On March 30, 2020, the CMS issued the Stark Blanket Waiver in response to the COVID-19 pandemic in order to facilitate Coronavirus related medical services. Retroactive to March 1, 2020, the circumstances and conditions under which the waivers apply are strictly and narrowly described as relating to the physician self-referral law (Stark Law).
Although temporary (at this time), health care providers, physicians and clinicians have a unique opportunity to take advantage of the Stark Blanket Waiver as it will protect financial relationships, remuneration and referrals (and the claims submitted as a result thereof) that are related to a broadly defined set of “COVID-19 Purposes.”
The blanket waivers define “COVID-19 Purposes” broadly to include the following:
• “Diagnosis or medically necessary treatment of COVID-19 for any patient or individual, whether or not the patient or individual is diagnosed with a confirmed case of COVID-19;
• Securing the services of physicians and other health care practitioners and professionals to furnish medically necessary patient care services, including services not related to the diagnosis and treatment of COVID-19, in response to the COVID-19 outbreak in the United States;
• Ensuring the ability of health care providers to address patient and community needs due to the COVID-19 outbreak;
• Expanding the capacity of health care providers to address patient and community needs due to the COVID-19 outbreak;
• Shifting the diagnosis and care of patients to appropriate alternative settings due to the COVID-19 outbreak; or
• Addressing medical practice or business interruption due to the COVID-19 outbreak in the United States in order to maintain the availability of medical care and related services for patients and the community.”
The CMS provided the following examples of how the Stark Blanket Waiver will enable flexibility for physicians and DHS entities:
• Non-Fair Market Value (FMV) Compensation. Hospitals and other providers may pay physicians above or below fair market value to rent equipment or receive services from physicians (or vice versa). Hospitals may rent space in a physician office related to COVID-19 patients below FMV or free of charge.
• Flexible Financial Support. A physician owner of a hospital may make a personal loan to the hospital without charging interest at FMV so that the hospital can make payroll or pay vendors.
• Medical Staff Benefits. Hospitals can provide benefits to medical staff, such as daily meals, laundry service or child care services.
• Non-monetary Compensation. Certain items and services that are related to the COVID-19 Purposes may be provided to physicians (e.g., continuing medical education regarding latest care protocols for COVID-19) without exceeding the annual non-monetary compensation cap.
• Hospital Capacity. Physician-owned hospitals may temporarily increase the number of licensed beds, operating rooms and procedure rooms, even if such increases would otherwise be prohibited under the Stark Law.
• Group Practice-Home Care. Any physician in a group practice may order medically necessary DHS that furnished to a patient by a technician or nurse in the patient’s home contemporaneously with a physician service that is furnished via telehealth by the physician who ordered the DHS.
• Relaxation of In-Office Requirement. Group practices can furnish medically necessary MRIs, CT scans or clinical laboratory services from locations such as mobile vans in parking lots that the group practice rents on a part-time basis. Physicians may provide clinical lab services related to Coronavirus detection and treatment because requirements that the DHS be provided in the same building as the physician office are waived; and financial relationship limitations between the physician (or family member) and the DHS provider are also waived.
These examples are merely illustrative, and each arrangement should be reviewed to ensure that it does not run afoul of other applicable state and federal laws including, specifically, applicable fraud, waste and abuse laws. Finally, although DHS entities and physician do not need to notify CMS to utilize the Stark Blanket Waiver, they “must make records relating to the use of the blanket waivers available to” CMS upon request.
We cannot stress strongly enough that the blanket waivers apply only if:
• Providers are acting in good faith to provide care in response to the COVID-19 pandemic; • Financial relationships or referrals are protected by one of CMS’ 18 permitted relationships; and • Financial relationships do not create fraud and abuse concerns.
REACH OUT TO US: These blanket waivers only temporarily permit payments and referrals between physicians and DHS entities if the relationship falls into one of CMS’ stated categories during the COVID-19 pandemic, even if such an arrangement would not meet a Stark Law exception. For now, the CMS is giving providers more freedom and flexibility as the COVID-19 pandemic continues, but keep in mind these blanket waivers will terminate at the end of the public health emergency. In the meantime we urge all physicians to examine their referral relationships, telemedicine practices, and hospital/surgery center connections for opportunities. Keep in mind, the Stark Law Waivers have no impact in the presence of fraud or abuse. We can assist with cash flow, liquidity, loans, insurance, restructuring, Tax credits and much more to get you through this crisis.
Telemedicine and virtual care have quickly become important tools in caring for your patients while keeping yourself and your staff safe as the COVID-19 pandemic evolves. It is a shame that a crisis like the Coronavirus is what it took to make telemedicine mainstream for most of the medical profession. Prior to the pandemic, telemedicine was not the success story it hoped to be.
