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Communicating guidelines and requirements to both patients and staff is a critical first step for protecting your independent practice during the COVID-19 pandemic, both in terms of safety and legal risks. For example, the Centers for Disease Control and Prevention (CDC) has recommended that everyone wear masks but your patients (and even some staff) may be resistant to wearing them.
Protect yourself and your practice by providing advance notice regarding your mask policy as well as any other pandemic-related guidelines or restrictions. Include the requirements in your intake documents and processes, post them inside and outside your practice, and enforce them uniformly while remaining legally compliant.
The question of legal risks is a major concern for you and your patients. The main goal is everyone’s health and safety. Threats of frivolous lawsuits should not be enough to pressure you into exposing your staff or patients. Document everything, particularly if a patient refuses to comply with your practice’s requirements.
Other questions regarding COVID-19 legal risks focus on reporting requirements. Legal experts writing in the National Law Review say that a number of states have included COVID-19 on their list of reportable communicable diseases. California, for example, requires:
… immediate telephonic reporting by health care providers knowing of, or in attendance on a case or suspected case of COVID-19. For patients, the medical group must make mandated reports to federal, state, and local public health authorities. For employees, however, unless the employer is the healthcare provider receiving the positive test result, the employer does not have a separate obligation to make a mandated report.
For employees testing positive for COVID-19 in California, however, the employer must record those cases in its OSHA 300 log per OSHA’s Injury and Illness Recordkeeping and Reporting Requirements, if the case is confirmed to be COVID-19, is “work-related” (as defined by 29 C.F.R. § 1904.5), and involves one or more of the general recording criteria set forth in29 C.F.R. § 1904.7, such as time away from work or medical treatment.
In addition, medical groups in California must comply with the state’s Aerosol Transmissible Diseases (“ATD”) standard to protect employees from diseases and pathogens transmitted by aerosols. The ATD standard requires medical groups to protect employees through effective:
If one of your clinical or administrative staff tests positive for COVID-19, you cannot legally reveal that employee’s medical diagnosis. You should, however, generally communicate the exposure or potential exposure without providing information that would identify the individual employee.
Other concerns about COVID-19 legal risks may involve your potential lack of resources for protecting staff and patients. Sean P. Byrne, JD, a malpractice defense lawyer, states that “In medical liability cases, the test is always: Did you comply with the standard of care? So did you act like a reasonably prudent provider would act under the same or similar circumstances?”
Byrne points out that a number of state laws protect you from being sued for simple negligence for COVID-19 related claims. He states that “You can’t be sued for COVID-19 related claims that are caused by a lack of resources. And resources can mean PPE, it can mean staffing, it can mean ICU beds.” He adds that “Ultimately, though, the test is usually going to be: Did you act reasonably? I think it’s advisable to include some language about COVID-19 in your discussions with your patients and in your documentation ….”
The American Medical Association (AMA) and more than 130 state, specialty, and national medical associations are asking Congress to protect physicians and other health professionals from medical liability lawsuits where health care services are provided or withheld in situations that may be beyond the control of physicians or their practices. For example, protection would apply in situations in which a physician was following government guidelines or lacked resources due to COVID-19. The protections would extend to those who provide care in good faith during the public health emergency and in a reasonable time period, such as 60 days, after the emergency declaration ends.
Janie Feldsher September 9, 2020Read
More changes have been announced by the Centers for Medicare and Medicaid Services (CMS) in response to the COVID-19 pandemic. In an announcement made on April 30, CMS “issued another round of sweeping regulatory waivers and rule changes to deliver expanded care to the nation’s seniors and provide flexibility to the healthcare system as America reopens.” Included in the changes are additional accommodations for telehealth as well as reduced restrictions on coronavirus testing.
CMS states that its goals during the pandemic are to:
The changes announced by CMS will apply immediately and remain in place for the duration of the public health emergency declaration. The initial set of temporary regulatory waivers and new rules was announced on March 30, with follow up on April 10. The April 30 announcement significantly expands those changes. Independent physicians do not have to apply for the blanket waivers and can begin using the announced flexibilities immediately.
The most recent announcement includes the following waivers and rule changes for providers:
In addition, as mandated by the CARES Act, CMS is paying for Medicare telehealth services provided by rural health clinics and federally qualified health clinics. Previously, these clinics could not be paid to provide telehealth expertise as “distant sites.” Now, Medicare beneficiaries located in rural and other medically underserved areas will have more options to access care from their home without having to travel.
