits, inspections, and evaluations. The OIG indicates its intention to review beneficiary access to drugs under Part D, as well as CMS’s implementation efforts to improve its monitoring, tracking, and collecting of overpayment recoveries. Building on Work Plan audits from several years ago, the OIG will review the flow and utilization of federal matching funds for Medicaid nursing home supplemental payments and related intergovernmental transfers. In addition, the OIG proposes to audit both the Head Start Program and the Refugee Resettlement Program and, based on congressional request, to review HHS email policies. The updates are summarized in this article and listed in the accompanying table.

Authored by: Thomas J. Bonura, 713.286.7181, tbonura@bakerdonelson.com
Reviewed by: William T. Mathias, 410.862.1067, bmathias@bakerdonelson.com

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Upcoming Events

National Institute on Health Care Fraud

May 2 – 4  – Seminar
San Francisco, CA
Learn more

 

How to Avoid Long Term Care Litigation

Tuesday, May 8 – Webcast
1:00 – 2:00 p.m. Central
2:00 – 3:00 p.m. Eastern
Learn more

When the Patient Becomes the Harasser

Thursday, May 10 – Webcast
10:30 – 11:30 a.m. Central
11:30 a.m. – 12:30 p.m. Eastern
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Jonell B. Beeler
Jackson
601.351.2427
jbeeler@bakerdonelson.com

Catherine A. Martin
Baltimore
410.862.1120
cmartin@bakerdonelson.com

Health Law Alert – February 2018 #2

New DOJ False Claims Act Guidance Delivers More Questions than Answers for Health Care Industry

The U.S. Department of Justice (DOJ) kicked off the new year by issuing two internal memoranda that are directly relevant to actions brought under the False Claims Act. The January 2018 memoranda offer valuable insight into how the DOJ intends to prosecute, or opt to dismiss, pending and future civil enforcement actions. These memoranda may have their biggest impact in the health care industry, with its plethora of qui tam matters and heavy reliance on manuals and other sub-regulatory guidance. Each memorandum is discussed more fully in “A New Year, a New, Firmer DOJ: Recently Released Parameters for DOJ in False Claims Act Litigation.”

The first such memorandum, issued January 10, 2018, emphasizes the DOJ’s “important gatekeeper role” in preserving resources, protecting government interests, and avoiding unfavorable precedent caused by weak cases. While the False Claims Act contains a dismissal provision, 31 U.S.C. § 3730(c)(2)(A), which explicitly gives the DOJ the power to seek to dismiss a case over the objection of a relator (who stands to gain financially if their lawsuit leads the government to recover money), the DOJ historically has been hesitant to exercise that authority. The January 10 memorandum, however, encourages DOJ attorneys to consider not only their power to seek dismissal, but also their responsibility to do so, and outlines seven common, but not exclusive, factors for U.S. attorneys to consider in deciding whether to dismiss a qui tam.

Authored by:
Thomas H. Barnard, 410.862.1185, tbarnard@bakerdonelson.com
Marisa Rosen Dorough, 407.367.5406, mdorough@bakerdonelson.com

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OIG February 2018 Work Plan Update

The OIG added three items to its Work Plan with the February 2018 update, as listed in the chart below. Two of the items concern annual reports, one addressing the performance of Medicaid Fraud Control Units and the other reporting on the use of price substitution in Medicare Part B drug purchasing. The third item relates to statistical sampling in Medicare fee-for-service administrative appeals of findings by program integrity contractors.

Program integrity contractors utilize statistical sampling to review payments to providers and to identify payments that may be improper. If the contractor identifies “a sustained or high level of payment error,” the contractor may use statistical sampling to extrapolate a total overpayment based on a larger population of claims. The statistical estimate for the sample is subject to challenge on appeal. Medicare Administrative Contractors (MACs) and Qualified Independent Contractors (QICs) are responsible for the first two levels of the appeals process, and, according to the OIG, “thus play a critical role in deciding which extrapolations will be upheld.”

Authored by:
Meredith N. Larson410.862.1123mlarson@bakerdonelson.com
Reviewed by:
 William T. Mathias410.862.1067bmathias@bakerdonelson.com

READ MORE


Key Health Care Provisions of Bipartisan Budget Act of 2018

The wide-reaching Bipartisan Budget Act of 2018 (BBA), passed by Congress and signed by the President on February 9, 2018, extends and modifies dozens of health care programs, including extending funding for two years for community health centers and extending the Children’s Health Insurance Program (CHIP) for an additional four years through Fiscal Year (FY) 2027. The bill also provides funding for a number of Medicare extenders and incorporates policy reforms from the CHRONIC Care Act and the Medicare Part B Improvement Act – affecting Stark Law compliance, physician payment plans, telehealth, home health services, and other programs. The bipartisan legislation also includes funding for the National Institutes of Health (NIH) and for efforts to combat the opioid crisis. Finally, the legislation repeals the Affordable Care Act’s (ACA) Independent Payment Advisory Board (IPAB) and eliminates the Medicaid Disproportionate Share Hospital (DSH) reductions scheduled for FY18 and FY19. Of note, the legislation does not include ACA market stabilization measures to address ongoing uncertainty and turmoil in the individual insurance market. Congress will now turn to enacting a full-year omnibus appropriations measure for FY18 under the newly passed BBA.

