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Searching for Articles published in April 2017.
Found 20 Results.

New Safe Harbor Permits Some Free Transportation to Patients

Posted on April 6, 2017, Authored by Emilu E. C. Starck
Emilu E. C. Starck
Attorney
Eau Claire Office
, Filed under Health Care

A new safe harbor was recently issued by the Health and Human Services (HHS) Office of Inspector General (OIG) that permits eligible health care providers to offer free or discounted transportation to established patients.  The safe harbor addresses concerns that offering free goods and/or services to patients might be considered payment of illegal “remuneration” in exchange for referrals. Use of free offers in connection with overt marketing remains a suspect practice, but the new safe harbor opens a limited window to permit providers to offer much needed transportation services to existing patients. Provided that a number of specific requirements are met, the transportation safe harbor permits certain health care providers to offer regular route “shuttle service” and/or transportation to established patients.  The transportation service can only be provided within a 25 mile radius (50 miles in rural areas) for the purpose of obtaining medically necessary services. Most health care service providers, such as hospitals, physician offices, skilled nursing facilities, ambulatory surgery centers, and others are eligible to provide transportation services.  However, organizations that primarily supply health care items, such as providers of durable medical equipment and pharmacies, cannot take advantage of the safe harbor.  In its commentary, the OIG noted many types of entities that do not directly render health care services to patients, such as Medicare Advantage organizations, managed care organizations, accountable care organizations, clinically integrated networks, and charitable organizations, may qualify for safe harbor protection as long as they do not shift the cost to federal health care programs or payers. Providers that operate transportation programs should adopt policies and procedures that define the operation of their program and include requirements that minimize potential risk of providing free transportation service.  Reliance on the safe harbor requires that the free or discounted local transportation services be included in a policy that is applied uniformly and consistently.  The program cannot be offered in a manner related to the past or anticipated volume or value of federal health care program business.  Free transportation must be offered to all patients regardless of the level or profitability of their service.  Complete compliance with the new safe harbor is the best way to ensure compliance.  Policies should include reference to the various safe harbor requirements.  For example, free or discounted services are subject to the following limitations: The services may only be provided to established patients.  An “established patient” is a person who has selected and initiated contact to schedule an appointment with a provider or supplier or who previously has attended an appointment with the provider or supplier; The services cannot include air, luxury, or ambulance-level transportation; The services cannot be publicly marketed or advertised by the eligible entity or the driver during the course of the transportation, and the drivers or others arranging for the transportation cannot be paid on a per-beneficiary-transported basis; The services may only be provided within 25 miles of the health care provider or supplier to or from which the patient would be transported, or within 50 miles if the patient resides in a rural area; The services can only be for the purpose of obtaining medically necessary items and services; and Associated costs cannot be shifted to Medicare, a state health care program, other payers, or individuals. The safe harbor also protects the offering of a shuttle service by eligible entities.  The term “shuttle” is defined as a vehicle that runs on a set route and on a set schedule.  The final rule allows eligible entities to provide shuttle services by complying with most of the criteria applicable for services to existing patients.  If the service is operated on a defined and regular route, the service is not limited to existing patients.  Most of the other provisions of the safe harbor for existing patients will apply to the shuttle service. Organizations that provide shuttle or patient transportation services should review their programs in view of the new safe harbor regulations.  The new regulations mandate written policies and procedures which must be uniformly enforced and followed.  This requires records be maintained that document compliance with safe harbor requirements.  Transportation programs that do not strictly meet all requirements of the safe harbor do not necessarily violate the anti-kickback statute.  However, safe harbor compliance is the best way to mitigate potential risk.

Ambulatory Surgery Center (ASC) Case Demonstrates Differential Value Theory of Remuneration

Posted on April 11, 2017, Authored by John H. Fisher, II
John H. Fisher, II
Attorney
Wausau Office
, Filed under Health Care

A relatively recent case involving buy-in terms in an ambulatory surgery center demonstrates how different valuations for referral sources and non-referral sources can be evidence of remuneration under the Medicare Anti-Kickback Statute (42 U.S.C. § 1320a-7b(a)-(b)).  The case also demonstrates how the initial investment terms that favor referral sources can foreclose reliance on safe harbor regulations. The case involved an ambulatory surgery center management company that purchased an interest in an ambulatory surgery center.  The company then offered shares of the company for investment to physicians who were in a position to refer surgical cases to the surgery center.  The physician investment was structured to meet the terms of the safe harbor regulations for ambulatory surgery center investments (“ASC Safe Harbors”).  The ASC Safe Harbors provide protection from remuneration received by a referring physician as a return on investment as long as the physician meets certain minimum practice revenue and surgical volume requirements. Physician investors must generally receive at least 1/3 of their practice income from the provision of surgical procedures and perform at least 1/3 of their surgical procedures in the center in which they hold an investment interest. The problem with the way the investment interest was structured is the different valuation that applied to the purchase made by the management company and the investment offer made to the referring physicians.  The management company purchased its investment at a much higher price than was offered to the physicians.  The differential valuation violated a threshold requirement of the ASC Safe Harbors that prohibits the initial investment interest to be based, in whole or in part, on the volume or value of referrals the investor might make to the entity.  It was very difficult for parties to justify the different value applied to the physician investment.  The only apparent difference appeared to be the physician investors were the referral sources for the surgery center. This case specifically involved an ambulatory surgery center investment but the concept of differential valuation could apply in other situations involving the Anti-Kickback Statute.  Different values paid to or received from referral sources and non-referral sources can suggest that at least one of the reasons for the differential is the volume or value of potential referrals.  This points out a general area of risk assessment for health care providers.  Areas where different pricing is applied to referral sources and non-referral sources could signify a potential violation of the Anti-Kickback Statute. Other Blogs and Articles Involving Ambulatory Surgery Centers Enforcing ASC Exclusion Provisions While Minimizing Legal Risk – Rethinking Strict Application of the Safe Harbors to Exclusion Decisions Ambulatory Surgery Center Compliance Federal Settlement Raises Issues for Physician Owned Surgery Centers Ambulatory Surgery Center – Anti-kickback Issues and Safe Harbor Regulation Compliance Ambulatory Surgery Center Compliance Federal Settlement Raises Issues for Physician Owned Surgery Centers Ambulatory Surgery Center Compliance Legal Practice Ambulatory Surgery Center Advisory Opinions Ambulatory Surgery Center Radiologist Rules – Proposed Simplified By CMS Anesthesia Company Model Advisory Opinion 12-06  

Self-Disclosure Has Become a Normal Part of the Compliance Process

Posted on April 12, 2017, Authored by John H. Fisher, II
John H. Fisher, II
Attorney
Wausau Office
, Filed under Health Care

As the Office of the Inspector General and Centers for Medicare & Medicaid Services make self-disclosure easier for providers, we have noticed an increase in the rate of cases that are being filed.  Assisting providers in making decisions whether to self-disclose, conducting internal investigations, and guiding the self-disclosure process when appropriate has become a large part of our compliance practice.  Here are just a few of the articles and other resources we have released regarding self-disclosure issues: Exercising Reasonable Care to Identify and Address Potential Overpayments Criminal Exposure for Failing to Repay Known Overpayment When to Use the OIG’s Self-Disclosure Protocols Excluded Party Cases Dominate OIG Published Self-Disclosure Settlements Self-Disclosure Process – Voluntary Self-Disclosure Decisions are not Always Easy When Does An Overpayment Become Fraud? How Simple Inattention Can Expose You to Penalties for Fraudulent Activities Provider Self-Disclosure Decisions – Voluntary Disclosure Process Provider Self-Disclosure Process For more information on the self-disclosure process and legal updates impacting this process, please check this blog for new posts.

