Law Offices of George W. Bodenger, LLC

CMS Finalizes Overhaul To Stark And Anti-Kickback Laws On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) released the final rules amending two (2) of the primary bodies of federal law governing commercial conduct in the healthcare industry, the physician self-referral prohibitions (known as the Stark Law) and the Anti-Kickback Statute (AKS). The Stark Law and AKS were initially created for a fee-for-service healthcare system, where there are fina...Continue reading

Providers Must Apply by November 6, 2020 for a Share of $20 Billion CARES Act Distribution On October 1, 2020, HHS announced it would be allocating an additional $20 billion as its Phase 3 General Distribution from the Provider Relief Fund (PRF) through the CARES Act. This Phase 3 General Distribution is intended for providers who were either excluded from the initial two (2) phases, or who were eligible under the first two (2) phases but require additional fundi...Continue reading

Provider Relief Fund Introduces Phase 3 General Distribution Around the time of the start of the coronavirus (COVID-19) pandemic, Congress established the Provider Relief Fund (PRF) through the CARES Act in order to help providers who were financially damaged by COVID-19. Through October 1, 2020, there were two (2) phases for general funding, and multiple targeted allocations. The Phase 1 General Distribution allocated $30 billion to eligible providers, and the Phase 2 ...Continue reading

As health systems develop and implement strategies around clinical care redesign and health care reform, industry participants often ask how clinically integrated networks (CINs) relate and compare to accountable care organizations (ACOs). While unquestionably linked, each of these concepts has its own unique definition and purpose. The following paragraghs present summary comparisons of key operating features and characteristics of CINs and ACOs. DEFINITION CIN - A netw...Continue reading

IMPLICATIONS OF TRUMP'S AFFORDABLE CARE ACT EXECUTIVE ORDER On January 27, 2017, President Trump signed his first executive order relating to the Affordable Care Act (the Act). The executive order directs the Secretary of the Department of Health and Human Services and all government agencies to exercise all authority and discretion available to them to waive, defer, grant exceptions from or delay the implementation of any provision or requirement of the act that would i...Continue reading

TELEMEDICINE IN PRIMARY CARE Primary care physician groups, especially those employed through health systems, are increasingly using mid-level practitioners (i.e., nurse practitioners, physician assistants) to visit patients virtually through the use of telemedicine technologies. This combination of clinical and technological resources is being directed toward patients who have difficulty getting to the doctor’s office, such as those in nursing homes and assisted living fa...cilities, and is expanding access to care by eliminating the need for a patient to come into the doctor’s office. Some primary care practices are using NPs and PAs to monitor patients with chronic conditions, such as diabetes, hypertension and asthma. Telemedicine visits also help reach patients who would not otherwise visit their primary care providers, allowing doctors to keep tabs on their sickest patients by having NPs or PAs do weekly check-ins, and can keep patients out of the hospital if problems are caught early. Physicians thinking of employing NPs or PAs to conduct telemedicine visits should know the rules, regulations and restrictions for telemedicine in their state. Of course, physicians also need to understand how such services will be reimbursed by third party payors. At this time, twenty-nine (29) states and the District of Columbia have laws that provide third party reimbursement for telemedicine services. Rules and regulations regarding the use of mid-level practitioners vary on a state by state basis. Certain states have relaxed their scope of practice laws to allow NP’s and PA’s to care for patients independently from physicians. Although telemedicine offers numerous potential benefits, the delivery of health care via telecommunication technology presents health care providers and organizations with unique risks and challenges. Some of the main areas of concern include the following: fears of a breakdown in the relationship between health professional and patient (for example, inability to perform the whole consultation); problems with the quality of health information (for example, lack of access to a patient's full medical record); and organizational complications (for example, problems with infrastructure planning and development). In addition, malpractice liability concerns have also been exacerbated by the move toward more telemedicine-based services, due to issues regarding location of service and determining jurisdiction. State legislators are actively seeking solutions to these challenges, because the provision of healthcare services using telemedicine is widely viewed as having a pivotal role in the health care delivery system in the future.