Fortunately, the CMS reacted and has loosened the regulations for telemedicine in response to the emergency. Telehealth services may now be delivered to Medicare beneficiaries by phone as long as video capability is available. Wondering how to get reimbursed? Have questions about what technology to use? Download these helpful resources:
CONTACT US: Remember, we are here to help you keep your practice healthy during the pandemic! Telemedicine is a financial and economic opportunity. It might just be here to stay as both you and your patients will become accustomed to the convenience. Reach out to us with questions about the financial health of your practice
A State of Emergency exists across the nation due to COVID-19. Many medical practices have been told to cut non-emergency services and elective procedures. Many states have now issued orders to dental offices to only respond to emergencies, and chiropractors have been ordered to shut their doors. Optometrists and ophthalmologists may be next along with therapists. Providers are concerned just like other businesses about paying rent, making payroll, and eventually forking over taxes. Those that are still open are concerned about their workers contracting the virus, lack of protocols, lack of safety equipment, and lack of a plan by state and federal legislators.
There are a few important topics we wish to address on behalf of our physician practices and medical groups regarding the pandemic COVID-19.
1. Many of our clients participate in ACOs. ACOs that participate in the Medicare Shared Savings Program are concerned they will be on the hook for penalties and won’t receive shared savings this performance year because of Coronavirus cases. The COVID-19 outbreak may drive up Medicare beneficiary spending this year, affecting the benchmark used to determine savings and losses in the program. The benchmark uses historical Medicare spending in addition to current performance year spending.
• According to a CMS spokesman, “The Medicare Shared Savings Program has policies in place to account for unexpected rises in Medicare beneficiary spending that have historically been used for natural disasters. The CMS can mitigate shared losses and calculate quality scores differently for ACOs affected with such issues. The agency implemented such policies for ACOs affected in performance year 2017 by Hurricanes, as well as the California wildfires.” The CMS spokesman also said it’s important to note healthcare providers in ACOs are part of the Medicare fee-for-service program, which has made special coverage considerations for Coronavirus such as testing.
• CMS recently announced relief for clinicians, providers, hospitals and facilities participating in quality reporting programs in response to COVID-19: Due to COVID-19, the Centers for Medicare & Medicaid Services is implementing additional extreme and uncontrollable circumstances policy exceptions and extensions for upcoming quality measure reporting and data submission deadlines for the following CMS programs:
MIPS/ACOs (Provider Programs)
2019 DATA SUBMISSION: 1. 2019 data submission deadline has been extended from March 31, 2020 to April 30, 2020. 2. MIPS eligible clinicians who have not submitted any MIPS data by April 30, 2020 will qualify for the automatic extreme and uncontrollable circumstances policy and will receive a neutral payment adjustment for the 2021 MIPS payment year.
2020 DATA SUBMISSION: 1. At this time CMS is evaluation options for relief around participation and data submission for 2020
Post-Acute Care (PAC) Programs:
2019 DATA SUBMISSION: 1. 2019 data submission for Oct. 1, 2019 – Dec. 31, 2019 (Q4) is optional. 2. If Q4 is submitted, it will be used to calculate the 2019 performance and payment (where appropriate).
2020 DATA SUBMISSION: 1. Data from Jan. 1, 2020 – June 30, 2020 (Q1 – Q2) DOES NOT need to be submitted to CMS. 2. Home Health and Hospice Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey data from Jan. 1, 2020 – Sept. 30, 2020 (Q1 – Q3) DOES NOT need to be submitted to CMS.
2. President Trump has declared COVID-19 a national emergency. Hospitals have activated there emergency response plans – have you and your physician practice? What protocols have you put in place? Accommodations for staff and patients? You must demonstrate some level of due diligence in assessing patient health and ensuring the safety of patients in your waiting room or you may be liable for not doing anything to protect your patients!
See recommendations below from the PBCMS in the event a patient with suspected COVID-19 seeks care:
a) Follow the CDC’s patient assessment protocol for early disease detection. If a patient calls to schedule an appointment for an acute respiratory illness (e.g., fever, cough, and difficulty breathing), he or she should be screened appropriately for COVID-19. The CDC strongly recommends that practices do not turn patients away simply because a patient presents with acute respiratory symptoms.
b) Practices should consider developing front-door and office signage that informs patients who are exhibiting any of the PUI evaluation criteria (e.g., presenting symptoms, recent contacts, and/or travel history) to notify facility personnel. Consider giving a quick questionnaire to patients upon check in, and include this information on the practice website, also.
c) In some communities with the potential for community spread, the CDC recommends exploring alternatives to face-to-face triage during visits if screening can take place over the phone or via telemedicine.
d) If presenting symptoms, travel history, or patient contacts are suspicious, immediately isolate patients coming into the office in a designated exam room with dedicated patient care equipment. A back entrance may be utilized, if available. Since most medical offices don’t have negative pressure airflow, a spare bathroom with negative exhaust fans may be an option in the medical office setting instead of a regular exam room. The CDC provides guidelines for environmental infection control in healthcare facilities
e) Once suspected patients are inside the facility, instruct them to put on a face mask, utilize tissues, practice good hand hygiene, and dispose properly of any contaminated protective equipment/tissues in a designated waste receptacle.
f) Follow Standard, Contact, and Airborne precautions including gloves, gowns, protective eyewear, and NIOSH-certified N95 respirators that have been properly fit-tested. This applies to all healthcare staff interacting with patients.
