Providers Get Unpleasant Surprise from Latest Provisions to the No Surprises Act

Efforts to stop surprise medical costs are continuing to evolve. The Departments of Health and Human Services (“HHS”), Labor, and Treasury (collectively, the “Departments”), and the Office of Personnel Management issued an interim final rule (“Interim Rule“) with comment period on September 30, 2021 that implements provisions of the No Surprises Act. The majority of the provisions in the Interim Rule become effective January 1, 2022. The information in this blog is taken from the Interim Rule, unless otherwise noted.

The Interim Rule seeks to protect consumers by implementing various new measures, some of which are listed below: Continue Reading

FTC Warns Health App Vendors: Comply with the Health Breach Notification Rule or Pay the Penalty!

By Elizabeth F. Hodge and Christy S. Hawkins on September 27, 2021 Posted in HIPAA, Privacy, and Data Security

Vendors of health applications (“health apps”) and connected devices that collect or use individuals’ health information, along with their service providers, are now on notice that they must provide timely notice to consumers and the Federal Trade Commission (FTC) when there is a security breach compromising health information. In response to the proliferation of health apps and connected devices that gather large volumes of individually identifiable health information, the FTC recently issued a Policy Statement explaining the scope of its Health Breach Notification Rule (the “Rule” or “HBNR”), the types of incidents that may trigger notice obligations, and that it intends to bring actions to enforce the Rule consistent with the Policy Statement. Specifically, certain health apps may be subject to the Rule, and sharing covered information without an individual’s authorization may trigger the Rule’s breach notification requirements. Continue Reading

Medicare & Medicaid Facilities Are Put On Notice: Employees Must Be Vaccinated

By Elizabeth F. Hodge, Danielle C. Gordet and Karen M. Buesing on September 14, 2021 Posted in Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Physicians

Medicare and Medicaid certified facilities will be required to ensure that their employees are vaccinated for COVID-19, the Centers for Medicare & Medicaid Services (CMS) announced on September 9, 2021. Healthcare providers with 100 or more employees also may be subject to a forthcoming Emergency Temporary Standard (“ETS”) from the U.S. Department of Labor’s Occupational Safety and Health Administration (“OSHA”) that also will require that employees be vaccinated for COVID-19. These mandates are part of President Biden’s new six-prong COVID-19 Action Plan (the “Plan”) that he announced last week.

The CMS Vaccine Mandate

Importantly, the new requirements will be a condition of participating in the Medicare and Medicaid programs and will be issued through emergency regulations as an Interim Final Rule with Comment Period expected to be published in October 2021. CMS will accept public comments after the rule is published. The Interim Final Rule will apply to any healthcare facility receiving Medicare or Medicaid reimbursement. The Interim Final Rule builds on the Administration’s August 18, 2021 announcement of a vaccination requirement for nursing facilities. This new rule will apply not only to nursing home staff, but also to staff in hospitals, dialysis facilities, ambulatory surgical centers, and home health agencies. It also will extend to clinical staff and individuals providing services under arrangements, as well as volunteers and staff who are not involved in direct patient, resident, or client care. CMS expects that this new action will protect patients of the 50,000 providers and over 17 million healthcare workers in facilities that receive Medicare and Medicaid funding. Continue Reading

Should You Consider Offering Cheaper Health Plan Coverage in 2022 for Vaccinated Employees?

By Beth Alcalde on August 31, 2021 Posted in Health Care Providers, Health Insurers & Managed Care Organizations, Hospitals & Health Systems, Physicians

If you still have unvaccinated workers in January, might you provide a financial incentive for employees to be vaccinated, by charging them higher healthcare insurance premiums? That is the question facing exhausted but dedicated corporate Human Resources leaders as they approach annual open enrollment season, in which employees are asked to lock in their 2022 benefit plan year’s elections. As the price for 2022 health plan and other coverages come into sharper focus around this time of year, final decisions on what portion of plan costs should be borne by the company and what portion should be passed along to employees loom on the horizon.

Updated for Expanded DDC Interpretation: New Help for the Florida Healthcare Transaction Attorney- Temporary Drug, Device, and Cosmetic Permits

By Martin R. Dix on August 30, 2021 Posted in Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment

Whoever authored this new legislation (Chapter 2021-135, Laws of Florida) deserves a pat on the back for an idea whose time has come. When an applicant files for a change of ownership (“CHOW”) or change of location for one of the permits authorized by the Florida Department of Business Professional Regulation, Division of Drugs, Devices, and Cosmetics (affectionately, “DDC”) under Part 1 of Chapter 499, FS, they can now also request a temporary permit for 90 days.