Sally Yates was Already Famous for Changing the Focus of Compliance Investigations - The Yates Memorandum

Posted on April 5, 2017, Authored by John H. Fisher, II
John H. Fisher, II
Attorney
Wausau Office
, Filed under Health Care

By now the whole world knows about Sally Yates.  We are likely to see a lot more of her as a central figure in Congressional investigations.  For some of us who deal with compliance investigations, Sally Yates was famous long before her refusal to defend the immigration ban.  She was the author of the famous “Yates Memorandum” that changed the focus of corporate investigations to require investigation of potential individual wrongdoing in order to receive cooperation credit from Federal prosecutors. The Yates Memo directs federal prosecutors, as well as civil attorneys investigating corporate wrongdoing, to maintain a focus on responsible individuals, recognizing that holding them accountable is an important part of protecting the public in the long term.  In fact, prosecutors are directed to first look at potential individual wrongdoing when investigating a case.  The new policy requires companies facing potential Federal civil and criminal charges to investigate individual wrongdoing and report it to the government in order to receive government cooperation credit.  The new federal policy applies to all federal criminal and civil prosecutions in all industries. The Yates Memo is the most recent in a line of actions by Federal prosecutors that began in the late 1990s that have increased the focus on seeking accountability from the individuals who perpetrate wrongdoing.  The Yates Memo resulted in an update to the U.S. Attorney’s Manual ("USAM") provisions covering Principles of Federal Prosecution of Business Organizations (USAM § 9-28.000).  Inclusion of principles into the USAM means the concepts in the Yates Memo are now operational and are required to be integrated into the prosecutorial decision making process across the country. 6 General Principles of the Yates Memorandum Principle 1:  “To be eligible for any cooperation credit, corporations must provide the Department all relevant facts about the individuals involved in corporate misconduct.” Principle 2:  “Both criminal and civil corporate investigations should focus on individuals from the inception of the investigation.” Principle 3:  “Criminal and civil attorneys handling corporate investigations should be in routine communication with one another.” Principle 4:  “Absent extraordinary circumstances, no corporate resolution will provide protection from criminal or civil liability for any individuals.” Principle 5:  “Corporate cases should not be resolved without a clear plan to resolve related individual cases before the statute of limitations expires and declinations as to individuals in such cases must be memorialized.” Principle 6:  “Civil Attorneys should consistently focus on individuals as well as the company and evaluate whether to bring suit against an individual based on considerations beyond that individual’s ability to pay.”

EPA’s Risk Management Plan (RMP) Final Rule Delayed

Posted on April 6, 2017, Authored by Russell W. Wilson
Russell W. Wilson
Attorney
Wausau Office
,

EPA’s new Risk Management Plan (“RMP”) Final Rule was to take effect on March 14, 2017.  EPA has delayed the effective date until June 19, 2017, and has proposed a further delay until February 19, 2019, in light of industry petitions for reconsideration and judicial review.  On February 28, 2017, the “RMP Coalition” filed its petition with the EPA seeking reconsideration of the Final Rule (“Petition”).  The Coalition, which is also seeking judicial review of the Final Rule in the U.S. Court of Appeals for the District of Columbia, is composed of the American Chemistry Council, the American Forestry & Paper Council, the American Fuel & Petrochemical Manufacturers, the American Petroleum Institute, the Chamber of Commerce of the United States of American, the National Association of Manufacturers, and the Utility Air Regulatory Group. Starting at the end, the Petition acknowledges that the pre-existing (which is to say, the current regulation until the Final Rule takes effect) “has proven to be a robust and effective process for improving safety and reducing accidental releases” of extremely hazardous chemicals.  (Petition, p. 21)  Moreover, the Petition asserts “the Coalition commits to work with the EPA, OSHA and other stakeholders on a new rulemaking in response to this Petition.  (Petition, p. 21)  The Final Rule as promulgated, according to the Petition, however, “rests on a faulty foundation.” First, the Petition asserts challenges to a host of procedural deficiencies during the rule making process. A.  Disclosure requirements to local emergency planning committees and the public could undermine security by allowing access to sensitive information by terrorists. B.  Inadequate notice and opportunity for public comment on the replacement of a predictable trigger for third-party auditing (based on non-compliance with specific regulations) with “an unpredictable one that relies entirely on the implementing agency’s discretion to determine which conditions “could lead to an accidental release.” C.  EPA’s omission of reasonableness of cost assessment and detailed cost-benefit analyses deprived industry and the public with a meaningful opportunity to address EPA’s inadequately supported conclusion that the Final Rule is cost effective. D.  Inadequate notice and opportunity for public comment on the replacement of representative sampling of covered processes with mandatory evaluation of each covered process at least every three years. E.  Inadequate notice and opportunity for public comment on the legal basis for third-party auditing and safer technology alternatives assessments. F.  EPA added numerous supporting documents after the close of the public comment period. Second, the Coalition’s Petition asserts that changed circumstances merit reconsideration and a refocusing of the Final Rule.  President Obama signed an Executive Order instructing various agencies, including OSHA, which administers its Process Safety Management (“PSM”) regulation, to consider revising the RMP in the wake of the massive explosion of ammonium nitrate at a facility located in West, Texas in 2013, given ammonium nitrate is not a regulated chemical under the RMP.  Just two days before the public comment period expired, however, the Bureau of Alcohol, Tobacco, Firearms and Explosives announced the explosion had been caused by an arsonist. The Coalition argues that the overarching emphasis in the rule making process would have centered on security and preventing intentional criminal or terrorist actions rather than on compliance with existing regulations if it had been known from the beginning the explosion was the work of an arsonist. The EPA’s RMP and OSHA’s PSM are demonstrably important programs that protect lives on and off chemical storage facility sites.  These regulations will not be going away.  It appears, however, the details of the Final RMP will be the subject of intricate legal argument and judicial scrutiny in the months, and more likely years, to come.