Authored by:
Sheila P. Burke202.508.3457sburke@bakerdonelson.com
Amit Rao202.508.3472arao@bakerdonelson.com
Sam E. Sadle202.508.3476ssadle@bakerdonelson.com

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President’s Budget on Health Care: Entitlement Reform, Opioid Funding, and Cuts to Health Programs

The President’s fiscal year 2019 (FY19) budget proposal for the Department of Health and Human Services (HHS) reflects the Trump Administration’s priorities to repeal and replace the Affordable Care Act (ACA) and implement significant reductions in federal spending for health care entitlements and domestic health programs. The budget assumes Congress will replace the ACA’s Medicaid expansion funding and insurance exchange subsidies with market-based block grants to the states (citing the Graham-Cassidy-Johnson-Heller proposal), generating $679 billion in net savings over the ten-year budget window. Like last year, the budget includes a proposed restructuring of Medicaid from an open-ended federal and state entitlement program to a per capita cap or block grant system beginning in FY20, projected to save approximately $1.4 trillion over ten years. However, unlike last year’s budget proposal, this year’s budget calls for substantial reforms and cuts in Medicare, producing $532 billion in total savings over ten years. The budget proposes reductions in Medicare reimbursements to post-acute care providers, graduate medical education programs, hospitals providing uncompensated care, and hospital-owned physician practices. The budget also proposes savings through efforts to lower Medicare payments and beneficiary out-of-pocket cost sharing for prescription drugs.

Related Resource: President’s FY19 budget Medicare legislative proposals and estimated budget impacts

Authored by:
Sheila P. Burke, 202.508.3457, sburke@bakerdonelson.com
Amit Rao, 202.508.3472, arao@bakerdonelson.com

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Co-Chairs, Health Care Regulatory Group

Jonell B. Beeler
Jackson
601.351.2427
jbeeler@bakerdonelson.com

Catherine A. Martin
Baltimore
410.862.1120
cmartin@bakerdonelson.com

www.bakeroberhealthlaw.com

PAYMENT MATTERS

Taking Pills for Pay: FDA Releases Information Sheet on Paying Research Subjects

In clinical research, compensating research subjects as an incentive for their participation is a common practice. However, paying research subjects can also pose ethical issues and create the potential for abuse such as undue inducement.

The Food and Drug Administration (FDA) does not provide firm guidance to institutional review boards (IRBs) and clinical investigators as to how they should calculate payments or the specific factors that should be considered in setting that compensation. Recently, however, the FDA updated their guidance for IRBs and clinical investigators on appropriate practices for paying or reimbursing research subjects. It is important to note that the information sheet is non-binding and meant to serve as a guide on how to approach payment and reimbursement to clinical research subjects.

Authored by:
 Ashley L. Thomas202.508.3429athomas@bakerdonelson.com

READ MORE


The New Option in Town: Applying for the Low Volume Appeals Settlement

In November 2017, the Department of Health and Human Services (HHS) announced new settlement options for providers and suppliers stuck in the backlog of the Medicare appeals process. One of the new options available is the Low Volume Appeals Settlement Options (LVA), which is geared towards providers and suppliers with fewer than 500 Medicare Part A or Part B claim appeals pending at the Office of Medicare Hearing and Appeals (OMHA).

HHS provided little information on LVA at the time of the announcement, as we noted in our previous alert, “HHS Reveals New Settlement Options to Address Medicare Appeals Backlog.” Since that time, HHS held a webinar on January 9, 2018 covering the logistics of the LVA process and clarifying any outstanding issues.

