Pete Stark Proposes Elimination of Whole Hospital Ownership Exception

Congressman Pete Stark has proposed a new piece to the Stark legislation which would eliminate the existing “whole hospital” exception for a physician ownership by inserting a provision into H.R. 3162, the Children’s Health and Medicare Protection Act, which would impose new hospital disclosure requirements and new physician ownership limitations. The text of the provision follows below. 

The physician ownership restriction would prohibit ownership by physicians of more than 40% of the total value of the investment interest held in the hospital and prohibit any individual physician ownership of more than 2%, while also prohibiting hospital assistance in financing the investment by the physicians.

The disclosure requirements would mandate that hospitals submit annual disclosure reports to the Secretary of Health and Human Services disclosing physician ownership and that the hospitals’ implement procedures that would require any referring physician owner to disclose to the referred patient the existence and extent of the referring physician ownership interest in the hospital.

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SEC. 651. LIMITATION ON EXCEPTION TO THE PROHIBITION ON CERTAIN PHYSICIAN REFERRALS FOR HOSPITALS.

(a) IN GENERAL.—Section 1877 of the Social Security Act (42 U.S.C. 1395) is amended

(1) in subsection (d)(2)—

(A)    in subparagraph (A), by striking "and" at the end;

(B)    in subparagraph (B), by striking the period at the end and inserting "; and"; and

(C)    by adding at the end the following new subparagraph:

"(C) if the entity is a hospital, the hospital meets the requirements of paragraph (3)(D).";

(2) in subsection (d)(3)

(A)      in subparagraph (B), by striking "and" at the end;

(B)      in subparagraph (C), by striking the period at the end and inserting "; and"; and

(C)      by adding at the end the following new subparagraph:

"(D) the hospital meets the requirements described in subsection (i)(1) not later than 18 months after the date of the enactment of this subparagraph."; and

(3) by adding at the end the following new subsection:

"(i) REQUIREMENTS FOR HOSPITALS TO QUALIFY FOR HOSPITAL EXCEPTION TO OWNERSHIP OR INVESTMENT PROHIBITION.

"(1) REQUIREMENTS DESCRIBED. For purposes of paragraphs subsection (d)(3)(D), the requirements described in this paragraph for a hospital are as follows:

"(A) PROVIDER AGREEMENT.—The hospital had a provider agreement under section 1866 in effect on July 24, 2007.

"(B) PROHIBITION OF EXPANSION OF FACILITY CAPACITY. The number of operating rooms and beds of the hospital at any time on or after the date of the enactment of this subsection are no greater than the number of operating rooms and beds as of such date.

"(C) PREVENTING CONFLICTS OF INTEREST.—

"(i) The hospital submits to the Secretary an annual report containing a detailed description of

"(I)    the identity of each physician owner and any other owners of the hospital; and

"(II)     the nature and extent of all ownership interests in the hospital.

"(ii) The hospital has procedures in place to require that any referring physician owner discloses to the patient being referred, by a time that permits the patient to make a meaningful decision regarding the receipt of care, as determined by the Secretary,

"(I)    the ownership interest of such referring physician in the hospital; and

"(II)     if applicable, any such ownership interest of the treating physician.

"(iii) The hospital does not condition any physician ownership interests either directly or indirectly on the physician owner making or influencing referrals to the hospital or otherwise generating business for the hospital.

"(D) ENSURING BONA FIDE INVESTMENT.—

"(i)    Physician owners in the aggregate do not own more than 40 percent of the total value of the investment interests held in the hospital or in an entity whose assets include the hospital.

"(ii)     The investment interest of any individual physician owner does not exceed 2 percent of the total value of the investment interests held in the hospital or in an entity whose assets include the hospital.

"(iii)    Any ownership or investment interests that the hospital offers to a physician owner are not offered on more favorable terms than the terms offered to a person who is not a physician owner.

"(iv)    The hospital does not directly or indirectly provide loans or financing for any physician owner investments in the hospital.

"(v)      The hospital does not directly or indirectly guarantee a loan, make a payment toward a loan, or otherwise subsidize a loan, for any individual physician owner or group of physician owners that is related to acquiring any ownership interest in the hospital.

"(vi)       Investment returns are distributed to investors in the hospital in an amount that is directly proportional to the investment of capital by the physician owner in the hospital.

"(vii)     Physician owners do not receive, directly or indirectly, any guaranteed receipt of or right to purchase other business interests related to the hospital, including the purchase or lease of any property under the control of other investors in the hospital or located near the premises of the hospital.

"(viii)    The hospital does not offer a physician owner the opportunity to purchase or lease any property

under the control of the hospital or any other investor in the hospital on more favorable terms than the terms offered to an individual who is not a physician owner.