Best Practices in Compliance Program Operation

Posted on April 4, 2017, Authored by John H. Fisher, II
John H. Fisher, II
Attorney
Wausau Office
, Filed under Health Care

Given the increased importance of compliance, it is helpful for providers to get a feel for what constitutes “best practice” when operating a compliance program.  “Best Practices” is a term thrown around all of the time in the business world.  It is used in many contexts and takes on a variety of meanings depending on who is using it and for what purpose.  Wikipedia defines “best practice” as follows: Best practices are generally-accepted, informally-standardized techniques, methods or processes that have proven themselves over time to accomplish given tasks. Often based upon common sense, these practices are commonly used where no specific formal methodology is in place or the existing methodology does not sufficiently address the issue.  The idea is that with proper processes, checks and testing, a desired outcome can be delivered more effectively with fewer problems and unforeseen complications. In addition, a "best" practice can evolve to become better as improvements are discovered.  Best practice is considered by some as a business buzzword, used to describe the process of developing and following a standard way of doing things that multiple organizations can use.  http://en.wikipedia.org/wiki/Best_practice As I was thinking about the concept of “best practices” in health care compliance, the Wikipedia definition seems to fall a little short of what I would have in mind when discussing “best practices” in health care compliance programs. The Miriam-Webster Dictionary defines “Best” as the superlative form of “good.”  “Best” means “excelling all others” and “offering or producing the greatest advantage, utility, or satisfaction.”  I believe the definition from Wikipedia is an accurate depiction of what the term “best practices” has become in the business world.  The term has been thrown around loosely to the point it no longer carries the meaning of the plain words that make up the two word “buzzword.” In the health care compliance context, I believe it is not advisable to direct your efforts toward the standard “buzzword” meaning of “best practices.”  Instead, you should focus attempting to achieve the meaning of “best practices” that is tied to the superlative form of the word “good.”  You should not focus on the “we are doing what everyone else is doing” or the “what we are doing will pass by in most cases” version of best practices when looking at your compliance plan.  The consequences of that approach could easily come back to bite you in the superlative. In reality, you may never be able to meet the truly “best” standard.  However, the point of the compliance program requirement is you are trying to make your compliance program and your organization “the best” when it comes to compliance.  Here are a few tips to help you attempt to meet the “best practices” standard: Act as if you are under a Corporate Integrity Agreement.  Always assume the government is looking over your shoulder and you will be called upon at some point to justify the effectiveness of your compliance program. Follow the government guidelines to the “t”.  Familiarize yourself with the Federal Sentencing Guidelines and Office of Inspector General Industry Guidance and integrate these requirements into your compliance plan. Stay current with government releases, speeches, regulations, comments, advisory opinions, and all other communication that help to define your obligations. Make your compliance plan a “living and breathing” documents that is continually up for revision based on specific things you learn about your specific organizations. Make sure your compliance officer focuses on compliance and does not wear other hats that compete for time, attention or perspective. Make certain sufficient resources are devoted to compliance.  Adopt the view it is better to spend money on compliance than to pay for mistakes down the road. If there is an area where you are not able to achieve “best practices” for financial or other reasons, be prepared to justify your shortcomings.  Key to all of this is to operate as if you will someday be required to defend the effectiveness of your compliance program.  These are just a few tips to get you thinking about your compliance approach.  Health care reform has made compliance programs mandatory for the first time.  There are also multiple indications the government wants organizations to devote more to compliance as a way to save health care costs.  It is clearly time for organizations of all types and sizes to re-focus their efforts on compliance within their organizations.

CMS Extends Compliance Date for New Home Health Conditions of Participation

Posted on April 4, 2017, Authored by John H. Fisher, II
John H. Fisher, II
Attorney
Wausau Office
, Filed under Health Care

In February, we reported on revisions to the Conditions of Participation for Home Health Agencies (HHA) released by the Centers for Medicare & Medicaid Services (CMS).  CMS has now proposed the effective date of new Conditions of Participation (CoP) be delayed by six months.  The original effective date of the new regulations was July 13, 2017.  The recently proposed rule would delay the effective date of the new CoP until January 13, 2018. The new CoP revisions published in January of this year were the first major revisions made to the rules in nearly 20 years.   The new rule reflects an increased focus on a patient-centered, data-driven, outcome-oriented process that continually promotes high quality patient care at all times.  The regulations represent a move away from regulatory focus on enforcement of prescriptive health and safety standards toward improving the quality of care for all patients.  Regulatory priorities are more focused on stimulating broad-based improvements in quality of care rather than expending resources on enforcing standards against marginal providers. The new regulations purport to permit greater flexibility in how home health agencies are permitted to meet quality standards.  The new focus stresses interdisciplinary patient care and aims at creating broad-based measurable improvements in quality of care while streamlining procedural burdens that impede providers. A few areas of change include new requirements for: More continuous, integrated care process across all aspects of home health services based on a patient-centered assessment, care planning, service delivery, quality assessment, and performance improvement. Use a patient-centered, interdisciplinary approach that recognizes contributions of various skilled professionals and their interactions with each other to meet the patient’s needs. Emphasis on quality improvements by incorporating an outcome-oriented, data-driven, quality assessment and performance improvement program specific to each HHA. Eliminate the focus on administrative process requirements that lack adequate consensus or evidence they are predictive of either achieving clinically relevant outcomes for patients or preventing harmful outcomes for patients. A focus on safeguards on patient rights. The extension of the effective date for the new regulations responds to concerns voiced by industry groups that there would be difficulties meeting the required timeline for implementing new quality assessment and improvement requirements

Suggested Questions for the Compliance Officer

Posted on April 19, 2017, Authored by John H. Fisher, II
John H. Fisher, II
Attorney
Wausau Office
, Filed under Health Care

In a previous blog post, I promised to release a list of questions a Board of Directors (Board) might ask its compliance officer.  This post is intended to fulfill that promise.  My intent is to help Board members exercise their oversight responsibility, assess the compliance officer, and further their understanding of the compliance program and risks faced by organizations. The Board should have an ongoing dialogue with compliance.  Initial questions can be turned into follow-up items at subsequent compliance sessions.  The Board’s questions will naturally evolve as their understanding of the process deepens.  The questions might change or grow more focused over time, but they should not stop.  The Board needs to continue its inquisitive process over the compliance process. Governing Body Compliance Responsibilities – Questions Board Members Might Ask of a Compliance Officer: Is anyone or anything within your organization impeding your ability to operate an effective compliance program?  For example, is management resistant of your compliance efforts? Does management completely embrace and support compliance functions? What is the scope of your responsibilities?  Do your responsibilities extend beyond your compliance obligations?  Do other obligations significantly impede the effective operation of the compliance program? Do you perceive any conflicts of interest from any other responsibilities you might have? What is involved in the compliance reporting process that permits employees and others to report compliance issues? Are your compliance efforts adequately funded?  Do you need to seek funds from other areas of the organization? Do you have sufficient staff to support your compliance efforts to the level of effectiveness appropriate for the organization? Have you been able to adequately address all compliance issues that come to your attention?  Are you able to address and resolve issues promptly? How frequently does the organization have an outside compliance effectiveness review conducted? What are the main gaps that exist in the compliance program? Do you have the ability to retain separate legal counsel to address compliance issues without having to check with management? What is needed from the Board of Directors to assure you are able to adequately operate an effective compliance program? Are you comfortable addressing compliance issues that may involve management or legal counsel? Do you maintain compliance resources such as applicable laws, rules, and regulations in a central location for easy access? How do you stay current on legal and regulatory issues that potentially impact the organization? What are the top regulatory risk areas that potentially impact the organization? Is there a process to continually identify new and emerging legal and regulatory risks? Do you regularly conduct compliance training? What training resources or expertise would be helpful for the Board to better understand the nature of its compliance oversight responsibilities? How do you know whether compliance training is effective?  How do you measure results? What issues that potentially impact the organization are focused on by applicable regulatory agencies? Is there an atmosphere within the organization that facilitates reporting of compliance concerns and assessment of perceived compliance issues.

