Healthcare EmpoweredThe finalized Radiation Oncology payment model and the Final CY 2021 Medicare Physician Fee Schedule (“MPFS”) have now been made public. Many in the industry will continue to face downward pressure on reimbursement during the coming year under the new MPFS payment rates set by Medicare which will drive overall cuts estimated to average 5.0% for all Medicare revenues.
Source: Reimbursement Pressure in Radiation Therapy & Block Lease Arrangements
A value-based arrangement is an arrangement entered into between a value-based enterprise (VBE) and one or more of its participants, or among VBE participants in the same VBE, for the provision of one or more value-based activities for a target patient population. The final rule defines a VBE participant as an individual or entity that engages in at least one value-based activity as part of a value-based enterprise, other than a patient acting in their capacity as a patient.
For purposes of the OIG’s new safe harbors, a VBE is two or more participants that: (1) are collaborating to achieve at least one value-based purpose; (2) are each a party to a value-based arrangement with the other (or at least one other participant in the same VBE); (3) have an accountable body or person responsible for financial and operational oversight of the VBE; and (4) have a governing document describing the VBE and how its participants intend to achieve the VBE’s value-based purpose(s).
The size and structure of a VBE can vary greatly from a large network of providers and suppliers; a separate legal entity, like an Accountable Care Organization (ACO); or just two providers contracting together to form a value-based arrangement.Finally, a value-based purpose is (1) coordinating and managing the care of a target patient population; (2) improving the quality of care for a target patient population; (3) appropriately reducing the costs to, or growth in expenditures of, payors without reducing the quality of care for a target patient population; or (4) transitioning from health care delivery and payment mechanisms based on the volume of items and services provided to mechanisms based on the quality of care and control of costs of care for a target patient population.
On December 3, the U.S. Department of Health and Human Services (HHS) issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to critical countermeasures against COVID-19.
A great resource of the a redline versions of the regulations that highlight the changes for the new revisions to Stark and the Anti-Kickback Statute. The documents may be accessed here:
The Federal Register versions of the revised regulations and accompanying commentary may be accessed here:
Hat tip to Holland and Hart.
In its final rule, the OIG defined what constitutes “telehealth technologies” more broadly than in its proposed rule, but otherwise chose to track the conditions for the exception contained in the underlying statute and not to implement any of the additional conditions that were included in the proposed rule.
Source: OIG Issues Final Rules on Anti-Kickback Statute and the Civil Monetary Penalty
The defendants are alleged to have conspired to pay and receive kickbacks in exchange for physicians’ orders that were used to submit claims for payment to federal health care programs. The conspirators obtained patient information, including protected health information and personally identifiable information, and used the information to create fictitious physicians’ orders. The conspirators then sold the physicians’ orders to each other and to other durable medical equipment providers. Within approximately eight months, the defendants collectively obtained more than $2.9 million in proceeds from the criminal scheme.
Source: Fifth Individual Charged in Health Care Kickback Conspiracy
According to the U.S. Department of Health & Human Services’ Breach Portal, sometimes called the “Wall of Shame,” 418 breaches of HIPAA were reported in 2019. Some 34.9 million Americans had their protected health information (PHI) compromised. How is this still happening?
Healthcare companies and practices make the biggest mistake by believing human behavior can be perfect all the time. … [R]esulting from this assumption about human behavior, healthcare providers cheap out and refuse to pay for sufficient security measures for their network. A cheap security system may not contain proper firewalls and leave devices vulnerable, while wholly unencrypted devices can be a nightmare. Healthcare employees leave their cell phones, laptops, or iPads in their vehicles while they run out for coffee or to the grocery. And what happens next? The vehicles are broken into, and PHI is at risk.
I think there is another erroneous assumption that employers make: they assume their business model will continue to be the same.
It is so easy when putting a deal together, to come up with workflows and policies that make the deal compliant. But as time goes on, the business model shifts, even slightly, in a way that makes the previously workflow and policy no longer compliant.
As a result, as part of their ongoing Compliance Program, Covered Entities should routinely audit their HIPAA Privacy and Security standards to ensure they are evolving with their business.
Source: Ways your Healthcare Company is Breaking the Law — Without Realizing it
The final rules for changes to the Stark Law and Anti-Kickback Statute (healthcare fraud & abuse laws) have been published and go into effect on January 19, 2020. Of course, health lawyers love this stuff, but it could impact other practice areas too.
Transaction attorneys, you already know to be very careful if your transaction or arrangement, in any way, involves a hospital, doctor, or any other healthcare provider or entity. Even if your deal does not involve a healthcare provider, but could impact reimbursement by any federal program, these statutes may be implicated.
Litigators, these statutes can apply to your cases too. If your case involves one of these improper payments or an improper business structures, you might have a contractual avoidance theory available to you, if you’re the defendant, or an additional claim of fraud, if you are the plaintiff.
The key point is that these statutes can apply in ways that don’t seem immediately obvious.
Source: Stark + AKS Final Rules
In a Special Fraud Alert issued on November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS-OIG) raised significant fraud and abuse concerns with companies offering or providing remuneration in connection with physician speaker programs. Speaker programs typically involve one health care professional presenting to others on a company’s drug or device, or a disease state relevant to the company’s products, in exchange for a speaker honorarium. While speaker programs may have some legitimate purposes, HHS-OIG warned of risk the programs create for drug or medical device companies and health care professional participants, if one purpose of the program is to induce or reward federal health care program referrals.
This has been a long time coming. There have been various prosecutions and settlements involving speaker programs over the years. I’m surprised it has taken this long for OIG to issue a Special Fraud Alert.
Yolanda Hamilton, MD, was found guilty by a federal jury of participating in a Medicare scheme that involved signing false “plans of care” and other medical documents for home health services that were used to submit fraudulent claims to Medicare. She allegedly received $30,000 in kickbacks during the four-year scheme. Prosecutors alleged that Dr. Hamilton and her co-conspirators submitted more than 2,500 fraudulent claims to Medicare, according to the Houston Chronicle.
Source: Houston physician sentenced to prison for $17M billing fraud
