Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.
In the beginning of June, 2020, the Department of Justice (“DOJ”) revised its Evaluation of Corporate Compliance Programs Guidance Document. The Document is designed to assist prosecutors in making informed decisions as to whether, and to what extent, the company’s compliance program is effectivefor purposes of determining, when a compliance violation has occurred, the appropriate form of any resolution or prosecution and monetary penalty. It also guides a prosecutor as to the company’s compliance obligations contained in any criminal resolution. The Document has been revised on three occasions since 2017, telegraphing the DOJ’s intent to prosecute those businesses without compliance plans, or without effective compliance plans, more harshly than those taking steps to identify and remedy risks.
A healthcare business’ failure to have in place a compliance program designed to detect and respond to potential fraud and security risks places it at a serious risk of civil and criminal liability. When a compliance issue is investigated, charged and resolved, DOJ prosecutors are instructed to consider whether the business has invested in and improved its corporate compliance program and internal controls systems. They must also determine whether those improvements have been tested to demonstrate that they would prevent or detect similar misconduct in the future. According to the DOJ, there are three fundamental questions that a prosecutor should ask when determining whether a business’ compliance plan is sound:read more
The debate over the pro’s and con’s of physician-owned hospitals has been raging for decades. Physician-owners say their hospitals are more patient-focused, provide higher quality care, obtain better outcomes and therefore receive higher patient satisfaction scores. They also point out their convenience and efficiency.
Opponents argue that physician-ownership leads to overutilization and cherry-picking of only the best patients. The less-desirable patients (both clinically and financially) are then left to be taken care of by the community hospitals. For those reasons, both the American Hospital Association and the Federation of American Hospitals remain strongly opposed to physician-owned hospitals.
Federally, the Stark Law includes an exception which allows a physician to refer patients to a hospital in which the physician has an ownership interest, so long as the ownership interest is in the entire hospital, and not just a subdivision of the hospital. However, in 2010, the federal government weighed in again on the issue, and passed the Affordable Care Act (ACA), which includes provisions which (i) restrict physician referrals to hospitals in which they hold an ownership interest; (ii) restrict any increases in physician-ownership of a hospital; and (iii) restrict expansion of physician-owned hospital facilities. CMS has granted exceptions to these restrictions, but those have been limited to rural hospitals and high Medicaid hospitals, and attempts to amend the law have failed. read more
Florida may become the “next Texas” on the issue of physician owned specialty hospitals. “Next Texas,” since there are a number of examples where the concept launched (and also flopped). Done right, such facilities could be a better fit for many patients, depending of course on patient co morbidity issues. In theory, they would be the perfect bridge between surgery centers and regular acute care hospitals. But the ability of such specialty focused care suggests a better staffing model and more targeted and efficient overhead, instead of the broad-based overhead of an acute care hospital at is spread out aver all cases, including those where overhead allocation is viewed as “just an expense.” read more
When COVID-19 passes and the world begins to return to normal, you can be guaranteed that many of your old “friends” will come to visit you. To minimize future liability, pain and time, you should be preparing today for tomorrow’s visitors:
The Lawyers. Lawyers come in many flavors, and can bring good or bad news. Depending on your initial reaction to the pandemic, and your subsequent actions as the panic started to die down you may see three types of lawyers: (1) Those that represent past or present employees who have lost their job or contracted COVID-19; (2) Those that represent patients who claim malpractice based on the care that you did or did not deliver, and also those patients who assert that they contracted COVID-19 at your office; and finally (3) Those that represent creditors or debtors of your practice. The actions you should take today are many and varied and beyond the scope of this overview, however, you should be asking the following questions of yourself: (i) did you file a claim for business interruption despite the fact that your insurance broker said you were wasting your time? (ii) does your malpractice carrier cover you for liability outside of the normal scope of providing care? (iii) are your documenting your actions throughout the pandemic to demonstrate that you were acting reasonably at a time when you did not have all the facts? (iv) did you look at your business insurance policies for coverage for employee claims, or workers comp claims, or OSHA claims? (v) did you research what other similarly situated companies are doing, as you will most likely be held to the same standards? (vi) did you follow guidance from State and Federal entities? and (vii) did you provide notice during the pandemic to debtors or other parties who have breached their obligations? read more
In my last post, I promised to keep you updated as to any new orders from the State Surgeon General that would further extend a practitioner’s ability to prescribe refills of non-malignant pain controlled substances using telehealth communications, or a qualified physician’s ability to recertify an existing qualified patient’s use of medical marijuana. The Surgeon General has extended the ability to continue assisting patients with these specific needs (as well as other needs) until May 31, 2020, through the issuance of Emergency Order 20-007 on May 9, 2020.