Authored by:
Donna K. Thiel202.508.3404dthiel@bakerdonelson.com
Tracy E. Weir202.508.3481tweir@bakerdonelson.com
Ashley L. Thomas202.508.3429athomas@bakerdonelson.com
Matthew W. Horton410.862.1182mhorton@bakerdonelson.com

READ MORE


Key Health Care Provisions of Bipartisan Budget Act of 2018

The wide-reaching Bipartisan Budget Act of 2018 (BBA), passed by Congress and signed by the President on February 9, 2018, extends and modifies dozens of health care programs, including extending funding for two years for community health centers and extending the Children’s Health Insurance Program (CHIP) for an additional four years through Fiscal Year (FY) 2027. The bill also provides funding for a number of Medicare extenders and incorporates policy reforms from the CHRONIC Care Act and the Medicare Part B Improvement Act – affecting Stark Law compliance, physician payment plans, telehealth, home health services, and other programs. The bipartisan legislation also includes funding for the National Institutes of Health (NIH) and for efforts to combat the opioid crisis. Finally, the legislation repeals the Affordable Care Act’s (ACA) Independent Payment Advisory Board (IPAB) and eliminates the Medicaid Disproportionate Share Hospital (DSH) reductions scheduled for FY18 and FY19. Of note, the legislation does not include ACA market stabilization measures to address ongoing uncertainty and turmoil in the individual insurance market. Congress will now turn to enacting a full-year omnibus appropriations measure for FY18 under the newly passed BBA.

Authored by:
Sheila P. Burke202.508.3457sburke@bakerdonelson.com
Amit Rao202.508.3472arao@bakerdonelson.com
Sam E. Sadle202.508.3476ssadle@bakerdonelson.com

READ MORE


Leslie Demaree Goldsmith
Baltimore
410.862.1133
lgoldsmith@bakerdonelson.com

Donna Thiel
Washington, D.C.
202.508.3404
dthiel@bakerdonelson.com


www.bakeroberhealthlaw.com

Health Law Alert – February 2018

BPCI Advanced – CMS Offers a Familiar Program with a New Twist

The Centers for Medicare & Medicaid Services (CMS) is launching BPCI Advanced – the successor program to the Bundled Payments for Care Improvement Initiative. Providers that like the current BPCI program, or simply missed the opportunity to join BPCI when it launched in 2013, should consider applying for BPCI Advanced before the March 12, 2018 application deadline.

CMS created the concept of bundled payments as a way to link payments across all health care providers during a single episode of care, with the aim of improving care and removing waste from the health care delivery system. BPCI Advanced builds on the work of CMS’s Center for Medicare and Medicaid Innovation (CMMI) and the foundation of the first BPCI initiative, which started in April 2013 and will end on September 30, 2018. The BPCI Advanced performance period will begin on October 1, 2018 and run through December 31, 2023.

Authored by:
Kristin M. Bohl, 410.862.1145, kbohl@bakerdonelson.com
Christopher P. Dean, 410.862.1176, cdean@bakerdonelson.com
Catherine A. Martin, 410.862.1120, cmartin@bakerdonelson.com
Ashley L. Thomas, 202.508.3429, athomas@bakerdonelson.com

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Post-Acute Care Providers Ponder Role in BPCI Advanced

As CMS’s approach to Alternative Payment Models continues to evolve, most recently with the release of BPCI Advanced, post-acute care providers may be left scratching their heads as they try to determine where they fit. An evaluation of Year 3 of the BPCI program, released in October 2017, identified shortened skilled nursing facility (SNF) stays as a primary driver of savings under both BPCI Model 2 and Model 3. Shorter SNF stays, and more efficient use of other types of post-acute care, will likely continue to drive savings for BPCI Advanced participants. Despite the role post-acute care (PAC) providers play in reducing costs, the updated iteration of the BPCI program reduces opportunities for them to benefit from the reductions in costs that they help to generate. Nonetheless, under BPCI Advanced, cooperating with participating physicians and hospitals to coordinate care for beneficiaries during BPCI episodes will remain important for SNFs and other PAC providers.

Authored by: Meredith N. Larson, 410.862.1123, mlarson@bakerdonelson.com

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Nursing Facility Discounts Approved in OIG Advisory Opinion 17-08

The OIG created an opening for nursing facility discounts to private payors when it approved a startup company’s proposal to create a network of nursing facilities willing to offer discounts on the daily rates charged to private long term care insurers and their policy holders in OIG Advisory Opinion 17-08. Because the nursing facilities involved also provide items and services that are reimbursed under federal health care programs, the OIG analyzed the arrangement under the beneficiary inducement prohibitions of the civil monetary penalty statute (beneficiary inducement CMP) and the Anti-Kickback Statute (AKS). The OIG ultimately concluded that neither AKS sanctions nor a CMP would be imposed due to the sufficiently low risk of fraud, abuse or beneficiary inducement under the facts at hand.

