The Evolving Role of Pharmacists in the Transformation to Payment for Quality and Cost-Effectiveness and the Attendant Legal Hurdles

By: Paul DeMuro, Ph.D., J.D., M.B.A., CPA, and Yesenia Prados, Pharm.D

The traditional role of pharmacists

When one thinks of pharmacists, one typically thinks of the individual in the retail pharmacy who fills his or her prescription that was “written” by a clinician. This traditional role of pharmacists was managing the production and dispensing of drugs. Pharmacists have only been considered dispensers, and not providers and thus their practice has been limited. Patients often viewed their pharmacists as businessmen and not as healthcare professionals. They thought their only role was to make a sale and patients were only there to make a purchase. Since patients often walked into a retail pharmacy where many things were being sold in addition to pharmaceuticals, this perception was probably not incorrect.

What pharmacists are doing today?

Today, the role of pharmacists is evolving such that pharmacists are much more involved in the management of patient care. Patients often see pharmacists as their go to health professional who is easily accessible. As pharmacists are now able to identify and meet a patient’s drug-related needs, they are attempting to lead the way and provide better patient care with their significant clinical knowledge, which has not been used to its full potential in the past. Pharmacists are now able to play an integral role in the healthcare system. The concept of clinical pharmacy has taken hold as the profession continues to move towards being patient-focused. In 2010, the Affordable Care Act identified pharmacists as medication therapy management (MTM) providers, allowing them to become formal members of the new integrated health care delivery models.

Please continue reading this article at AIMM’s website.

Posted in Care Delivery, Clinical Integration, Paul DeMuro | Tagged , , , , , , , , , , , ,

Beware of Excluded Individuals and Entities

By: Anne Novick Branan

One of the recent enforcement trends landing practitioners in hot water is the federal government’s pursuit of those who employ Medicare or Medicaid excluded individuals or entities. Federal statutes allow the Office of Inspector General for the Department of Health and Human Services (OIG) to exclude individuals and entities from participating in federal healthcare programs if they have been convicted of fraud or engaged in other misconduct. State Medicaid programs are required to exclude from participation any person or entity that has been excluded by the OIG. As of April 2016, more than 60,000 individuals and 3,000 entities were excluded from participation in federal healthcare programs.

Federal healthcare programs are prohibited from paying for items or services that have been furnished by someone who has been excluded from participation in these programs. Providers must ensure that they do not bill for services furnished by excluded persons. An excluded individual or entity engaged by a provider directly or even indirectly, such as through a staffing agency can raise concern. Companies, like home health agencies and labs, that bill federal programs for services prescribed or ordered by an excluded physician are also at risk. Excluded individuals may include nurses, physicians, or x-ray technicians, among others. Excluded individuals in administrative roles, like coders or marketers, who do not directly furnish healthcare services can also cause trouble for providers.

Please visit this page to continue reading.
Posted in Anne Novick Branan, Fraud/Abuse | Tagged , , , , , , , ,

CMS Announces New Flexibility with MACRA

By: Mike Segal

It is now quite clear that the Medicare Access and CHIP Reauthorization Act, or MACRA, enacted into law in 2015, will have a telling effect on how Medicare reimburses for physician services.

In April 2016, the Centers for Medicare & Medicaid Services (CMS) released a voluminous proposed rule for implementing MACRA.  The full implementation of MACRA, with monetary bonuses and penalties, will not occur until 2019.  However, the proposed rule made clear that 2019 results for MACRA’s MIPS model (where it is estimated that more than 90% of all physicians will be placed at the inception of MACRA) would be based on physician performance in 2017.  Thus, every Medicare provider physician in the country was expected to get ready for 2017 in very short order.

CMS gave stakeholders until the end of June to comment on the proposed rule. The final rule was, and is still, expected to be released by November.

Heavy among the comments was that physicians would have great difficulty being ready by 2017.  Many asked that the implementation of MACRA be delayed.

Responding to these comments, on September 8, in the CMS Blog (talk about 21st Century – to be update you must keep your eye on the CMS blog!), Andy Slavitt, Acting Administrator of CMS, announced some new flexibility in the pace of MACRA reporting for 2017.   The blog now provides four options, two of which are new:

  1. Option One – So long as the provider submits some data to the CMS Quality Payment Program (QEP), including data from after 2016, there will be no payment penalty imposed for 2019 (NOTE: no definition of the word “some” was provided – presumably that will come later).
  2. Option Two – If the provider only elects to participate for 2017, and report information to the QEP, for a certain amount of days, it may qualify for a small bonus.
  3. Option Three – The provider may report in full for 2017, as originally anticipated.
  4. Option Four – The provider may participate in MACRA’s APM model, for practices willing to accept some considerable risk, for 2017.

