Tag: Health Law

June 24th – Healthcare Quarterly Update: Cybersecurity and Health Data Privacy by Bloomberg BNA

Washington, DC

Join Bloomberg BNA for this essential event that explores concerns relating to cyber-security and health data privacy. Healthcare industry experts Kirk Nahra and David Holtzman will join HHS’s Iliana Peters for a comprehensive examination of:
• Big data in the healthcare sector and how to protect information
• Protecting patient and organization information
• Federal enforcement of HIPAA Privacy, Security, Data Breach rules
• Practical up to date information on current issues
• And so much more.

Click here to register today!

Identify actionable issues, secure your organization, and earn CLE credits.

A breakfast panel with accomplished scholars and an HHS representative. This conversation will address practical considerations for ensuring that patient’s data is being properly handled in full compliance with all regulations and ethical responsibilities. Healthcare practitioners are increasingly required to address concerns of Data privacy and Cyber-security; attending this panel will assist you in identifying actionable points in the law common to many legal practices.

Healthcare Quarterly Update: Cybersecurity and Health Data Privacy by Bloomberg BNA

Washington, DC

Join Bloomberg BNA for this essential event that explores concerns relating to cyber-security and health data privacy. Healthcare industry experts Kirk Nahra and David Holtzman will join HHS’s Iliana Peters for a comprehensive examination of:
• Big data in the healthcare sector and how to protect information
• Protecting patient and organization information
• Federal enforcement of HIPAA Privacy, Security, Data Breach rules
• Practical up to date information on current issues
• And so much more.

Click here to register today!

Identify actionable issues, secure your organization, and earn CLE credits.

A breakfast panel with accomplished scholars and an HHS representative. This conversation will address practical considerations for ensuring that patient’s data is being properly handled in full compliance with all regulations and ethical responsibilities. Healthcare practitioners are increasingly required to address concerns of Data privacy and Cyber-security; attending this panel will assist you in identifying actionable points in the law common to many legal practices.

DaVita Agree to $495 Million Settlement in Alleged Medicare Fraud Lawsuit Filed by Qui Tam Whistleblowers

On Monday, May 4, 2015, DaVita Kidney Care, a division of DaVita Healthcare Partners, Inc. (DaVita), and one of the leading dialysis services providers in the United States, agreed to pay the U.S. Government $450 million for allegedly violating the False Claims Act (FCA) when it continuously discarded good medicine and then billed Medicare and Medicaid for it. DaVita also agreed to pay $45 million for legal fees.

According to the lawsuit filed in 2011 by two former employees of DaVita, between 2003 and 2010, when DaVita administered iron and vitamin supplements such as Zemplar, Vitamin D, and Venofer, vials containing more than what the patients needed were used and the rest was thrown away. For example, if a patient only needed 25 milligrams of medicine, DaVita allegedly used a 100 milligram vial, administered only 25 mg, and tossed the rest in the trash. Although before 2001, this practice was condoned by the National Centers for Disease Control and Prevention (CDC) in order to prevent infectious outbreaks caused by the re-entry of the same vial of medicine, the CDC subsequently changed it policies to outlaw this practice.

This FCA lawsuit alleging that DaVita misused and mishandled of medicine, and overbilled Medicare and Medicaid is not the first such allegation against DaVita, which is not a stranger to FCA lawsuits. In fact, DaVita previously settled two other lawsuits in which it allegedly violated the FCA. In October 2014, DaVita agreed to pay the U.S. Government $350 million for allegedly persuading physicians or physician groups to refer their dialysis patients to DaVita by offering kickbacks for each patient referred. And in 2012, DaVita agreed to pay $55 million to the federal government for overbilling the government for Epogen, an anemia drug. These lawsuits were filed by former employees who decided to come forward as whistleblowers and to help to uncover what they considered to be illegal practices by DaVita. Under the FCA, such whistleblowers can bring what is known as a “qui tam” lawsuit, which is brought by a private citizen to recover money obtained by fraud on the government. As an incentive to bring qui tam lawsuits, the FCA provides that qui whistleblowers receive between 15 and 30 percent of the amount of funds recovered for the government.