Are Too Many Eggs in One Basket?

Posted on April 19, 2017, Authored by John D. Leary
John D. Leary
Attorney
Eau Claire Office
, Filed under Banking and Financial Matters

In the last two weeks, 75 Wisconsin dairy farmers were notified by their dairy that it could not accept their milk.  The dairy and its farmer suppliers are caught in a U.S.-Canada trade dispute over “ultra-filtered” milk.  Almost overnight, a market disappeared. The net result is a million pounds of milk per day in Wisconsin needs a new home, and time and options are limited.  In 2016, Wisconsin farmers exported more than $3.4 billion worth of agricultural products to 150 countries.  https://datcp.wi.gov/Documents/2016AgExportHighlights.pdf.  Of that total, over 50% was exported to Canada and Mexico, which are signatories to the North American Free Trade Agreement (“NAFTA”).  Another 31% went to China, Korea, and Japan.  More than just agricultural borrowers may be affected by trade policy.  In total in 2016, Wisconsin alone exported over $21 billion of products.  http://inwisconsin.com/export/wisconsin-export-data/ For Wisconsin dairy farmers, the closing of the Canadian ultra-filtered milk market and the nature of dairy farmer’s general reliance on a single processor has conspired to threaten the existence of dozens of farms, and is a grim reminder of the effect trade disputes can have on a business. The rejection of the Trans Pacific Partnership Trade Agreement (TPP), the potential renegotiation of the NAFTA, and a tougher trade stance with China may all further impact future exports. Trade policy is not the only cause of cancellation notices in Wisconsin this spring.  Another 20 dairy farmers received cancellation notices due to their dairy losing a cheese contract. The immediate concern for lenders is if their borrowers are among those receiving cancellation notices.  With the spring flush approaching, there is going to be more milk, not less, and many dairy processing facilities are already approaching full capacity.  Do your borrowers have markets for their milk? Dairy farms are not the only agricultural sector affected.  For example, Mexico is threatening to find alternate sources for corn and other U.S. exports should a threatened 20% border tax be imposed to pay for a border wall between the U.S. and Mexico.  http://www.agriculture.com/news/crops/mexico-prepared-to-source-south-american-corn.     The recent news of nearly 100 dairy farmers receiving cancellation notices is an unfortunate reminder of the old adage not to put all your eggs in one basket.  Even if you don’t have a borrower directly affected, lenders should still heed the reminder of risks of trade policy and inability to diversify. For dairy farmers, that means reviewing your borrower’s milk marketing efforts and assessing the risk.  Is there a contract, how long is it for, can it be cancelled, if so, what are the notice requirements, how strong is the buyer, are there alternative buyers, how can your borrower reduce risks, etc.?  If exports diminish, can the domestic market absorb the difference?  If not, what is the impact on pricing? Most business don’t have the same perishable goods risks a dairy farmer does, but both the potential changes in trade policy and the inability to diversify markets are current and significant risks for borrowers in many sectors.  And over concentration in market sectors can be a risk for lenders as well. 

Banks and Credit Unions Agree to a (Temporary) Cease Fire

Posted on April 27, 2017, Authored by Ruder Ware Attorneys, Filed under Banking and Financial Matters

It’s not every day that community bankers and credit unions agree. Whether it is over tax-exempt status or capital requirements, we have become accustomed to the battle between community banks and credit unions.  For example, an entire section of the Independent Community Bank Association’s website is dedicated to advocating against the “expansionist agenda” of credit unions.   So, this month when three associations representing community banks and credit unions jointly sent a letter to the Board of Governors of the Federal Reserve it rightfully deserves our attention. In the letter, the Independent Community Bankers of America, the Credit Union National Association, and the National Association of Federally-Insured Credit Unions implore the Federal Reserve to take an operational role in the delivery of real-time payments.  Specifically, the letter urges the Federal Reserve to take on three operational roles: (1) to serve as an “on-ramp” to real-time payments; (2) to serve as a real-time payments operator, much like it is for checks, ACH payments, and wire transfers; and (3) to maintain a “payments directory” that would link together financial institutions and private-sector payments directories. Who knows what real-time payments will drive the digital economy, but regardless of the means the Federal Reserve should play an operational role ensuring the payment system of the future is universally accessible and has safety standards beyond reproach. 

Legal and Compliance Issues Impacting Medical Practices Using Laser Technology

Posted on April 7, 2017, Authored by John H. Fisher, II
John H. Fisher, II
Attorney
Wausau Office
, Filed under Health Care

Medical practices that routinely use laser technology are subject to some of the same legal issues as other types of practices. Use of lasers creates additional compliance issues and highlights certain compliance risk areas. Our special coverage issue contains articles on some of the legal issues impacting these practices. • Compliance Program Operation. All medical practices should have an active compliance program effective at identifying risk areas and taking steps to ensure compliant practice. Risk areas specific to the practice should be integrated into a continuously operating compliance program. • Fraud and Abuse. Fraud penalty calculations under the False Claims Act (FCA) result in exorbitant penalties, even based on otherwise reasonable overpayment amounts. There has been  a steady flow of fraud and abuse cases involving practices using lasers, even where there is no actual knowledge of a non-complying practice. • 60-Day Repayment Rules. Federal law provides an overpayment not repaid within 60 days after discovery becoming a false claim and exposes the practice to the draconian remedies under the FCA summarized above. This requires practices to establish standard policies identifying how overpayments are handled. Mistakes made in this area can be extremely costly. • Whistleblower Risks. The recent fraud cases are being used aggressively as advertising by attorneys who focus on whistleblower cases. Whistleblower lawyers take their cases on a contingency fee basis and encourage cases be brought under the Draconian damage provisions in the federal FCA. • Supervision of Physician Extenders. Proper supervision of physician extenders is dictated by state law and reimbursement requirements (for example “incident to” rules under Medicare). Every medical practice using physician extenders should have written policies on supervision which clearly communicate requirements to physicians and staff. Documentation of appropriate supervision is also necessary. • Tele-dermatology Issues. The use of telehealth technologies is rapidly increasing. Dermatology is one specialty area that benefits from the expansion of telehealth using both real time and “store and forward” technologies. The use of telehealth in the practice of dermatology facilitates expert consultation and long distance examination reaching into remote areas. • HIPAA Stage 2 Audits. As OCR continues to move forward with its multi-stage audit program, the consequences of OCR finding a deficiency in HIPAA practices are becoming more serious. A systematic review of HIPAA policies and procedures should be conducted to ensure all required elements are covered.