Authored by: Kathleen R. Salsbury, 202.508.3411, ksalsbury@bakerdonelson.com
Reviewed by: William T. Mathias, 410.862.1067, bmathias@bakerdonelson.com

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OIG Offers Additional Guidance on Gainsharing Arrangement in Advisory Opinion 17-09

A non-profit acute care hospital may share cost savings for certain spinal surgeries with neurosurgeons in a multi-specialty physician group following approval by the U.S. Department of Health & Human Services, Office of Inspector General (OIG). In Advisory Opinion 17-09, the OIG determined that the parties had incorporated sufficient safeguards in the gainsharing arrangement to avoid sanctions under both the civil monetary penalty prohibiting a hospital’s payment to a physician to induce the reduction or limitation of medically necessary services to Medicare or Medicaid beneficiaries (the Gainsharing CMP) and the Anti-Kickback Statute (AKS).

The advisory opinion is notable for two firsts. It is the first advisory opinion to address gainsharing since the passage of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which modified the Gainsharing CMP to prohibit only inducements made to reduce or limit medically necessary services under Medicare or Medicaid. Furthermore, it is the first gainsharing advisory opinion involving a large multi-specialty physician group.

Authored by:
Ashley L. Thomas, 202.508.3429, athomas@bakerdonelson.com
William T. Mathias, 410.862.1067, bmathias@bakerdonelson.com

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OIG January 2018 Work Plan Update

The OIG added six new items to its Work Plan with the January 2018 update. Consistent with prior Work Plan missives, the OIG continues to focus its efforts on reducing prescription opioid misuse. Additionally, similar to the December 2017 Work Plan update, the Medicare Advantage industry may be interested to know the OIG is examining elements impacting risk-adjusted payments to Medicare Advantage organizations. Those involved in the orthotic device industry should be aware that the OIG is scrutinizing reimbursement for certain off-the-shelf orthotic devices. Furthermore, the OIG is analyzing claims data to determine the prevalence of potential abuse to Medicare beneficiaries. Lastly, the OIG will examine states that receive block grants related to the Child Care Development Fund to ensure program integrity. Read on for brief descriptions of the six new items.

Authored by: Daniel A. Stephenson, 615.726.5678, dstephenson@bakerdonelson.com
Reviewed by: William T. Mathias, 410.862.1067, bmathias@bakerdonelson.com

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Quotable: Non-profits and the New Tax Law

Jackie Henson and Bill Robinson explain what non-profits need to know about the new tax law in this interview with HealthLeaders.

“This provision, this 21% excise tax, once you start getting into it, is not going to be an easy provision to comply with,” says Jacqueline Henson, an attorney and specialist in tax-exempt organizations with the Washington, D.C. office of the Baker Donelson law firm. “It will make life difficult not necessarily for the largest of the largest organizations, but for the mid-sized. I don’t think non-profits know what’s going to hit them yet.”

READ THE INTERVIEW

Co-Chairs, Health Care Regulatory Group

Jonell B. Beeler
Jackson
601.351.2427
jbeeler@bakerdonelson.com

Catherine A. Martin
Baltimore
410.862.1120
cmartin@bakerdonelson.com

www.bakeroberhealthlaw.com

Health Law Alert

OIG November 2017 Work Plan Update

The OIG added four items to its Work Plan with the November 2017 update, as listed on the chart below. Interestingly, three of the four new items relate to Medicaid. Hot topics include prescriptions for extreme amounts of opioids and Medicaid’s use of telemedicine. Hospitals will want to know that the OIG is looking into hospital inpatient billing for severe malnutrition. Below are brief descriptions of the four new items.

Following a trend from the previous two Work Plan updates and consistent with the government’s growing focus on the opioid crisis, the OIG will be examining prescriptions for extreme amounts of opioids to Medicaid beneficiaries. The OIG observes that Medicaid beneficiaries, particularly those on disability, are more susceptible to opioid abuse because they are more likely to have conditions that require pain relief. The OIG intends to look at the issue from both the beneficiary side and the prescriber side. The overall goal of the study is to generate “baseline data about beneficiaries receiving extreme amounts of opioids and prescribers with questionable patterns for opioids in Medicaid.”

Authored by: Michaela D. Poizner,
615.726.5695mpoizner@bakerdonelson.com

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OIG Advisory Opinion 17-06: Another Medigap/PHO Arrangement Approved

Advisory Opinion 17-06 joins a long list of opinions approving arrangements between a Medicare Supplemental Health Insurance (Medigap) insurer and a preferred hospital organization (PHO). While this advisory opinion does not offer new insights with respect to Medigap/PHO arrangements, the OIG has remained consistent in its approach to them.

As with prior similar requests, the Medigap insurer here sought approval of an agreement in which it would contract with a PHO, and the hospitals within the PHO’s network would provide discounts of up to 100 percent on the Medicare Part A inpatient hospital deductibles covered by the insurer. The hospitals would not provide any additional benefits to the Medigap insurer or its policyholders, and the insurer would pay a fee to the PHO for administrative services each time it received a discount. The Medigap insurer would also return a portion of the savings to those policyholders who had an inpatient stay at a network hospital via a $100 credit toward their next renewal premium. The use of non-network hospitals would not subject policyholders to penalties or otherwise affect liability for costs covered by the Medigap plans.