It is important to note that CMS is only providing the new options for 2017. It still expects all providers to be able to fully report by 2018.

In addition, given the fact that the MPIS model is to be budget neutral, taking potentially negative practices off the grid almost certainly means that the MPIS or APM bonuses, or both, will be reduced for 2019.

Posted in Care Delivery, Mike Segal | Tagged , , , , , , , , , , , , , , ,

Mount Sinai Affiliated Hospitals to Pay $3 Million Settlement for Delaying Medicaid Overpayments

By: Fred Segal

On August 24, 2016, the US Attorney for the Southern District of New York, in conjunction with the US Department of Health and Human Services, Office of the Inspector General (OIG) announced that it settled a whistleblower suit with three hospitals in the Mount Sinai Health System in New York City for violating the federal “60-day” rule (60-Day Rule) governing the repayment of identified overpayments. According to the US Attorney, the three hospitals, working under a partnership called Continuum Health Partners, Inc. (Continuum) “learned that it had received over $800,000 in potential Medicaid overpayments in 2011,” and “had an obligation under the law to return those funds within 60 days.  Instead, Continuum delayed repayment for more than two years and only fully repaid the Medicaid program in 2013.”

Of significance, this is the OIG’s first settlement for violations under the 60-Day Rule since CMS published a final rule (Final Rule) clarifying certain parts of the 60-Day Rule, which was promulgated by the enactment of the Patient Protection and Affordable Care Act (i.e. “Obamacare,” or “PPACA” in 2010. Section 1128J(d)(2) of PPACA provides that an “overpayment be reported and returned by the later of—(A) the date which is 60 days after the date on which the overpayment was identified; or (B) the date any corresponding cost report is due.”

After PPACA’s enactment, amongst a number of items, providers had sought clarification as to the meaning of when an overpayment “was identified”. The Final Rule provides “that a person has identified an overpayment when the person has or should have, through exercise of reasonable diligence, determined that the person received an overpayment and quantified the amount of the overpayment.

The complaint in the whistleblower suit discussed above was filed in April 2011. It alleges that, in 2010, Continuum was alerted by the New York State Comptroller that it submitted erroneous claims for Medicaid payment between 2009 and 2010. Continuum subsequently conducted an internal investigation in February 2011 identifying “approximately 900 claims totaling over $1million that may have been wrongly submitted to and paid by Medicaid.” Notwithstanding this discovery, Continuum did not fully repay the erroneous claims until March 2013 (almost two years later), which the complaint alleges is a violation of the 60-Day Rule.

Posted in Compliance, Fred Segal, Regulatory | Tagged , , , , , , , , , , , , ,

OCR to Increase Efforts to Investigate Privacy Breaches of Unsecured Protected Heath Information Affecting Fewer Than 500 Individuals

By: Edward J. Welch

The Office for Civil Rights (OCR) is the agency within the U.S. Department of Health and Human Services (HHS) that investigates privacy breaches of unsecured, protected health information (PHI) under the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The exponential growth in the use of electronic devices for the storage and transmission of PHI correspondingly has increased the risk to healthcare organizations of experiencing a Breach of PHI and subsequent, costly OCR investigation.

The HIPAA Breach Notification Rule, 45 CFR §§ 164.400-414, requires HIPAA covered entities and their business associates to provide notification following a Breach of PHI. A Breach of PHI is defined as the acquisition, access, use or disclosure of unsecured PHI, in a manner not permitted by HIPAA, which poses a significant risk of financial, reputational, or other harm to the affected individual.  Following a Breach of PHI, covered entities must provide notification of the breach to affected individuals, the Secretary of HHS, and, in certain circumstances, to the media.  The reporting protocol for a Breach of PHI varies depending upon the number of individuals affected by the breach.  If a Breach of PHI affects 500 or more individuals, a covered entity must notify the Secretary of the breach without unreasonable delay and in no case later than 60 calendar days from the discovery of the breach. If a Breach of PHI affects fewer than 500 individuals, a covered entity must notify the Secretary of the breach within 60 days of the end of the calendar year in which the breach was discovered.  An investigation by the OCR is virtually assured when a covered entity experiences a Breach of PHI affecting more than 500 individuals.  Such a regulatory investigation likely will be time-consuming and nerve-wracking.  The risk that the OCR may decide to impose a civil money penalty in response to a covered entity’s failure to address a Breach of PHI is real and ever-present.