U.S. Supreme Court Denies the Trump Administration’s Request to Suspend the Pending Litigation in the Sixth Circuit Court of Appeals over the Clean Water Rule

Posted on April 4, 2017, Authored by Russell W. Wilson
Russell W. Wilson
Attorney
Wausau Office
,

On April 3, 2017, the United States Supreme Court denied a request from the Trump Administration to place a hold on the pending litigation in which the EPA’s and the U.S. Army Corps of Engineer’s Clean Water Rule is being challenged.  The basis for the Trump Administration’s request was the Executive Order signed on February 28, 2017, titled “Presidential Executive Order on Restoring the Rule of Law, Federalism, and Economic Growth by Reviewing the ‘Waters of the United States’ Rule.”  That executive order calls for the EPA, the Corps, and other executive department and agency heads to “. . . rescind or revise, or publish for notice and comment proposed rules rescinding and revising” the Clean Water Rule.  The order further directs the agencies to consider the definition proposed by Justice Scalia in Rapanos v. United States, 547 U.S. 715 (2006). The Clean Water Rule defines the jurisdiction of the Clean Water Act.  Many challenges have been filed in U.S. district courts and U.S. Circuit Courts of Appeals.  The threshold procedural issue is whether jurisdiction over hearing the challenges to the rule lies in the district courts or in the courts of appeals.  The challenges that were filed in the courts of appeals were consolidated in the Sixth Circuit, which ruled in February 2016 that it has jurisdiction to hear them.  Lawsuits filed in federal district courts are also pending.  In the meantime enforcement of the Clean Water Rule remains under a stay pending these various challenges.  Against this background the Trump Administration asked the Supreme Court to place a hold on the underlying litigation in light of its February 28, 2017, Executive Order, but the Court refused to do so.  It appears the Clean Water Rule will eventually be decided by the Supreme Court.

Attorney Melissa Kampmann Joins The American College of Trust and Estate Counsel As Fellow

Posted on April 6, 2017, Authored by ,

Ruder Ware is pleased to announce that Melissa Kampmann has become a Fellow with The American College of Trust and Estate Counsel.  The American College of Trust and Estate Counsel is a nonprofit association of lawyers and law professors skilled and experienced in the preparation of wills and trusts; estate planning; and probate procedure and administration of trusts and estates of decedents, minors and incompetents. Its more than 2,500 members are called "Fellows" and practice throughout the United States, Canada and other foreign countries. To qualify for membership, a lawyer must have no less than 10 years' experience in the active practice of probate and trust law or estate planning. Lawyers and law professors are elected to be Fellows based on their outstanding reputation, exceptional skill, and substantial contributions to the field by lecturing, writing, teaching and participating in bar activities. Melissa Kampmann chairs the Trusts & Estates Practice Group.  As a seasoned estate planner and Certified Financial Planner, Melissa counsels individuals and families on creating a plan for the transfer and preservation of their assets during their lifetime and at death. Melissa works with a client's trusted advisors to create a flexible life plan that meets their goals, both emotional and financial in addition to guiding clients through the probate and trust administration process.

Disputing Inaccurate Reports Under the Physician Payment Sunshine Act

Posted on April 6, 2017, Authored by John H. Fisher, II
John H. Fisher, II
Attorney
Wausau Office
, Filed under Health Care

The Affordable Care Act added the Physician Payment Sunshine Act (Sunshine Act) as section 1128G to the Social Security Act. The Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical supplies and certain group purchasing organizations to report annually to the Centers for Medicare & Medicaid Services (CMS) certain payments or items of value that are provided to physicians and teaching hospitals.  The Sunshine Act also requires CMS to publish payments reported on a public Web site. In 2013, CMS issued final regulations interpreting and clarifying the requirements of the Sunshine Act.  The final regulations clarify the reporting process, identify exceptions and exclusions from the reporting requirements, and provide further details regarding what constitutes a reportable relationship.  The final rule delineates the specific data elements reporting organizations are required to include and the required reporting format.  Reporting organizations failing to make required reports are subject to potential civil monetary penalties. Physicians are often surprised to see the information reporting agencies submit.  Early on, errors in reporting were frequent as reporting companies struggled to integrate reporting requirements into their compliance process.  Reports tend to be more accurate now, but there are certainly instances where reporting organizations create reports that should be questioned.  A process is included to afford physicians and teaching hospitals to review and dispute the information a reporting organization proposes to report.  The regulations require physicians to exercise diligence to review information being submitted that describes items of benefit they are alleged to have received.  The regulations include a 45-day review and correction period, but report information does not automatically come to a physician unless affirmative action is taken to sign up to receive this information. If the physician or teaching hospital receive notification, a process can be used to dispute the proposed disclosure with the applicable manufacturer.  There is a very short time window to dispute and resolve the issue before publication is made for the applicable year so it is critical a dispute be invoked promptly upon receipt of notice of the proposed report.  Signing up for notifications also permits access to the web-based dispute system.  The review period lasts for 45 days and reporting organizations have 15 days after the end of this period to correct data to resolve disputes. Errors in amount, the nature of items reported, and methodology of calculating or allocating expenditures among numerous recipients are frequent areas of error.  For example, situations have occurred where expenditures that benefitted numerous physicians were allocated to a single physician.  The opportunities for error in reporting are endless; particularly given the multiple parties that can be involved in the reporting chain for the reporting company. Inaccurate reporting is not without consequence to the subject of the report.  Inaccurate reports can be indicative of conflict of interest and can impact publication or reviewer credibility.  A report can also be an indication of further potential fraudulent payments and can result in further government investigation regarding the fair market value of services provided in a consulting or other relationship.  In extreme cases, payments inflated over fair market value for services that are actually and legitimately provided can indicate potential Anti-Kickback Statute and other compliance violations which can carry significant penalties.  If a review is based on an inaccurate or inflated report, a positive resolution can likely be reached with investigators.  However, anyone who has ever been involved in a government compliance investigation understands the intangible damage the process can create. In order to avoid complication that could result from inaccurate reports, physicians and other reporting subjects should be certain to register to receive notification of proposed Physician Sunshine Act reports.  Any inaccuracies should be disputed promptly.