Janie Feldsher May 25, 2020Read
The Centers for Medicare and Medicaid Services (CMS) has made several announcements related to healthcare during the COVID-19 pandemic. The measures are designed to aid independent physicians and other providers who have begun seeing patients using telehealth options and who are making additional adjustments to cope with the outbreak. On April 20, CMS announced an incentive for clinicians to assist with research that will help monitor the spread of the virus and will aid in the search for a solution to the outbreak.
If you participate in the Merit-based Incentive Payment System (MIPS), the performance-based track of the Quality Payment Program (QPP), you can now earn credit when you, your physician’s assistant, your nurse practitioners, or other clinicians on your team participate in a clinical trial and report clinical information on COVID-19. By participating and attesting to the new COVID-19 Clinical Trials improvement activity, you will provide vital data that will help drive improvement in patient care and develop best practices to manage the spread of the virus.
In making the announcement, CMS Administrator Seema Verna said, “CMS is supporting efforts of researchers to obtain solid, actionable data to accelerate the development of new treatments and our understanding of the coronavirus. Today’s action encourages clinicians to report data that will help us monitor the spread of the virus, find innovative medical solutions, and unleash scientific discovery as we seek to overcome this terrible disease.”
Participating in a clinical trial carries a high weight from a scoring perspective. When you report your activity, you will automatically earn half of the total credit needed to earn a maximum score in the MIPS improvement activities performance category, which counts as 15 percent of the MIPS final score.
To receive this credit for the new MIPS COVID-19 Clinical Trials improvement activity, you will need to attest that you are participating in a COVID-19 clinical trial using a drug or biological product to treat a patient with a COVID-19 infection. You will then report your findings through a clinical data repository or clinical data registry for the duration of the study.
There is flexibility in the type of clinical trial that you choose to participate in, including the traditional double-blind placebo-controlled trial to an adaptive or pragmatic design that flexes to workflow and clinical practice. In its announcement, CMS also provided information on a database of privately and publicly funded clinical studies currently being conducted on coronavirus.
Examples of clinical trials include those conducted by the National Institute of Health (NIH). You might also choose to report through a clinical data repository such as Oracle’s COVID-19 Therapeutic Learning System. Oracle has developed and donated a system to the U.S. government that allows clinicians and patients to record the effectiveness of promising COVID-19 drug therapies at no cost.
As a physician on the front line of providing care to patients infected with COVID-19, you can contribute significantly to scientific research and evidence to fight the Coronavirus Disease 2019 (COVID-19) pandemic. Participation in these clinical trials will lead to improvements in care delivery and the ability to treat COVID-19 patients and will enable you to earn valuable MIPS credit for your practice.
Chris Anderson May 11, 2020Read
As the COVID-19 situation begins to stabilize in many locations, the Centers for Medicare & Medicaid Services (CMS) has issued guidance on providing essential non-COVID-19 care to patients in certain locations. The announcement was made in coordination with the federal plan for Opening Up America Again. The CMS recommendations will serve as a guide to independent practices who may be able to re-open their practices in areas with a low incidence of COVID-19.
On March 18, CMS announced that all elective surgeries, non-essential medical, surgical, and dental procedures should be delayed during the 2019 Novel Coronavirus (COVID-19) outbreak. In making the most recent announcement, CMS Administrator Seema Verma said:
Today, some areas of the country are experiencing fewer cases and lower incidence of the virus, necessitating a more tailored and flexible approach. Every state and local official will need to assess the situation on the ground to determine the best course forward, but these guidelines provide a gradual process for restarting non-COVID-19 essential care while keeping patients safe.
The new CMS recommendations for providing essential care to patients without symptoms of COVID-19 are specifically targeted to communities that are in Phase 1 of the Guidelines for Opening Up America Again with low incidence or relatively low and stable incidence of COVID-19 cases.
In making the announcement, CMS emphasized the importance of restarting care that is currently being postponed, “such as certain procedural care (surgeries and procedures), chronic disease care, and, ultimately, preventive care.” The organization recognized that there are a number of patients who continue to have ongoing healthcare needs that have been deferred during COVID-19.
Independent practices located in states or regions that have passed the Gating Criteria regarding symptoms, cases, and hospitals that were announced on April 16, they may proceed to Phase I. Even so, CMS is strongly encouraging the maximum use of telehealth where appropriate.
