Author: TFG Health Services

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Clarifying New Stark Law Changes and Modifications for 2021

TFG Health Services

On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a final rule to modernize and clarify the Stark Law. This reflects the most recent efforts by the Department of Health and Human Services (HHS) to establish exceptions and safe harbors to appropriately tailor the reach of the Stark Law’s strict liability-based civil penalties and the Anti-Kickback Statute’s criminal penalties to protect from enforcement certain non-abusive and beneficial arrangements. HHS notes that these rules are the culmination of its effort to address concerns within the health care industry that these laws, as well as the Civil Monetary Penalty (CMP) Law, have operated as barriers to the delivery of value-based care to improve quality of care, health outcomes, and efficiency. The final rules discussed below were scheduled to be published in the Federal Register December 2, 2020, they take effect 60 days from then, which falls on January 31, 2021. CMS clarified on February 22, 2021 that the regulations finalized in the final rule are in effect.

Many of the exceptions to the Stark Law require that one or more of the following requirements be met:

  • That the compensation arrangement be commercially reasonable,
  • That the compensation methodology not be determined in a manner that takes into account the volume or value of referrals (or other business generated between the parties), and
  • That the amount of compensation paid be fair market value (FMV).

To provide further clarity, CMS finalized its definition of the requirements and terms as follows:

Commercial Reasonableness: “Commercially reasonable means that the particular arrangement furthers a legitimate business purpose of the parties to the arrangement and is sensible, considering the characteristics of the parties, including their size, type, scope, and specialty. An arrangement may be commercially reasonable even if it does not result in profit for one or more of the parties.” This still ensures that parties cannot protect abusive arrangements under the guise of ‘commercial reasonableness.” According to CMS, some of the purposes that could qualify as “legitimate business purposes” of the parties to an arrangement includes:

  • Addressing community need,
  • Providing timely access to healthcare services,
  • Fulfilling licensure or regulatory obligations, such as under the Emergency Medical Treatment and Labor Act,
  • Providing charity care, and,
  • Improving quality and health outcomes.

Value Based Arrangements: CMS established three new, permanent exceptions to the physician self-referral law for value-based arrangements and definitions for terminology integral to such a system:

  1. Value-based arrangements with full financial risk: CMS finalized the exception to extend the time within which a value-based enterprise needs to assume full financial risk, expanding its proposed six-month window to 12 months after the commencement of the value-based arrangement. This additional time will allow participants to make structural changes and take other actions to prepare to be at full risk.
  2. Value-based arrangements with meaningful downside financial risk: CMS finalized its definition of “meaningful downside financial risk” to mean a physician is at risk for at least 10 percent of the remuneration to be received by the physician. This risk can be reflected in paybacks, withholds, incentive bonuses, and other payment structures, so long as at least 10 percent of the physician’s total remuneration is at risk to the entity remitting that remuneration. This is a substantial change from CMS’ proposal to make physicians at risk for 25 percent of their remuneration, and should provide more flexibility for those entities seeking to engage with individual physicians for risk-bearing relationship
  3. Any value-based arrangement provided the enumerated requirements are met: Most impactful is CMS’ explicit regulatory requirement that a value-based enterprise monitor and assess the success of its value-based arrangements at least annually, or once during the term of the arrangement if it is for a term of less than one year, and either terminate the arrangement or replace ineffective activities if the arrangement is found to not be working. CMS is providing parties with a grace period to terminate or revise the arrangement, allowing 30 days to terminate, and 90 days to replace, ineffective activities or outcomes measures, following a determination that the arrangement is not successful.

CMS made the new, tiered value-based exceptions available to indirect compensation arrangements that include a value-based arrangement in the unbroken chain of financial relationships between a physician and a designated health services entity, and announced its decision to not include a price transparency requirement in its value-based exceptions.

A safe harbor was added to the above: Care coordination arrangements to improve quality, health outcomes, and efficiency. Requires no assumption of downside risk by parties to a value-based arrangement in order to protect in-kind remuneration exchanged to engage in value-based activities that are directly connected to the coordination and management of care for the target patient population. Recipients are required to pay at least 15% of either the offeror costs or the fair market value of the remuneration.