SMALL AND RURAL MEDICAL PRACTICES NOT PREPARED FOR MACRA, ACCORDING TO GAO A recent Government Accountability Office (GAO) report highlights that small and rural physician practices face significant problems with the implementation of Medicare’s value-based payment models under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Value-based payment models require physicians to take steps toward using electronic health record (EHR) systems to better track and mon...itor quality of patient care. The GAO review found that small physician practices (defined as having fifteen (15) or fewer physicians) and rural physician practices (defined as those located outside of an urban area) are less prepared for this transition than their large, urban counterparts. The GAO report focused on five (5) areas that will likely prove challenging to these small and rural practices: 1. Financial Resources and Risk Management. GAO posits that many small and rural practices lack the finances to make investments in EHR systems, particularly when such investments are not likely to yield significant returns for several years. 2. Health I/T and Data. To be successful under value-based payment models, physician practices will need to hire and train professional staff and develop experience EHR systems and analyzing data. 3. Population Health Management Care Delivery. Population health management in rural areas can be more complex, particularly when patients are required to travel long distances to receive care. 4. Quality and Efficiency Performance Measurement and Reporting. Practices with relatively few patients may find that proper measurement of quality and efficiency can be easily distorted by patients with multiple morbidities, requiring greater levels of care. 5. Effects of Model Participation and Managing Compliance with Requirements. Small physician practices typically operate with leaner staffing levels, which could create difficulty in balancing and finding time for direct patient care, care management activities and additional administrative duties associated with value-based payment models. -------------------------------------------------------------------- Despite these challenges, and the fact that the political climate is uncertain, industry observers believe that MACRA is not going away, as it has significant bipartisan Congressional support. As such, medical practices are well-advised to continue to prepare for the new MACRA payment system, which the Centers for Medicare and Medicaid Services will implement in 2017.

HOUSE FILES MOTION TO DELAY AFFORDABLE CARE ACT LITIGATION IN LIGHT OF NEW TRUMP PRESIDENCY On November 21, 2016, the U.S. House of Representatives filed a motion with the D.C. Court of Appeals requesting a temporary hold on briefing in U.S. House of Representatives v. Burwell as a result of Donald Trump’s election earlier that month. The case is currently on appeal by President Obama’s administration after the District Court found that the appropriation of funds to pay cost...-sharing subsidies to health insurers under Section 1402 of the Affordable Care Act did not receive Congressional approval and that it was unlawful for the Government to pay subsidies under such circumstances. The House asked the D.C. Court of Appeals to grant a temporary stay of the briefing schedule until February 21, 2017, at which point the House proposed that the parties would file a joint status update on the matter, which would specify either (i) that the parties were considering settlement or dismissal of the case, or (ii) a new briefing schedule. The House argued that a temporary stay of the briefing schedule would provide President-Elect Trump and his administration time to decide on continuing the prosecution of the case or to otherwise resolve the appeal. The House motion also requested, as an alternative, a 45-day extension of the briefing schedule if the Court of Appeals did not grant the temporary hold on briefing until February 21. In response, the Obama administration filed a motion to continue the briefing schedule uninterrupted, stating that the House identified no harm to completing the briefing schedule to which the parties agreed and positing that the issues under appeal are not changed by the election outcome. The House’s brief is currently due on December 23, 2016, with the reply due on January 19, 2017.

TELEMEDICINE A SIGNIFICANT OPPORTUNITY TO IMPROVE HEALTHCARE DELIVERY Telemedicine is "the use of technology to deliver health care, health information or health education at a distance." It increases contact between patients and health care providers, generally without requiring the physical contact of in-person physician visits. Within telemedicine, there are three (3) main types of services: store-and-forward (also known as asynchronous communication), real-time video (s...Continue reading