Provisions of the FCA make it unlawful for a person or company to defraud governmental programs, such as Medicare or Medicaid.

Posted by the Whistleblower Practice Group at Tycko & Zavareei LLP

© 2015 by Tycko & Zavareei LLP

FDA Regulation of mHealth Updates

Covington & Burling LLP

At the Food Drug and Law Institute’s annual conference on April 21, 2015, Bakul Patel, Associate Director for Digital Health, Office of Center Director, Center for Devices and Radiological Health (CDRH), held a discussion of “FDA Regulation of Mobile Health/Medical Applications.”  There have already been several important developments in FDA regulation of mHealth products this year.  Patel stated that FDA recognizes the importance of digital health, and its potential to drive be

ARTICLE BY

Cassie Scherer
Covington & Burling LLP
Covington E-Health

tter health outcomes and promote patient engagement.  Patel discussed two recently released draft guidances that impact FDA regulation of mHealth, the draft General Wellness Guidance and the draft Accessories Guidance, and highlighted that FDA continues to work promote innovation while at the same time protecting patient safety.  The public comment period for these guidances ended on April 20th, and Patel noted that CDRH did not receive many comments.  Finally, Patel emphasized that industry can continue to reach out to FDA with questions about mobile health at mobilemedicalapps@fda.hhs.gov or digital health at digitalhealth@fda.hhs.gov.

The discussion draft of the 21st Century Cures Act includes sections that would exclude “health software” from regulation as a medical device, and would require FDA to promulgate regulations to establish standards and procedures for regulating “medical software.”  New 21st Century Cures language may be released by the end of this month.  We will be watching closely to see if there are any changes to the software language.

Moving to the Cloud: Some Key Considerations for Healthcare Entities

Covington & Burling LLP

Healthcare providers, health plans, and other entities are increasingly utilizing cloud services to collect, aggregate, store and process data.  A recent report by IDC Health Insights suggests that 80 percent of healthcare data is expected to pass through the cloud by 2020.  As a substantial amount of healthcare data comprises “personal information” or “protected health information” (PHI), federal and state privacy and security laws, including the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act, raise significant questions for healthcare providers and health plans utilizing the cloud in connection with such data.  Such questions include whether HIPAA requirements extend to cloud providers, how and if entities storing health data on the cloud will be notified in case of a breach, and whether storage of data overseas by cloud providers triggers any additional obligations or concerns.

Given the complex legal issues at play, any contract between a healthcare provider or health plan and a cloud service provider that involves using the cloud in connection with PHI should therefore address the regulatory restrictions and requirements applicable to PHI.  By way of example, recent guidance from the HHS Office for Civil Rights suggests that health care providers must likely have a business associate agreement in place with their cloud service provider.  Moreover, although cloud providers might not regularly access the data they store and may never “use” or “disclose” that data as those terms are defined under HIPAA, cloud providers probably need to adhere to HIPAA breach notification requirements.  There have also been indications of late that HHS may consider it advisable, if not required, that entities subject to the HIPAA Security Rule encrypt PHI data even when that data is at rest and not being transmitted electronically.  The recent data breaches involving health plans Anthem and Premera highlight the vulnerability of health care data and may lead to additional pressure for providers to implement additional encryption measures.

Even if HIPAA rules do not apply to cloud service provider contracts, healthcare providers and health plans storing data on the cloud should be aware that many states now have privacy and breach notification laws which could come into play.

Finally, in addition to addressing the regulatory requirements and data privacy and security, a healthcare provider or health plan should negotiate appropriate service level terms with the cloud provider that address such issues as the performance requirements for the cloud network and the process and procedures for addressing problems with the cloud network.  The healthcare provider or health plan should also include appropriate back-up and disaster recovery provisions in the contract with the cloud provider, as well as appropriate remedies in the event it suffers losses as a result of the contract.

