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Stark Law / Stark Anti Kickback Statute

The Stark Law anti kickback statute lawyer is federal legislation that was intended to limit physician referrals that might constitute significant conflicts of interests. In the absence of a specific exception, the Stark Law anti kickback statute lawyer prohibits physicians and other health care providers from making certain referrals for designated health care services when the referring physician or health care provider, or a member of his or her family, has a financial relationship with the entity providing that service. This prohibition applies specifically to Medicare and Medicaid patients. Health care providers who are subject to the Stark anti kickback statute lawyer include dentists, osteopaths, podiatrists, optometrists and chiropractors as well as medical doctors. Family members subject to the Stark anti kickback statute lawyer includes spouses, parents, children, stepchildren, in-laws, grandparents, grandchildren, and the spouses of these individuals.

In the original legislation, which was passed as a provision to the 1989 Omnibus Budget Reconciliation Act, “designated health care services” were specified as clinical laboratory services that might be covered under Medicare Part B services. The 1993 Omnibus Budget Reconciliation Act expanded these services to include physical therapy, occupational therapy, radiology and imaging studies, medical and prosthetic equipment, inpatient and outpatient hospital services, home health services and outpatient prescription drugs for both Medicare and Medicaid patients. The original law is often known as Stark I while the expansion of its scope that occurred in 1993 is familiarly known as Stark II.

In 2007, the Center for Medicaid and Medicare Services made additional modifications to the Stark Law anti kickback statute lawyer’s scope, which became known as Stark III.

Stark anti kickback Statute on Physician Investments

There have been many ongoing regulatory changes made by the Centers for Medicare and Medicaid Services, which have changed the physician investment guidelines in the Phase III final regulations of Stark Law/ Stark Anti Kickback Statute, and in the 2008 Medicare Physician Fee final rules. The 2008 Fee schedule limits reimbursements for diagnostic tests, and prohibits independent diagnostic testing facilities sharing their facilities with another Medicare provider, or supplier. Investment opportunities are possible, you need to be aware of the legal and regulatory procedures before taking any financial actions.

Ambulatory Surgical Centers

Stark III, nor the 2008 fee schedule, has imposed any restrictions at all on a physician’s ability to invest in an ambulatory surgical center. ASC services aren’t health services covered by the Stark Law/ Stark Anti Kickback Statute. The Stark Law/ Stark Anti Kickback Statute, prohibits a physician from referring a Medicare or Medicaid patient to an entity which he, or a family member, has a financial interest in for any of the 11 designated health services.

Investments in an ASC, have to comply with the federal anti kickback statute’s safe harbor provisions. The anti kickback Statute prohibits anyone for offering, paying, or soliciting, or getting, any financial compensation in exchange for a referral of medicare or medicaid business. The anti kickback Statute has many exceptions, which are known as safe harbors, which will allow you to engage in conduct which would ordinarily violate the anti kickback statute. The Safe Harbor for investments in ASC is composed of four categories: surgeon owned ASCs, single speciality ASCs, multi-specialty ASCs, and hospital/physician ASCs. Safe Harbor protection will only apply if there’s full compliance with all of the standards. The standards require the following:

  • Each physician investor is in a position to refer patients directly to the ASC and perform the surgery on such patients
  • Derive at least 1/3 of his medical practice income, from procedures he performs at the ASC
  • Performs at least 1/3 of the procedures that will be performed in an ASC setting at the ASC investment entity.

Medical Space / Medical Equipment Leasing / Management Companies

These types of companies are great investment opportunities for physicians. Typically, leasing companies will own or lease space/equipment, or sublease the space/equipment to a healthcare facility. In return for this, the health care facilities pays a rental fee. Management companies manage a health care facility, by doing things like billing, accounting, collecting, hiring/firing, on behalf of the facility. In exchange, the facility pays the company a management fee. There are absolutely no restrictions on the physician that invests in a medical space/equipment leasing company, or in a medical management company. Under the ASC safe harbor, physicians who have a desire to invest in an ASC have to be in a position to directly refer patients to the ASC and perform surgery on the patients. Primary care physicians can invest in a medical space leasing company which owns, or leases, the building, in which the ASC is located. The primary care physician can invest in a medical space leasing company, which owns/leases the building in which the ASC is located and that leases/subleases the space to the ASC, or a medical equipment leasing company which owns/leases equipment to the ASC, and a management company which manages the ASC. Any investments in a medical space/medical equipment leasing company must be structured within the Small Investment Safe Harbor. This requires that no more than 40% of the investment interests be held by investors who are in a position to make a referral in service of the company. No more than 40% of the entities gross revenue can come from referrals/business generated from outside investors.

Lease agreements between leasing companies, and healthcare facilities, and the management agreements between the management companies should be structured to abide by the applicable Safe Harbors and exceptions to the Stark Law anti kickback statutes. The Safe Harbors for leases and the management agreements and the Stark Law exception for leases require, that the rent for the leases and the management fee be billed at a fair market value.

Hospitals

Hospitals are great investment opportunities for physicians. They have to be structured within the Safe Harbors, i.e. the Small Investment Safe Harbor, and Stark Law exceptions. The Stark Law/ Stark anti kickback Statute, as an exception which is known as the “whole hospital exception,” which allows a physician to refer his patients for any of the 11 health services to a hospital where he has an ownership interest, if the referring physician is authorized to do services at the hospital, and if the physicians ownership is in the entire hospital and not just a specific department of the hospital.