Authored by: Andrew J. Droke,
865.971.5170adroke@bakerdonelson.com

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“Breaking Bad” News: Sharing PHI During Opioid Crisis

In response to President Trump’s declaration of the opioid crisis as a public health emergency, the Office for Civil Rights (OCR) released guidance intended to educate health care providers on how they can respond to requests for protected health information (PHI) during an opioid crisis. OCR’s guidance does not reveal any new or revised standards for disclosure of PHI, but rather it instructs health care providers on how existing HIPAA rules apply to sharing PHI with a patient’s family members, close friends or legal representative during a crisis situation, such as an opioid overdose.

The guidance illustrates how PHI may be shared without the patient’s consent in an opioid crisis, but the prevailing HIPAA rules permit disclosure of PHI any time the criteria noted below are satisfied. Specifically, providers may share PHI:

  • with a patient’s family, and close friends when doing so is in the best interests of an incapacitated or unconscious patient; and
  • when doing so would prevent or diminish a serious and imminent threat to the patient’s health and safety.

Authored by: Ashley L. Thomas,
202.508.3429athomas@bakerdonelson.com
Reviewed by: Tracy E. Weir,
202.508.3481tweir@bakerdonelson.com

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Physician Practice Penalized by DOJ for 60-Day Overpayment Rule Violation

The Department of Justice (DOJ) imposed False Claims Act penalties against First Coast Cardiovascular Institute (FCCI) for failing to work credit balances and repay overpayments to federal health care programs. On October 13, 2017, DOJ announced that FCCI agreed to pay $448,821 to resolve False Claims Act allegations brought by a former employee of FCCI. The qui tam lawsuit alleged that FCCI wrongfully delayed repayment of approximately $175,000 in potential overpayments to federal health care programs beyond 60 days. This settlement represents a warning to providers who intentionally drag their feet in the face of a potential overpayment, and fail to diligently investigate and repay monies owed to federal health care programs.  Authored by: Stewart W. Kameen,
410.862.1068, skameen@bakerdonelson.com

Reviewed by: William T. Mathias, 410.862.1067, bmathias@bakerdonelson.com

READ MORE


Webinar | LTC Disaster Readiness: How Your Facility Can Prepare, Respond, and Recover

As recovery efforts take center stage in areas affected by natural disasters that have recently impacted our nation, it is critical that the long term care industry is aware of the unique issues presented by these events.

This webinar covers the regulatory framework relevant to this industry, including new requirements that went into effect on November 15, 2017, as well as additional changes sometimes implemented post-event, and the rules and requirements specifically applicable to entities who may be eligible for aid through federally funded relief programs, including those administered through the Federal Emergency Management Agency. The session concludes with recommendations for disaster response and preparedness, including a summary of common issues and best practices to minimize risks. Presented by Baker Donelson attorneys Ernest B. Abbott, Wendy Huff Ellard, Meredith N. Larson, and Danielle Trostorff.

View the webinar here.


Co-Chairs, Health Care Regulatory Group

Jonell B. Beeler
Jackson
601.351.2427
jbeeler@bakerdonelson.com
Catherine A. Martin
Baltimore
410.862.1120
cmartin@bakerdonelson.com

Peer Review Not Protected: U.S. Supreme Court Will Not Disturb Florida Decision Limiting the Patient Safety and Quality Improvement Act

By Alisa L. Chestler, CIPP/US and Andrew J. Droke

A multi-year discovery dispute regarding the adverse medical incident reports of a Jacksonville, Florida hospital concluded on October 2, 2017 when the United States Supreme Court denied a petition for a writ of certiorari in Southern Baptist Hospital of Florida, Inc. v. Charles. Because the Supreme Court declined to hear the case, the Supreme Court of Florida’s January 2017 decision will continue to limit the protections afforded to certain peer review activities under the federal Patient Safety and Quality Improvement Act (PSQIA).

Health care providers that collect and report information to patient safety organizations (PSOs) should perform a detailed review of their patient safety evaluation (PSE) systems, as reporting systems may require restructuring to ensure that the privileges afforded by PSQIA will apply.

The Patient Safety and Quality Improvement Act vs. Florida Constitution Amendment 7

PSQIA was enacted in 2005 with the goal of improving patient safety and health care quality by establishing a voluntary, confidential, and non-punitive system for the reporting of medical errors and near-miss data. The free-flow of information was intended to improve patient outcomes. As a result, providers, facilities, and health systems have established PSE systems to collect and report data to PSOs, which then aggregate, analyze, and use the information to help minimize medical risk by providing feedback and assistance.