CMS finalized these definitions with a few noteworthy comments and modifications, including:

  • Referrals are not explicitly excluded from the definition of “value-based activity”; however, referrals generally are not items or services for which a physician may be compensated under the Stark Law.
  • CMS finalized its definition of “value-based arrangement” to clarify that such arrangements must be among only parties within the same value-based enterprise.
  • Maintenance of quality of care will not be considered a permissible value-based purpose absent a reduction of costs to, or growth in expenditures of, the payor. While maintaining quality is important, CMS does not believe that permitting remuneration for maintenance alone is consistent with HHS’ goals.
  • No particular providers or manufacturers are excluded from eligible value-based enterprise participants, unlike OIG’s corresponding final rule for the Anti-Kickback Statute safe harbors.

Fair Market Value: CMS restructured the FMV definition by establishing three separate FMV definitions:

(1) generally,

(2) for the rental of equipment, and

(3) for the rental of office space.

CMS finalized the three separate FMV definitions as follows:

  • General—The value in an arm’s-length transaction:
    • Consistent with the general market value of the subject transaction.
  • Rental of equipment—With respect to the rental of equipment, the value in an arm’s-length transaction:
    • Of rental property for general commercial purposes (not taking into account its intended use); and,
    • Consistent with the general market value of the subject transaction.
  • Rental of office space—With respect to the rental of office space, the value in an arm’s-length transaction:
    • Of rental property for general commercial purposes (not taking into account its intended use);
    • Without adjustment to reflect the additional value the prospective lessee or lessor would attribute to the proximity or convenience to the lessor where the lessor is a potential source of patient referrals to the lessee; and,
    • Consistent with the general market value of the subject transaction.

Notably, the revised definition of FMV eliminates the connection to the volume or value standard. CMS noted that “a careful reading of the statute shows that the FMV requirement is separate and distinct from the volume or value standard and the other business generated standard,” and thus there is no need to intertwine the discrete standards.

In addition to the delineated definitions for FMV set forth above, CMS finalized its proposal to define general market value separately from FMV and delineate the definitions for general market value similar to the FMV definitions:

  • Assets: “the price that an asset would bring on the date of acquisition of the asset as the result of bona fide bargaining between a well-informed buyer and seller that are not otherwise in a position to generate business for each other.”
  • Compensation: “the compensation that would be paid at the time the parties enter into the service arrangement as the result of bona fide bargaining between well-informed parties that are not otherwise in a position to generate business for each other.”
  • Rental of equipment or office space: “the price that rental property would bring at the time the parties enter into the rental arrangement as the result of bona fide bargaining between a well-informed lessor and lessee that are not otherwise in a position to generate business for each other.”

CMS spent a significant amount of space in the final rule reconciling the terms FMV and general market value, stating that it: “continue[s] to believe that the [FMV] of a transaction—and particularly, compensation for physician services—may not always align with published valuation data compilations, such as salary surveys. In other words, the rate of compensation set forth in a salary survey may not always be identical to the worth of a particular physician’s services.”

In making its point, CMS discussed when “extenuating circumstances may dictate that parties to an arm’s length transaction veer from values identified in salary surveys…a hospital may find it necessary to pay a physician above what is in the salary schedule, especially where there is a compelling need for the physician’s services.”

The most significant takeaways from the Stark Law final rule stem from CMS’s acknowledgment that: not all physicians, or compensation arrangements, are the same; compensation arrangements may have qualitative benefits that outweigh quantitative costs, i.e., profitability; and salary surveys are only a starting point in the valuation of a healthcare transaction.

Other Items of Note

CMS also finalized, among other changes:

  • Providing a grace period if any non-compliance issues are reconciled within 90 calendar days of the expiration or termination of a compensation arrangement, if after the reconciliation, the entire amount of remuneration for items or services is paid as required under the terms and conditions of the arrangement.
  • Revising the definition of “designated health services” to exclude inpatient services paid for under prospective payment systems if furnishing those services does not increase the amount of Medicare’s payment to the hospital.
  • Removing its carve-out of surgical devices, items, or supplies from the definition of “remuneration.”
  • Stating policies that will reduce the number of unbroken chains of financial relationships that fall within the Stark Law’s definition of “indirect compensation.”
  • Confirming that the exception for isolated transactions does not apply to multiple services provided over a period of time, even if there is only a single payment for all the services.
  • Making changes to the definition of “group practice” to clarify circumstances under which the profits of a group practice may be shared with its members, including compensation that relates to participation in a value-based arrangement, and confirming that a physician practice that wishes to qualify as a group practice may not distribute profits from designated health services on a “service-by-service” basis.
  • Excluding titular ownership or interests arising from a qualified employee stock ownership plan from the definition of “ownership or investment interests.”
  • Confirming that the exception for Electronic Health Records (EHR) expressly includes cybersecurity software and services, and making permanent the EHR exception by removing the sunset provision.