Stark Law/ Stark anti kickback Statute Lawyers

Many activities that give rise to liability under the Stark Law anti kickback statute lawyer are also actionable under the anti kickback statute, but whereas the Stark Law anti kickback statute lawyer carries civil penalties, the anti kickback statute attaches criminal penalties to the solicitation for referrals. The anti kickback statute was included under the 2010 Patient Protection and Affordable Care Act as an update to an existing piece of legislation called the False Claims Act, which is a more general piece of legislation that makes any person or business that is attempting to deceive the government liable for fraud.

Under the terms of the anti kickback Law, “a person need not have actual knowledge … or specific intent to commit a violation.” In other words, ignorance of the law is no excuse, and medical providers who violate the False Claims Act cannot argue successfully that they were unaware that the anti kickback Law existed.

Exceptions

Certain financial relationships are recognized as exceptions to theStark Law/ Stark anti kickback Statute. In addition to the exceptions and exclusions codified in the law, the administrator of the Center for Medicaid and Medicare Services also has the right to create regulatory exceptions.

Physicians may refer patients to other physicians who are working in the same practice, for example, and they may refer that patient for laboratory, radiology, outpatient pharmacy and other services that are provided by their practice. This is known as the In-Office Ancillary Services Exception.

Physicians may also refer Medicaid and Medicare patients to receive designated health services at for-profit hospitals that said physicians have an ownership stake in so long as that stake is in the whole hospital and not in any specific department. This is known as the Whole Hospital Exception. In order to be eligible for the Whole Hospital Exception, the referring physician must have privileges at the hospital.

The Stark Law anti kickback statute lawyer describes its exceptions at some length and codifies the conditions that must be met in order for the exception to apply. Each condition must be complied with strictly, or the referring provider may be committing a Stark Law anti kickback statute lawyer violation. This is why it’s so important to consult with a health law attorney any time a health care provider is considering accepting referrals from a physician with whom he or she has a preexisting financial relationship.

Enforcement

TheStark Law/ Stark anti kickback Statute is enforced by a number of federal agencies, including the Department of Justice, the Department of Health and Human Services and the Center for Medicaid and Medicare Services. Since the 2010 passage of the Patient Protection and Affordable Care Act and its anti kickback amendment to the False Claims Act, the government has become increasingly aggressive about prosecuting Stark Law anti kickback statute lawyer violations.

Stark Law anti kickback statute lawyer Violations

Penalties for violating the Stark Law/ Stark anti kickback Statute can be quite severe. Noncompliant practitioners and institutions risk denial of payment, as well as the imposition of a $15,000 civil fine for every service that’s found to be a violation as well as a $100,000 civil fine for every relationship that’s found to be a violation. Additionally ,Stark Law/ Stark anti kickback Statute violations may open the door for criminal prosecutions under the anti kickback Statute. Any form of compensation, such as a free NYC car lease, can be considered a form of Stark law violation.

Rather than risk violations, prudent practitioners and health care institutions would be wise to implement proactive compliance programs that will allow them to evaluate any vulnerability they may have under the Stark Law anti kickback statute lawyer as well as any self-reporting obligations that may exist. An experienced attorney specializing in health care law can be a valuable resource in helping set up aStark Law/ Stark anti kickback Statute compliance program.

In instances where a violation of theStark Law/ Stark anti kickback Statute may have occurred, it is important to consult with a health care attorney immediately. As noted above, the Affordable Care Act amended existing federal law to impose criminal penalties on payments that represent a conflict of interest. Such overpayments must be reported and returned within 60 days of the identification of the overpayment. The Center for Medicaid and Medicare Services has the right to decrease civil penalties for Stark Law anti kickback statute lawyer violations when violations are self-disclosed.

Stark Law anti kickback Statute FAQ

Stark Law Overview

When conducting business, health care providers are required to navigate regulations, on a federal level when it comes to self-referrals, more commonly known as the Stark Law. It is also referred to as a federal anti-kickback statute. In addition, health care providers have to navigate state fraud and abuse statutes, which may, or may not, mirror federal rules. Many health care providers who are business savvy, may be restricted as a result of fee splitting prohibitions, notice requirements, Medicare conditions of participation, or certification requirements + billing rules. If you’re considering expanding your business, and purchasing other service provider holdings – then you must be aware of the anti-kickback implications of your business decisions.

The Stark law, is a physician self-referral prohibition, which was unveiled in 1995 and has since expanded. Originally, it only applied to clinical lab services. Now, it applies to a large amount of designated health services, in addition to any financial relationship between a physician and an entity which performs or bills for the DHS. Essentially, physicians are prohibited from referring designated healthy services which are payable by medicare/medicaid, where the the physician has a financial relationship with the designated health services company. There are plausible exceptions.  If no exceptions exist, then there are very severe penalties, including denial of payment, refund of payment, and a $15,000 per service monetary penalty, in addition to a $100,000 civil penalty for each scheme considered to be a circumvention scheme.

Most situations that deal with Stark Laws, have to be evaluated under the Anti-kickback statute. This statute provides for criminal penalties for individuals and entities, who knowingly, pay, solicit,  renumeration in order to induce business which is payable from medicare or medicaid. Violations of this anti kickback statute can result up to fines up $25,000, in addition to imprisonment of up to 5 years, or both. Violations can also result in exclusion from medicare programs.

There are also many laws, federal and state, which create a potential problem for healthcare providers and other businesses. This means you could also be impacted by state anti kickback statutes, state self referral prohibitions (which are similar to the federal Stark regulations). Health care providers also have to be aware of medicine prohibitions which exist in many states, and specific medicare rules which apply to different types of health care providers.

Physicians are prohibited from referring DHS which is payable by medicare, or medicaid, to an entity with which the physician has a financial relationship. This is crucial. Penalties can be severe. Phase I final regulations define physician as a DO, MD, Doctor of Dental Surgery or Dental Medicine, Doctor of Podiatric Medicine, Doctor of Optometry, or a chiropractor.