TRUMP'S EARLY INITIATIVES IN HEALTHCARE While the country is still reeling from Republican Donald Trump’s surprise election victory this past Tuesday, it is important that we now look back at what he said during the campaign, to attempt to figure out what his presidency will mean for healthcare reform. Although no one has a complete picture of what the healthcare industry will look like under the Trump administration in 2017, it is clear that healthcare providers must prepar...e for changes ahead in the Affordable Care Act, price transparency, their continued participation in Medicare accountable care organizations and Medicaid expansion at the state level. Trump's focus in the early days of his presidency, from a healthcare standpoint will, undoubtedly, involve the Affordable Care Act. But, despite his campaign rhetoric about dismantling the healthcare reform law, it does not mean that he can repeal the law, in its entirety. First of all, even though the word, repeal, had some weight during the campaign, the Affordable Care Act is a 2,000 plus page piece of legislation, and not everything can be repealed, from a practical standpoint. Indeed, neither the Republican Party or Trump would want to see millions of people suddenly become uninsured. The Trump administration will grapple with developing and implementing a transition that keeps people insured while moving toward more affordable health plans. It is reasonable to assume that there will be no repeal without an alternative in place that minimizes disruption of the overall market. It is likely, however, that, in his early days in office, Trump will withdraw the appeals of certain components of the law that are currently caught up in litigation, including the appeal to cost-sharing subsidies, and causing the Department of Health and Human Services direct reinsurance payments back to the Treasury Department. It is expected that Trump will also pursue his want of complete price transparency for all healthcare providers so that consumers can shop for the best price for procedures and examinations. Trump is a business man at heart, who believes in a free market, where businesses can practice in a less government-mandated environment, and price transparency will create a more free market based system.. Less clear, under the Trump administration, is what will become of some of the CMS pilot programs, such as the accountable care organizations under the Medicare Shared Savings Programs that were endorsed by the Obama administration. Trump is expected to take a close look at those programs to determine whether they are saving money as promised. In addition, it is also not clear what Trump will do regarding those states that have yet to expand Medicaid. During his campaign, Trump talked about moving people off Medicaid and to other forms of private insurance once we have a more predictable economy and the job creation across the country has progressed.

U.S. SENATE COMMITTEE ON FINANCE RELEASES WHITE PAPER ON STARK LAW On June 30, 2016, Senate Finance Committee Chairman Orrin Hatch released a white paper examining potential changes to the Federal physician self-referral prohibitions, known as the Stark Law. The white paper, entitled Why Stark, Why Now? Suggestions to Improve the Stark Law to Encourage Innovative Payment Models, was issued following insights and comments provided by thought leaders in this area of the l...aw. The white paper can be found at http://www.finance.senate.gov//Stark%20White%20Paper,%20SF The white paper acknowledges that the Stark Law has become increasingly unnecessary for, and a significant impediment to, value-based payment models that Congress, CMS, and commercial health insurers have promoted. The risk of overutilization, which drove the passage of the Stark Law, is largely or entirely eliminated in alternative payment models. When physicians earn profit margins not by the volume of services but by the efficiency of services and treatment outcomes, their economic and self-interest aligns with the interest to eliminate unnecessary services. Key suggestions identified in the white paper to address the shift to value-based payment models include: Changes to the Stark Law to allow providers to implement innovative, new payment models, including potential new waivers or exceptions, expansion of existing waivers or exceptions, broadening CMS’s regulatory authority; Repealing the compensation arrangement prohibition, or repealing the Stark Law in its entirety; Changes to implement the Medicare Access and CHIP Reauthorization Act of 2015, with options for payment systems that include both fee-for-service and alternative payment models; Making Stark Law technical violations (of form rather than substance) subject to separate sanctions and limited liability. This white paper also discusses the need to amend Stark Law definitions such as fair market value, volume and value of referrals, and commercial reasonableness and to take other actions designed to mitigate the potential for harsh and unreasonable Stark Law fines and penalties. The white paper also discusses healthcare providers’ perspectives on the impact of the Stark Law and highlights the law’s complexity, the severity of its penalties, its significant compliance costs, and its negative impact on efforts to integrate health care delivery.