Reach Out To Us: The Stark Law contains a large number of exceptions which describe ownership interests, compensation arrangements, and forms of remuneration which do not apply. New exceptions and safe harbors will promote coordinated services among healthcare providers and emphasize value-based payment and collaborative care. Let us assist you in finding your way through this tangled web so that you are in compliance but not missing out on any financial opportunities. These revisions demonstrate the need for tax and accounting professionals who understand the healthcare industry, so you can better practice medicine. Contact us toll free at 855-542-7537.

Articles

Business Insurance Medical Providers Should Not Be Without

TFG Health Services

Most medical providers know they must buy malpractice insurance. It’s a no-brainer like Workers Compensation for their employees. There is more that should be considered essential however – here is a list that medical providers should strongly consider for their practice (and peace of mind):

  • Commercial General Liability Policies will cover the following risks:
    • Property damage,
    • Bodily injury,
    • Reputational harm, and
    • Advertising injury.
  • Renter or Owner Property Insurance will cover you for:
    • Fire,
    • Water damage from leaking pipes or rain (see below),
    • Trees falling onto your property, and
    • Theft.
  • Flood Insurance, is needed especially if you are located in a flood zone, because rising water is generally NOT covered under standard property insurance. Inexpensive, but important in Florida where a hurricane can cause water damage to your property.
  • Employment Practices Liability Policies cover claims and lawsuits over:
  • Wrongful termination,
    • Discrimination,
    • Workplace harassment, and
    • Retaliation from current or past employees.
  • Theft and Employee Misconduct Policies cover a business when dishonest employees do bad things.
  • Cyber Insurance is worth considering for larger practices that might get hacked and/or forced to pay a ransom, or fear inadvertent leak of patient information. Be sure your IT systems are set up correctly and properly protected.
  • Business Interruption Insurance should not be an afterthought. If your office is damaged by fire or hurricane, or other act of nature, and you cannot conduct business. It can cover your costs to set up an alternate location, provide cash for a temporary workforce, make up for lost income from operations, pay for equipment rental, and so much more.

Reach Out To Us: Is it time for an insurance policy audit for your practice? TFG can help you with deductibles, limits of coverage, gaps that might exist, review of premiums, etc. Buying business insurance is an important decision for health care providers, especially if you have a relatively large staff, or multiple offices. In addition, policies should be reviewed periodically, especially if your circumstances have changed. 

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Coronavirus Attacks Medical Practice Finances – Here Is The Rx

TFG Health Services

The potential for further financial hardship awaits physicians who are unprepared for the double punch of both a continuing pandemic and an economic downturn in 2021.

Office visits are cut by fear and by social distancing, folks are finding they prefer telemedicine, and surgeries are on hold, meaning revenue streams are trickling in or running dry. In addition, your investment portfolio is on the corona-coaster. It will take a lot for doctors, dentists and other healthcare providers to weather the continuing financial storm. Look to improve liquidity first.

Here is a list of things to start working on today for you and your practice that will have an immediate impact:

1. Revisit your budget and expenses;
2. Examine your debt-to-income ratio;
3. Conserve cash;
4. Put major purchases on hold;
5. Make sure if you received any financial assistance from the SBA or HHS you are documenting and reporting as required;
6. Look into refinancing your mortgage while rates are at historic lows;
7. Look into refinancing your student loans while you’re at it too, if you don’t qualify for PSLF;
8. Check up on your investments, asset allocation and diversification – ask for a portfolio audit;
9. Don’t forget your emergency fund;
10. Schedule a meeting for proactive tax planning for both 2020 and 2021. Make sure you are taking advantage of every opportunity to minimize your tax liability!

Reach out to us: Don’t underestimate the importance of tax planning in times like these and taking advantage of available tax credits. Although physician practices, clinics, surgery centers, dental offices, and other health care businesses were among the most common recipients of loans under the Paycheck Protection Program, that alone is not enough to help you weather the financial storm still ahead. Talk to us about your viable options. A new financial action plan or restructuring may help you and your practice weather the economic pressures on the medical field right now. Prepare to position yourself for the recovery after the pandemic with:
• Budget analysis
• Cash flow analysis
• Expense analysis
• New financial projections

Call us toll free at 855-542-7537 or email CPA@Fuoco.com.

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Pandemic Hurt Physicians But PPP And Tax Credits Can Help

TFG Health Services

Big drops in patient visits during the pandemic have decreased U.S. primary care physicians’ revenues, a Harvard study reports in the June 25th issue of Health Affairs.