Stark defines referral very broadly. Referral is a request by a physician, for any item or service, which is payable under medicare or medicaid. That means a request by a physician for a consultation with another physician – and any medical tests, or procedures, which are ordered by the other physician. Referral doesn’t include services which are performed by a referring/ordering physician. Physicians who personally perform the DHS that they order for their patients CAN structure it in a manner which doesn’t violate Stark.

There are numerous exceptions available to Stark, including the In-Office Ancillary Services exception, and the Whole Hospital exception, The Bona Fide Employment Exception, and many others. Each exception has a number of variables which must be strictly complied with, in order for the exception to apply. If even one of the variables isn’t met, there is a potential Stark Law violation. That means it’s crucial for providers to get help from an attorney who understands Stark Law, and can ensure that every aspect of the exception is properly being followed.

If a physician is referring diagnostic testing under the In-Office ancillary services exception, then the physician has to provide written notification to the patient at the time of the referral. This notification must state the patient isn’t obligated to get services at the facility with which the physician has a relationship. The notice has to list at least 5 other facilities within a 25 mile radius. If there are less than 5 suppliers, you have to list all suppliers within the radius, and include the name/address/phone number of the supplier. The list can’t include hospitals as one of the five facilities – but you can include hospitals in addition to the five facilities.

CMS has created an advisory opinion process – through which various parties in a financial arrangement can get a written opinion from CMS concerning whether the proposed financial arrangement will constitute a financial relationship under Stark II, and whether this meets the exception. In the event you have violated Stark – you have some options. You have to both, and return the overpayment, and notify the entity to whom the overpayment was returned in writing for the reason the overpayment occurred. It has to be done within 60 days of the identification of the overpayment, of the date any corresponding cost report is actually due.

If you retain an overpayment after this window, you will be liable under the False Claims Act. This means huge civil penalties, treble damages, and exclusion from federal programs in the future.

What does the Stark law physician referral law prohibit

The anti kickback statute prohibits a healthcare provider from referring his/her patients to an entity for a health service, if the healthcare provider or an immediate family member of his/her has a financial interest with the entity – unless there’s a legally reasonable reason. There are exceptions, which are specified in the Stark Law. The anti kickback statute also prohibits an entity from from presenting a claim for any DHS that is provided under a prohibited referral. In summary, no medicare payments can be made for DHS as a result of a prohibited referral. Entities who make such referrals and collect payments, have to make timely refunds for any money which is collected for such referrals. If you don’t, there could be civil penalties, in addition to criminal penalties.

What’s a physician practice, in terms of the definition of a physician organization

Physician practice, is a medical practice, which is comprised of 2 or more physicians, which provides patient care services. It can be a group of physicians who practice together, but don’t meet all of the requirements of §411.352 for “group practices”.

What is the Stark Law Ban on physician self-referral

Stark II ban took effect in 1995. In 2001, the CMS, issued the first part of the final regulations implementing the ban. Phase I regulations took effect in 2002, and contained many changes in terms of the Stark II ban, which impacted healthcare providers. Phase I addresses the prohibition, and exceptions, that pertain to ownership and investment interests. Phase II, created new regulation exceptions and addressed issues of the Phase I rules. Phase I and Phase II regulations were meant to be read as an integrated, and comprehensive rulebook.

What are the penalties for violating the Stark Law anti kickback statute

Penalties can be harsh. They can include a denial of payment, requiring refund of payment, imposition of a $15,000 per service civil penalty, or an imposition of a $100,000 per civil monetary penalty for each arrangement which is deemed a circumvention scheme.

What is an immediate family member per the Stark law anti kickback statute law?

Immediate family member applies to husband, wife, parent, child, siblings, step-siblings/childs/brothers/families in law, mothers in law, brothers in law, and all in-law relatives, in addition to grandparents/grandchildren, and spouses of grandparents/grandchildren.

What designated health services are subject to the ban?

The DHS covered by the Stark law include the following services:

  • clinical laboratory services
  • PT services
  • OT and speech language services
  • radiology services
  • radiation therapy services
  • DME and services
  • parentral and enteral nutrients, equipment and supplies
  • prosthetics, orthotics, prosthetic devices and supplies
  • home health services
  • outpatient prescription drugs
  • inpatient/outpatient hospitalization services

What are the Stark Law prohibitions

The Stark law anti kickback statute applies to physicians who refer medicare, or medicaid, patients for services, to entities which they have a financial interest. The list of DHS and the types of financial relationships involved are very broad. In order to ensure you’re not violating Stark Law, you need to ensure you’re working with an attorney who can advise you accordingly.  The Stark anti kickback statute became effective on Jan 1, 1995, but in 2001 – the government released regulations interpreting the statute.

What is the Stark Law Self-Referral Disclosure Protocol

Section 6409 of the ACA, was signed into law in 2010. Section 6409(a) of the ACA, required the creation of a Medicare self-referral disclosure protocol. This new protocol creates a process through which providers of services, and suppliers, have a method to self-disclosure actual/potential violations of the physician self-referral stark law. The SRDP requires that health care providers submit all information crucial to CMS, and it gives the secretary of HHS to reduce the amount due and owed in violations of section 1877 of the act. The SRDP was intended to help facilitates the resolution of matters, that are in a reasonable assessment, actual or potential violations of the physician self-referral law. As a result, a disclosing party can make a submission under the SRDP – with the intent of resolving it’s potential overpayment liability exposure for conduct it self identified. The SRDP was revised in May, 2011, in order to provide further clarification about information which should be submitted to disclosing parties. In addition to reporting the actual/potential amount due, the SDRP now requires that as a part of the submission to CMS, disclosing parties have to provide the total amount of remuneration a physician received as a result of the potential violation during the “look back,” period.

