Pennsylvania’s New Opioid Laws and How They Impact Physicians

On November 2, 2016, the Pennsylvania Legislature passed a package of new laws aimed at combating the growing heroin and opioid epidemic. These laws have a significant impact on practicing physicians statewide, especially because some took effect immediately after they were signed into law, while others are not effective until January 1, 2017.  Click the link to read the full article: Pennsylvania’s New Opioid Laws and How They Impact Physicians. 

Independent Medical Staff Denied Title VII Protection

It has not been unusual for employed physicians to seek the protection provided to independent medical staff members through the due process procedures provided by medical staff by-laws. The case of Levitin and Chicago Surgical Clinic v. Northeast Community Hospital is the exact opposite; Dr. Levitin was an independent medical staff member seeking Title VII protection from a hostile work environment usually provided only to employees.

This is the first time I have seen that argument made, and it was rejected on summary judgment by the United States District Court of the Northern District of Illinois. Dr. Levitin alleged that Northeast Community Hospital, and the medical staff officers thereof, had created a hostile work environment through a pattern of allegedly sham and retaliatory peer review activities.

Dr. Levitin was in private practice as the sole shareholder of Chicago Surgical Clinic, and practiced as a general surgeon. Although Dr. Levitin was in private practice, she alleged that she was compensated by the hospital through her participation in a Physician Hospital Organization (PHO) and as of many owners in a cyber knife joint venture. The Court found that financial relationship insufficient to create an employment relationship.

Dr. Levitin alleged a number of other factors in support of her argument that she was controlled by the hospital, i.e.:

• Dr. Levitin was subjected to hospital policies such as mandatory call coverage, credentialing and peer review, and quality assurance;
• The hospital provided the “tools of the trade”, meaning the hospital facilities, the staff, supplies, etc.; and
• Dr. Levitin’s medical staff relationship could be terminated by the hospital and/or the medical staff.

The Court found that none of these factors were persuasive with respect to establishing an employment relationship with the hospital, especially since Dr. Levitin’s relationship with the hospital was not exclusive and she was free to have a similar relationship with as many other hospitals as she liked, and granted the hospital’s Summary Judgment Motion.

BASIC CONTRACT ISSUES FOR NEW PHYSICIAN CONTRACTS

INTRODUCTION

When physicians have finally completed the medical education journey, many are confronted with a “physician employment contract,” usually from a hospital or medical practice, which could define the essential terms of their professional relationship for many years to come.  If the parties live happily ever after, neither may ever read the contract again.  However, if a problem arises, the scramble to find and read the contract begins.

New physicians are always at a significant disadvantage in this process.  The “Employer,” whether hospital or medical practice, has invested significant resources into designing a contract which gives emphatic attention to the key terms upon which the physician was focused at signing (money, time, vacation, employee benefits) but is otherwise a fairly one-sided agreement; perhaps it is even presented as the “form contract we give to all the doctors.”  Residents and fellows may be pulled a little deeper into that dilemma if they remain with the teaching institution at which they completed their studies because the new contract may not appear to be that much different from the prior “student” contract.

Since this contract will basically control your professional life, by not only defining how you must work and for how much, but also by controlling where you might practice when the contract ends though “restrictive covenants,” you are well advised to read it carefully and consult an experienced healthcare lawyer before signing any contract.

The following outline is a fundamental review of the basis issues which should appear in most contracts.

I.        COMPENSATION:  The most important item of the contract will be the compensation.  Compensation is typically divided into three categories, i.e., base compensation, productivity or incentive compensation, and other bonuses.

A.      Base compensation is guaranteed annual salary, usually payable in accordance with the employer’s payroll practices.  Base compensation in multi-year contracts should escalate in future years to reflect added value or inflation, unless there is a productivity component in addition to the base compensation.  Experienced advisors should have comparative compensation information by specialty.

B.      Productivity compensation is typically based upon some formula, usually either net collections or some other productivity measure such as WRVUs.  Productivity based upon collections typically requires some collection level in excess of expenses or in excess of a collection target.  Be careful to clearly define the productivity formula, particularly the amount and methodology for allocating expenses.  Productivity based upon work units requires a clear understanding of how those units will be generated, i.e., by the physicians or by other ancillary providers, and whether it will include ancillary revenue, such as imaging, drugs and biologicals, etc.  Furthermore, healthcare reform may eventually create Accountable Care Organizations, medical homes, substantive Pay 4 Performance (P4P) models, and Medicare MIPS models.  Therefore, incentive based arrangements which rely on collections or WRVUs should include a commitment to make a good faith attempt to incorporate new compensation models in an equitable manner.