Researchers report that, “…..as a result of decreases in office visits and fees for services from March to May during the pandemic, a full-time primary care physician will lose an average of more than $65,000 in revenue in 2020. Overall, primary care practices nationwide stand to lose nearly $15 billion.

The losses may force many practices to close, and weaken the health system dramatically. Revenue may continue to fall with a second wave of infection this year or if reimbursement rates for telehealth visits return to pre-pandemic levels. There is already a shortage of primary care providers in the United States.

Our healthcare accountants and advisors understand that half of primary care practices are small and physician-owned with limited access to capital and other support that could help them weather the pandemic storm. Thus the Fuoco Group and team at TFG Health Services has developed a presentation to assist healthcare providers in understanding and maximizing the SBA assistance out there, whether PPP loans, or EIDLs, or available pandemic tax credits. Power point presentation is attached HERE.

Since this article was published the The Consolidated Appropriations Act, 2021, has made additional PPP Loan money available, streamlined forgiveness, and extended many tax breaks for medical groups. Let us help guide you if you missed round one, or would like to dip into the well a second time. More info here: https://www.fuoco.com/component/content/article/641-new-ppp-loan-parcel-plus-tax-provisions-packaged-in-2021-covid-relief-bill

Reach Out To Us: Researchers said their findings show the need for a financial plan to support independent primary care doctors and small, independent practices. Although physician clinics, surgery centers, dental offices, small hospitals, and other health care businesses were among the most common recipients of loans under the Paycheck Protection Program, that alone is not enough. Talk to us about your viable options. We can help you gather the information and calculate the numbers you need to present to your bank for forgiveness. A new financial action plan or restructuring may help you and your practice weather the economic pressures on the medical field right now. Prepare to position yourself for the recovery after the pandemic with:
• Budget analysis
• Cash flow analysis
• Expense analysis
• New financial projections

Our tax experts can also help dentists and physicians take advantage of tax credits available, contact us with questions at CPA@Fuoco.com.

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PRF Grants Received By Healthcare Providers Will Be Taxed

TFG Health Services

The IRS has confirmed that Provider Relief Fund payments made available through the federal Coronavirus Aid, Relief, and Economic Security Act (CARES Act) cannot be excluded from taxation under a disaster relief exemption. Therefore, the payments do constitute gross taxable income, unless otherwise carved out under an existing exclusion, such as if the provider is a 501(c) nonprofit.

The IRS clarified that for-profit healthcare providers including hospitals and independent physician practices will be subject to the 21% corporate tax rate on the grants they received from the COVID-19 Provider Relief Fund, even though the two laws that set aside $175 billion in grants to help providers cover lost revenue and Coronavirus-related expenses didn’t explicitly state that the funds would be taxable.

The IRS issued guidance stating that the grants are taxable income days before a tax filing deadline on July 15. Both hospitals and independent physician practices will be subject to the 21% corporate tax rate. The IRS guidance came in response to a question about whether a health care provider that receives a Provider Relief Fund payment may exclude it from gross income as a qualified disaster relief payment under section 139 of the Internal Revenue Code. The IRS responded “No,” and said a payment to a business does not fit the definition of a qualified disaster relief payment under section 139, even if the business is a sole proprietorship. The relief fund payment is therefore included in gross income under section 61 of the code.

Tax-exempt healthcare providers are not subject to tax on relief payments, the IRS said. However, the relief payment may be taxable under section 511 if the payment reimburses the tax-exempt provider for expenses or lost revenue attributable to an unrelated trade.

The American Medical Association is asking Congress to exempt physicians from being taxed on the payments received from the Provider Relief Fund. This provision may be included in the next COVID-19 relief package expected at the end of July.

Reach Out To Us: Given that many healthcare providers may ultimately return unused payments from the Provider Relief Fund, taxpayers should be conscious of the tax consequences of payments received in one tax-year and returned in another year. Additionally, the guidance only applies for federal tax purposes so taxpayers should also consider the state and local tax treatment of the payments.

Our tax experts can help physicians take advantage of tax credits available, and assist with budget and cash flow planning, as well as expense analysis and new financial projections. Contact us with questions at CPA@Fuoco.com.