g) Limit staff exposure to suspected patients, with the exam room door kept closed. Maintain records of staff-patient contact, i.e., who was assigned to work with the patient, either in a log or in the medical record. Any unprotected occupational exposure by staff members should be assessed and monitored.
h) When there is a reasonable presumption that a patient may have been exposed to COVID-19, contact the local or state health department regarding patient testing, and for locations designated to triage suspected patients so exposure is limited in general medical offices. Suspected cases must be reported to applicable local and state health departments.
i) Once the patient exits the room, conduct surface disinfection while staff continues to wear personal protective equipment (PPE).
j) Provide information on the virus to the patient and close contacts, including how to follow infection-control practices at home, such as in-home isolation, hand hygiene, cough etiquette, waste disposal, and the use of face masks.
3. Healthcare providers are concerned about the scarcity of PPE, testing kits, protective gear, medications, prescription delays, and COVID-19 copay issues, among other concerns. New York has been one of the states hit the hardest by the Coronavirus outbreak, yet suppliers are struggling to make testing for the virus widely available, with local officials estimating it could take weeks more to reach peak testing capacity. Cases in New York continue to climb as they do around the country. The Defense Production Act will help with marshaling critical supplies, as will the $2 Trillion dollar stimulus package that would inject several billion into the hospital system just passed by Congress. Dr. William Valenti, Chair of MSSNY’s Infectious Diseases Committee, discusses the current Coronavirus outbreak in a March 11th podcast here: https://www.buzzsprout.com/51522/2982079.
An unidentified flaw in test kits distributed by the federal government in February, which gave some false results, has set the country back; boosting testing is crucial disease experts say, to assess the scope of the U.S. outbreak and identify where it is spreading most rapidly. 1.5 million test kits were to already be available by the end of last week, but progress has been slow due to regulatory hurdles at the federal and state level (even thought the FDA is now granting regulatory authority to the states), as well as logistical and technical challenges, and supply chain issues. There is a critical shortage of the physical components needed to carry out tests: extraction kits to isolate viral RNA from specimens, reagents that determine whether Covid19 is present in the sample, and a lack of test swabs.
4. Have you considered implementing telehealth if you haven’t already? What about offering immunity enhancing services or products, vitamin infusions etc.? With respect to telehealth services, The AMA has made recommendations to the CMS for provisions that were included in the first supplemental spending bill passed by Congress. “We have urged CMS to substantially expand its coverage of patient-physician telephone conversations. Telehealth services should also be extended to ongoing care needs unrelated to COVID-19 during this time of “social distancing,” which is particularly relevant to elderly Medicare beneficiaries who are most at risk of severe complications from exposure to the virus. In addition, we have recommended a solution to CMS about currently inadequate ICD-10 diagnosis coding for COVID-19.”
This week the Trump administration announced it will temporarily expand telehealth services under Medicare to cover such interactions at the same rate as in-person visits and allow the suspension of certain HIPAA requirements so doctors can provide services with their personal phones. A range of providers will be able to deliver telehealth services, including doctors, nurse practitioners, clinical psychologists, and licensed clinical social workers. Visits using the telehealth services will be considered the same as in-person visits and will be paid as if the patient were seen in the office. This expansion of Medicare telehealth services will continue for the duration of the COVID-19 public health emergency.
5. In the midst of the crisis Florida lawmakers passed sweeping legislation to expand the roles that pharmacists play in the state’s health-care system, including allowing pharmacists to test and treat patients for the flu and strep throat and treat people with chronic medical conditions, including arthritis, asthma, chronic obstructive pulmonary diseases, Type 2 diabetes, HIV, AIDS, obesity, or “any other chronic condition” adopted in rules. This may be helpful as the healthcare system continues to become more and more overwhelmed with COVID-19.
Concurrently the Florida Senate and House backed a bill that allows advanced practice registered nurses to provide primary care independently of physicians and for certified nurse midwives to work autonomously. The final version of the Advanced Nurses Bill was something of a compromise between the House and Senate. For instance, the bill doesn’t include independent practice for physician assistants or certified registered nurse anesthetists.
6. Additionally, the IRS advised that high-deductible health plans (HDHPs) can be used to pay for 2019 Novel Coronavirus (COVID-19)-related testing and treatment, without jeopardizing their status. This also means that an individual with an HDHP that covers these costs may continue to contribute to a health savings account (HSA). As stated in Notice 2020-15, health plans that otherwise qualify as HDHPs will not lose that status merely because they cover the cost of testing or treatment of COVID-19 before plan deductibles have been met. As in the past, any vaccination costs continue to count as preventive care and can be paid for by an HDHP.
Contact Us:Does your medical practice need a check-up for Coronavirus? We can help keep your practice healthy during the economic downturn due to Coronavirus. We can discuss the short- and long-term impacts on your business operations and the right steps to take now to minimize your risk. Do you have business interruption insurance? We have ideas how you can be proactive and revise your original 2020 business plan.