On August 18, 2016, the OCR announced that it had begun an initiative to more widely investigate the root causes of breaches affecting fewer than 500 individuals. Prior to this announcement, the OCR had prioritized investigation of reported Breaches of PHI affecting greater than 500 individuals and would investigate breaches affecting fewer than 500 individuals only as resources permitted.  While Regional Offices will still retain discretion to prioritize which smaller breaches to investigate, the announcement marks an increased focus upon smaller breaches.  In prioritizing their investigations, Regional Offices will consider:

  • The size of the breach;
  • Whether theft or improper disposal of unencrypted PHI was involved;
  • Whether the breach involved an unwanted intrusion to an IT system (for example, by hacking);
  • The amount, nature and sensitivity of the PHI involved; or
  • Instances where numerous breach reports from a particular covered entity or business associate raise similar issues.

The Regional Offices may also consider the lack of breach reports affecting fewer than 500 individuals when comparing a specific covered entity or business associate to like-situated covered entities and business associates.

The OCR’s announcement serves as: a reminder that covered entities must remain vigilant of even the smallest Breaches of PHI; and incentive to safeguard against breaches and to maintain effective policies and procedures to deal with a breach, should one occur. Policies and procedures for the storage, use and dissemination of PHI regularly should be reviewed and updated.


Posted in Edward Welch, Risk/Liability, Technology | Tagged , , , , , , , , , , , , , ,

Broad and Cassel Represents Three of the Top Ten ACOs in the Country


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45 Broad and Cassel Attorneys Named 2017 Best Lawyers® in America, Four Selected as Lawyers of the Year

Broad and Cassel is pleased to announce that 45 of the firm’s attorneys have been included in The Best Lawyers in America® 2017. Additionally, four attorneys were named a “Lawyer of the Year” in their respective specialty areas.

Only one attorney in each practice area in each region is named a “Lawyer of the Year,” and Broad and Cassel attorneys took home the “Lawyer of the Year” designation in four practice areas for three metro areas in the state.

Broad and Cassel attorneys named a “Lawyer of the Year” include:

  • Managing Partner Mark Raymond for Litigation – Mergers and Acquisitions in Miami
  • Partner Beverly Pohl for Appellate Practice in Fort Lauderdale
  • Partner Clifford Hertz for Land Use and Zoning Law in West Palm Beach
  • Of Counsel Anne Novick Branan for Health Care Law in Fort Lauderdale

The following Broad and Cassel attorneys were selected for recognition among The Best Lawyers in America 2017:

  • C. David Brown, II, Chairman, Government Relations Practice, Land Use and Zoning Law, and Real Estate Law*
  • Jeffrey A. Deutch, Managing Partner, Real Estate Law*
  • Gabriel L. Imperato, Managing Partner, Criminal Defense: White-Collar, Health Care Law and Personal Injury Litigation – Defendants**
  • Patricia Lebow, Managing Partner, Commercial Litigation*
  • Mark F. Raymond, Managing Partner, Bet-the-Company Litigation, Commercial Litigation, Litigation – Banking and Finance, Litigation – Mergers and Acquisitions, Litigation – Real Estate, Litigation – Securities, and Public Finance Law*
  • M. Stephen Turner, Managing Partner, Commercial Litigation*
  • Robert Alfert, Jr., Partner, Construction Law, Eminent Domain and Condemnation Law, and Litigation – Construction*
  • Sara W. Bernard, Partner, Real Estate Law
  • Michael Bittman, Partner, Health Care Law*
  • Steven Ellison, Partner, Litigation – Real Estate
  • Peter R. Goldman, Partner, Commercial Litigation
  • Clifford I. Hertz, Partner, Land Use and Zoning Law, and Real Estate Law
  • Arvin J. Jaffe, Partner, Banking and Finance Law
  • Carlos E. Loumiet, Partner, Banking and Finance Law*
  • Richard B. MacFarland, Partner, Real Estate Law*
  • George Mahfood, Partner, Mass Tort Litigation/Class Actions – Plaintiffs
  • Douglas L. Mannheimer, Partner, Government Relations Practice and Health Care Law
  • Daniel S. Newman, Partner, Commercial Litigation, Litigation – Securities, and Securities Regulation
  • Lester J. Perling, Partner, Health Care Law*
  • Beverly A. Pohl, Partner, Appellate Practice*
  • Douglas Rillstone, Partner, Environmental Law, Land Use and Zoning Law, and Litigation – Environmental*
  • Carl V. Romano, Partner, Real Estate Law
  • Carl Rosen, Partner, Tax Law, and Trusts and Estates
  • Stephanie Russo, Partner, Health Care Law
  • Mike Segal, Partner, Health Care Law*
  • James E. Slater, Partner, Real Estate Law*
  • Jeremy Springhart, Partner, Construction Law and Litigation – Construction
  • Douglas E. Starcher, Partner, Public Finance Law and Securities/Capital Markets Law
  • Charles Stratton, Partner, Eminent Domain and Condemnation Law*
  • George W. Tate III, Partner, Construction Law
  • Jo O. Thacker, Partner, Real Estate Law
  • James J. Wheeler, Partner, Real Estate Law
  • Michael K. Wilson, Partner, Commercial Litigation, Construction Law and Litigation – Construction*
  • Patricia Baloyra, Of Counsel, Land Use and Zoning Law
  • C. Ken Bishop, Of Counsel, Eminent Domain and Condemnation Law*
  • Anne Novick Branan, Of Counsel, Health Care Law
  • Paul R. DeMuro, Of Counsel, Health Care Law**
  • Jacqueline S. Miller, Of Counsel, Construction Law, Land Use and Zoning Law and Real Estate Law
  • Mark R. Osherow, Of Counsel, Commercial Litigation
  • A. Wayne Rich, Of Counsel, Land Use and Zoning Law
  • A. Jeffry Robinson, Of Counsel, Corporate Law
  • Emery H. Rosenbluth, Jr., Of Counsel, Bet-the-Company Litigation and Commercial Litigation
  • Jon A. Sale, Of Counsel, Criminal Defense: General Practice and Criminal Defense: White-Collar
  • Stephen Siegel, Of Counsel, Health Care Law
  • Jayne C. Weintraub, Of Counsel, Criminal Defense: White-Collar