The Gating Criteria includes:
CMS states that non-COVID-19 care should be offered to patients as clinically appropriate and in an area that has the necessary resources to quickly respond to a surge in COVID-19 cases if necessary. The decision regarding whether to provide non-COVID-19 care should be consistent with public health information and in collaboration with state public health authorities.
All aspects of non-COVID-19 care should be considered, including:
Independent physicians within these areas should continually evaluate whether their region remains a low risk of incidence and should be prepared to cease non-essential procedures if there is a surge in COVID-19 cases.
Janie Feldsher May 8, 2020Read
The COVID-19 pandemic has affected healthcare providers in many ways. Some physicians are stressed with how to continue providing quality care to their patients. Healthcare delivery has shifted to telehealth in many locations. Independent physicians are feeling the financial strain of the outbreak. To help alleviate some of the distress placed on providers by the coronavirus outbreak, relief funds have been appropriated to hospitals and other healthcare providers under the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
The CARES Act was initially signed into law on March 27, 2020 and included $100 billion for the Provider Relief Fund. The first round of funding, $30 billion, was distributed in early and mid-April and was “proportionate to providers’ share of Medicare fee-for-service reimbursements in 2019,” according to the US Department of Health & Human Services (HHS).
HHS has announced that it “has begun distributing the remaining $20 billion of the $50 billion general distribution to Medicare providers to augment providers’ allocations so that the whole $50 billion general distribution is allocated proportional to providers’ share of 2018 net patient revenue.”
On April 24, a portion of providers were automatically sent an advance payment based off the revenue data they submitted in CMS cost reports. Providers without adequate cost report data on file will need to submit their revenue information to the General Distribution Portal for additional general distribution funds.
In addition, the COVID-19 Uninsured Program Portal, which allows healthcare providers who have conducted COVID-19 testing or provided treatment for uninsured COVID-19 individuals on or after February 4, 2020 to request claims reimbursement, is now live. HHS has clarified that it “broadly views every patient as a possible case of COVID-19.” The organization has also stated that “a healthcare provider’s eligibility is not adversely affected if it ceased operations as a result of the COVID-19 pandemic, so long as the healthcare provider provided diagnoses, testing, or care for individuals with possible or actual cases of COVID-19.”
The terms and conditions of receiving the relief funds include:
Independent practices are being significantly impacted by the coronavirus. The Medical Group Management Association (MGMA) conducted a survey in early April and received 724 applicable responses, approximately 75% of which were part of independent medical practices and employed less than 50 full-time-equivalent (FTE) physicians.
The survey revealed that 97% of those practices have experienced a negative financial impact directly or indirectly related to COVID-19. The survey also found that, on average, practices have experienced a 55% decrease in revenue and 60% decrease in patient volume since the beginning of the COVID-19 crisis.
Elation Health is dedicated to supporting independent physicians throughout the coronavirus outbreak. We have developed a COVID-19 Resource Center that includes information on Financial Resources for your practice, as we are committed to ensuring your success in dealing with the economic effects of COVID-19.
Chris Anderson May 4, 2020Read
In an ongoing effort to provide financial relief for healthcare providers, the Centers for Medicare & Medicaid Services (CMS) has expanded its Accelerated and Advance Payment Program, opening up $34 billion for a broader group of physicians, hospitals, and suppliers. The payment program, expanded in response to the 2019 Novel Coronavirus (COVID-19) pandemic, has been expanded for the duration of the public health emergency.
The new streamlined process has reduced processing times for requests for accelerated or advance payments. The timeframe is expected to be between four and six days during the COVID-19 pandemic, down from the normal timeframe of three to four weeks. CMS has already approved over 17,000 requests.
Accelerated or advance payments are provided during the period of the public health emergency to any Medicare provider or supplier who submits a request to the appropriate Medicare Administrative Contractor (MAC) and who meets the required clarifications. Part A providers and Part B suppliers, including doctors, non-physician practitioners, and durable medical equipment (DME) suppliers are eligible. CMS has indicated that, while most of these providers and suppliers can receive three months of their Medicare reimbursements, certain providers can receive up to six months.
