Just How Confidential is Information in Patient Safety Information?

patient safety informationBy: Jacqueline Bain

Not too long ago, when something would go wrong in a hospital, a patient’s medical record might note the facts of what had happened (“Mrs. Jones was found on the floor of her hospital room with a swollen wrist. An x-ray revealed a wrist fracture.”), while the hospital’s incident report would analyze why it happened in order to prevent further harm (“Orderly Green forgot to raise the guardrails on Mrs. Jones’ bed. Mrs. Jones fell out of her bed as a result of the displaced guardrail. Let’s put in place a policy that all guardrails must be raised if an orderly steps more than three feet from a patient’s bed.”). Should Mrs. Jones decide to sue the hospital, she and her attorney would have access to the medical record, but not necessarily the incident report.

Incident reports like the one mentioned above have long been meant as a learning tool for facilities to analyze unfortunate occurrences on their premises and learn from their mistakes to prevent future harm. However, these reports often contain admissions of fault, or near admissions of fault. So how can a hospital balance its need to improve on past practices without opening itself to a mountain of liability? Florida’s state laws seemingly contrast with Federal laws.Continue reading

DME Compliance Alert: Back Braces Under Specific Review by Medicare

medicare appeal

DME telehealth

By: Susan St. John

DME Compliance Alert: Department of Health and Human Services, Office of Inspector General, updated its work plan in January 2018 to include heightened scrutiny of off-the-shelf orthotic devices, specifically back braces for HCPCS Cods L0648, L0650 and L1833 due to one MAC identifying improper payment rates as high as 79 to 91 percent. Of specific concern is the lack of documentation of medical necessity, including Medicare beneficiaries being prescribed back braces without an encounter with the referring physician within 12 months prior to an orthotic claim being filed. The OIG plans to analyze billing trends nationwide, and expects to issue a report sometime in 2019.Continue reading

Healthcare Compliance: Providers Must Use Plans They Have in Place

medical practice complianceBy: Jacqueline Bain

In 2015, Assistant Attorney General Leslie Caldwell spoke publicly about the importance for every healthcare provider to not only have a compliance program on its shelf, but also being sure that the compliance program is “tailored to the unique needs, risks and structure of each business or industry.” Assistant Attorney General Caldwell explained, “the adequacy of a compliance program is a factor when [the DOJ] decide[s] how and whether to prosecute a company.  The lack or insufficiency of a compliance program can have real consequences for a company when a violation of law is discovered.”Continue reading

Healthcare Compliance: Providers MUST Have Corporate Compliance Programs

healthcare compliance

healthcare complianceBy: Jacqueline Bain

How serious is the federal government that corporate compliance is necessary for healthcare providers?

In late 2015, the Department of Justice (DOJ) hired the agency’s first Compliance Counsel. Then, in early 2017, the DOJ published “common questions” that US Attorneys should ask as part of a criminal investigation when the DOJ evaluates a company’s compliance program. The “common questions” published by the DOJ describe specific factors that prosecutors should consider in conducting an investigation of a corporate entity, determining whether to bring charges, and negotiating plea or other agreements. These factors include “the existence and effectiveness of the corporation’s pre-existing compliance program” and the corporation’s remedial efforts “to implement an effective corporate compliance program or to improve an existing one.”Continue reading

Resurgence of Medical Practice Acquisitions in Private Equity

telemedicine contract

medical practice saleBy: Jeff Cohen

Private money (e.g. private equity) is back chasing those selling medical practices and medical business acquisitions.  This time around it is very different from similar activity in the 90s.  Back then, the movement was public companies aggregating gross income dollars, which for a time drove stock prices.  Today’s private money buyers are looking to maximize profitability through achieving efficiency and aggregating large groups for leverage and the development of new income streams.  Though stock (in the form of warrants and options or stock itself) if often on the table, it doesn’t have to be.  Buyers are doing all cash deals, albeit to some degree on an earnings basis.  If you want the full price, you have to remain involved and do what you can to maintain revenues and perhaps even drive them up.