When to Use the OIG’s Self Disclosure Protocols

Posted on April 3, 2017, Authored by John H. Fisher, II
John H. Fisher, II
Attorney
Wausau Office
, Filed under Health Care

The HHS Office of Inspector General offers providers an opportunity to self-disclose certain violations in exchange for avoiding some of the more draconian penalties that may otherwise apply under applicable regulations.  Even though the OIG’s Provider Self-Disclosure Protocols (“SDP”) can be very compelling, the decision whether to utilize the OIG’s self-disclosure protocols is often very difficult. To begin, the SDP is not available in all situations.  The SDP is limited to situations that potentially violate Federal criminal, civil, and administrative laws for which Civil Monetary Penalties are authorized.  The SDP requires the disclosing party to identify the specific legal provisions that were potentially violated and acknowledge the conduct potentially violated the identified laws.  The OIG does not use the SDP to provide opinions on whether a law was violated by the conduct described as the basis for the self-disclosure. The SDP is not available to disclose and settle Stark Law violations that do not also potentially violate the Anti-Kickback Statute.  The Center for Medicare and Medicaid Services maintains a separate process that can be used for Stark Law only issues.  The OIG protocols are generally used where there is a potential violation of the Anti-kickback Statute, overpayments that become False Claims under the 60-day repayment rule, and other cases where CMP statutes are potentially implicated. It is not always clear whether a violation of a CMP law has occurred.  Those involved in health care law are familiar with the level of ambiguity that often exists with respect to specific billing rules and other regulatory standards.  On the other hand, the potential liability for making the wrong call about whether an infraction has actually occurred can be quite significant.  This may force the provider to make use of the SDP as a risk mitigation device; even in cases where it is less than clear that a violation has occurred. Additional penalties are often present when a provider “knows or should know” that a regulation has been violated or an overpayment exists.  A decision whether a provider “should” have known about an overpayment or other infraction is often made on the margins in the context of a self-disclosure decision.  For example, failing to repay an overpayment within 60 days of gaining actual or imputed knowledge can triple the amount of penalties and add up to $22,000 per claim to the price tag.  It might be easy to determine that a provider did not have actual knowledge as of a certain date.  It is much more difficult to determine when the provider should have had knowledge through the operation of an effective compliance program.  If the date of imputed knowledge was more than 60 days before the date of disclosure, there is potential liability for increased damages; even if actual knowledge was obtained within the 60-day repayment period.  The SDP might be considered to mitigate the potentially enhanced damages that would be potentially applicable under the False Claims Act in this situation. Not every situation where there has been a billing error amounts to fraud or wrongdoing requiring use of the self-disclosure protocol.  Many overpayments that are identified through audit can be dealt with at the intermediary level.  Where investigation raises questions about whether incorrect bills are “knowingly” submitted, the self-disclosure process may provide some mitigation of potential loss.  Situations where the provider perhaps “should have known” raise more difficult issues of analysis. When errors are discovered, the provider’s best bet is to be forthright and deal with the matter “head on.”  It is never a good alternative to pretend the situation does not exist or will never be discovered or brought to light.  These cases can come to light in strange and unexpected ways.  A reasonable investigation should be conducted that leads to a reasoned decision about the nature of the violation.  The SDP is available to mitigate potential damages when investigation reveals there is potential exposure to enhanced civil monetary penalty exposure.

Three Recent Fraud Cases Involving Dermatologists Illustrate Primary Compliance Risks in Dermatology Practices

Posted on April 5, 2017, Authored by John H. Fisher, II
John H. Fisher, II
Attorney
Wausau Office
, Filed under Health Care

Three relatively recent cases involving dermatology billing practices illustrate some of the main compliance risks faced by dermatology practices.  These risk areas include: Improper use of multiple removal CPT codes; Billing for “impossibly long days”; Failure to follow supervisions rules required to permit “incident to” billing; Creating incentives for overutilization; and Performing “outlier” levels of service that cannot be justified Misdiagnosis, Overutilization, Violation of “Incident to” Billing Rules, Improper Incentives to Overutilize, Potential Practice Beyond Licensure - November 15, 2016 An allegation from a competing dermatologist resulted in a Federal government investigation of a Florida dermatologist.  The dermatologist was accused of charging the Medicare program for unnecessary biopsies and radiation treatments that were not rendered, not properly supervised, or given by unqualified physician assistants.  It was alleged the doctor was not even in the country when some of the procedures at issue were performed.  The unnecessary charges were alleged to have totaled around $49 million over a 6-year period. The dermatologist did not admit wrongdoing in the settlement.  Rather, he alleged the overbilling resulted from his unique practice that relied on radiation, instead of disfiguring surgery, to help patients.  The doctor claimed he had cured “over 45,000 non-melanoma skin cancers with radiation therapy” over a 30-year period.  The problem with that argument appears to be the fact that the dermatologist was not trained or qualified in providing radiation oncology treatments. There are a number of interesting things about this case.  The case was brought by a competing physician as a whistleblower.  The physician who brought the case expressed concern about having to treat patients that the accused doctor had misdiagnosed with squamous cell carcinoma. The case also alleged significant billing for services allegedly provided when the doctor was not even in the office.  The accused doctor alleged he was available by phone while the procedures at issue were being performed.  This raises interesting issues under the rules regarding “incident to” billing.  Those rules permit a physician to bill for physician extender services.  In order to qualify to bill a service as “incident to” a physician’s service, the billing physician must meet supervisions requirements.  The physician must be physically present within the office suite during the performance of the procedure in order to qualify to bill a service as “incident to” the physician’s services. It appears there were a number of things going on in this case. There appears to have been a pattern of diagnosing a higher level of severity than was supported by the patient’s condition. There was a routine use of radiation therapy, even in cases that were not medically appropriate.  This placed patients at potential risk. There appears to have been questions whether the accused doctor was authorized to perform radiation therapy. There were issues regarding improper use of the “incident to” billing rules when the doctor was not present to actively supervise the service. There was also some evidence the doctor had offered incentives for staff to misdiagnose and over utilize the radiation treatment. There was an alleged kickback arrangement with another physician who operated a clinical laboratory. Criminal Conviction of Dermatologist Excessive Use of Multiple Removal Codes - 2015 A Chicago area dermatologist was convicted of committing Medicare fraud by submitting false claims for more than 800 patients that led to payment of reimbursement of approximately $2.6 million.  The doctor was accused of falsely diagnosing patients and submitting bills without proper documentation of the necessary condition.  Most of the claims appear to have involved diagnosis of actinic keratosis, or sun-induced skin lesions that have potential to become cancerous.   The doctor was found guilty of criminal charges arising from this matter in 2015. The dermatologist was alleged to have falsely documented hundreds of cases of medically unnecessary cosmetic treatments he reported as involving the removal of lesions (CPT 17004).  According to court records, the physician billed under the CPT code applicable to the removal of 15 or more lesions on a more or less routine basis.  These treatments were allegedly performed on hundreds of repeat patients over a number of years.  Many of the patients received this treatment on 10 or more visits.  Medicare reimbursed this treatment by paying up to $352.40 per treatment.  When these numbers are summarized, it becomes difficult to deny that abuse was going on in this case.  Evidence presented suggested the dermatologist falsely claimed to have removed more than 150 pre-cancerous lesions from approximately 350 Medicare patients, more than 450 patients covered by Blue Cross and Blue Shield, and additional patients covered by Aetna and Humana health insurance. This case appears to have been a relatively clear case of actual fraud rather than failure to properly document the nature of the service.  Even though the case represents an extreme situation, it still holds some lessons for providers who are not attempting to commit fraud.  A few lessons that can be extracted from this case include: Care should be taken when using multiple removal codes such as 17004.  These types of codes should not be used systematically.  Over time, the removal numbers add up to indicate potential fraud.  The record should be accurately and completely documented to support use of multiple removal codes. Care should be taken not to bill codes relating to time increments or work units that, in the aggregate, result in an unrealistic amount of time in a given day.  Granted, some providers are more efficient than others, but at some point multiple procedure time units become excessive and can be statistically sampled to determine whether the individual doctor is within a standard range of services. Failure to Supervise and Impossibly Long Days Payment of $302,000 and Forced Corporate Integrity Agreement – July 2016 The government alleged the dermatologist in this case repeatedly billed for services under the “incident to” billing rules during periods when the dermatologist was not present in the office.  Some of the services were allegedly performed when the doctor was traveling out of the country.  The government also alleged the doctor billed for impossibly long days including one day where 26 hours were billed. This case illustrates the need to comply with the “incident to” billing rules.  Those rules permit a physician extender’s services be billed under the physician in certain circumstances.  In order to qualify to bill incident to, the physician must be physically present within the office suite at the time the extender performs the service.  The physician cannot order the procedure and then leave the office while the procedure is being performed.  There are new Medicare rules clarifying some aspects of the “incident to” billing rules.  There was a previous ambiguity that some providers interpreted as permitting the physician that ordered the service to bill for the services, even though another physician actually supervised the performance of the service.  The rules revision clarified only the supervising physician can bill the services as “incident to” his or her service.  The ordering physician can only bill the service if he or she also supervises the extender.