ARTICLE BY

Paige M. Jennings
Anna Kraus
Ramy Ramadan
Lee J. Tiedrich
Covington & Burling LLP
Covington E-Health

Erin Smith Aebel: Integrating Legal Marketing into your Practice

The National Law Review - Legal Analysis Expertly Written Quickly Found

Erin Smith Aebel has spent her almost twenty year career developing knowledge in the field of Health Care Law, and a significant amount of her effort has gone into integrating solid marketing techniques into her legal practice.  This combination has proved highly successful, as she has accumulated a long list of awards and a bustling, busy practice. As aPartner and Health Care Practice Co-Administrator for Shumaker, Loop and Kendrick Law Firm in Tampa, Florida she graciously allowed the National Law Review the chance to ask her some questions about where she’s been and what she does in her practice.

Aebel began her career with a feeling many law student graduates have:  relief.  “I took whatever job I could get.  My main consideration at my first job was that they hired me,” Aebel says with a laugh.  For the first few years of Aebel’s career she spent getting experience—learning litigation, and really finding out what she wanted to do.

It turned out Aebel wanted to work in Health Law.  “Health Law was a new, growing field at that point, and I realized that was the work I wanted to do.  But I also realized I needed to learn, that I needed to develop the know-how so I could be effective.”  This led her to Shumaker, Loop and Kendrick, a firm that had a senior partner working in Health Law.  Along with realizing she wanted to work in Health Law, Aebel says, “I realized that I wanted to prevent problems before they started.” This realization led her away from litigation based practice to more transactional work.   Over the years, Aebel developed that expertise and grew to love the field of Health Law.  “The law is constantly changing,” Aebel says, “each new year brings new federal and state regulations, so there is always something to learn.  It’s never a rote practice.  But the longer I’ve practiced, the more I know, and my depth of knowledge has grown.”

One of the most striking things about speaking with Aebel is how fluidly she’s integrated good marketing practices into her work.  It comes across that she genuinely enjoys marketing, and she understands completely how it benefits her practice and her firm.

One thing she shares is that she works systematically to figure out a plan for her business.  She says, “I identify who I want to work with, and I figure out the steps I need to take, and I keep all that information in one place.  I make a chart, and I look at it regularly.  This identifies the steps and forces you to take them.”  By creating this road map, her marketing activities have a purpose and a function.  That said, she also works hard to keep herself active in the community and to keep herself front of mind with clients and potential clients.  She says, “I speak and write whenever I can because they are excellent ways to market yourself as a specialist.”  Aebel herself started small with public speaking.  She began by doing paralegal seminars to get more comfortable with being in front of a group, and her public speaking grew from there.  Now she is sought after for her expertise, and she says, “With practice, almost anyone can become comfortable public speaking.”

Additionally, Aebel methodically works out who her referral sources are, and where her business comes from, and nurtures those relationships.  She says,” I work to develop good relationships with other attorneys who don’t do what I do, financial advisors, and CPAs.  These relationships are like growing a garden in some ways: I nurture them, water them, making sure I’m professional, quick to return communications and that I’m generally good to work with.  I find people who are meaningfully in my business and I grow those relationships, so they will continue to want to work with me.”

To hear Aebel talk about it, marketing is easy.  But keep in mind she has been on the firm’s Marketing Committee for eight years, and she was just recently been appointed as a co-chair to the firm-wide marketing and business development committee. and she was instrumental in growing her firm’s marketing philosophy. Her interest in marketing grew from an unlikely source:  a rough mentor experience.   Aebel says,   “I didn’t have a good mentor experience, but this turned out to be a good thing.  It taught me to be more independent.”

Now, Aebel is eager to find other women in business to connect with, and she is eager to help young attorneys find their way.  Her advice is simple.  Aebel says, “I would advise young attorneys that what they do now grows the foundation for ten years down the road.  In that spirit, young attorneys should network with their peers, not just in the community, and spend time on it—think ahead!”