Exceptions to the Stark law referral prohibition related to compensation arrangements

For purposes of 411.353, the following compensation arrangements aren’t considered a financial relationship.
(a) Rental office space: Payments for use of office space made by a lessee to a lessor, if the lease arrangement is set in writing, and signed, and specifices the premises it covers. The lease arrangement is at least 1 year, and if it’s terminated – then the parties cannot enter into a new arrangement for the same space during the first year of the original lease. In addition, the space rented/leased doesn’t exceed what’s reasonable/necessary for legitimate business purposes of the lease – and is used exclusively by the lessee when it is being used. The lessee can make payments for the use of space consisting of common areas, assuming the payments don’t exceed the pro-rated share of the expenses for the space, based on the ratio of the office space and the usage of it by all people occupying the office space. In addition, the rental charges over the term of the lease are set in advance, and are market rates. To be compliant with Stark Law, The rental charges cannot be determined by volume/value of the referrals, or other business generated by the parties. Nor, can the rental charges be based on a formula, which is based on % of the revenue raised, billed, collected, or a per unit of service rental charges. The lease arrangement has to be commercially reasonable, even if no referrals are made between the parties.

(b) Rental Equipment: Payments made by a lessee for the use of equipment under the conditions: the arrangement is set in writing, and specific the equipment covered. The equipment leased doesn’t exceed what’s reasonable, and necessary, for legitimate business arrangements. The duration is of the lease is at least 1 year. The rental charges are set in advance, and are consistent with a fair market value. The lease arrangement is commercially reasonable, even if no referrals are made.

(c) Bona fide employment relationships: Any amount of money which is paid by an employer to a physician, or immediate family member, who has a bona fide employee relationship with the employer for provision of services if the following variables are satisfied: The employment is for identifiable services, and the amount of financial remuneration is consistent with the fair market value of the services, and has nothing to do with the overall volume of referrals of value of referrals made by the referring physician. In addition, the remuneration is made under an arrangement which is reasonable, even if no referrals are made to the employer.

(d) Personal Service Arrangements: Remuneration from an entity under an arrangement to a physician, or his/her immediate family member, to a group practice, including remuneration for a physician service which is furnished to a nonprofit blood center, if the following conditions are met: The arrangement is set out in writing, and signed, and specifies the services covered by the arrangement. The arrangement covers all the services which are to be done by the physician, or an immediate family member, to the entity. The requirement is met, if all the arrangements between the entity, and the physician, or family members, incorporate each other by reference, or if they all cross-reference a master list of contractual relationships which are maintained and updated centrally, and is available for review. The total list of services covered by the arrangement don’t exceed what’s reasonable and necessary. The duration of the agreement, to be compliant with Stark Law, is at least 1 year – if the agreement is terminated with/without cause, then the parties cannot enter into the same or similar arrangement during the first year of the original agreement. The compensation to be paid for each arrangement has to be set in advance, and cannot exceed the fair market value, except in the situation where there is a physician incentive plan. The compensation cannot take into account volume/value of referrals of business generated between the parties. The services furnished under each arrangement don’t involve the promotion/counseling of a business relationship, or any other activity which violates Federal/State laws.

(e) Physician incentive plan exceptions: In a physician incentive plan, between a doctor an entity, the compensation can be determined in a manner – which takes into account directly, or indirectly, the volume/value of any referral or other business generated by the parties. This applies if the incentive plan meets the following: no specific payment is made directly/indirectly under the plan to a physician or group, as an inducement to reduce/limit medically necessary services furnished. Upon request of the secretary, the entity provides access to all information regarding the plan, in order to allow the Secretary to determine that the plan is in compliance with paragraph (d2) of the section.

What are Stark Law Advisory Opinions

Under Section 1877(g)(6) of the Social Security Act, the CMS is required to issue written advisory opinions. These opinions are designed to provide physicians guidance on referrals, for DHS that are payable by Medicare to an entity which he/she has a financial relationship with, and whether these referrals are prohibited under the Medicare program by section 1877 of the Act. These advisory opinions are available to the general health care community through the CMS website, as specified by regulation 42 CFR 411.384(b). These Stark Law advisory opinions are a part of a binding opinion, that help health care providers better understand section 1877 of the Act. The requestor, must be a party to the existing/proposed financial arrangement, and is the only individual/entity who can rely on the advisory opinion. In each and every opinion, the CMS will apply the law to a set of facts involving proposed business transactions. Determinations will be made, and an opinion will be given, about the entities in each situation, and how their proposed relationship has Stark Law implications. No third parties are bound by, the advisory opinion. Before publication of the advisory opinion, certain information is redacted, such as information about the requesting parties. In addition, any confidential business information, and individual specific information, is protected and hidden.

On January 1, 2017, a new submission process will be effective. Under the new process, party/parties can submit a request electronically to CMS by emailing 1877advisoryopinion@cms.hhs.gov. One hard copy of the request, and a payment as a check/money order payable to CMS for $250 must be sent to the Baltimore office.

Stark Law and Physician Owned Hospitals

Section 6001 of the ACA of 2010, amended section 1877 of the SSA in order to impose new requirements on physician owned hospitals, in order to allow them to qualify for the whole hospital and rural provider exception. A physician owned hospital, is generally prohibited from expanding facility capacity. However, a physician owned hospital which qualified as an applicable hospital or high Medicaid facility can request an exception to this prohibition from the Secretary.