Can Overpayments Create Criminal Liability?

Posted on April 11, 2017, Authored by John H. Fisher, II
John H. Fisher, II
Attorney
Wausau Office
, Filed under Health Care

We hear a lot about potential liability under the False Claims Act (FCA) for the failure to repay overpayments within 60 days of discovery. Focus on the 60-day rule has taken focus away from the potential for criminal charges for retaining known overpayments.  Section 1128B(a)(3) of the Social Security Act (42 U.S.C. § 1320a-7b(a)(3)) makes it a crime to conceal or fail to disclose any occurrence that affects the initial or continued right to any benefit payment.  A violation of the statutes requires showing the charged individual has knowledge of the event affecting the right to the applicable benefit.  A violation of the statute is a felony and is punishable by a maximum of five years in prison and a fine of $250,000 for individuals or $500,000 for corporations. The Office of Inspector General has applied this statute, even in cases where the overpayment occurs innocently but a party fails to repay a known overpayment.  This type of situation is clearly subject to the FCA where repayment is not made within 60 days.  Criminal responsibility is also a potential particularly when a decision is made not to repay after learning about the existence of an overpayment.  Criminal exposure is present for the entity as well as the individuals who are responsible for failing to make repayment of a known overpayment.  There is an element of ambiguity regarding application of the criminal component, but this has not stopped prosecutors from asserting the statute in the past. The Federal Criminal False Claims Statute (18 U.S.C. § 287) can also apply to impose potential criminal liability.  This statute applies potential criminal liability on any person who “makes or presents” any claim to an agency of the U.S. Government “knowing such claim to be false, fictitious, or fraudulent.”  This statute can lead to a potential 5 year imprisonment plus potential criminal penalties.  Conspiracies to violate the Federal Criminal Claims Statute impose double penalties on participants.  Failing to disclose and repay known overpayments could form the basis of a violation of this statute as well. Other criminal statutes could potentially apply to the failure to repay known overpayments.  Mention of these above statutes is not intended to be an exhaustive list of potential exposure. Self-disclosure is a strong consideration whenever overpayments are discovered.  The self-disclosure programs offered by the OIG and Centers for Medicare & Medicaid Services can greatly reduce exposure when a provider discovers overpayments.  In advance of using either protocol, an internal investigation should be conducted to determine exactly what occurred.  This will help identify the nature and extent of exposure and will also help develop the case for disclosure.  Federal investigation standards as described in the Yates Memo will often guide the investigation process and should be considered when structuring the investigation process.  The Yates Memo requires an investigation to consider potential individual wrongdoing.  Failure to investigate and disclose potential individual wrongdoing can have a negative impact on governmental cooperation. It is very possible an issue that is the subject of a potential self-disclosure is relatively new to the compliance department.  This does not necessarily mean the issue is new to others within the organization.  Something that looks like a simple overpayment may have been intentionally overlooked by an individual in the management chain, billing department, or provider staff.  This potential makes the investigation much more difficult than it might originally appear.  Federal standards now require the investigator to look for individuals who may have had earlier knowledge of an impropriety.  Failure to identify individual wrongdoing increases risk to the organization and can result in the failure of the Federal government to cooperate in the settlement of a case.

Exercising Reasonable Care to Identify and Address Potential Overpayments

Posted on April 5, 2017, Authored by John H. Fisher, II
John H. Fisher, II
Attorney
Wausau Office
, Filed under Health Care