* Denotes 10th year on the list
** Denotes 20th year on the list

Since it was first published in 1983, Best Lawyers® has become universally regarded as the definitive guide to legal excellence. Best Lawyers lists are compiled based on an exhaustive peer-review evaluation. For the 2017 Edition of The Best Lawyers in America©, 7.3 million votes were analyzed, which resulted in almost 55,000 leading lawyers being included in the new edition. Lawyers are not required or allowed to pay a fee to be listed; therefore inclusion in Best Lawyers is considered a singular honor. Corporate Counsel magazine has called Best Lawyers “the most respected referral list of attorneys in practice.”

Posted in Practice News | Tagged , , , , ,

BCBA Appoints Shachi Mankodi to Women in Leadership Committee

We are pleased to announce that Shachi Mankodi, senior counsel in the firm’s FoSMankodi_72dpi_140widthrt Lauderdale office, has been appointed to serve as vice chair of the Broward County Bar Association’s (BCBA) Women in Leadership Committee.

Mankodi will work closely with BCBA staff to further professionalism in the practice of law throughout Broward County and organize continuing legal education seminars of benefit to the greater membership and community at large. She will serve a one-year term.

As a member of the firm’s Health Law Practice Group, Mankodi represents individuals and organizations in licensure disputes and proceedings as well as compliance and reimbursement matters involving the Medicaid and Medicare programs. She also has been involved in coordinating state health care policy for the Office of the Governor and has provided legislative policy analysis and recommendations to executive agencies.

Active in various community and professional organizations, Mankodi is a member of the South Asian Bar Association and IMPACT Young Ambassadors for Memorial and Joe DiMaggio Children’s Hospital Foundations, among others. She holds a bachelor’s degree from Johns Hopkins University and earned her juris doctor from Florida State University College of Law.

Posted in Practice News, Shachi Mankodi | Tagged , , , , , , , , , , , ,

Reminder to Health Care Providers: You Have to Disclose to Patients That You Are an Investor in the Entity To Which You Are Referring Them

By: Fred Segal

Attorneys may sometimes discover that, unknown to the client, their clients may be engaging in conduct that is violative of the law. Much of the time, the client simply isn’t aware that such law exists. One of the more common statutory provisions that slips through the cracks is Florida Statute Section 456.052. The foregoing statute provides that a health care provider must disclose, to a patient, his or her investment interest in an entity before he or she refers the patient to such entity. The term “health care provider” in this context not only includes physicians, but also chiropractors, podiatrists, optometrists, and dentists.

Please visit South Florida Hospital News and Healthcare Report to continue reading.

Posted in Care Delivery, Fred Segal, Regulatory | Tagged , , , , , , , , , , ,

July 2016 Health Law Update Now Available

Please visit this page for the July 2016 installment of Broad and Cassel’s “Health Law Update.” Topics include Medication Therapy Management, balance billing legislation, false claims and healthcare providers and bankruptcy.

If you would like to receive the “Health Law Update” in your inbox, please use the form found at the link below:

Sign Up Now

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