ARTICLE BY

Eilene Spear
OF
The National Law Review / The National Law Forum LLC

Hospital Antitrust Skirmish Over Economist

IMS_expert_blktype-transparent

Antitrust law is designed to help the Davids of the world maintain a level playing field with the Goliaths. That objective was realized when Boise, Idaho-based hospital operator St. Alphonsus Health System, Inc. (“St. Al’s”) sued rival St. Luke’s Health System, Ltd. (“St. Luke’s”), to block St. Luke’s acquisition of the Saltzer Medical Group (“Saltzer”), one of Idaho’s largest and oldest independent medical groups.

St. Al’s argued that St. Luke’s acquisition of Saltzer would give St. Luke’s such a dominant market share of the adult primary care market in Nampa, Idaho that it could raise prices and block referrals to St. Al’s by having Saltzer steer patients to St. Luke’s. St. Al’s fears certainly seemed well-founded: Saltzer accounted for 43% of the adult primary care physicians, and about 90% of the pediatric physicians in the Nampa market. Since St. Luke’s accounted for about 24% of the primary care physicians in Nampa, the combined entity would have about 67% of the adult primary care physicians in Nampa.

The Federal Trade Commission (FTC) and Idaho Attorney General (AG) launched their own investigations and ultimately joined St. Al’s lawsuit. Things didn’t go well initially for St. Al’s as the judge refused to preliminarily enjoin the acquisition, concluding that St. Al’s was unlikely to suffer irreparable harm before a trial could be held in the case. St. Luke’s proceeded to complete the transaction.

However, in January 2014, after a bench trial, the judge concluded that the deal would have anti-competitive effects in terms of raising health care costs due to the increased negotiating leverage of the combined entity. The judge directed St. Luke’s to unwind the transaction, and divest itself of Saltzer’s assets. St. Luke’s has appealed to the Ninth Circuit. At oral argument, St. Luke’s contended that the trial court had failed to adequately consider the deal’s benefits.

Along the way, the trial court had an opportunity to decide a motion by the FTC and Idaho AG to exclude the testimony of St. Luke’s economist, Dr. Alain Enthoven, concerning the quality-related benefits of the acquisition. Saint Alphonsus Med. Ctr. – Nampa, Inc. v. St. Luke’s Health Sys., Ltd., No. 1:12-CV-00560-BLW, 2013 WL 5637743 (D. Idaho Oct. 15, 2013). A major thrust of the objection was that Dr. Enthoven had not read any of St. Luke’s physician service agreements (“PSA’s”), and therefore could not credibly testify as to “whether the acquisition creates the requisite integration to achieve the purportedly greatest benefits of integrated patient care.”

The Court denied the motion. After reviewing the facts shared in the decision, the argument seems like a stretch and we feel the Court reached the right result. As the Court observed, despite not having read the PSA’s, Dr. Enthoven interviewed six top executives from St. Luke’s and Saltzer, and reviewed thirty depositions. The Court believed this effort enabled Dr. Enthoven to testify credibly concerning the quality-enhancing benefits of moving away from the fee-for-service model of compensation and toward the quality-based model of compensation.

The judge also rejected the FTC’s contention that Dr. Enthoven was unqualified to testify regarding how the use of health information technology, such as electronic medical records, promotes higher quality care in light of Dr. Enthoven’s admission at his deposition that he was not a “healthcare IT expert.” Observing that Dr. Enthoven was testifying as an economist, not a programmer, the judge ruled that Dr. Enthoven was qualified to explain how various healthcare IT tools promoted higher  quality care even if he didn’t understand the mechanics of how those tools worked. This conclusion also seems correct, and not really a close call at all.

Do you agree with our conclusion that the Court made the right call in denying the motion to exclude Dr. Enthoven’s expert testimony?