Having the option to request a temporary permit is especially important when pursuing a CHOW. In a typical healthcare CHOW process, the parties are hammering out the terms of the agreement while the healthcare regulatory team coordinates with state agency personnel to arrange issuance of the healthcare entity permit exactly on the effective date of the transaction. The problem is that the parties’ preferred closing schedule may not coincide with statutory time frames and the schedules of the state agency permit processors. So, prior to this new legislation, if, for example, the parties want to close in 10 days, but the state can’t process the application for 30 days, then the parties would be left with no permit for 20 days after the scheduled closing. The new owner loses business and the provider’s patients struggle to find a provider to serve them while the buyer awaits the new permit. Also, if there are drugs on the premises, what happens to them when the permit is no longer in effect? Continue Reading

Caveat Emptor: Private Equity Firms Are Increasingly Vulnerable to Qui Tam Lawsuits

By William J. Spratt, Jr. and Jeremy Burnette on August 10, 2021 Posted in Fraud & Abuse & False Claims Act, Healthcare M&A, Joint Ventures, Transactions & Health Ventures

The U.S. Department of Justice (“DOJ”) has settled six qui tam lawsuits brought in various jurisdictions by whistleblowers against a private equity firm and its portfolio healthcare companies. A group of diagnostic testing companies and the private equity firm, which held a minority investment interest in the parent, settled claims that they violated the False Claims Act (“FCA”) and the federal Anti-Kickback Statute (“AKS”). On July 21, 2021, the DOJ announced that the government settled FCA claims against the Alliance Family of Companies, LLC (“Alliance”), a national electroencephalography (“EEG”) diagnostic testing company, and Ancor Holdings LP (“Ancor”), the private equity firm that invested in Alliance. Alliance agreed to pay $13.5 million and Ancor agreed to pay $1.8 million to settle the FCA lawsuits. The Relators will receive approximately $2.3 million of the settlement proceeds.

The whistleblowers’ qui tam complaints alleged that Alliance violated the AKS by providing EEG interpretive reports to non-neurologist physicians who referred patients to Alliance to enable them to bill government healthcare programs for services they did not provide. Alliance reportedly paid independent contractor neurologists to interpret EEG tests, and it provided those interpretive reports to the referring physicians to enable them to bill for the professional interpretation of the tests. The DOJ contended that the provision of the interpretive reports allowed the referring physicians to bill for the study, induced the physicians to refer the tests to Alliance, and constituted remuneration in exchange for the referral, a violation of the AKS. The submissions of claims by Alliance and by the referring physicians were deemed by DOJ to constitute false claims in violation of the FCA. Continue Reading

New Help for the Florida Healthcare Transaction Attorney- Temporary Drug, Device, and Cosmetic Permits

By Martin R. Dix on July 29, 2021 Posted in Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment

Having the option to request a temporary permit is especially important with a CHOW. In a normal health care CHOW process, the parties are hammering out the terms of the agreement while the health care due diligence team coordinates with state agency personnel to have them issue the health care entity permit exactly on the date that the parties wish to close. The problem is that the buyer’s and seller’s schedules may not completely coincide with statutory time frames and the schedules of the state agency permit processors. So, if the buyer and seller want to close in 10 days, but the state can’t process the application for 30 days, then if the parties close the deal there will be no permit for 20 days. The new owner loses business and the provider’s patients struggle to find a provider to serve them while the buyer awaits the new permit. Also, if there are drugs on the premises, what happens to them when the permit is no longer in effect? Continue Reading

Decision Reminds Providers of Limits on Restricting Employee Communications with Media

By Karen M. Buesing on July 20, 2021 Posted in Health Care Providers, Healthcare Law, Hospitals & Health Systems, Physicians

Hospitals and medical groups that bar staff from communicating with the media should take another look at those prohibitions following a recent federal appellate decision finding such a policy unlawful under the National Labor Relations Act (NLRA).

Multiple news accounts have detailed incidents where doctors and nurses were disciplined or fired for speaking out about staffing issues or inadequate Personal Protective Equipment. However, hospitals and medical groups should recognize that such complaints may be protected under both the NLRA and the Occupational Safety and Health Act (OSH Act), or similar state laws.

In May, a Maine hospital was required to reinstate an activities coordinator in the rehabilitation department after firing her for writing a letter to the editor expressing support for nurses and doctors in their respective labor disputes and urging management to heed the nurses’ staffing demands and concerns about risk to patient safety. Her letter criticized management as out of touch with patient care and negatively affecting hospital staff and the local community. Continue Reading

Have Paper Prescriptions Gone the Way of the Horse and Buggy? Almost.

By Martin R. Dix on July 19, 2021 Posted in Healthcare Law, Pharmacy, Drugs, Medical Devices & Equipment, Physicians

For most Florida prescribers whose licenses haven’t renewed since 2019, it’s time to commence electronic prescribing. In 2019, the legislature enacted legislation that required electronic prescribing. However, this requirement became effective on the earlier of the prescriber’s license renewal date or July 1, 2021. Section 456.42(3), Florida Statutes requires health care practitioners to “electronically transmit prescription(s).” This term is not defined and, while it likely was intended to mean “electronic prescribing,” it does not say that.

The requirement that practitioners electronically transmit prescriptions only applies to those health care practitioners licensed by law to prescribe (MDs, DOs, APRNs, PAs, podiatric physicians, dentists, and optometrists) who:

Maintain an electronic health records system (“EHR”); or
Prescribe medicinal drugs as an owner, employee or contractor of a licensed health care facility or practice that maintains EHR

New Florida Laws Focus on Health Care

By Danielle C. Gordet and Kirk S. Davis on July 15, 2021 Posted in Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Pharmacy, Drugs, Medical Devices & Equipment, Physicians

Before closing its 2021 session, the Florida Legislature passed several bills that impact health care, summarized below.

The first bill discussed below regarding civil liability became effective on March 29, 2021. The majority of the other bills became effective on July 1, 2021. Continue Reading