"(E) PATIENT SAFETY.?

"(i) Insofar as the hospital admits a patient and does not have any physician available on the premises to provide services during all hours in which the hospital is providing services to such patient, before admitting the patient:

"(I)    the hospital discloses such fact to a patient; and

"(II)     following such disclosure, the hospital receives from the patient a signed acknowledgment that the patient understands such fact.

"(ii) The hospital has the capacity to:

"(I)      provide assessment and initial treatment for patients; and

"(II)     refer and transfer patients to hospitals with the capability to treat the needs of the patient involved.

"(2)     PUBLICATION OF INFORMATION REPORTED.—The Secretary shall publish, and update on an annual basis, the information submitted by hospitals under paragraph (1)(A)(i) on the public Internet website of the Centers for Medicare & Medicaid Services.

"(3)     COLLECTION OF OWNERSHIP AND INVESTMENT INFORMATION.—For purposes of clauses (i) and (ii) of paragraph (1)(D), the Secretary shall collect physician ownership and investment information for each hospital as it existed on the date of the enactment of this subsection.

"(4)     PHYSICIAN OWNER DEFINED.—For purposes of this subsection, the term 'physician owner' means a physician (or an immediate family member of such physician) with a direct or an indirect ownership interest in the hospital.".

(b) ENFORCEMENT.

(1)       ENSURING COMPLIANCE.—The Secretary of Health and Human Services shall establish policies and procedures to ensure compliance with the requirements described in such section 1877(i)(1) of the Social Security Act, as added by subsection (a)(3), beginning on the date such requirements first apply. Such policies and procedures may include unannounced site reviews of hospitals.

(2)     AUDITS.—Beginning not later than 18 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall conduct audits to determine if hospitals violate the requirements referred to in paragraph (1).

Securing Rights to Your Website

Securing Rights to Your Website, By: Lee Kim

About the author: Lee Kim is an intellectual property associate at Tucker Arensberg, P.C.  She specializes in copyrights, trademarks, trade secrets, and patents.  See http://www.tuckerlaw.com/att/alpha/K/kim_lee.html

1. Securing Your Domain Name

If you are creating a website, you should first register at least one domain name of your choice with a reputable domain name registrar.  While there are many domain name registrars out there, well-regarded registrars include register.com, Go Daddy, and Network Solutions.

Tip: It is recommended that you register the domain name yourself instead of having a third party (e.g., consultant) do this on your behalf.  Domain name registrars such as the ones named above generally have support numbers that one can call if one needs assistance registering the domain name(s) of choice.

Why this is recommended: There are individuals, companies, and other entities (a.k.a. "cybersquatters") that attempt to make money by holding one's domain name hostage.  For example, if one owns a trademark and the domain name that is being held hostage is identical or substantially similar to that trademark, then one needs to go through a dispute resolution process such as the Uniform Dispute Resolution Policy ("UDRP"), below.

Tip: Since domain name registration is relatively inexpensive, it is recommended that one register several domain name variants, such as top level domain ("TLD") variants (e.g., .org, .com, .net, .us, and the like) and singular/plural variants of the domain name.  You also may consider registering commonly misspelled variants of your domain name.  Also, there are commercial services which monitor the web for misuse of your domain name.  Thomson CompuMark is one such reputable provider.  Thomson CompuMark's website has the following Uniform Resource Locator ("URL"): http://www.thomson-thomson.com.

Why this is recommended: There are individuals, companies, and other entities (a.k.a. "typosquatters") that attempt to make money off of typo-variants of domain names and oftentimes ask for exorbitant sums of money in exchange for these domain names.  See, e.g., http://searchengineland.com/070711-083600.php for an article on domain name best practices.  See, e.g., http://www.icann.org/tlds/ for an informational page on TLDs.  For example, if one owns a trademark and the domain name that is being held hostage is identical or substantially similar to that trademark, then one needs to go through a dispute resolution process such as the Uniform Dispute Resolution Policy ("UDRP"), below.

Question: What if someone holds my domain name hostage (i.e., a cybersquatter) or someone has a typo-variant of my domain name (i.e., a typosquatter)?

Answer: Often, the domain name is parked and the domain name owner makes revenue using click-through links.  Some domain name registrars and other Internet domain services offer domain name holders cash for parked domain names in exchange for the traffic that their respective domain name generates through the click-through links.  See, e.g., https://www.godaddy.com/gdshop/park/landing.asp?se=; http://www.whypark.com/.  If the cybersquatter or typo-squatter has a domain name that is identical or substantially similar to your trademark or service mark, has no rights or legitimate interests in the domain name, and is using the domain name in bad faith, then you may be able to successfully dispute the third party's ownership of that domain name and request transfer or cancellation of the domain name by filing a Uniform Dispute Resolution Policy ("UDRP") complaint against that third party.  See http://www.icann.org/dndr/udrp/policy.htm for the UDRP policy.  The complaint may be filed with a dispute resolution provider such as the National Arbitration Forum or the World Intellectual Property Organization.
 