ARTICLE BY

Joshua Fruchter, Esq.
OF
IMS ExpertServices

Just in Time for the Holidays: Another HIPAA Settlement

Mcdermott Will Emery Law Firm

On December 2, 2014, the Office for Civil Rights (OCR) and Anchorage Community Mental Health Services, Inc., (ACMHS) entered into a Resolution Agreement and Corrective Action Plan (CAP) to settle alleged violations of the HIPAA Security Rule, which governs the safeguarding of electronic protected health information (ePHI).  OCR initiated an investigation into ACMHS’s compliance with HIPAA after receiving a March 2, 2012 notification from the provider regarding a breach of unsecured ePHI affecting 2,743 individuals.  The breach resulted from malware that compromised ACMHS’s information technology resources.

OCR’s investigation found that ACMHS (1) had never performed an accurate and thorough risk assessment of the potential risks and vulnerabilities to the confidentiality, integrity and availability of ePHI held by ACMHS; (2) had never implemented Security Rule policies and procedures; and (3) since 2008, had failed to implement technical security measures to guard against unauthorized access to ePHI transmitted electronically, by failing to ensure that appropriate firewalls were in place and regularly updated with available patches.

ACMHS agreed to pay $150,000 and to comply with the requirements set forth in the CAP to settle the allegations.  The CAP has a two-year term and obligates ACMHS to take the following actions:

  • Revise, adopt and distribute to its workforce updated Security Rule policies and procedures that have been approved by OCR

  • Develop and provide updated security awareness training (based on training materials approved by OCR) to applicable workforce members, and update and repeat the training annually

  • Conduct annual risk assessments of the potential risks and vulnerabilities to the confidentiality, integrity and availability of ePHI held by ACMHS, and document the security measures implemented to reduce the risks and vulnerabilities to a reasonable and appropriate level

  • Investigate and report to OCR any violations of its Security Rule policies and procedures by workforce members

  • Submit annual reports to OCR describing ACMHS’s compliance with the CAP

In announcing the settlement, OCR Director Jocelyn Samuels said, “[s]uccessful HIPAA compliance requires a common sense approach to assessing and addressing the risks to ePHI on a regular basis.  This includes reviewing systems for unpatched vulnerabilities and unsupported software that can leave patient information susceptible to malware and other risks.”  A copy of the Resolution Agreement and CAP can be found here.

The settlement is another reminder that covered entities and business associates should ensure that they have taken steps necessary and appropriate to safeguard the ePHI in their possession.  Conducting regular ePHI risk assessments, addressing any identified security vulnerabilities, implementing and updating comprehensive HIPAA policies and procedures, and appropriately training workforce members who have access to ePHI are all steps that covered entities and business associates must take to comply with HIPAA and protect ePHI.

Health Resources and Services Administration (HRSA) Withdraws 340B Program Proposed Rule

Mcdermott Will Emery Law Firm

On November 14, 2014, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) withdrew a proposed rule that would have provided guidance on a variety of topics related to the 340B Federal Drug Pricing Program.  The “mega rule,” which had been submitted to the White House Office of Management and Budget in April 2014, was expected to cover important 340B Program matters, such as patient eligibility, contract pharmacy arrangements, and eligibility for hospitals and off-site facilities.  Now, in lieu of the proposed rule, HRSA has announced its intention to release notice-and-comment guidance to “address key policy issues raised by various stakeholders committed to the integrity” of the 340B Program.  Additionally, HRSA plans to issue proposed rules related to civil monetary penalties for manufacturers, calculating the 340B ceiling price and administrative dispute resolution.

The decision to withdraw the proposed rule, coupled with HRSA’s intention to release regulatory guidance on similar issues, may be viewed as a response by HHS to a recent federal court decision limiting HHS’s ability to promulgate notice-and-comment rules.  In a May 23, 2014, decision, the U.S. District Court for the District of Columbia held that HHS did not have the requisite statutory authority to promulgate a notice-and-comment rule pertaining to the purchase of orphan drugs by certain Covered Entities.  Further, the withdrawal may indicate a decision by HRSA to scale back its issuance of notice-and-comment rules for the 340B Program, limiting formal rulemaking to areas where the statutory authority to do so is explicit.  The withdrawal of the proposed mega rule demonstrates HRSA’s position that it does not possess the broad authority necessary to issue a formal rule of this scope.

