COVID-19 Legal Resources for Healthcare Providers and Suppliers

Welcome to Wachler & Associates COVID-19 resource page.

Update: Expansion of CARES Act Provider Relief Fund

Pursuant to the CARES Act, which provided $175 billion in relief funds to assist hospitals and other health care providers who are assisting in combatting the 2019 Novel Coronavirus (“COVID-19”), the Department of Health and Human Services has already allocated $30 billion on April 10, 2020 to qualifying providers and health care facilities. This $30 billion was a general allocation to all providers who billed Medicare in 2019, distributed proportionally to providers based on 2019 Medicare fee-for-service revenue.

Beginning Friday, April 24, HHS began distributing an additional $20 billion in general allocations. This $20 billion will be allocated to the same providers as the initial $30 billion and will be distributed proportionally to the net revenue. Providers who have already submitted revenue information in their 2018 Center for Medicare & Medicaid Services (“CMS”) cost reports were automatically paid on April 24. If a provider has not submitted a CMS cost report, they must submit their revenue information to HHS through the Provider Relief Fund Application Portal. If a provider received money automatically, they still must submit and update their revenue information to the portal to be verified. All providers receiving money in this second wave still need to sign the attestation and accept the terms and conditions, which can be found on HHS’ website.

As part of the terms and conditions, the eligible providers and facilities who are receiving general distribution funds must agree to the following:

  1. The Payment is defined as the funds received from the relief fund, and the Recipient means only the healthcare provider, whether it is an individual or an entity, receiving the payment.
  2. The Recipient must certify that it:
    1. Billed Medicare in 2019;
    2. Provided or currently provides, after January 31, 2020, diagnoses, testing, or care for individuals with possible or actual cases of COVID-19;
    3. Is not terminated from participation in Medicare
    4. Is not excluded from participation in Medicare, Medicaid, or any other Federal health care programs; and
    5. Does not currently have any Medicare billing privileges revoked.
  3. The Recipient must certify that the Payment will only be used to prevent, prepare for, and respond to coronavirus, and shall reimburse the Recipient only for health care related expenses or lost revenues that are attributable to coronavirus.
  4. The Recipient must certify that it will not use the Payment to reimburse expenses or losses that have been reimbursed from other sources or that other sources are obligated to reimburse.
  5. The Recipient must submit reports required by the Secretary in order to ensure compliance with the conditions imposed on the Payment.
  6. Not later than 10 days after the end of each calendar quarter, a Recipient that received more than $150,000 total in funds must submit a report to the Secretary containing the following information:
    1. The total amount of funds received from HHS;
    2. The amount of funds received that were expended or obligated for any given project or activity;
    3. A detailed list of all projects or activities for which large covered funds were expended or obligated, including the name and description of each project or activity and the estimated number of jobs created or retained by the project or activity; and
    4. Detailed information on any level of sub-contracts or sub-grants awarded by the covered recipient or its subcontractors or subgrantees.
  7. The Recipient must maintain appropriate records and cost documentation and shall submit a copy of such records and cost documentation to the Secretary upon request and agrees to any audits.
  8. The Recipient must certify that it will not seek to collect from the patient out-of-pocket expenses in an amount greater than what the patient would have otherwise been required to pay if the care had been provided by an in-network Recipient.

While these terms and conditions are lengthy, Recipients can essentially use the funds for lost revenue attributable to COVID-19 and health care expenses attributable to COVID-19.. This is an extremely broad category with very little guidance as to what would be covered, so Recipients should consult with health law attorneys to develop a compliance plan. In both instances of lost revenue or health care expenses, Recipients must document everything that they spend the fund on, and the method used to determine how to allocate the funds. Detailed documentation could help these providers and other facilities avoid recoupment and avoid potential exposure under the False Claims Act.

In addition to the $50 billion in additional general distributions, there will also be several targeted allocations. A portion of the fund will be used to reimburse healthcare providers, at Medicare rates, for COVID-19 treatment of the uninsured on or after February 4, 2020. To qualify, providers must: (1) enroll as a provider participant; (2) check patient eligibility and benefits; (3) submit patient information; (4) submit claims; and (5) abstain from balance billing for any COVID-19 related treatment. After completion of all four steps, these providers should receive payment via direct deposit.