To qualify for advance or accelerated payments the provider or supplier must:
CMS advance and accelerate payments are not a part of the funding available as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. CARES Act funding of $100 billion does not have to be repaid. The advance and accelerated payments available through CMS are a loan that providers must pay back. CMS will begin to apply claims payments to offset the accelerated and advance payments 120 days after they are disbursed.
CMS clarifies that the provider/supplier can continue to submit claims as usual after the issuance of the accelerated or advance payment; however, recoupment will not begin for 120 days. Providers will receive full payments for their claims during the 120-day delay period. At the end of the 120-day period, the recoupment process will begin and every claim submitted by the provider will be offset from the new claims to repay the accelerated/advanced payment. Instead of receiving payment for newly submitted claims, the provider’s outstanding accelerated/advance payment balance is reduced by the claim payment amount. The process will be automatic.
The Department of Health and Human Services (HHS) will be providing additional information on how healthcare providers and suppliers can access CARES Act funds in the coming weeks. The CARES Act provides $100 billion in relief funds to hospitals and other healthcare providers on the front lines of the coronavirus response. This funding will be used to support healthcare-related expenses or lost revenue attributable to COVID-19.
Janie Feldsher April 21, 2020Read
The Coronavirus Aid, Relief, and Economic Security (CARES) Act was officially signed into law on March 27, 2020. The CARES Act offers financial relief for many individuals and small businesses. There are also a number of provisions in the Act that are beneficial to healthcare professionals. Independent physicians should be aware of several immediate key takeaways from the CARES Act.
The Centers for Medicare & Medicaid Services (CMS) is increasingly recognizing the critical need for and benefits of telehealth, noting that “with the emergence of the virus causing the disease COVID-19, there is an urgency to expand the use of technology to help people who need routine care, and keep vulnerable beneficiaries and beneficiaries with mild symptoms in their homes while maintaining access to the care they need.”
The CARES Act opens up additional opportunities for independent physicians to take advantage of telehealth for their patients. Providers no longer need a pre-existing relationship with a patient to provide telehealth services and Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) are now sites of care for telehealth.
The American Medical Association (AMA) has outlined the provisions of the CARES Act that expand telehealth:
To provide financial relief for healthcare providers, the CARES Act boosts Medicare payments by 2 percent through the end of 2020 for physicians, hospitals, nursing homes, and home health. In addition, the Act requires all private insurance plans, Medicare, and Medicaid to cover COVID-19 treatments and vaccine and makes all coronavirus tests free.
Given the critical need for healthcare providers during the COVID-19 pandemic, the CARES Act also addresses the issue of liability for volunteers who offer their help during the emergency response. According to the AMA fact sheet, “physicians who provide volunteer medical services during the public health emergency related to COVID-19 have liability protections. These new protections are in addition to those provided by the Volunteer Protection Act of 1997. Volunteers are defined as those who are not paid for their services.”
Janie Feldsher April 17, 2020Read
The Centers for Medicare & Medicaid Services (CMS) has announced a deadline extension, along with several exceptions from reporting requirements for primary care providers and other healthcare professionals participating in Medicare quality reporting programs. The changes affect upcoming measure reporting and data submission for those programs. CMS is taking these steps in an effort to provide relief for providers during the current COVID-19 pandemic.
CMS states that it is taking actions to assist the “clinicians, providers, and facilities participating in Medicare quality reporting programs including the 1.2 million clinicians in the Quality Payment Program and on the front lines of America’s fight against the 2019 Novel Coronavirus (COVID-19).” CMS Administrator Seema Verma says, “In granting these exceptions and extensions, CMS is supporting clinicians fighting Coronavirus on the front lines.”
The deadline for 2019 data submission for the Quality Payment Program (QPP) – Merit-based Incentive Payment System (MIPS) has been extended from March 31, 2020 to April 30, 2020. In addition, MIPS eligible providers who do not submit MIPS data by the new deadline will qualify for the automatic extreme and uncontrollable circumstances policy and will receive a neutral payment adjustment for the 2021 MIPS payment year.
Primary care providers are included in the MIPS option of the QPP if they are an eligible clinician type and meet the low volume threshold, which is based on allowed charges for covered professional services under the Medicare Physician Fee Schedule (PFS) and the number of Medicare Part B patients who are furnished covered professional services under the Medicare Physician Fee Schedule.