Without the proposed rule, important facets of the 340B Program remain uncertain.  Manufacturers and Covered Entities that sought guidance on key practical issues such as patient definition now must continue to wait for clarification.  As noted, going forward HRSA will seek to clarify “key policy issues” but has yet to announce whether the topics covered by the proposed rule will be addressed.  HRSA’s regulatory guidance on these issues may never come, however, if the U.S. District Court for the District of Columbia (which is hearing further briefing on the aforementioned case concerning HHS’s regulatory guidance on the orphan drug rule) further restricts HHS’s ability to issue guidance.

In the face of continuing uncertainty, 340B Program participants, including Covered Entities, should stay current and closely follow available guidance from HRSA and the 340B Prime Vendor (Apexus).  Until clear guidance has been issued pertaining to subjects such as patient definition and contract pharmacy compliance, 340B Program participants should continue to follow and document best practices to ensure compliance with all 340B Program requirements.

ARTICLE BY

David S. Ivill
Emily J. Cook
Joseph M. Parise
OF
McDermott Will & Emery

A Look Ahead: Top 5 Health Law Issues for 2014

vonBriesen

 

From Affordable Care Act implementation to the continued transition to quality and evidence-based medicine, we expect to see a host of new regulatory and industry changes in 2014. Moreover, federal and state governments will continue to ramp up detection and enforcement of fraud, abuse, and other laws. These changes provide ample opportunities for lawyers to represent and counsel health care industry clients.

In addition to health lawyers, these changes and new opportunities will also affect lawyers who practice in other areas, including business, antitrust, technology, employee benefits, and elder law. Below is an overview of five hot issues in health care law that practitioners – new and seasoned – should monitor in 2014.

1. Affordable Care Act Implementation

Exchanges and the Individual Market. As millions of Americans obtain insurance on the individual market through Exchanges (a.k.a. the “Marketplace”), the ACA individual mandate and the individual insurance market will create a host of issues for health lawyers in 2014. Beginning early in the year, health lawyers will be called on to address coverage, enrollment, and compliance issues. Attorneys and firms looking to expand their ACA practice should consider employee benefits regulations and related legal issues as ACA implementation continues and employers look for help understanding and complying with coverage requirements and pay or play rules.

Medicaid. The ACA’s expansion of Medicaid will also bring increased attention to the Medicaid program in 2014. Attorneys should be prepared to see increased scrutiny of program integrity in the coming year, including inspector general attention at the state and federal levels (e.g., program audits). Attorneys may be called upon to address these and other Medicaid issues in 2014, including issues with eligibility, covered benefits, and movement between Exchanges and Medicaid.

Tax Exemption. Section 501(r) of the Internal Revenue Code, introduced as part of the ACA, requires, among other things, that tax-exempt hospitals conduct a community health needs assessment and adopt a written financial assistance policy. Hospitals that do not meet the 501(r) requirements risk an excise tax, taxing of hospital revenue, and revocation of exempt status. Proposed regulations outlining the 501(r) requirements were released in 2013, and final rules are expected in 2014.

2. Health Information Privacy and Security

This year is shaping up to be another big year for health information privacy and security and the Health Insurance Portability and Accountability Act (HIPAA), as providers, payers, and businesses that support the health care industry (including lawyers) adapt to new compliance requirements and increased liability under the Omnibus Rule regulatory scheme.

This is an area that will be important for health lawyers, as the Omnibus Rule outlines clear compliance requirements for lawyers providing legal services to providers and payers. (For more information on lawyers as business associates, see “Casting a Wider Net: Health Information Privacy is Not Just For Health Lawyers” in the September 2013 Wisconsin Lawyer).