Recognizing that the collection and reporting of this data also presents the potential for increased liability exposure, Congress established a statutory privilege for “patient safety work product,” which generally includes “any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements” created for or supplied to a PSO.

In contrast, in 2004, Florida adopted a constitutional amendment commonly referred to as “Amendment 7,” which established a state-wide right of access to the adverse medical incident records of health care providers. Because of the breadth of this provision, Amendment 7 has frequently been relied upon by plaintiffs in medical malpractice litigation to collect records from defendant providers.

The conflict between the confidentiality afforded by PSQIA and the access secured via Amendment 7 was squarely before the court in Charles. There, a medical malpractice plaintiff served written discovery requests seeking all adverse medical incident reports in the defendant hospital’s history as well as other records of treatment and care during specific time periods. In response, the defendant hospital produced two occurrence reports related to the patient at issue, but objected to providing any additional adverse medical incident data based upon the privileges afforded by PSQIA.

After the trial court granted the motion to compel and the First District Court of Appeal reversed, the plaintiff appealed to the Supreme Court of Florida. Favoring access under Amendment 7, Florida’s high court held that the hospital’s adverse medical incident records did not qualify as patient safety work product under PSQIA and that the federal act did not preempt Amendment 7. Thus, the adverse medical incident data sought was discoverable.

The Florida Supreme Court specifically opined that the requested reports were not privileged because Florida law required the hospital to maintain the records. In so holding, the court effectively established a rule whereby Florida health care providers must create reports solely for the purpose of submission to a PSO in order for the reports to qualify as privileged patient safety work product. Further, even if this conflicts with the stated purposes of PSQIA, the United States Supreme Court’s October 2, 2017 denial of the hospital’s petition for a writ of certiorari concludes the inquiry.

Now, even if prepared via a PSE system and reported to a PSO, PSQIA will not protect from discovery the adverse medical incident reports created by Florida health care providers to comply with state reporting obligations. Health care providers should take steps to revise their PSE systems accordingly.

What You Need to Know

Because the U.S. Supreme Court will not revisit the decision in Charles, Florida health care providers should review and consider whether their PSE systems combine state-required reporting obligations with reports to PSOs. The combination of reporting functions is likely to limit the ability to shield such reports from discovery in civil litigation.

If you have any questions or would like assistance in evaluating your PSE systems, please contact a member of the BakerOber Health Law Group or Health Care Litigation Team.

About the Authors

Alisa L. Chestler, CIPP/US
Nashville
615.726.5589
achestler@bakerdonelson.com
Andrew J. Droke
Knoxville
865.971.5170
adroke@bakerdonelson.com

Health Law Alert

OIG Work Plan – October 2017 Update

Ashley L. Thomas, 202.508.3429athomas@bakerdonelson.com Reviewed by William T. Mathias410.862.1067,    bmathias@bakerdonelson.com

The OIG added five new items to its Work Plan with its October 2017 monthly update. This is a decrease from the nine new items added to the Work Plan with the September 2017 update. (For more information on last month’s Work Plan update, see “OIG Work Plan – September 2017 Update“).

Last month, the Secretary of the Department of Health and Human Services (DHHS), Tom Price, resigned from his position as Secretary after news broke that he had used private charter flights and military aircraft at taxpayer expense. The OIG will review whether Secretary Price’s use of private charter flights was in compliance with applicable federal regulations and DHHS policies and procedures.

The rising cost of drugs for rare and complex conditions has become an issue of concern for state Medicaid programs. While high-cost specialty drugs are a small portion of the total of all drugs dispensed, they represent a disproportionate and growing share of total drug spending. Further complicating this issue is that there is no standard definition for specialty drugs, posing challenges in management of specialty drug costs. The OIG will examine how state Medicaid programs define specialty drugs and review strategies on management of specialty drug costs, such as formularies, cost sharing, step therapy, and prior authorization.
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CMS Advisory Opinion 2017-01 Approves Pop-up Alerts to Physicians Through Online Laboratory Portal

Michaela D. Poizner, 615.726.5695mpoizner@bakerdonelson.com

A clinical laboratory has received a green light from CMS to offer pop-up notifications alerting physicians of various potential issues (Laboratory Alerts) through its web-based portal for ordering and reporting results of diagnostic tests. CMS reviewed the proposal to offer the Laboratory Alerts in Advisory Opinion 2017-01, issued in September 2017, and determined that the Laboratory Alerts do not constitute remuneration (42 C.F.R. § 411.351) creating a compensation arrangement that implicates the physician self-referral law (the Stark Law).
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CMS Clarifies Streamlined Submission to Self-Referral Disclosure Protocol for Physician Organizations

Kristin Cilento Carter, 410.862.1109kcarter@bakerdonelson.com

In an apparent effort to reduce redundancy, CMS issued an FAQ clarifying a simplified process for submissions to the CMS Voluntary Self-Referral Disclosure Protocol (SRDP) involving financial relationships with physicians who are deemed to “stand in the shoes” of their physician organization.