C.      Other types of bonuses include signing bonuses, retention bonuses that are paid following completion of annual benchmarks, and severance bonuses for premature termination.

II.       TERM:  The contract term is the number of years that the contract will be in force.  The term of physician employment contracts usually reflects some initial probationary period or qualifying period during which the physician will be an employee of the practice prior to an opportunity to become a shareholder.  Employment contracts with hospitals do not have shareholder options in the future.  This probationary period varies by geographic region of the country, but is typically 2 to 3 years.  You should assure that the initial contract continues to exist until replaced by a shareholder employment contract.  Many contracts contain “evergreen” renewal provisions, which automatically renew contract term from year to year without requiring any action by either the employer or the employee.  Be careful with evergreen contracts which contain no provisions for salary escalation.

III.      BENEFITS:  Most contracts simply state that you participate in the benefit plans in accordance with the terms and conditions of the plans; get the details.

A.      Retirement Plan:  Check participation, vesting and contribution rates.  Get a copy of the Summary Plan Description (SPD) mandated by ERISA.

B.      Health Insurance:  Most practices and all hospitals will have an employee benefit description.

IV.     BUSINESS EXPENSES:  Get the business expense policy.  If you have additional specific needs, discuss these before the contract is signed.

A.      Professional Dues:  Hospitals, specialty societies

B.      Pager/Communications/Cell Phone

C.      CME

D.      Travel and Parking

E.      Moving and Relocation

V.      MALPRACTICE INSURANCE:  Malpractice premiums are typically covered as one of the business expenses in the contract.  There are two types of malpractice insurance, i.e., occurrence and claims made.  Occurrence malpractice insurance covers the physician for any event that occurred during the term of the malpractice policy regardless of when the claim is made.  Claims made malpractice insurance, which is the less valuable coverage, covers incidents only if they both occur and are the subject of a claim made during the term of the policy, hence the name “claims made.”  When employment at an entity with claims made insurance ends, the malpractice insurance typically ends also, meaning that any future claims will not be covered unless a reporting endorsement, sometimes known as a “tail,” is purchased.  The tail should be covered as a business expense.  Sometimes, the responsibility for the tail is divided based upon the cause for termination.  If the practice terminates the physician or fails to make the physician a shareholder, then the practice pays the tail.  If the physician resigns without cause to pursue some other opportunity, the physician is responsible for the tail.  The amount of malpractice insurance varies from state to state.  Some states require a minimum level of malpractice insurance.  Some states also have state funds, such as catastrophic loss funds, into which premiums or surcharges are paid by the physician.  The physician should make sure that these additional elements are included in the malpractice coverage.

VI.     CLINICAL DUTIES:  The description of clinical duties is usually a fairly generic provision of the employment contract, but the physician should pay careful attention to the scope of those duties to make sure that the office facilities and hospitals at which the physician is required to practice are identified, that the parties understand how additional offices or hospitals can or cannot be added, how many patient office hours are expected, and how call coverage responsibilities will be divided among the physicians in the practice.  Typical language is “equitable allocation,” which does not quite mean equal.  It is common for senior physicians to take less call than junior physicians, but language stating that the call is simply assigned by the employer is too vague.  The contract should also state whether moonlighting is or is not allowed.

VII.    TERMINATION:  Contracts will typically have a termination clause which defines several different methods for termination.

A.      Expiration:  The contract can simply expire at the end of the term.

B.      Termination for Cause:  The contract can be terminated by either party for cause, which is usually defined as some breach of the contract by the other party, or the occurrence of certain events such as loss of medical license, loss of DEA number, Medicare exclusion, conviction of a crime, etc.

C.      Other Material Breaches:  The contract can also be terminable for more ambiguous breaches, such as the failure to perform duties in accordance with employer standards, and attention to patients, etc.  Ambiguous events such as these should be subject to a “notice and cure provision,” which requires the employer to first give notice of the alleged breach sufficient to describe the problem and give the physician the opportunity to cure that breach over some period of time; the purpose of  this type of provision is to prevent surprise terminations.

