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

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?

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.

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

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

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

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 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

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.

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

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New Florida Laws Focus on Health Care

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

Pelvic Examination Law – Florida Takes a Second Look

Posted in Health Care Providers, Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Physicians

The Florida medical community was left concerned and confused by the passage of the original 2020 pelvic examination law. As we discussed in our past blog, practitioners believed the law was overly burdensome, and they were unsure how to implement it. Senator Lauren Book’s new bill, SB 716, sought to make consent clear through an amendment to the original law. It became effective July 1, 2021.

The updated law revises the definition of “pelvic examination” and the situations in which consent is required for pelvic examinations. Unfortunately, the new law still misses the mark on clarifying when consent is and is not required. Due to the continued lack of clarity, it is essential that providers review policies and consent forms to ensure they understand what is required of them when conducting pelvic examinations. If appropriate policies and consent forms have not been implemented, now is the time to put them in place. Continue Reading

Group Health Plan Sponsors are Getting Serious About Pricing Transparency – Are You Keeping Up?

Posted in Health Care Providers, Health Insurers & Managed Care Organizations, Healthcare Law, Hospitals & Health Systems, Physicians

In early July, the Department of Health and Human Services (HHS), the Department of Labor (Labor), and the Department of the Treasury (Treasury) (collectively, the Departments), along with the Office of Personnel Management (OPM) released an interim final rule related to the No Surprises Act, legislation designed to protect patients from unexpected medical bills.

The Departments’ interim final rule arrives in the broader context of a number of new health cost transparency obligations imposed upon plan sponsors (the employers or organizations that offer group health plans to employees) beginning in early 2022. While third parties can implement many of the pricing transparency measures, plan fiduciaries must ultimately ensure compliance. As compliance deadlines for new pricing transparency requirements for group health plans draw near, plan sponsors will need to use the second half of 2021 to prepare. Continue Reading

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