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TFG Client Spotlight – Dr. Jay Ajmo, PGA Dentistry & Jupiter Dentistry

TFG Health Services

Our February client in the spotlight is the distinguished and award-winning dentist, Dr. Jay Ajmo, DDS, DABOI, DICOI. Dr. Ajmo has just shared the exciting news that he has expanded his practice for sedation dentistry and minimally invasive dental implants offered at PGA Dentistry and opened a Jupiter location. Now you can also “Change Your Smile, Change Your Life” conveniently at Jupiter Dentistry if you live in North Palm Beach County!

Choosing the right dentist can make all the difference in your appearance and your overall health. It can even affect your ability to eat and speak properly. Just like PGA Dentistry, the staff at Jupiter Dentistry is dedicated to the highest standard of care. The professional care team is led by Dr. Ajmo, at this state-of-the-art facility who is committed to delivering the best experience possible. Dr Ajmo works closely with Dr. Jessica Wyatt in the Jupiter office. They both use the latest technology to provide the safest, most effective, and most comfortable care possible like 3D CT scans, digital x-rays, and lasers. If you suffer from dental anxiety, there are IV sedation services available for all procedures. Patients can receive the dental care they need in a private treatment room without having to feel nervous or worried.

Patients choose Dr. Ajmo and Dr. Wyatt because they are well known for exceptional restorative dentistry services, stunningly beautiful smile makeovers, and comprehensive dental implant services.

Dr. Jay Ajmo has been practicing cosmetic, implant, and reconstructive dentistry in Palm Beach Gardens since 1987. He is committed to continuously updating his skills and techniques and has earned post-doctorate credentials and internationally recognized certifications in cosmetic dentistry, dental implant surgery, and reconstructive dentistry. Dr. Ajmo also holds a Mastership from the Misch International Implant Institute. Voted “South Florida’s Most Distinguished Cosmetic Dentist” by The Best of South Florida and a “Top Doctor” by Consumer Research Counsel of America, Dr. Ajmo is one of only 400 dentists in the USA to hold a Diplomate Certification with the American Board of Oral Implantologists. Dr. Ajmo’s passion for his patients is evident in the quality of his care and patient referrals that extend throughout South Florida, and even across the globe in Europe.

Dr. Jessica Wyatt graduated from the University of Miami with a Bachelor’s of Science in Chemistry and Biology. She earned her Doctor of Dental Surgery from Columbia University College of Dental Medicine in New York, New York. Dr. Wyatt is an active member of the American Academy of Cosmetic Dentistry, the America Academy of Facial Esthetics and the Academy of General Dentistry. Dr. Wyatt’s areas of focus are in cosmetic & restorative dentistry. She’s also proficient in all forms of the most extensive non-surgical and non-invasive facial injectables.

No matter what your age or your dental needs, if your New Year’s resolution included a promise to yourself of a smile makeover and healthier set of teeth, either Jupiter Dentistry or PGA Dentistry is the right choice for exceptional results in restorative, cosmetic, and implant dentistry. Both locations are dedicated to improving patients’ quality of life with beautiful, healthy, teeth and smiles that they can enjoy for a lifetime.

Visit www.jupiterdentistry.com to explore the full range of options and services available to you such as: single or multiple tooth replacements, implants, crowns, bridges, dentures, full mouth reconstructions, oral surgery, root canal therapy and so much more. And don’t forget to ask the staff about “Teeth Next Day,” the exciting new zirconia implant bridge which is the ultimate in full-arch dental restorations. Jupiter Dentistry is conveniently located in the Three Palms Plaza at 2151 Alternate A1A South, Suite 1300, in Jupiter, FL 33477. Call (561) 250-0995 for hours and appointments available.

Of course you can still get the full range of options and services available from Dr Ajmo and his team at PGA Dentistry in Palm Beach Gardens. The office is located at 7100 Fairway Dr #59, Palm Beach Gardens, FL 33418. For hours and appointments visit www.pgadentistry.com or call (561) 468-5565 or 561-627-8666.

The Fuoco Group is proud to provide Dr. Jay Ajmo a full range of tax and accounting services, as well as a 360 degree business and financial advisory program for both his locations as part of our “new financial dialogue.” Become a part of the Fuoco client family and enjoy the benefits of our expertise. We are more than just accountants, we are trusted business advisors that will beat your expectations.

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TFG Client Spotlight – Dr. Ivy Faske, My Personal Pediatrician

TFG Health Services

Fuoco group is proud to announce that our latest client in the spotlight is the award-winning pediatrician of Jupiter and the Palm Beaches, Ivy Faske, MD.