Keep in mind, that to prescribe a refill of a controlled substance for chronic non-malignant pain, the practitioner must be an MD, DO, APRN, or PA licensed in Florida and designated as a controlled substance prescribing practitioner. Further, to prescribe such controlled substances using telehealth communications during this public health emergency, the patient must be an existing patient of the prescribing practitioner. read more
Earlier today, Governor DeSantis issued Executive Order 20-144 extending the State of Emergency declare in Executive Order 20-52 for another 60 days. Pursuant to the extension of Executive Order 20-52, the State Surgeon General’s Order 20-003 is also extended another 60 days as its expiration is tied to the expiration of Executive Order 20-52. Thus, telehealth providers from other states with valid and unencumbered licenses may continue to provide telehealth services to persons in Florida without registering with the Department of Health. Telehealth services must still be provided using two-way audio and video communications. Audio-only telephone calls are not permitted under Florida’s existing telehealth statute and have not been waived or suspended via the State Surgeon General’s Orders. read more
Access to telehealth for Medicare beneficiaries was further increased by the Trump Administration April 30, 2020. These new changes allows all health care professionals eligible to bill Medicare for services to provide services via telehealth communications and to bill the Medicare program for such services. Additionally, certain services may now be provided using audio technology only.
For a list of services eligible for reimbursement by the Medicare Program, including services requiring audio technology only, download here. There are approximately 180 different codes reimbursable by Medicare if provided via telehealth communications.
The newest relief for small business and health care providers was passed by the Senate on April 21st, by the House on April 23rd, and became law on April 24, 2020. This new Act, provides for $484 billion in additional relief to small businesses and healthcare providers. $100 billion of the relief has been allocated to the Department of Health and Human Services and of that amount $75 billion is earmarked “to reimburse health care providers for health related expenses or lost revenues that are attributable to the coronavirus outbreak.” The remaining $25 billion will be used for expenses to research, develop, validate, manufacture, purchase, administer, and expand capacity for COVID-19 test to effectively monitor and suppress COVID-19.
The $75 billion provided under the Act will remain available until expended and will be used to prevent, prepare for, and respond to coronavirus to reimburse necessary expense or lost revenues incurred as a result of COVID-19. However, if a health care provider has already had expenses or lost revenues incurred due to COVID-19 reimbursed from other sources or that other sources are obligated to reimburse (like the CARES Act), any funds received from the $75 billion cannot be used as a “double dip” by that health care provider.
A big difference for health care providers with this Act, is that unlike the CARES Act that provided a direct deposit to health care providers based on Medicare fee for services reimbursement, no application necessary, this Act requires the health care provider to apply for relief funds. Eligible health care providers include public entities, Medicare or Medicaid enrolled suppliers and providers, profit and not-for-profit entities that provide diagnoses, testing, or care for individuals with possible or actual cases of COVID-19 (so as to accommodate the “lost revenues” provision, this could mean any patient treated since January 31, 2020, and is not necessarily limited to patients treated for COVID-19 symptoms without testing confirmation). Health care providers should act quickly and apply for funds as soon as possible as the HHS Secretary will review applications and make payments on a rolling basis. Payment may be a pre-payment, prospective payment, or a retrospective payment as determined by the HHS Secretary. Health care providers must submit an application that includes statements justifying the need of the provider for the payment. The provider must have a valid tax id number (could be an individually enrolled physician). As with the CARES Act, HHS will have the ability to audit how relief funds are expended and must start reporting obligations of funds to the House and Senates Committees on Appropriations within 60 days from the date of enactment of this Act. Reporting will continue every 60 days thereafter. read more
The Secretary of Health and Human Services issued blanket waiver of the Stark Law on March 30th in order to facilitate COVID related medical services. The waivers apply only to financial relationships and referrals related to COVID. The circumstances and conditions under which the waivers apply are strictly and narrowly described. Moreover, the waivers have no impact in the presence of fraud or abuse. With respect to physicians wanting to provide designated health services (e.g. clinical lab services) related to COVID detection and treatment, for instance–
the federal requirement that the DHS be provided in the same building as the physician office is waived; and
the financial relationship limitations between the physician (or family member) and the DHS provider is waived.
The waiver also contains specific examples of waived interactions between providers and hospitals, including— read more
Breaking News: The State Surgeon General issued Emergency Order 20-004 at approximately 6:01 p.m. on April 15, 2020. Emergency Order 20-004 extends all the provisions of Emergency Order 20-002 until May 8, 2020, unless further extended. Thus, certain practitioners licensed in other states may provide telehealth services to persons in Florida without having to register with the Department of Health. Also, Emergency Order 20-003, issued March 21, 2020, named additional clinical practitioners licensed in other states that may provide telehealth services to persons in Florida. The following professionals that hold an active, valid, and unencumbered license in another state, that are not under investigation or current discipline, and have not had their license revoked in any jurisdiction, may provide telehealth services in Florida: read more