D.      Unilateral Termination Without Cause:  Contracts typically give both the employer and the employee the opportunity to terminate the contract without cause upon sufficient advance notice.  Termination of this type raises several questions.

a.       How much notice will the practice require?  Practices typically want time to recruit a replacement physician, but that time is usually too long to permit an employed physician to accept another position, so the parties must negotiate a satisfactory compromise.

b.       How much notice will the physician require?  Will that notice be different for non-renewal of the contract or failure to make shareholder after two or three years of employment compared to “premature” termination during the first year of employment.  It is certainly unfair to expect that employment could be terminated just 90 days after the start of the contract because the employer/practice changes its collective mind.  In such circumstances, early terminations are usually combined with greater notice or severance payments.

c.       Defining the cause for termination is very important with respect to the enforcement or applicability of the restrictive covenant.

VIII.   RESTRICTIVE COVENANTS:  The enforceability of restrictive covenants depends upon the state, i.e., the jurisdiction, in which the practice is located.  Some states prohibit restrictive covenants.  State that do permit the enforcement of restrictive covenants usually require that they be reasonable, so that they are no broader than reasonably necessary to protect the employer.  Just as an example, restrictive covenants that would prohibit the physician from practicing medicine within 200 miles of the office location will not be enforceable simply because it is improbable that a competing practice 200 miles away would do any harm to a practice.  Note that the geographic scope will definitely depend upon the nature of the practice and the population density.  While a 25 mile radius in a rural area might be appropriate, a 25 mile radius in New York City would not be.  Restrictive covenants will have the following components:

1.       Geographic Scope

2.       Time Period

3.       Prohibition of Practice/Resignation of Medical Privileges at Certain Hospitals

4.       Prohibited Activities

A crucial point is whether the restrictive covenant will be enforceable upon unilateral termination or non-renewal of the contract by practice/employer, particularly if that is coupled with the practice’s decision not to make a physician a shareholder or owner of the practice.  Enforcing the restrictive covenant in those situations makes it painless for the practice to withhold shareholder status and simply recruit a new physician.  If the restrictive covenant is designed not to apply in those situations, the practice must balance whether the right step is to proceed with shareholder status.

IX.      CONFIDENTIALITY INTELLECTUAL PROPERTY:  Most contracts provide that the intellectual property you create during employment (inventions, devices, publications, etc.) is the property of the employer.  These clauses state that patient lists and demographic information are property of the practice.  Provide exceptions if necessary.

X.       LOAN FORGIVENESS:  There are a variety of loan forgiveness issues that could come into play.  Federal programs allow forgiveness for service in underserved areas and on an income based repayment plan for 10 years of service at non-profit healthcare institutions.  In addition, hospitals and practices sometime offer additional benefits.  However the cash flow and tax implications of federal forgiveness, which are income tax free, versus private subsidy programs which are typically taxable as compensation, should be diligently evaluated.

XI.      ­­­­­­­­­­­­­­­­PRACTICE BUY-IN:  (A Topic for Another Day)

WARNING

Although the foregoing discussion may appear to present a thorough analysis of the issues, you should always consult an experienced lawyer, explain to them your expectations about your new position, and let them review your contract in light of those expectations.  It is always preferable to have experienced counsel in this process.  Since the contract will define how much money you will make, what you will be required to do to make it, and how your dream opportunity can be “terminated” while you are to be contractually banished from practicing medicine in that market (which could be your hometown), you are not doing yourself any favors by asking your college roommate who has become a lawyer “to take a quick look” at your contract.

I’ve been practicing in this area for almost 35 years and have helped hundreds of doctors with these contracts.  I would be happy to help you with yours.

Tags:  “Physicians’ Contracts” “Physician Contracts” “Restrictive Covenants” “Healthcare Reform”

 

 

 

Basic Contract Issues for New Physician Contracts

INTRODUCTION

When physicians have finally completed the medical education journey, many are confronted with a “physician employment contract,” usually from a hospital or medical practice, which could define the essential terms of their professional relationship for many years to come.  If the parties live happily ever after, neither may ever read the contract again.  However, if a problem arises, the scramble to find and read the contract begins.