Another targeted allocation is for COVID-19 high impact areas. $10 billion will be allocated to targeted hospitals in areas that have been particularly impacted by COVID-19. These hospitals needed to provide their TIN, NPI, total number of intensive care unit beds as of April 10, 2020, and the total number of admissions with a positive diagnosis for COVID-19 from January 1, 2020 to April 10, 2020, to the authentication portal before 3:00 p.m. on April 25, 2020. While the portal deadline has passed, it is still active, and hospitals should still submit information in the event that there are still remaining funds.

Another $10 billion has been allocated to rural health clinics and hospitals on the basis of operating expenses—this method is used primarily because many rural facilities are extremely unprofitable right now, which could lead to these very important facilities having to close down. Rural facilities are more exposed to any slight decline in revenue or increases in expenses related to COVID-19 as compared to their urban counterparts.

The last targeted allocation is $400 million that will be allocated to Indian Health Service facilities, also based on operating expenses.

Providers and other healthcare facilities should be checking the HHS website daily for updates. HHS has not yet announced allocation of all the funds appropriated by Congress so there will likely be more distributions in the coming weeks. Wachler & Associates will continue to closely monitor and provide updates on any material changes regarding the current provider relief funds, additional allocations of funds, and other developments under the CARES Act relevant to healthcare providers and suppliers.

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Update: Summary of CMS Initiatives to Improve Access to Telehealth During COVID-19 Pandemic

On April 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued another round of widespread changes expanding access to telehealth services in response to the COVID-19 pandemic. CMS’ most recent changes further an unprecedented expansion of Medicare coverage for telehealth services to allow beneficiaries access to physicians and other healthcare providers from their own home and without the risk of exposure to COVID-19.

Prior to onset of the current public health emergency, Medicare’s coverage of telehealth was limited to specific services provided via an interactive audio and video telecommunications system between a healthcare provider at a “distant site” and a beneficiary at an “originating site” as defined by Medicare. Most notably, in order to qualify as an “originating site” at which a beneficiary could obtain telehealth services covered by Medicare, the beneficiary was required to be in a physician office, healthcare facility, or other authorized site located in either a county outside a Metropolitan Statistical Area (MSA) or a rural Health Professional Shortage Area (HPSA) in a rural census tract. In addition to Medicare’s requirements related to technology, covered services, and location of the healthcare provider and beneficiary, state law also applies to telemedicine services rendered to Medicare beneficiaries. For example, state law generally requires healthcare providers engaged in telemedicine to be licensed in both the state where the provider renders the telemedicine service and the state where the beneficiary obtains the telemedicine service. State law often dictates the type of technology required to perform telemedicine; however, Medicare’s requirement to use interactive audio and video telecommunications system generally satisfies any separate state requirements. State law will also govern various other issues depending on the specific telehealth arrangement including, for example, electronic prescribing of controlled substances, diagnostic testing, and clinical laboratory services. In addition to clinical and billing limitations, telemedicine arrangements also implicate federal and state fraud and abuse laws including, but not limited to: the federal Stark law and Anti-Kickback Statute (AKS), state self-referral, anti-kickback and fee-splitting laws; and state Corporate Practice of Medicine Doctrines (CPOMs). While this article focuses on Medicare’s expansion of telehealth coverage, please note that state departments of health, Medicaid programs, and licensure boards have also expanded access to telehealth services via waivers, policy changes, and other initiatives in response to COVID-19.

Medicare’s expansion of telehealth coverage in response to the COVID-19 pandemic results from several initiatives implemented by CMS under the Social Security Act’s Section 1135 waiver authority, the Coronavirus Preparedness and Response Supplemental Appropriations Act, and the Coronavirus Aid, Relief, and Economic Security (CARES) Act. Collectively, CMS’ expansion of telehealth coverage includes, but is not limited to, the following changes as of April 30, 2020:

  • Effective March 6, 2020, Medicare will reimburse healthcare providers for office, hospital, and other visits furnished via telehealth in all locations and all areas of the country. Accordingly, Medicare will reimburse healthcare providers for telehealth services provided to beneficiaries located at any healthcare facility or their home.
  • CMS has waived limitations on types of healthcare providers eligible to provide Medicare-covered telehealth services. Whereas Medicare coverage of telehealth was previously limited to services performed by physicians, physician assistants (PAs), nurse practitioners (NPs), and several other types of providers, Medicare will now pay for telehealth services provided by physical therapists, occupational therapists, and speech language pathologists.
  • CMS has increased the range of telehealth services reimbursable by Medicare, including Medicare telehealth visits, virtual check-ins and e-visits. Virtual check-ins, which are brief communications (5-10 minutes) with patients in their home, may be provided via audio-only telephone or other telecommunicatio ns device. Virtual check-ins will generally be used to determine whether an office visit or other service is needed by the beneficiary. Medicare providers may bill for virtual check-ins by reporting HCPCS codes G2012, as well as remote evaluations of recorded videos and/or images submitted by patients by reporting G2010. E-visits may be provided to patients as online evaluation and management (E&M) services. Physicians may bill e-visits by reporting CPT codes 99421-99423 and HPCCS codes G2061-G2063. For both virtual check-ins and e-visits, CMS will not impose any geographic or location restrictions. CMS will require individual services to be initiated by the patient, however CMS will allow providers to educate patients regarding access to these services prior to the patients’ initiation. While Medicare initially limited virtual check-ins to established patients, Medicare providers may now provide these services to both new and establish patients as of April 30, 2020.
  • CMS has expanded Medicare telehealth services to include more than 80 additional services. Additional telehealth service covered by Medicare include emergency department visits, initial nursing facility and discharge visits, and home visits provided by clinicians eligible to provide telehealth services reimbursed by Medicare. Unlike virtual check-ins and e-visits, these additional telehealth services must satisfy Medicare’s traditional telemedicine requirements described above, including use of interactive audio and video telecommunications systems that permit real-time interaction between a healthcare provider at a “distant site” and patient at an “originating site,” however for duration of the COVID-19 public health emergency, Medicare will reimburse for telehealth services provided to beneficiaries located at any healthcare facility or their home.
  • Medicare telehealth services will be reimbursed under the Physician Fee Schedule at the same rate as in-person services. While Medicare coinsurance and deductible amounts apply for these services, the Department of Health & Human Services (HHS) Office of Inspector General (OIG) has been directed to provide increased flexibility for healthcare providers to waive or reduce coinsurance and/or deductible (cost-sharing) amounts for telehealth services provided to federal healthcare program beneficiaries. Absent such flexibility, routine waivers of cost-sharing amounts subject providers and suppliers to potential liability under the federal Civil Monetary Penalty (CMP) authorities’ Beneficiary Inducement Statute, as well as federal and state anti-kickback and false claims laws.
  • CMS is waiving the video requirement for certain providers. CMS will reimburse eligible healthcare providers for specific telemedicine services provided via audio-only telephone communications with patients. Effective April 30, 2020, CMS broadened the list of services that may be provided by telephone to include a range of behavioral health and patient education services. CMS also increased payment for audio-only telephone services to equal payment for similar outpatient visits, with payment retroactive to Mach 1, 2020.
  • Effective March 17, 2020, the Department of Health & Humans Services (HHS) Office for Civil Rights (OCR) will waive penalties and otherwise exercise enforcement discretion regarding HIPAA violations by Medicare providers rendering telehealth services in good faith via common communications methods. Whereas OCR previously established that telemedicine services provided through Skype, FaceTime, and similar technologies cannot comply with HIPAA, healthcare providers may use these technologies to provide Medicare covered services during the COVID-19 public health emergency.
  • CMS will allow telehealth to satisfy Medicare face-to-face visit requirements related to home health, hospice, and inpatient rehabilitation facilities.
  • Home health agencies (HHAs) and hospices may also provide telehealth services to Medicare beneficiaries. HHAs may provide a service to a beneficiary using telehealth if the services are part of the beneficiary’s plan of care and the telehealth services do not replace in-personal visits needed per the plan of care. If appropriate and feasible, hospice providers may render telehealth hospice case to Medicare beneficiaries receiving routine home care.
  • For purposes of qualifying for Medicare’s Home Health Benefit, Medicare beneficiaries will be considered homebound if a physician determines the beneficiary needs skilled services and should not leave home due to suspected or confirmed COVID-19 (or other medical contraindication).