Physicians especially have to know what they’re dealing with and then have at least a basic understanding of the issues that will drive these deals.  To begin with, “private equity” simply means private investors (typically a group that pools their capital) that buy a portion or all of a company.  Their investments are usually much larger than venture capital firm deals.  They are not publicly traded entities.  What do they want?  To invest money in mature businesses, grow a company’s profitability and then “flip” their ownership to another buyer, typically in three to five years form their launch date.  In contrast, venture capital firms usually invest in start-ups, buy 100% of the company and require control.Continue reading

The Federal Opioid Fraud and Abuse Detection Unit: An Enforcement Initiative Lacking in Resources for Prevention and Treatment of Opioid Abuse

By: Jacqueline Bain

Earlier this month, Attorney General Jeff Sessions announced the formation of the Opioid Fraud and Abuse Detection Unit, which is a pilot program of the United Stated Department of Justice. AG Sessions noted that there are three components to approach the opioid crisis that our nation faces: prevention, treatment and enforcement.

  1. Prevention. AG Sessions noted briefly that the DOJ is undertaking that component through raising awareness, through drug take-back programs, and through DEA’s 360 Strategy program, which incorporates law enforcement, diversion control and community outreach to tackle the cycle of violence and addiction in US cities. He also stated that law enforcement is a component of prevention.
  2. Treatment. AG Sessions articulated that treatment can help break the cycle of addiction and crime and help people get their lives back together.
  3. Enforcement. AG Sessions dove deep in the area of enforcement, reasoning that enforcing our laws helps keep drugs out of the hands of our citizens, decreases their availability, drives up their price, and reduces their purity and addictiveness. He added, “Enforcement will make a difference in turning the tide in this epidemic.”

Continue reading

Medical Marijuana Law: Medical Use in Florida Part II

Florida physician self referral law

florida law marijuanaBy: Susan St. John

The Board of Medicine and Board of Osteopathic Medicine Joint Committee on Medical Marijuana (the “Committee”) have started the journey to developing rules pursuant to the Medical Marijuana Use Act, Senate Bill 8A, Chapter 2017-232, Laws of Florida, Section 381.986, Florida Statutes). The Committee’s first conference was held July 14, 2017, with a follow-up conference being held August 3rd. A third conference is scheduled for August 25th during the Board of Osteopathic Medicine’s monthly meeting.Continue reading

Starting Healthcare Business: What to Consider

By: Jeff Cohen

As a healthcare business lawyer, I’ve seen nearly everything entrepreneurs think might be a good idea.  They usually come to me when starting a healthcare business with questions like:

  1. Do you like an LLC better than an Inc., and if so why;
  2. Does the Stark Law (or the Anti-Kickback Statute) allow us to do this?;
  3. Is it ok to allocate ownership and profit distribution differently?;
  4. Will insurers pay for this?; and
  5. WWMT?  (What Would Medicare Think?).

These are great questions.  And they’re off base.  In fact, they’re not only off base. They’re also out of order.  Here’s one for you–Continue reading

Expanding the Reach of your Medical Practice through Telemedicine

“Wherever the art of Medicine is loved, there is also a love of Humanity.” ― Hippocrates

telemedicine lawBy: Shobha Lizaso

The need for healthcare services is growing at an exponential rate throughout the US and across the world while the number of healthcare providers is dwindling in comparison which paves the perfect way for telemedicine. The ease of healthcare access should be standard for all people, but many go without healthcare because of their geographic location or lack of funds. From these circumstances, technology has risen as the new champion for the provision of healthcare; technology is building necessary connections between healthcare providers and patients through telemedicine. The field of telemedicine complements traditional medical care in various ways already, and it is expected to continue to expand through the healthcare industry. Some current uses are as follows:Continue reading

HIPAA Security Basics: Keeping your Medical Web-Based Business Compliant

By: Shobha Lizaso

Medical web-based businesses have been on the rise, while the number of HIPAA enforcement actions by the US Department of Health and Human Services (HHS) has risen exponentially as well. Since the beginning of this year, HHS has announced several large settlements with companies that failed to comply with HIPAA Compliance requirements. For example, in January, HHS announced a $2.2 million settlement with a health insurance company when a breach resulted from a stolen portable USB device containing PHI. Also, In February, HHS announced a penalty of $3.2 million against a medical center for a breach that arose from a theft of an unencrypted laptop containing PHI. This enforcement activity is becoming the norm, so it is best to ensure that your medical website is legally compliant.

If you are handling any PHI on or through your website, you must ensure that your website is up to speed with HIPAA compliance. Here are some recommendations to address the security and privacy of PHI that your website may manage (please note that this is not a comprehensive list):Continue reading