When the Center for Medicare and Medicaid Services (CMS) finally issued final regulations under the 60-day repayment rule, it implemented a new standard requiring a provider to affirmatively exercise reasonable diligence to identify potential overpayments.  This was a change from the proposed regulations that held providers to a much lower affirmative duty to exercise diligence to find potential overpayments.  When a provider receives “credible information” that indicates a potential overpayment, affirmative steps must be taken in a timely and good faith manner to investigate.  Failure to meet the standard of reasonable diligence can result in significant penalties under the False Claims Act (FCA).  In some cases criminal liability can attach as well; particularly when evidence strongly indicates a problem might exist and a deliberate decision is made not to investigate or repay an amount due. By now most health care providers are at least generally aware of the 60-day repayment rule.  That rule originated as part of the Affordable Care Act in 2010.  The rule provides that the failure to repay a known overpayment within 60 days after discovery results in potential penalties under the FCA.  This means a simple overpayment is multiplied by a factor of three.  Additionally, penalties can be assessed in amounts ranging from a minimum of $11,000 and a maximum of approximately $22,000 per claim.  Financial exposure under the FCA can be very substantial; particularly when there is a systematic billing error that impacts a large number of claims over a significant period of time.  The lookback period for imputed False Claims is 6 years, which amplifies the potential exposure when the “tip of the iceberg” is discovered in a current year audit. The initial statutory provision left some ambiguity regarding application of the 60-day repayment rule.  One significant ambiguity relates to when the 60-day time period begins to run.  The statute states the 60-day period commences upon “identification” of the overpayment but included no clarification of when a provider is deemed to have identified the existence of an overpayment.  It was not clear whether identification occurred when there was an allegation that an overpayment exists, when an amount of overpayment was calculated, when the existence of the overpayment was verified, or at some other time.  It was also unclear whether actual knowledge of an overpayment was required or whether knowledge could be imputed in certain circumstances. CMS provided clarification on the issue of identification in the final regulations, but the clarification places significant burdens on providers.  Under the final rules, the provider is deemed to have identified an overpayment not when actual knowledge is obtained, but rather when the provider “should have” identified the overpayment through the exercise of “reasonable diligence.”  The new standard requires providers to conduct a timely and good faith investigation when it receives credible information an overpayment might exist.  Failing to take reasonable steps to investigate will result in imputed knowledge and deemed “identification” of the overpayment.  In other words, the 60-day clock starts to run when the investigation should have commenced. It is useful at this point to mention what constitutes an overpayment that invokes the statutory requirement.  An overpayment exists when the provider receives any funds to which they are not entitled.  There is no requirement of an amount threshold, substantiality, or materiality.  Any overpayment invokes the statute and becomes a potential false claim if not repaid within the 60-day period.  There are situations where the amount of overpayment is so small that the provider might determine it not worth the resources to identify, quantify and repay.  When making this determination, it should be kept in mind the FCA will apply if a whistleblower case is brought or a government investigation is commenced and finds the overpayment.  FCA liability can result in large penalties; particularly where there are multiple claims involved.  It should also be kept in mind that criminal statutes impose felony penalties for the willful failure to return known overpayments. Overpayments that are self-discovered and repaid before they become false claims are relatively easy to manage.  Once the FCA potentially attaches, these situations become increasingly complicated to manage.  The OIG Self Disclosure process should be considered where potential for significant penalties is present.  The Self Disclosure Protocols permit resolution at a minimum of 1.5 times the amount of the overpayment.  Full disclosure of the facts and investigation is required as part of the self-disclosure process.  Only civil penalties are subject to settlement under the protocol.  The wrong facts disclosed as part of the SDP process can lead to criminal charges against the entity or individuals.  Criminal charges cannot be settled using the SDP. Where amounts are smaller, a provider may decide to repay without going through the protocol process.  A determination of which option is right in the specific situation should be made with the involvement of legal counsel that has experience with these issues. Proper operation of a compliance program is the best defense to mitigating exposure under the 60-day rule.  Prompt investigation should be conducted whenever there is a credible allegation of an overpayment.  Compliance risk identification and proactive auditing can also help mitigate risk by identifying problems early and by demonstrating the compliance process is being effectively operated.  This will help avoid allegations that overpayments should have been discovered sooner through the exercise of a reasonable compliance program.  Most importantly, ignoring alleged overpayments is never an answer that mitigates risk.  All credible allegations must be investigated and appropriate repayment should be made using one of the available methods.  The requirements of the final rule should be baked into compliance program policies and procedures and staff should be educated on the need to investigate and return overpayments within required timeframes.

Do You Have The Power?

Posted on April 3, 2017, Authored by Aric D. Burch
Aric D. Burch
Attorney
Wausau Office
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When you hear the words “estate planning,” what do you think? The most common answers I hear mention “wills” or “trusts.” Although estate planning includes those documents, which carry out your plan after death, it also includes documents to help carry out your wishes while you are living. These documents are called powers of attorney, and every estate plan should have a Power of Attorney for Health Care and a Durable Power of Attorney for Finances. This article focuses on the Durable Power of Attorney for Finances. The Durable Power of Attorney for Finances allows you to name someone to make your financial decisions when you are no longer able to do so (the “Agent”). It is “durable,” meaning it remains effective even if you become incapacitated after signing the document. The Durable Power of Attorney for Finances can either be effective immediately upon signing or only become effective under certain circumstances (typically when the Power of Attorney for Health Care is activated). The Durable Power of Attorney for Finances contains numerous provisions related to various financial actions, such as provisions related to investments, real estate, taxes, beneficiary designations, and gifting. Careful thought must be given to using a standard Durable Power of Attorney for Finances form found online. These forms, although valid if executed properly, usually have very broad, general powers. These general powers may not allow your Agent to do the things necessary to fully care for you or carry out your overall estate plan. For example, if you have concerns about paying for long-term care (e.g., nursing home), your Durable Power of Attorney for Finances must contain provisions allowing your Agent to apply for Medicaid, create trusts if necessary, enter into contracts for your care, and allow large gifts to be made. These provisions are rarely found in standard forms. In dealing with gifts, a standard form does not contain adequate provisions. If you want your Agent to be able to make gifts, you must consider placing restrictions on your Agent to protect you from their making large gifts.  However, to plan for long-term care, your agent may need to make large gifts as part of that planning process. A standard form will not provide the flexibility to protect you from large gifts and allow for adequate long-term care planning. Reconciling the need for limitations on gifting and an Agent’s need to make large gifts to plan for your care is something you should discuss with an attorney who has experience with these types of issues. Do not wait to create your Durable Power of Attorney for Finances. This often overlooked document is necessary to avoid an expensive guardianship proceeding, should you be unable to make financial decisions for yourself. It is a document that is vital to ensure your estate plan, once in place, will be carried out both during your lifetime and upon your death.

Exercising Board Oversight of the Compliance Function

Posted on April 19, 2017, Authored by John H. Fisher, II
John H. Fisher, II
Attorney
Wausau Office
, Filed under Health Care

How the Board can Enhance Compliance Effectiveness The Board of Directors (Board) of an organization has oversight responsibilities over the compliance program.  Board members are often unsure of the nature and scope of their responsibilities over compliance.  The roll of many Boards is limited to receiving occasional updates from the compliance officer.  Compliance is then checked off the “to-do” list and the Board moves on to other issues until their next compliance update. The way compliance has evolved over the years, makes it necessary for corporate boards to take more active responsibility for their compliance oversight function.  Board members should be inquisitive about compliance and should not assume the compliance officer is performing all tasks required in an effective compliance program.  Like any other class of employee, there are some compliance officers who perform effectively and others who will let things slide if they are not held accountable by the Board. Best practice is for the compliance officer to have a direct line of responsibility to the Board.  Reporting to other executives inherently diminishes the independence of the compliance officer and potentially impedes the performance of compliance activities.  Compliance office independence is good for the program; at least if the compliance officer is adequately performing the compliance role.  Where there is independence, the Board is really the only place the compliance officer’s activities are assessed.  Matching compliance independence with Board apathy over compliance creates a perfect storm for the compliance program to be operated ineffectively.  This underlines the need of Board members to be inquisitive and press the compliance officer.  Asking the compliance officer pointed questions is one technique that can enhance the Board’s understanding of its role while it assesses the effectiveness of the compliance officer. Board members should be attentive to agenda items that involve compliance.  If regular agenda items do not exist, Board members should ensure they are included in the future.  A compliance program is not effective unless the compliance officer regularly reports to the Board.  When compliance issues are on the agenda, Board members should come prepared with questions to ask the compliance officer.  This process will help the Board better understand issues the specific organization faces.  It will also help the Board adequately and effectively conduct its oversight responsibilities and will result in a more effective compliance process. As a follow up to this Article, I will be posting a list of questions Board members may wish to ask the compliance officer.  The questions should be tailored to the nature of the business and level of understanding Board members have regarding their oversight role.