Recent Stark Law Cases and Penalties

 

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Stark Law / Stark Anti Kickback Statute

The Stark Law anti kickback statute lawyer is federal legislation that was intended to limit physician referrals that might constitute significant conflicts of interests. In the absence of a specific exception, the Stark Law anti kickback statute lawyer prohibits physicians and other health care providers from making certain referrals for designated health care services when the referring physician or health care provider, or a member of his or her family, has a financial relationship with the entity providing that service. This prohibition applies specifically to Medicare and Medicaid patients. Health care providers who are subject to the Stark anti kickback statute lawyer include dentists, osteopaths, podiatrists, optometrists and chiropractors as well as medical doctors. Family members subject to the Stark anti kickback statute lawyer includes spouses, parents, children, stepchildren, in-laws, grandparents, grandchildren, and the spouses of these individuals.

In the original legislation, which was passed as a provision to the 1989 Omnibus Budget Reconciliation Act, “designated health care services” were specified as clinical laboratory services that might be covered under Medicare Part B services. The 1993 Omnibus Budget Reconciliation Act expanded these services to include physical therapy, occupational therapy, radiology and imaging studies, medical and prosthetic equipment, inpatient and outpatient hospital services, home health services and outpatient prescription drugs for both Medicare and Medicaid patients. The original law is often known as Stark I while the expansion of its scope that occurred in 1993 is familiarly known as Stark II.

In 2007, the Center for Medicaid and Medicare Services made additional modifications to the Stark Law anti kickback statute lawyer’s scope, which became known as Stark III.

Stark anti kickback Statute on Physician Investments

There have been many ongoing regulatory changes made by the Centers for Medicare and Medicaid Services, which have changed the physician investment guidelines in the Phase III final regulations of Stark Law/ Stark Anti Kickback Statute, and in the 2008 Medicare Physician Fee final rules. The 2008 Fee schedule limits reimbursements for diagnostic tests, and prohibits independent diagnostic testing facilities sharing their facilities with another Medicare provider, or supplier. Investment opportunities are possible, you need to be aware of the legal and regulatory procedures before taking any financial actions.

Ambulatory Surgical Centers

Stark III, nor the 2008 fee schedule, has imposed any restrictions at all on a physician’s ability to invest in an ambulatory surgical center. ASC services aren’t health services covered by the Stark Law/ Stark Anti Kickback Statute. The Stark Law/ Stark Anti Kickback Statute, prohibits a physician from referring a Medicare or Medicaid patient to an entity which he, or a family member, has a financial interest in for any of the 11 designated health services.

Investments in an ASC, have to comply with the federal anti kickback statute’s safe harbor provisions. The anti kickback Statute prohibits anyone for offering, paying, or soliciting, or getting, any financial compensation in exchange for a referral of medicare or medicaid business. The anti kickback Statute has many exceptions, which are known as safe harbors, which will allow you to engage in conduct which would ordinarily violate the anti kickback statute. The Safe Harbor for investments in ASC is composed of four categories: surgeon owned ASCs, single speciality ASCs, multi-specialty ASCs, and hospital/physician ASCs. Safe Harbor protection will only apply if there’s full compliance with all of the standards. The standards require the following:

  • Each physician investor is in a position to refer patients directly to the ASC and perform the surgery on such patients
  • Derive at least 1/3 of his medical practice income, from procedures he performs at the ASC
  • Performs at least 1/3 of the procedures that will be performed in an ASC setting at the ASC investment entity.

Medical Space / Medical Equipment Leasing / Management Companies

These types of companies are great investment opportunities for physicians. Typically, leasing companies will own or lease space/equipment, or sublease the space/equipment to a healthcare facility. In return for this, the health care facilities pays a rental fee. Management companies manage a health care facility, by doing things like billing, accounting, collecting, hiring/firing, on behalf of the facility. In exchange, the facility pays the company a management fee. There are absolutely no restrictions on the physician that invests in a medical space/equipment leasing company, or in a medical management company. Under the ASC safe harbor, physicians who have a desire to invest in an ASC have to be in a position to directly refer patients to the ASC and perform surgery on the patients. Primary care physicians can invest in a medical space leasing company which owns, or leases, the building, in which the ASC is located. The primary care physician can invest in a medical space leasing company, which owns/leases the building in which the ASC is located and that leases/subleases the space to the ASC, or a medical equipment leasing company which owns/leases equipment to the ASC, and a management company which manages the ASC. Any investments in a medical space/medical equipment leasing company must be structured within the Small Investment Safe Harbor. This requires that no more than 40% of the investment interests be held by investors who are in a position to make a referral in service of the company. No more than 40% of the entities gross revenue can come from referrals/business generated from outside investors.

Lease agreements between leasing companies, and healthcare facilities, and the management agreements between the management companies should be structured to abide by the applicable Safe Harbors and exceptions to the Stark Law anti kickback statutes. The Safe Harbors for leases and the management agreements and the Stark Law exception for leases require, that the rent for the leases and the management fee be billed at a fair market value.

Hospitals

Hospitals are great investment opportunities for physicians. They have to be structured within the Safe Harbors, i.e. the Small Investment Safe Harbor, and Stark Law exceptions. The Stark Law/ Stark anti kickback Statute, as an exception which is known as the “whole hospital exception,” which allows a physician to refer his patients for any of the 11 health services to a hospital where he has an ownership interest, if the referring physician is authorized to do services at the hospital, and if the physicians ownership is in the entire hospital and not just a specific department of the hospital.