MIPS performance is measured through the data clinicians report in four areas:
The CMS announcement also stated that:
CMS recognizes the burden placed on providers who are responding to the COVID-19 pandemic, in having to also focus on data collection and reporting for MIPS. The agency also acknowledges that the numbers may be somewhat skewed during a time of national emergency, particularly in regard to cost, readmissions, and patient experience. Quality measure data collection and reporting during the pandemic may not be reflective of the provider’s true performance and CMS seeks to hold healthcare organizations harmless for not submitting data during this time.
Going forward, CMS has indicated it will continue to monitor the COVID-19 situation. Healthcare providers must focus on caring for patients first and foremost so additional options will be assessed for offering additional relief to primary care providers and their staff during the emergency period.
Janie Feldsher March 30, 2020Read
Senator Bernie Sanders (D-Vermont) is a candidate in the 2020 presidential election and a proponent of a one-payer healthcare program. Specifically, Sanders introduced a bill in the Senate and includes a plan in his campaign that has been labeled Medicare for All. Although credited with the term and with the initiative, it was actually Republican Senator Jacob Javits who proposed expanding Medicare to cover all Americans in 1970 through a program he called “Medicare for all.”
The program Sanders has proposed is somewhat different from that submitted by Javits and actually expands the concept of Medicare as it exists today. The senator cites the fact that medical bills are the primary cause of bankruptcy for Americans and that people need a healthcare program that will cover more, if not all, of their expenses while ensuring they receive the highest quality care. Sanders states that “We should be spending money on doctors, nurses, mental health specialists, dentists, and other professionals who provide services to people and improve their lives.”
The Sanders platform states that the way to reduce costs and to refocus payments, away from private insurance and giant pharmaceutical companies, is by “Joining every other major country on Earth and guaranteeing health care to all people as a right, not a privilege, through a Medicare-for-all, single-payer program.” His plan would virtually eliminate private insurance and replace it with the expanded government-sponsored program.
The Washington Times reports that the Medicare for All program proposed by Sanders “would cover all U.S. residents, including illegal immigrants. It would pay for doctor and hospital visits, prescription drugs, dental and vision services, and long-term care. Private insurance would be allowed, but only as a supplement.” Many of those services, including dental and vision, are not now covered under basic Medicare plans.
Medicare for All, as proposed by Sanders, would also focus on the affordability of prescription drugs specifically. His plan would:
Janie Feldsher March 2, 2020Read
Biometrics are gathered to digitally identify individuals, based on unique physical characteristics. Biometrics include fingerprints, facial features, voice cadence, and other identifiers. The US Department of Homeland Security uses biometrics primarily for immigration purposes, vetting and credentialing, detecting illegal entry attempts, and verifying visa applications. In healthcare, biometrics are used to identify patients and to ensure that employees have access only to the information they need to know.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) required HHS to adopt national standards for electronic health care transactions and code sets, unique health identifiers, and security. In 2009, as part of the American Recovery and Reinvestment Act (ARRA), the Health Information Technology for Economic and Clinical Health (HITECH) Act was signed into law. The HITECH Act addresses the privacy and security concerns associated with the electronic transmission of protected health information.
As the use of biometrics becomes more prevalent in healthcare, providers must exercise care in regard to adhering to the regulations of HIPAA and the HITECH Act. Biometrics are in the category of protected health information (PHI) and as such, healthcare providers must ensure that appropriate safeguards are put in place to protect the confidentiality and integrity of the information.
Illinois was the first state to recognize the importance of protecting data gathered through biometrics. In 2008, the state passed the Biometric Information Privacy Act (BIPA), which applies to healthcare, hospitality, retail, and any employer who uses fingerprint technology. Many businesses use employees’ fingerprints, for example, for timekeeping purposes.
BIPA requires healthcare providers to, in most instances:
Following the example set in Illinois, five other states – Texas, Washington, California, New York, and Arkansas – have passed similar biometric statutes. The California Consumer Privacy Act (CCPA), which will go into effect in 2020, defines biometric data as “physiological, biological or behavioral characteristics, including … DNA[,] that can be used … to establish individual identity,” which includes “sleep, health, or exercise data that contain identifying information.”
Given the definitions of HIPAA, the HITECH Act, and biometrics as they are used in healthcare, there is a risk involved in collecting and maintaining this data. As with all PHI, steps must be taken to ensure the security and integrity of biometrics when used in a healthcare setting to comply with federal regulations and to provide patients with appropriate data safeguards.
Janie Feldsher February 19, 2020Read