CMS RELEASES NEW OVERPAYMENT RULES FOR MEDICARE On February 11, 2016, the Centers for Medicare & Medicaid Services (CMS) published a final rule (the Final Rule) dealing with the return of overpayments made to providers. The Final Rule became effective on March 14, 2016. The Final Rule eases obligations for Medicare Part A and Part B providers and suppliers to return overpayments to avoid potential liability under the federal False Claims Act. The major provisions of this ...Final Rule include clarifications around: (i) the meaning of overpayment identification; (ii) the required lookback period for overpayment identification; (iii) the methods available for reporting and returning identified overpayments to CMS, which are summarized below: Definition of Overpayment Identification An overpayment must be reported and returned by the later of: (i) the date which is sixty (60) days after the date on which the overpayment was identified, or (ii) the date any corresponding cost report is due, if applicable. This Final Rule states that a person has identified an overpayment when the provider or supplier has or should have, through the exercise of reasonable diligence, determined an overpayment was received and quantified such overpayment amount. Lookback Period Overpayments must be reported and returned only if the provider or supplier identifies the overpayment within six (6) years of the date the overpayment was received. Although six (6) years is a fairly extended lookback period, this change included in the Final Rule is a significant improvement over the ten (10) year lookback period contained in the 2012 proposed rule. How to Report and Return Overpayments Providers and suppliers must use an applicable claims adjustment, credit balance, self-reported refund or another appropriate process to satisfy the obligation to report and return overpayments. The Final Rule also states that if a provider or supplier has reported a self-identified overpayment through the Self-Referral Disclosure Protocol, managed by CMS, or the Self-Disclosure Protocol, managed by the Office of the Inspector General, the provider or supplier is considered to be in compliance with the provisions of this rule, so long as they are actively engaged in the respective protocol.

GENERAL ADVISORY - ALTERNATIVE FEE ARRANGEMENTS OFFERED In today’s legal services market, most law firms (both large and small) remain tied to the billable hour. The Bodenger firm, however, offers alternative fee arrangements that are designed to ensure that our clients receive the outside expertise that is needed within realistic spending expectations. This blog post summarizes the types of fee agreements that we offer to our clients as alternatives to traditional billable h...Continue reading

PENALTIES FOR FALSE CLAIMS ACT VIOLATIONS INCREASED ALMOST TWOFOLD, EFFECTIVE AUGUST 1, 2016 Penalties for false claims submitted by healthcare providers and others have nearly doubled. Effective August 1, 2016, the U.S. Justice Department has increased these per claim penalties as a result of the Bipartisan Budget Act of 2015, which requires such penalties to increase by August 2016 to account for inflation. False Claim Act per claim penalties are often applied in cases ...where healthcare defendants are accused of violating the Anti-Kickback Statute and the Stark Law. The minimum per claim penalty will be increased to $10,781 from the current level of $5,500 per claim. The maximum per claim penalty will increase from $11,000 to $21,563. Violations of the Federal False Claims Act often involve thousands of individual claims, meaning these penalties can add up to millions and even billions of dollars in a single case. It is important to note that this increase in these penalty per claim amounts does not, in and of itself, represent a change in what constitutes a violation of the False Claims Act, from a legal perspective. As such, compliance efforts should not change markedly as a result of this change of law. It does, however, increase the government’s leverage enough that False Claims Act compliance should continue to be a very high priority for healthcare organizations. Defendants in False Claims Act cases often do not end up directly paying amounts driven by the per claim penalty components, because these cases very often settle for agreed upon amounts that do not reflect per claim penalties. Even in settlements, however, the new penalties might lead to higher settlement payments because the starting numbers for settlement discussions will be greater. Settlement amounts are very often based on a multiple of damages, or the government’s actual losses, and the associated per claim penalty does not end up being part of the overall settlement amount.

George Bodenger has over 20 years of experience representing healthcare providers, pharmaceutical companies, and medical device manufacturers in a wide variety of regulatory, transactional and government litigation matters. This broad experience and comprehensive understanding of the healthcare delivery system makes us unique in our ability to assist clients in achieving their business objectives while ensuring compliance with relevant healthcare laws and regulations. Our Firm mission is to provide sophisticated legal services at least equal to "big firm" quality standards, at a fraction of the cost and with cost certainty, through low hourly rates, fixed fees and other creative billing arrangements.