Stark Law/ Stark anti kickback Statute Lawyers

Many activities that give rise to liability under the Stark Law anti kickback statute lawyer are also actionable under the anti kickback statute, but whereas the Stark Law anti kickback statute lawyer carries civil penalties, the anti kickback statute attaches criminal penalties to the solicitation for referrals. The anti kickback statute was included under the 2010 Patient Protection and Affordable Care Act as an update to an existing piece of legislation called the False Claims Act, which is a more general piece of legislation that makes any person or business that is attempting to deceive the government liable for fraud.

Under the terms of the anti kickback Law, “a person need not have actual knowledge … or specific intent to commit a violation.” In other words, ignorance of the law is no excuse, and medical providers who violate the False Claims Act cannot argue successfully that they were unaware that the anti kickback Law existed.

Exceptions

Certain financial relationships are recognized as exceptions to theStark Law/ Stark anti kickback Statute. In addition to the exceptions and exclusions codified in the law, the administrator of the Center for Medicaid and Medicare Services also has the right to create regulatory exceptions.

Physicians may refer patients to other physicians who are working in the same practice, for example, and they may refer that patient for laboratory, radiology, outpatient pharmacy and other services that are provided by their practice. This is known as the In-Office Ancillary Services Exception.

Physicians may also refer Medicaid and Medicare patients to receive designated health services at for-profit hospitals that said physicians have an ownership stake in so long as that stake is in the whole hospital and not in any specific department. This is known as the Whole Hospital Exception. In order to be eligible for the Whole Hospital Exception, the referring physician must have privileges at the hospital.

The Stark Law anti kickback statute lawyer describes its exceptions at some length and codifies the conditions that must be met in order for the exception to apply. Each condition must be complied with strictly, or the referring provider may be committing a Stark Law anti kickback statute lawyer violation. This is why it’s so important to consult with a health law attorney any time a health care provider is considering accepting referrals from a physician with whom he or she has a preexisting financial relationship.

Enforcement

TheStark Law/ Stark anti kickback Statute is enforced by a number of federal agencies, including the Department of Justice, the Department of Health and Human Services and the Center for Medicaid and Medicare Services. Since the 2010 passage of the Patient Protection and Affordable Care Act and its anti kickback amendment to the False Claims Act, the government has become increasingly aggressive about prosecuting Stark Law anti kickback statute lawyer violations.

Stark Law anti kickback statute lawyer Violations

Penalties for violating the Stark Law/ Stark anti kickback Statute can be quite severe. Noncompliant practitioners and institutions risk denial of payment, as well as the imposition of a $15,000 civil fine for every service that’s found to be a violation as well as a $100,000 civil fine for every relationship that’s found to be a violation. Additionally ,Stark Law/ Stark anti kickback Statute violations may open the door for criminal prosecutions under the anti kickback Statute. Any form of compensation, such as a free NYC car lease, can be considered a form of Stark law violation.

Rather than risk violations, prudent practitioners and health care institutions would be wise to implement proactive compliance programs that will allow them to evaluate any vulnerability they may have under the Stark Law anti kickback statute lawyer as well as any self-reporting obligations that may exist. An experienced attorney specializing in health care law can be a valuable resource in helping set up aStark Law/ Stark anti kickback Statute compliance program.

In instances where a violation of theStark Law/ Stark anti kickback Statute may have occurred, it is important to consult with a health care attorney immediately. As noted above, the Affordable Care Act amended existing federal law to impose criminal penalties on payments that represent a conflict of interest. Such overpayments must be reported and returned within 60 days of the identification of the overpayment. The Center for Medicaid and Medicare Services has the right to decrease civil penalties for Stark Law anti kickback statute lawyer violations when violations are self-disclosed.

Stark Law anti kickback Statute FAQ

Stark Law Overview

When conducting business, health care providers are required to navigate regulations, on a federal level when it comes to self-referrals, more commonly known as the Stark Law. It is also referred to as a federal anti-kickback statute. In addition, health care providers have to navigate state fraud and abuse statutes, which may, or may not, mirror federal rules. Many health care providers who are business savvy, may be restricted as a result of fee splitting prohibitions, notice requirements, Medicare conditions of participation, or certification requirements + billing rules. If you’re considering expanding your business, and purchasing other service provider holdings – then you must be aware of the anti-kickback implications of your business decisions.

The Stark law, is a physician self-referral prohibition, which was unveiled in 1995 and has since expanded. Originally, it only applied to clinical lab services. Now, it applies to a large amount of designated health services, in addition to any financial relationship between a physician and an entity which performs or bills for the DHS. Essentially, physicians are prohibited from referring designated healthy services which are payable by medicare/medicaid, where the the physician has a financial relationship with the designated health services company. There are plausible exceptions.  If no exceptions exist, then there are very severe penalties, including denial of payment, refund of payment, and a $15,000 per service monetary penalty, in addition to a $100,000 civil penalty for each scheme considered to be a circumvention scheme.

Most situations that deal with Stark Laws, have to be evaluated under the Anti-kickback statute. This statute provides for criminal penalties for individuals and entities, who knowingly, pay, solicit,  renumeration in order to induce business which is payable from medicare or medicaid. Violations of this anti kickback statute can result up to fines up $25,000, in addition to imprisonment of up to 5 years, or both. Violations can also result in exclusion from medicare programs.

There are also many laws, federal and state, which create a potential problem for healthcare providers and other businesses. This means you could also be impacted by state anti kickback statutes, state self referral prohibitions (which are similar to the federal Stark regulations). Health care providers also have to be aware of medicine prohibitions which exist in many states, and specific medicare rules which apply to different types of health care providers.

Physicians are prohibited from referring DHS which is payable by medicare, or medicaid, to an entity with which the physician has a financial relationship. This is crucial. Penalties can be severe. Phase I final regulations define physician as a DO, MD, Doctor of Dental Surgery or Dental Medicine, Doctor of Podiatric Medicine, Doctor of Optometry, or a chiropractor.