New physicians are always at a significant disadvantage in this process.  The “Employer,” whether hospital or medical practice, has invested significant resources into designing a contract which gives emphatic attention to the key terms upon which the physician was focused at signing (money, time, vacation, employee benefits) but is otherwise a fairly one-sided agreement; perhaps it is even presented as the “form contract we give to all the doctors.”  Residents and fellows may be pulled a little deeper into that dilemma if they remain with the teaching institution at which they completed their studies because the new contract may not appear to be that much different from the prior “student” contract.

Since this contract will basically control your professional life, by not only defining how you must work and for how much, but also by controlling where you might practice when the contract ends though “restrictive covenants,” you are well advised to read it carefully and consult an experienced healthcare lawyer before signing any contract.

The following outline is a fundamental review of the basis issues which should appear in most contracts.

I.        COMPENSATION:  The most important item of the contract will be the compensation.  Compensation is typically divided into three categories, i.e., base compensation, productivity or incentive compensation, and other bonuses.

A.      Base compensation is guaranteed annual salary, usually payable in accordance with the employer’s payroll practices.  Base compensation in multi-year contracts should escalate in future years to reflect added value or inflation, unless there is a productivity component in addition to the base compensation.  Experienced advisors should have comparative compensation information by specialty.

B.      Productivity compensation is typically based upon some formula, usually either net collections or some other productivity measure such as WRVUs.  Productivity based upon collections typically requires some collection level in excess of expenses or in excess of a collection target.  Be careful to clearly define the productivity formula, particularly the amount and methodology for allocating expenses.  Productivity based upon work units requires a clear understanding of how those units will be generated, i.e., by the physicians or by other ancillary providers, and whether it will include ancillary revenue, such as imaging, drugs and biologicals, etc.  Furthermore, healthcare reform may eventually create Accountable Care Organizations, medical homes, substantive Pay 4 Performance (P4P) models, and Medicare MIPS models.  Therefore, incentive based arrangements which rely on collections or WRVUs should include a commitment to make a good faith attempt to incorporate new compensation models in an equitable manner.

C.      Other types of bonuses include signing bonuses, retention bonuses that are paid following completion of annual benchmarks, and severance bonuses for premature termination.

II.       TERM:  The contract term is the number of years that the contract will be in force.  The term of physician employment contracts usually reflects some initial probationary period or qualifying period during which the physician will be an employee of the practice prior to an opportunity to become a shareholder.  Employment contracts with hospitals do not have shareholder options in the future.  This probationary period varies by geographic region of the country, but is typically 2 to 3 years.  You should assure that the initial contract continues to exist until replaced by a shareholder employment contract.  Many contracts contain “evergreen” renewal provisions, which automatically renew contract term from year to year without requiring any action by either the employer or the employee.  Be careful with evergreen contracts which contain no provisions for salary escalation.

III.      BENEFITS:  Most contracts simply state that you participate in the benefit plans in accordance with the terms and conditions of the plans; get the details.

A.      Retirement Plan:  Check participation, vesting and contribution rates.  Get a copy of the Summary Plan Description (SPD) mandated by ERISA.

B.      Health Insurance:  Most practices and all hospitals will have an employee benefit description.

IV.     BUSINESS EXPENSES:  Get the business expense policy.  If you have additional specific needs, discuss these before the contract is signed.

A.      Professional Dues:  Hospitals, specialty societies

B.      Pager/Communications/Cell Phone

C.      CME

D.      Travel and Parking

E.      Moving and Relocation

V.      MALPRACTICE INSURANCE:  Malpractice premiums are typically covered as one of the business expenses in the contract.  There are two types of malpractice insurance, i.e., occurrence and claims made.  Occurrence malpractice insurance covers the physician for any event that occurred during the term of the malpractice policy regardless of when the claim is made.  Claims made malpractice insurance, which is the less valuable coverage, covers incidents only if they both occur and are the subject of a claim made during the term of the policy, hence the name “claims made.”  When employment at an entity with claims made insurance ends, the malpractice insurance typically ends also, meaning that any future claims will not be covered unless a reporting endorsement, sometimes known as a “tail,” is purchased.  The tail should be covered as a business expense.  Sometimes, the responsibility for the tail is divided based upon the cause for termination.  If the practice terminates the physician or fails to make the physician a shareholder, then the practice pays the tail.  If the physician resigns without cause to pursue some other opportunity, the physician is responsible for the tail.  The amount of malpractice insurance varies from state to state.  Some states require a minimum level of malpractice insurance.  Some states also have state funds, such as catastrophic loss funds, into which premiums or surcharges are paid by the physician.  The physician should make sure that these additional elements are included in the malpractice coverage.