Under the revised SRDP process that became effective as of June 1, 2017, CMS requires SRDP participants to utilize very specific forms to provide detailed information regarding the self-disclosure, including the SRDP Disclosure Form identifying information regarding the disclosing party; the Physician Information Form identifying information regarding each physician included in the disclosure; and the Financial Analysis Worksheet identifying the potential overpayment based on a six-year look back period. Notably, the SRDP forms instruct that for each physician included in the disclosure, a disclosing entity must submit a separate Physician Information Form providing the details of the financial relationship(s) between the physician(s) and disclosing entity. Given this instruction, in circumstances where the disclosed financial arrangement involved a large physician-owned organization, a disclosing entity seemingly would have been required to submit multiple redundant Physician Information Forms for each physician owner who is deemed to “stand in the shoes” of the organization pursuant to 42 C.F.R. § 411.354(c).
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CMS Requests Industry Feedback on “New Direction” for the Innovation Center

Matthew W. Horton, 410.862.1182mhorton@bakerdonelson.com

CMS is seeking comments through a Request for Information (RFI) on a “new direction” for the CMS Innovation Center. The RFI includes focus areas identified by CMS, but the RFI welcomes all stakeholder input on “additional ideas and concepts,” including the “future direction of the Innovation Center.” This is an opportunity for stakeholders to provide feedback or suggest new ideas that could shape the Innovation Center’s policies and priorities on future payment models. The deadline to submit comments to the RFI is November 20, 2017.
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Texas Medical Board Proposes New Rules on Heels of Relaxed Telemedicine Laws

Emily H. Wein, 410.862.1160ewein@bakerdonelson.com

The Texas Medical Board recently proposed changes to its telemedicine regulations (22 Tex. Admin. Code §§ 174.1 – 174.12) to follow the amendments to Section 111 of the Texas Occupations Code governing the practice of telemedicine and telehealth. (See 2017 Texas Senate Bill 1107.) The statutory amendments, among other things, removed the in-person exam requirement for purposes of establishing a valid practitioner-patient relationship and added a provision allowing the establishment of such relationship through “telemedicine medical services.” The revised law also tasks the state regulatory boards for medicine, nursing, physician assistants and pharmacy with the joint promulgation of rules relative to valid prescriptions, with the mandate that such rules allow for the establishment of a practitioner-patient relationship via telemedicine.
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Payment Matters – 09/15/17

Court of Appeals Reverses D.D.C. Order Requiring HHS to Eliminate Medicare Appeals Backlog by December 31, 2020

Stewart W. Kameen,

410.862.1068, skameen@bakerdonelson.com

Leslie Demaree Goldsmith,

410.862.1133, lgoldsmith@bakerdonelson.com

Hopes were dashed for sooner relief from the backlog of Administrative Law Judge (ALJ) appeals. With the backlog of Medicare reimbursement appeals steadily growing, a reversal by the U.S. Court of Appeals for the District of Columbia complicated matters by undoing a four-year reduction plan that required the Secretary of Health and Human Services (HHS) to eliminate the backlog of appeals by December 31, 2020. Am. Hosp. Ass’n et. al. v. Price, No. 17-5018 (D.C.Cir. Aug. 11, 2017). The Court of Appeals vacated the order and remanded for further consideration as to whether the reduction plan was attainable through lawful means.

As explained in an earlier edition of Payment Matters on December 5, 2016, a U.S. District Court for the District of Columbia granted summary judgment in favor of the American Hospital Association (AHA) in its quest to reduce and eliminate the backlog of Medicare reimbursement appeals. In that decision, the court targeted the multi-year delays in the Medicare appeals process at the ALJ stage, the third of four stages of administrative appeals, during which some current appeals are now predicted to stall for more than a decade and newly-filed appeals for even longer. The entire appeals process is designed on a one-year timeline from start to finish and the district court noted that HHS is “bound by statutorily mandated deadlines, of which it is in flagrant violation as to hundreds of thousands of appeals.” As of June, more than 600,000 appeals are pending at the ALJ stage. AHA v. Price, slip op. at 21. Even so, the Court of Appeals disagreed with the lower court’s December 5, 2016 solution, which adopted one of AHA’s proposals that required HHS to reduce the backlog as follows:

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Targeted Probe and Educate – CMS Changes Its Approach to Auditing

Christopher P. Dean, 410.862.1176, cdean@bakerdonelson.com

Medicare providers and suppliers will now be subject to Targeted Probe and Educate (TP&E) audits beginning this fall. These TP&E audits will focus on limited audits of individual providers and provider education. This new program expands on an existing CMS pilot auditing program, which applied previously to only three MAC jurisdictions.