Stark defines referral very broadly. Referral is a request by a physician, for any item or service, which is payable under medicare or medicaid. That means a request by a physician for a consultation with another physician – and any medical tests, or procedures, which are ordered by the other physician. Referral doesn’t include services which are performed by a referring/ordering physician. Physicians who personally perform the DHS that they order for their patients CAN structure it in a manner which doesn’t violate Stark.

There are numerous exceptions available to Stark, including the In-Office Ancillary Services exception, and the Whole Hospital exception, The Bona Fide Employment Exception, and many others. Each exception has a number of variables which must be strictly complied with, in order for the exception to apply. If even one of the variables isn’t met, there is a potential Stark Law violation. That means it’s crucial for providers to get help from an attorney who understands Stark Law, and can ensure that every aspect of the exception is properly being followed.

If a physician is referring diagnostic testing under the In-Office ancillary services exception, then the physician has to provide written notification to the patient at the time of the referral. This notification must state the patient isn’t obligated to get services at the facility with which the physician has a relationship. The notice has to list at least 5 other facilities within a 25 mile radius. If there are less than 5 suppliers, you have to list all suppliers within the radius, and include the name/address/phone number of the supplier. The list can’t include hospitals as one of the five facilities – but you can include hospitals in addition to the five facilities.

CMS has created an advisory opinion process – through which various parties in a financial arrangement can get a written opinion from CMS concerning whether the proposed financial arrangement will constitute a financial relationship under Stark II, and whether this meets the exception. In the event you have violated Stark – you have some options. You have to both, and return the overpayment, and notify the entity to whom the overpayment was returned in writing for the reason the overpayment occurred. It has to be done within 60 days of the identification of the overpayment, of the date any corresponding cost report is actually due.

If you retain an overpayment after this window, you will be liable under the False Claims Act. This means huge civil penalties, treble damages, and exclusion from federal programs in the future.

What does the Stark law physician referral law prohibit

The anti kickback statute prohibits a healthcare provider from referring his/her patients to an entity for a health service, if the healthcare provider or an immediate family member of his/her has a financial interest with the entity – unless there’s a legally reasonable reason. There are exceptions, which are specified in the Stark Law. The anti kickback statute also prohibits an entity from from presenting a claim for any DHS that is provided under a prohibited referral. In summary, no medicare payments can be made for DHS as a result of a prohibited referral. Entities who make such referrals and collect payments, have to make timely refunds for any money which is collected for such referrals. If you don’t, there could be civil penalties, in addition to criminal penalties.

What’s a physician practice, in terms of the definition of a physician organization

Physician practice, is a medical practice, which is comprised of 2 or more physicians, which provides patient care services. It can be a group of physicians who practice together, but don’t meet all of the requirements of §411.352 for “group practices”.

What is the Stark Law Ban on physician self-referral

Stark II ban took effect in 1995. In 2001, the CMS, issued the first part of the final regulations implementing the ban. Phase I regulations took effect in 2002, and contained many changes in terms of the Stark II ban, which impacted healthcare providers. Phase I addresses the prohibition, and exceptions, that pertain to ownership and investment interests. Phase II, created new regulation exceptions and addressed issues of the Phase I rules. Phase I and Phase II regulations were meant to be read as an integrated, and comprehensive rulebook.

What are the penalties for violating the Stark Law anti kickback statute

Penalties can be harsh. They can include a denial of payment, requiring refund of payment, imposition of a $15,000 per service civil penalty, or an imposition of a $100,000 per civil monetary penalty for each arrangement which is deemed a circumvention scheme.

What is an immediate family member per the Stark law anti kickback statute law?

Immediate family member applies to husband, wife, parent, child, siblings, step-siblings/childs/brothers/families in law, mothers in law, brothers in law, and all in-law relatives, in addition to grandparents/grandchildren, and spouses of grandparents/grandchildren.

What designated health services are subject to the ban?

The DHS covered by the Stark law include the following services:

  • clinical laboratory services
  • PT services
  • OT and speech language services
  • radiology services
  • radiation therapy services
  • DME and services
  • parentral and enteral nutrients, equipment and supplies
  • prosthetics, orthotics, prosthetic devices and supplies
  • home health services
  • outpatient prescription drugs
  • inpatient/outpatient hospitalization services

What are the Stark Law prohibitions

The Stark law anti kickback statute applies to physicians who refer medicare, or medicaid, patients for services, to entities which they have a financial interest. The list of DHS and the types of financial relationships involved are very broad. In order to ensure you’re not violating Stark Law, you need to ensure you’re working with an attorney who can advise you accordingly.  The Stark anti kickback statute became effective on Jan 1, 1995, but in 2001 – the government released regulations interpreting the statute.

What is the Stark Law Self-Referral Disclosure Protocol

Section 6409 of the ACA, was signed into law in 2010. Section 6409(a) of the ACA, required the creation of a Medicare self-referral disclosure protocol. This new protocol creates a process through which providers of services, and suppliers, have a method to self-disclosure actual/potential violations of the physician self-referral stark law. The SRDP requires that health care providers submit all information crucial to CMS, and it gives the secretary of HHS to reduce the amount due and owed in violations of section 1877 of the act. The SRDP was intended to help facilitates the resolution of matters, that are in a reasonable assessment, actual or potential violations of the physician self-referral law. As a result, a disclosing party can make a submission under the SRDP – with the intent of resolving it’s potential overpayment liability exposure for conduct it self identified. The SRDP was revised in May, 2011, in order to provide further clarification about information which should be submitted to disclosing parties. In addition to reporting the actual/potential amount due, the SDRP now requires that as a part of the submission to CMS, disclosing parties have to provide the total amount of remuneration a physician received as a result of the potential violation during the “look back,” period.