In addition to the telemedicine-specific initiatives highlighted above, other CMS waivers and policy changes aimed at combating the COVID-19 pandemic indirectly increase access to telehealth services. For example, CMS waivers related to Medicare provider enrollment requirements effectively improve access to telehealth by expanding the healthcare workforce and the types of healthcare providers eligible to receive reimbursement for covered services rendered to Medicaid beneficiaries.

Finally, while this update summarizes the various waivers, policy changes, and other initiatives implemented within Medicare program, please note that CMS also published a COVID-19 Telehealth Toolkit for state Medicaid programs and Children’s Health Insurance Program (CHIP). CMS intends for this toolkit to provide states with “a wide range of tools and guidance to support their ability to care for their Medicare and CHIP beneficiaries during this public health emergency.” CMS’ COVID-19 Telehealth Toolkit aims to accelerate states’ use of telehealth in Medicaid and CHIP by providing guidance focused on the following issues: patient populations eligible for telehealth; coverage and reimbursement policies; providers and practitioners eligible to provide telehealth; technology requirements; and pediatric consultations.

Due to CMS’ continued attention to increasing access to telehealth during the COVID-19 pandemic, and as evidence by the series of initiatives implemented by CMS thus far, we expect CMS to continue to evaluate opportunities to remove barriers to telehealth that will allow patients to receive appropriate Medicare covered services in the safety of their own home. Wachler & Associates will continue to monitor all CMS guidance related to telehealth and publish updates regarding any material developments impacting healthcare providers and suppliers.

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Private Payor Snapshot: Blue Cross Blue Shield of Michigan (BCBSM) Initiatives Related to COVID-19

The COVID-19 pandemic’s unprecedented impact on the healthcare industry has induced responses from all industry stakeholders, including third-party payors such as Medicare, state Medicaid programs, and commercial insurers. While Medicare’s response to COVID-19 has received significant attention within the provider and supplier community, it is important for healthcare providers and supplier to be aware of the waivers, policy changes, and other initiatives implemented by commercial insurers. Since each private payor determines the best approach to support its members and alleviate the burden on participating healthcare providers, it is critical that healthcare providers and suppliers review press releases, plan websites, and other publicly available information related to each plan with which the provider participates or otherwise regularly bills for healthcare services and items provided to plan members. Accordingly, we are providing a brief overview of the initiatives taken by Blue Cross Blue Shield of Michigan (BCBSM) in response to the COVID-19 pandemic. Our goal is for this private payor snapshot tot trigger healthcare providers and suppliers to review the third-party payor initiatives applicable to their practice and benefit from the additional opportunities made available to participating providers during the COVID-19 public health emergency.

Waiver of member cost-sharing for COVID-19 treatment: BCBSM is still implementing this change in their system and the change will be temporary. Therefore, the waiving of member cost sharing will not appear when a provider checks member eligibility and benefits in BCBSM’s system, but the claims for COVID-19 treatment should still process with the member cost share waived. BCBSM has also asked providers not to submit claims for COVID-19 treatment until after May 1, 2020 to complete the roll out of the cost-sharing waiver and other system changes. COVID-19 claims submitted prior to May 1, 2020 may need to be reprocessed or resubmitted.

Transferring MA members from acute care hospitals to SNFs: For all transfers of an MA member from an acute care hospital to an SNF occurring between April 3 and May 31, 2020, BCBSM has waived the requirement to obtain clinical review for the first three days of skilled nursing facility stay. Hospitals must still notify naviHealth prior to the transfer.

Temporary Suspension of Sequestration: Blue Cross and BCN have temporarily suspended the 2% sequestration reduction for Blue Cross and BCN MA providers. Blue Cross and BCN expect to implement the change in the system by May 1, 2020 and expect the 2% sequestration reduction to be suspended for the remainder of 2020 and reinstated on January 1, 2021.

Extension of Authorization Durations for Elective and Non-Urgent Procedures: Approval of authorization requests for elective procedures, including physical, occupational, and speech therapy that are made prior to May 31, 2020 will be valid for 180 days. The earliest date of request for which an approval will be valid for 180 days is as follows: Blue Cross or BCN utilization management – March 13, 2020; AIM Specialty Health – April 6, 2020; and eviCore Healthcare – March 26, 2020.

Support for Outpatient Behavioral Health Treatment Delivered Via Telemedicine: Some PHP and IOP are now payable via telemedicine.