VI.     CLINICAL DUTIES:  The description of clinical duties is usually a fairly generic provision of the employment contract, but the physician should pay careful attention to the scope of those duties to make sure that the office facilities and hospitals at which the physician is required to practice are identified, that the parties understand how additional offices or hospitals can or cannot be added, how many patient office hours are expected, and how call coverage responsibilities will be divided among the physicians in the practice.  Typical language is “equitable allocation,” which does not quite mean equal.  It is common for senior physicians to take less call than junior physicians, but language stating that the call is simply assigned by the employer is too vague.  The contract should also state whether moonlighting is or is not allowed.

VII.    TERMINATION:  Contracts will typically have a termination clause which defines several different methods for termination.

A.      Expiration:  The contract can simply expire at the end of the term.

B.      Termination for Cause:  The contract can be terminated by either party for cause, which is usually defined as some breach of the contract by the other party, or the occurrence of certain events such as loss of medical license, loss of DEA number, Medicare exclusion, conviction of a crime, etc.

C.      Other Material Breaches:  The contract can also be terminable for more ambiguous breaches, such as the failure to perform duties in accordance with employer standards, and attention to patients, etc.  Ambiguous events such as these should be subject to a “notice and cure provision,” which requires the employer to first give notice of the alleged breach sufficient to describe the problem and give the physician the opportunity to cure that breach over some period of time; the purpose of  this type of provision is to prevent surprise terminations.

D.      Unilateral Termination Without Cause:  Contracts typically give both the employer and the employee the opportunity to terminate the contract without cause upon sufficient advance notice.  Termination of this type raises several questions.

a.       How much notice will the practice require?  Practices typically want time to recruit a replacement physician, but that time is usually too long to permit an employed physician to accept another position, so the parties must negotiate a satisfactory compromise.

b.       How much notice will the physician require?  Will that notice be different for non-renewal of the contract or failure to make shareholder after two or three years of employment compared to “premature” termination during the first year of employment.  It is certainly unfair to expect that employment could be terminated just 90 days after the start of the contract because the employer/practice changes its collective mind.  In such circumstances, early terminations are usually combined with greater notice or severance payments.

c.       Defining the cause for termination is very important with respect to the enforcement or applicability of the restrictive covenant.

VIII.   RESTRICTIVE COVENANTS:  The enforceability of restrictive covenants depends upon the state, i.e., the jurisdiction, in which the practice is located.  Some states prohibit restrictive covenants.  State that do permit the enforcement of restrictive covenants usually require that they be reasonable, so that they are no broader than reasonably necessary to protect the employer.  Just as an example, restrictive covenants that would prohibit the physician from practicing medicine within 200 miles of the office location will not be enforceable simply because it is improbable that a competing practice 200 miles away would do any harm to a practice.  Note that the geographic scope will definitely depend upon the nature of the practice and the population density.  While a 25 mile radius in a rural area might be appropriate, a 25 mile radius in New York City would not be.  Restrictive covenants will have the following components:

1.       Geographic Scope

2.       Time Period

3.       Prohibition of Practice/Resignation of Medical Privileges at Certain Hospitals

4.       Prohibited Activities

A crucial point is whether the restrictive covenant will be enforceable upon unilateral termination or non-renewal of the contract by practice/employer, particularly if that is coupled with the practice’s decision not to make a physician a shareholder or owner of the practice.  Enforcing the restrictive covenant in those situations makes it painless for the practice to withhold shareholder status and simply recruit a new physician.  If the restrictive covenant is designed not to apply in those situations, the practice must balance whether the right step is to proceed with shareholder status.

IX.      CONFIDENTIALITY INTELLECTUAL PROPERTY:  Most contracts provide that the intellectual property you create during employment (inventions, devices, publications, etc.) is the property of the employer.  These clauses state that patient lists and demographic information are property of the practice.  Provide exceptions if necessary.