Health lawyers are also awaiting the 2014 release of another major HIPAA rule – expected to outline requirements for tracking uses and disclosures of health information – as well as legislative changes in Wisconsin dealing with confidentiality of mental health records (an in-depth Wisconsin Lawyer article on this is forthcoming).

Lawyers that deal with health information should be familiar with HIPAA and other federal and state laws protecting the confidentiality of health information to address an increased emphasis on HIPAA audits, security, and technology issues in 2014.

3. Provider Reimbursement and Emphasis on Quality Care

Medicare Billing and Payment. As of this writing, Congress is still debating options for repealing the sustainable growth rate (SGR), which is part of a reimbursement formula used to calculate Medicare physician payments. For years, the SGR has resulted in cuts to physician payments. However, Congress has always used SGR “doc fixes” to extend and delay the cuts (most recently, on Dec. 18, 2013, a 23.7 percent cut set to take effect Jan. 1, 2014, was delayed until March).

However, bipartisan efforts in Congress may make 2014 the year of the SGR repeal. Health care attorneys should take note because the SGR repeal will mean significant changes in how Medicare physician reimbursement is calculated, and the wide-spread effect will touch any number of contractual arrangements that use Medicare reimbursement to set compensation terms.

Quality-based Reimbursement. We have seen a steady change from productivity-based compensation models, which pay for volume, to quality-based reimbursement models, and 2014 will continue this progression. Attorneys that represent physicians and physician practices should be prepared for the introduction (or addition) of quality metrics in physician compensation arrangements, as well as an increase in co-management arrangements and opportunities, which engage physicians in hospital management to better align physicians and hospitals.

Narrow Networks. With additional products available in the individual insurance market in 2014 and an increased focus on performance-based contracting, payers are tying rate increases to quality metrics and tightening provider networks. Attorneys representing physician groups may see an increase in narrow network products and, as a result, their clients’ exclusion from networks.

Changing reimbursement concepts are not new but some methodologies will affect physician behavior, require more patient engagement, and influence efficiency as the industry demands accountable care and continues to introduce quality-based incentives.

4. Increased Joint Venture Activity and Market Consolidation

We expect to see increased joint venture activity and market consolidation in 2014. Increasing market share and patient population allows providers and payers to introduce and monitor their quality care initiatives to a broader base of patients and standardize care with the hope of better outcomes and efficiency. Attorneys representing parties in these transactions should be mindful of fair market value and other fraud and abuse requirements, leasing and construction considerations, and potential antitrust implications.

5. Government Enforcement

The health care industry has seen increased government scrutiny, including emphasis on payment, program integrity, and compliance. From Medicare and Medicaid compliance audits, Strike Teams, increased HIPAA penalties, overpayment recoupment, to fraud and abuse self-disclosures and intervening in whistleblower suits, the federal government is improving its enforcement mechanisms used against hospitals and providers. The federal agencies and their contractors have increased their damages and penalty recoveries over the last few years, and we expect this to continue in 2014.

The primary goal of the U.S. Department of Health and Human Services Office of Inspector General’s (OIG) strategic plan for 2014 to 2018 is fighting fraud, waste, and abuse. In order to achieve its goal, the OIG intends to build upon existing enforcement models, refine self-disclosure protocols, and use all appropriate means (including exclusions and debarments) to maximize recovery.

If you are new to health care, or if you want to expand your practice into health law, these areas of strict liability and increased enforcement will be fundamental to your practice in 2014. Understanding the complex regulations and strict liability statutes is fundamental to providing sound legal and business advice to health care clients.

Honorable Mentions

Retail health clinics and on-site health services, changes in medical malpractice standards, increased emphasis on post-acute care, non-physician health care professionals, and the corporate practice of medicine will also be hot topics in 2014.

This article was first published in WisBar Inside Track, Vol. 6, No. 1, a State Bar of Wisconsin publication.

Article by:

Meghan C. O’Connor

Of:

von Briesen & Roper, S.C.