TP&E will focus the MACs on targeting high-risk areas while encouraging Medicare providers and suppliers to understand and correct their billing behavior to prevent future incorrect claims. TP&E begins with MACs identifying providers and suppliers with either high claims error rates or with billing practices that differ materially from other similar providers and suppliers. The MACs will use data analysis to identify these two groups and it was implied that the MACs could rely on the Common Working File; historical billing, payment and utilization data; and other internal or external sources to conduct their data analysis.

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Telehealth: Avoid the Risks and Reap the Benefits for Healthier, Happier Residents

Emily Wein presented this webinar highlighting some of the benefits and risks of telehealth within the long term care industry. Federal and state regulations present significant obstacles to growth in all areas of telehealth. In this presentation, Emily provides a brief regulatory status update, comments on recent trends and identifies potential areas of opportunity and concern in the future. View the webinar here.

Editors

Leslie Demaree Goldsmith

Baltimore

410.862.1133

lgoldsmith@bakerdonelson.com

Donna Thiel

Washington, D.C.

202.508.3404

dthiel@bakerdonelson.com

State AGs Data Breach Settlement Reinforces the Importance of Patch Management

By Bill O’Connor, CISSP, CIPP/US

A recent settlement between Nationwide Mutual Insurance Company and attorneys general from 32 states and the District of Columbia (the “Attorneys General”) over a 2012 data breach reinforces the importance of patch management.

On August 9, 2017, the Attorneys General and Nationwide, on behalf of itself and its wholly-owned subsidiary, Allied Property & Casualty Insurance Company (collectively, “Nationwide”), entered into an Assurance of Voluntary Compliance that requires Nationwide to, among other things, pay $5.5 million to the Attorneys General. The settlement is in response to an October 3, 2012 data breach experienced by Nationwide that resulted in the loss of sensitive personal information for 1.27 million consumers. The breach affected potential customers who were seeking insurance quotes from Nationwide. The sensitive personal information included driver’s license numbers, Social Security numbers, and Nationwide internal credit-related scores.

The 2012 data breach was alleged to be the result of Nationwide’s failure to apply a critical security patch that led to hackers exploiting a vulnerability in Nationwide’s web hosting software. After the breach occurred, Nationwide addressed the software vulnerability by applying the previously unapplied software patch. Nationwide admits it experienced a data breach, but denies any wrongdoing related to the breach. Shortly after the data breach occurred, Nationwide notified the affected consumers and offered free credit monitoring and $1 million of free identity theft insurance coverage with no deductible.

In addition to the $5.5 million payment, the settlement – titled as an “Assurance of Voluntary Compliance” – requires Nationwide to complete additional tasks, which may or may not have already been completed, such as:

  • Maintaining an online disclosure statement informing potential customers that it retains a consumer’s personal information even if the consumer does not become an insured
  • For a period of three years:
    • Appoint an individual to the role of Patch Policy Supervisor to maintain, review and revise Nationwide’s patch management policies and procedures
    • Appoint an individual to the role of Patch Supervisor to monitor and manage the installation of available patches
    • Maintain and, on at least a semi-annual basis, update an inventory of all covered systems
    • Regularly review and update its Incident Management Policy and Procedures
    • Deploy and maintain a system management tool to identify available patches on a near real-time basis and scan covered systems to identify unapplied patches
    • Implement processes and procedures to notify Nationwide’s patch management personnel about available patches
    • Implement processes and procedures to evaluate the severity of available patches and prioritize any responsive mitigation actions, and document in writing the applicable risk severity and actions taken
    • Purchase and install an automated feed of common vulnerabilities to Nationwide’s intrusion detection/intrusion prevention systems and security information and event management technology
    • On at least a semi-annual basis, perform an internal patch management assessment of its covered systems
    • On at least an annual basis, hire an outside, independent provider to perform a patch management audit of its covered systems
  • One year after the settlement, certify to the Attorneys General that it is in compliance with these requirements

All organizations that collect personal information from consumers should take heed of the requirements set forth in the Nationwide settlement. These requirements reinforce the importance of implementing an effective patch management program. Failure to apply critical security patches can not only lead to data breaches, but can also make organizations vulnerable to ransomware attacks (as seen by the recent WannaCry ransomware attacks on systems that had not applied an available Microsoft security patch).

If you have any questions or concerns about your organization’s patch management program, or other data privacy and cybersecurity questions, please reach out to Bill O’Connor, CISSP, CIPP/US, or any member of Baker Donelson’s Data Protection, Privacy and Cybersecurity Team, and we will be happy to assist.

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