X.       ­­­­­­­­­­­­­­­­PRACTICE BUY-IN:  (A Topic for Another Day)

WARNING

Although the foregoing discussion may appear to present a thorough analysis of the issues, you should always consult an experienced lawyer, explain to them your expectations about your new position, and let them review your contract in light of those expectations.  It is always preferable to have experienced counsel in this process.  Since the contract will define how much money you will make, what you will be required to do to make it, and how your dream opportunity can be “terminated” while you are to be contractually banished from practicing medicine in that market (which could be your hometown), you are not doing yourself any favors by asking your college roommate who has become a lawyer “to take a quick look” at your contract.

I’ve been practicing in this area for almost 35 years and have helped hundreds of doctors with these contracts.  I would be happy to help you with yours.

 

 

CMS Posts Open Payment Data – $7.52 Billion in 2015

CMS published the 2015 Open Payment Data on June 30, 2015.  This is the link to the notice and the CMS site: https://openpaymentsdata.cms.gov/

CMS has presented tables in its press release showing the highest paid specialties and highest paying companies.  Over the last two years, Novartis has paid approximately $842 million to 344,000 recipients, which is an average of $2,500.  Genentech has paid $855 million to 44,000 recipients, making their average approximately $20,000.  Note that we are using the term recipient to reflect each of the records posted by CMS there could well be more than one record posted for any specific recipient.

 

 

Tucker Arensberg’s Michael Cassidy Named a Top Author by JD Supra

The law firm of Tucker Arensberg, P.C. is pleased to announce Michael Cassidy has been named a Top Author by JD Supra.  Mike is the founder and frequent contributor to the Med Law Blog (www.medlawblog.com).  This award recognizes the top authors being read by executives, in-house counsel, media and other professionals across the JD Supra platform in 2015.  The Top 200 Authors were selected based on their engagement with readers, general visibility and thought leadership in selected categories from over 34,000 authors that publish on JD Supra.

Mike’s practice focuses on representing physicians and other healthcare providers in all issues relating to the business of health care and has been certified in Healthcare Compliance (CHC) by the Health Care Compliance Association (HCCA).  Mike concentrates his practice in Health Law, chairs the firm’s Business and Finance Department, and is a member of the Health Law Practice Group and the Employee Benefits Practice Group, and currently co-chairs the HALA National Practitioner Data Bank Work Group.

Mike earned his Juris Doctor from the University of Pittsburgh School of Law and his Bachelor of Arts from Brown University.

Tucker Arensberg is an 85 attorney law firm headquartered in Pittsburgh, PA with offices in Harrisburg, PA and New York, NY.  It is a full service regional firm providing service to its clients in the areas of  general business law, banking, insolvency and creditors’ rights, estates and trusts, school and municipal law, health care, litigation, mergers and acquisitions, energy, technology and intellectual property, environmental, labor and employment, real estate, workers’ compensation, employee benefits, and investment management and fiduciary services.  For more information on the firm, please visit www.tuckerlaw.com

JD Supra delivers need-to-know legal and business content to professionals in all industries via more than 100 proprietary social feeds, on mobile platforms, in daily email digests and as news across the web.  JD Supra connects over 34,000 professionals writing on important topics to executives, in-house counsel and the media.

Final 60 Day Overpayment Rule

CMS has issued the final regulations to implement that section of the Affordable Care Act amending the Social Security Act to provide that retention of identified overpayment could be a false claim and be subject to both the False Claims Act (FCA) and the Civil Money Penalty Act (CMP).

ACA § 6402(a) established new Social Security Action § 1128J(d), 42 USC § 1320a-7(k)(b).  The statute and the final rule require reporting and returning of an identified overpayment no later than 60 days after the date on which the overpayment has been reasonably identified.  There has been significant debate over the definition of “reasonably identified” and the “look back” period, which is essentially the statute of limitations requiring that similar overpayments in prior years be identified, reported and returned as well.  CMS originally proposed a 10 year look back.

The final rule states that an overpayment has been identified when a person “has, or should have, through the exercise of reasonable diligence, determined that the person has received an overpayment and quantified the amount.  A provider will be considered as having acted with “reasonable diligence” when it conducts a “timely, good faith investigation” within “six months from receipt of credible information, except in extraordinary circumstances.”  Therefore, a provider has six months from the time they reasonably suspect that overpayment has been made to conduct an investigation and identify the overpayment, and then 60 more days to report and return the overpayment.  The look back period has been defined as six (6) years.  The CMS press release and the final regulation are linked.

 

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