Extended of Authorization Dates on Select Medical and Pharmacy Benefit Drugs: For PPO (commercial) and BCN HMOSM (commercial) members for authorizations scheduled to expire between March 1 and June 1, 2020, the authorization end dates for select medical and pharmacy benefit drugs has been extended to August 1, 2020. For Medicare Plus Blue and BCN MA members for authorizations that are scheduled to expire between April 1 and May 31, 2020, the authorization end dates for select medical drugs has been extended to August 31, 2020.

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CARES Act Provider Relief Fund

On March 27, 2020, the President signed off on the bipartisan CARES Act that provides $100 billion in relief funds to hospitals and other healthcare providers on the front lines of the 2019 Novel Coronavirus (“COVID-19”) response. Pursuant to the CARES Act, the Department of Health and Human Services (HHS) has decided to allocate $30 billion to providers beginning on April 10, 2020. It is being called the “CARES Act Provider Relief Fund.” The CARES Act Provider Relief Fund grants a one-time payment to qualifying providers or facilities who certify that the payment will only be used to prevent, prepare for, and respond to COVID-19, and to reimburse providers who have lost revenue because of the COVID-19.

Providers and facilities do not need to apply for the payment, as the money will be automatically deposited to the bank account associated with the provider’s Tax Identification Number (TIN). Not every healthcare provider and facility will qualify. Qualifying providers and facilities are ones that:

  1. Received Medicare fee-for-service (FFS) reimbursements in 2019;
  2. Agree not to seek collection of out of pocket payments from a COVID-19 patient that are greater than what the patient would have been expected to pay if the care was provided by an in-network provider;
  3. Are in an area heavily impacted by COVID-19 and are struggling to keep their business open; and
  4. If they ceased operation in response to COVID-19, they may still receive funds so long as the provider or facility provided diagnoses, testing, or care for individuals with possible or actual cases of COVID-19.

Eligible providers and suppliers need not apply for the payment, but once they obtain the payment as a direct deposit via Automated Clearing House through Optum Bank under the title “HHSPAYMENT,” they must take a few additional steps. It should be of note that providers and facilities who normally receive a paper check for reimbursement from CMS will receive a paper check in the mail for this payment within the next few weeks. Within 30 days of receiving the payment providers and facilities must sign an attestation confirming the receipt of the funds and agreeing to the terms and conditions of the payment. Essentially, keeping these funds is conditional on the provider’s acceptance of the Terms and Conditions. Not returning the payment within 30 days of receipt will be viewed as acceptance of the Terms and Conditions. But if the provider or facility chooses to reject the funds, the provider or facility must contact HHS within 30 days of receipt of payment and then remit the full payment to HHS as instructed. The CARES Act Provider Relief Fund Payment Attestation Portal will guide providers through the attestation process to accept or reject the funds.

HHS is calculating the payment amount based on the provider’s or facility’s share of total Medical FFS reimbursements in 2019. There were approximately $484 billion worth of Medicare FFS payments in 2019. Thus, to calculate how much money they should be receiving, a provider or facility should divide their Medicare FFS (not including Medicare Advantage) payments they received in 2019 by $484,000,000,000, and then multiply that number by $30,000,000,000. This payment will not ever need to be repaid, unless the provider or facility rejects the payment initially, as outlined above.

Relief payments are made according to an organization’s or sole practitioner’s TIN, not by the provider’s NPI or other individual identifying number. For large organizations and health systems, they will receive a payment for each of their TINs that bill Medicare. Employed physicians of a large group should not expect to receive an individual payment, because their employing organization will already receive one based on its TIN. Individual physicians and providers in a group practice will also likely not receive individual payments, because the group practice itself will receive the payment. Only solo practitioners who fill Medicare will individually receive a payment under their TIN used to bill Medicare.

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DME Competitive Bidding Program Changes for COVID-19

The Durable Medical Equipment, Prosthetics, Orthotics, & Supplies (“DMEPOS”) competitive bidding program was implemented in 2003. The Medicare Prescription Drug, Improvement, and Modernization Act established Medicare’s DME competitive bidding program and requires that Medicare base its payment methodology for DMEPOS using a competitive bidding process.