Exceptions to the Stark law referral prohibition related to compensation arrangements

For purposes of 411.353, the following compensation arrangements aren’t considered a financial relationship.
(a) Rental office space: Payments for use of office space made by a lessee to a lessor, if the lease arrangement is set in writing, and signed, and specifices the premises it covers. The lease arrangement is at least 1 year, and if it’s terminated – then the parties cannot enter into a new arrangement for the same space during the first year of the original lease. In addition, the space rented/leased doesn’t exceed what’s reasonable/necessary for legitimate business purposes of the lease – and is used exclusively by the lessee when it is being used. The lessee can make payments for the use of space consisting of common areas, assuming the payments don’t exceed the pro-rated share of the expenses for the space, based on the ratio of the office space and the usage of it by all people occupying the office space. In addition, the rental charges over the term of the lease are set in advance, and are market rates. To be compliant with Stark Law, The rental charges cannot be determined by volume/value of the referrals, or other business generated by the parties. Nor, can the rental charges be based on a formula, which is based on % of the revenue raised, billed, collected, or a per unit of service rental charges. The lease arrangement has to be commercially reasonable, even if no referrals are made between the parties.

(b) Rental Equipment: Payments made by a lessee for the use of equipment under the conditions: the arrangement is set in writing, and specific the equipment covered. The equipment leased doesn’t exceed what’s reasonable, and necessary, for legitimate business arrangements. The duration is of the lease is at least 1 year. The rental charges are set in advance, and are consistent with a fair market value. The lease arrangement is commercially reasonable, even if no referrals are made.

(c) Bona fide employment relationships: Any amount of money which is paid by an employer to a physician, or immediate family member, who has a bona fide employee relationship with the employer for provision of services if the following variables are satisfied: The employment is for identifiable services, and the amount of financial remuneration is consistent with the fair market value of the services, and has nothing to do with the overall volume of referrals of value of referrals made by the referring physician. In addition, the remuneration is made under an arrangement which is reasonable, even if no referrals are made to the employer.

(d) Personal Service Arrangements: Remuneration from an entity under an arrangement to a physician, or his/her immediate family member, to a group practice, including remuneration for a physician service which is furnished to a nonprofit blood center, if the following conditions are met: The arrangement is set out in writing, and signed, and specifies the services covered by the arrangement. The arrangement covers all the services which are to be done by the physician, or an immediate family member, to the entity. The requirement is met, if all the arrangements between the entity, and the physician, or family members, incorporate each other by reference, or if they all cross-reference a master list of contractual relationships which are maintained and updated centrally, and is available for review. The total list of services covered by the arrangement don’t exceed what’s reasonable and necessary. The duration of the agreement, to be compliant with Stark Law, is at least 1 year – if the agreement is terminated with/without cause, then the parties cannot enter into the same or similar arrangement during the first year of the original agreement. The compensation to be paid for each arrangement has to be set in advance, and cannot exceed the fair market value, except in the situation where there is a physician incentive plan. The compensation cannot take into account volume/value of referrals of business generated between the parties. The services furnished under each arrangement don’t involve the promotion/counseling of a business relationship, or any other activity which violates Federal/State laws.

(e) Physician incentive plan exceptions: In a physician incentive plan, between a doctor an entity, the compensation can be determined in a manner – which takes into account directly, or indirectly, the volume/value of any referral or other business generated by the parties. This applies if the incentive plan meets the following: no specific payment is made directly/indirectly under the plan to a physician or group, as an inducement to reduce/limit medically necessary services furnished. Upon request of the secretary, the entity provides access to all information regarding the plan, in order to allow the Secretary to determine that the plan is in compliance with paragraph (d2) of the section.

What are Stark Law Advisory Opinions

Under Section 1877(g)(6) of the Social Security Act, the CMS is required to issue written advisory opinions. These opinions are designed to provide physicians guidance on referrals, for DHS that are payable by Medicare to an entity which he/she has a financial relationship with, and whether these referrals are prohibited under the Medicare program by section 1877 of the Act. These advisory opinions are available to the general health care community through the CMS website, as specified by regulation 42 CFR 411.384(b). These Stark Law advisory opinions are a part of a binding opinion, that help health care providers better understand section 1877 of the Act. The requestor, must be a party to the existing/proposed financial arrangement, and is the only individual/entity who can rely on the advisory opinion. In each and every opinion, the CMS will apply the law to a set of facts involving proposed business transactions. Determinations will be made, and an opinion will be given, about the entities in each situation, and how their proposed relationship has Stark Law implications. No third parties are bound by, the advisory opinion. Before publication of the advisory opinion, certain information is redacted, such as information about the requesting parties. In addition, any confidential business information, and individual specific information, is protected and hidden.

On January 1, 2017, a new submission process will be effective. Under the new process, party/parties can submit a request electronically to CMS by emailing 1877advisoryopinion@cms.hhs.gov. One hard copy of the request, and a payment as a check/money order payable to CMS for $250 must be sent to the Baltimore office.

Stark Law and Physician Owned Hospitals

Section 6001 of the ACA of 2010, amended section 1877 of the SSA in order to impose new requirements on physician owned hospitals, in order to allow them to qualify for the whole hospital and rural provider exception. A physician owned hospital, is generally prohibited from expanding facility capacity. However, a physician owned hospital which qualified as an applicable hospital or high Medicaid facility can request an exception to this prohibition from the Secretary.

Recent Stark Law Cases and Penalties

 

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