According to experts the most important things to consider when choosing a pediatrician are: credentials, experience, current best practices, confidence in their philosophy of care, and how your doctor interacts with your child or newborn. Dr. Ivy Faske has it all, as well as a special superpower: “…..the ability to keep the parents calm as well as the child.”

In fact, it was a “cool, calm, and collected” pediatrician that inspired Ivy to take the leap into medicine. As a little girl, she was fascinated by what the doctor was doing and why. As a new medical student at the University of South Florida, Ivy was hooked on pediatrics the day she worked with a pediatrician who was able to calm a child in order to examine them, and then cared for them with compassion and cured them with skill. That was in 1982!

Fast forward to current times and Dr. Faske has been in private practice in Palm Beach Gardens for more than 33 years. Dr. Faske is a Fellow of The American Academy of Pediatrics. She served for 6 years as Chief of Pediatrics for the Palm Beach Gardens Medical Center, and was a past president of the Palm Beach Pediatric Society.

It is her devotion to her patients, and the desire to share the skills she developed over the years, that was her inspiration to write her book, “They Do Come With Instructions!” It chronicles years of diagnosis and observations about the physiology, care and development of newborns to young children. It features photos of Dr. Faske’s patients throughout the years so that you can easily identify newborn rashes, sore and strep throats, chicken pox, conjunctivitis, fifth disease, eczema, hives, poison ivy, ringworm, and so much more. It also includes vaccine information sheets for all routine childhood vaccines.

Florida born and raised, Dr. Faske is originally from Miami. She now calls Palm Beach Gardens home. Giving back to the healthcare community in which she works and lives has always been a priority for Dr. Faske. Over the years she has served as President of the Palm Beach County Medical Society, and currently is President of the PBCMS Services, which is the charitable arm of the Society.  Dr. Faske was the Chair of the Women Physicians section of PBCMS, and won the Women in Medicine Leadership Award in 2008. In 2015, the PBCMS presented her with its Humanitarian Award during the Heroes in Medicine Celebration. Dr. Faske was the recipient of the Society’s coveted Excellence in Medicine Award in 2019.

Dr. Faske has been voted by her peers as a “Top Doctor” in Palm Beach County almost every year since 1998. In 2020, the readers of the Palm Beach Post and community at large voted her the “Best Pediatrician” in Palm Beach County. What continues to inspire this award winning pediatrician and leader in the medical community? In Dr. Faske’s own words: “I love seeing children develop through the years, and hope that by having good experiences at the doctor while they are young, they will continue to seek proper care as an adult.”

Dr. Faske’s hospital affiliations include Jupiter Medical Center and St. Mary’s Medical Center. Her office is conveniently located at 11211 Prosperity Farms Road, Suite A102, in Palm Beach Gardens, Florida. The office phone number is (561) 626-4677, and she can be emailed at Office@mypersonalpediatrician.com. Oh, and just in case you need a baby shower gift, Dr. Faske’s book website is: www.theydocomewithinstructions.com. For more information visit http://www.mypersonalpediatrician.com/.

The Fuoco Group is proud to provide Dr. Faske with a customized range of tax and accounting services, as part of our “new financial dialogue.” Become a part of the Fuoco client family, and enjoy the benefits of our expertise. We are more than just accountants, we are trusted business advisors that will beat your expectations.

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It Took A Pandemic To Push Thru Stark Law Changes

TFG Health Services

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.

Check out the more than 60 specific waivers and other changes announced in the Emergency Declaration: https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf.   

Healthcare providers, including DHS entities and physicians, should continue to monitor the CMS Coronavirus Waivers & Flexibilities website for any further developments in responding to the COVID-19 pandemic: https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers.

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.

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TFG Health Physician Telemedicine Toolkit

TFG Health Services

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:

AAFP: https://www.aafp.org/patient-care/emergency/2019-coronavirus/telehealth.html

CMS General Provider Telehealth and Telemedicine Tool Kit: https://www.cms.gov/files/document/general-telemedicine-toolkit.pdf

AMA Telemedicine Quick Set-up Guide: https://www.ama-assn.org/practice-management/digital/ama-quick-guide-telemedicine-practice

Expansion of Telehealth and Licensing Waivers During Pandemic: http://connectwithcare.org/state-telehealth-and-licensure-expansion-covid-19-chart/

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

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Modern Healthcare Meets Its Match With Coronavirus

TFG Health Services

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.

Click here for a Clinician Screening Tool for Identifying Persons with Coronavirus Disease: https://pbcms.memberclicks.net/assets/docs/nCoVProviderAlgorithmCHD2020-02-28.pdf

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.