Medicare’s DME competitive bidding process ultimately reduces Medicare beneficiaries’ out-of-pocket expenses for DME, saves Medicare money, and still provides beneficiaries with high quality items. The DME competitive bidding process works as follows: the supplier electronically submits a bid for selected products; bids are evaluated based on bid price, supplier eligibility, and financial stability; and then the contract is awarded to the supplier who had the best bid price, eligibility, and financial stability. The supplier must then agree to accept assignment on all claims for bid items and receive reimbursement based the set amount.

During the 2019 Novel Coronavirus (“COVID-19”) pandemic, and pursuant to the President’s Public Health Emergency declaration, the Centers for Medicare & Medicaid Services (“CMS”) is removing the non-invasive ventilator product category from Round 2021 of DME competitive bidding. CMS’ intent is to allow any Medicare-enrolled DME supplier to furnish these ventilators and receive payments for such ventilators as covered under Medicare. The DME competitive bidding program would normally limit supply of these ventilators by excluding capable DME suppliers. While limiting the number of suppliers for a given DME product would not ordinarily create a public health issue, current unprecedented demand for non-invasive ventilators for COVID-19 patients necessitates increased access to these ventilators.

Importantly, for any Round 2021 bidder who only bid in the competitive bidding area for the non-invasive ventilator category, the bid surety bond does not meet the forfeiture conditions and thus the surety bond will not be collected by CMS. Round 2021 contracts are scheduled to be effective from January 1, 2021 through December 31, 2021, meaning that the bidding process is ongoing throughout 2020 and thus during the COVID-19 pandemic, which is why the non-invasive ventilator category had to be removed in 2020 for the 2021 Round.

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COVID-19 and 1135 Waivers

Much has been written about COVID-19 and “1135 Waivers.” They have been discussed in relation to licensure requirements for health care professionals, HIPAA and the Emergency Medical Treatment and Active Labor Act (EMTALA). But what exactly are 1135 Waivers and why are they important?

In the event the President of the United States declares an emergency or disaster under either the Stafford Act or the National Emergencies Act and the Secretary of HHS (Secretary) declares a Public Health Emergency under Section 312 of the Public Health Service Act, Section 1135 of the Social Security Act authorizes the Secretary to temporarily waive or modify certain Medicare, Medicaid, CHIP and HIPAA requirements. The purpose of the 1135 Waivers is to help ensure that health care items and services are available to meet the needs of beneficiaries, and allows providers to be reimbursed during an emergency or disaster even if, due to COVID -19, they cannot comply with one or more requirements that would otherwise bar reimbursement. Under an 1135 Waiver, a provider’s noncompliance would not result in the provider being subjected to sanctions, so long as the goods or services were provided in good faith and there is no fraud or abuse.

1135 Waivers last for up to 60 days, unless they are extended by the Secretary, and typically end no later than the termination of the emergency period. They apply only to federal requirements and can be either blanket waivers or waivers that are requested by individual states or providers and approved on a case by case basis. Blanket waivers are applicable nationally or to large groups of similarly situated providers affected by the emergency or disaster.

Importantly, 1135 Waivers do not allow for reimbursement for services that would not otherwise be covered, do not allow individuals to be eligible for Medicare who otherwise would not be eligible, and are not a grant or financial assistance program.

On January 31, 2020. Secretary Azar declared a public health emergency for the entire United States as a result of the coronavirus pandemic. Following this, on March13, 2020, the President issued a National Emergency Declaration and the Secretary issued 1135 Waivers. The 1135 Waivers have a retroactive date of March 1, 2020 and waive a range of requirements, including, without limitation, the waiver of the 3-day prior hospitalization requirement for coverage of a SNF stay; the waiver of the application fee, finger-based criminal background checks and site visit that are part of the screening requirements for provider enrollment; and the waiver of the requirement that out-of-state providers be licensed in the state where they provide services if they are licensed in another state (note that this last waiver does not apply to CHIP). For a complete list of the 1135 Waivers, please click here.

In addition, to the blanket waivers, States have applied for and received waivers related to their Medicaid programs. Currently, approximately 34 states have been granted such waivers, the first of which was Florida, followed closely by Washington. Florida’s waiver, among other things, allows the State to provide flexibilities in Medicaid provider screening and in reimbursement of out-of-state providers, remove prior authorization and medical necessity processes for benefits covered under Florida Medicaid, and waives certain pre-admission and annual resident review assessments.

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