Question: Can I register my domain name as a trademark or a service mark?

Answer: Yes, if the domain name functions as a trademark or service mark which serves to identify your company's name, products, and/or services.  The domain name may be registered with the United States Patent and Trademark Office ("USPTO") under certain conditions such as these. 

Question: What are the benefits of trademark or service mark registration of my domain name?

Answer: By obtaining a trademark or service mark registration with the USPTO, one may have legal recourse against a cybersquatter or typo-squatter under federal law.  Further, having the trademark or service mark registration leads to a stronger case if one has to file a complaint based upon the UDRP.  See, e.g., http://www.uspto.gov/web/offices/tac/tmfaq.htm#Basic002.

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MS.1.20 : A Chance to Establish Neutral Peer Review

Although the newly adopted Joint Commission Standard MS.1.20 will compel hospitals and medical staffs to re-evaluate the provisions of the medical staff by-laws on a multitude of issues, I would like to focus just upon peer review issues from the physician’s perspective, i.e., the physician who is the “target” of the peer review investigation or process.

While some stakeholders in this process from all perspectives, i.e., hospitals, physicians, administrators, medical staff officers, reject the notion that sham peer review is a problem, there is nevertheless almost universal acknowledgment that the peer review process is a threatening process to physicians being investigated. True peer review is not designed as a threatening process; it is a process intended to correct behavior and improve the quality of care. Although summary suspension and other disciplinary acts at the later stages of the peer review process inevitably occur, and in many and even in perhaps the substantial majority of cases may be justified, disciplinary actions should be an unfortunate result of a process rather than the goal of a process.

However, since the disciplinary peer review process (as distinguished from typical morbidity and mortality conferences) is very secretive and is conducted without the participation and sometimes without the knowledge of the target physician, the perception of this process as being a secretive and punitive process is all to often supported by the facts. MS.1.20 provides the opportunity to improve this process from the physician perspective, without changing either the confidentiality of the process from the perspective of a third party or affecting the control or governance of the process by the hospital or medical staff. Confidentiality was never intended to exclude physician participation. After all, most of the gory details of the process are not only disclosed, but highlighted and emphasized, once a decision to impose adverse peer review is made. My suggestions are as follows:

1.         Knowledge and Representation on the Ad Hoc/Investigative Committee: Standard bylaws provide that an investigative committee is appointed or assigned to investigate complaints about physicians. Physicians are typically notified that this action has occurred, but we believe physicians should always be notified and should also have the opportunity to approve or appoint one member of the committee, without regard to the total number of members of the committee. The goal is not to achieve a voting balance of power or stalemate, but simply to assure the absence of secrecy and the presence of accountability.

2.         Physician Participation in the Investigated Process: Standard bylaws often provide that the physician is granted the opportunity to meet with the investigative committee and discuss the findings. However, once findings have been made, the participation of the physician is almost irrelevant. The opportunity for the committee to make a decision considering all perspectives has already been lost. Physician participation in the process must start at the inception of the process, as it would in lower level peer review not intended to result in disciplinary consequences. 

3.         Hearing Committee Representation: As with the investigative committee, a physician representative should be included on the hearing committee. This is again without regard to the numbers, because the goal of this safeguard is not to create minority voting power or stalemates, but simply to assure that the physician is represented where it counts, in the deliberative process. The current deliberative process is unapologetically skewed to favor the hospital and facilitate the outcome desired by the hospital. The hospital, or the medical staff executive officers appointed or elected with hospital support, select the hearing panel members, whom deliberate in private and often with the participation in advice of hospital counsel. It is not necessary that the physician being investigated have any control over this process; it is merely important that a physician representative bring openness and the light of day to the process.   

Joint Commission Adopts New MS.1.20 Standards

Hospitals

Revisions to Standard MS.1.20 Approved

At its June meeting, the Joint Commission Board of Commissioners approved revisions to Standard MS.1.20, which addresses medical staff bylaws, rules and regulations, and policies.  These revisions were written with the intent of supporting and reinforcing a productive working relationship between the organized medical staff and the governing body – consistent with the requirements of the new Leadership Chapter – while minimizing disruptions to the hospital, including its medical staff.  All of the requirements in Standard MS.1.20 must be jointly approved by the organized medical staff (or the medical staff executive committee, if so delegated by the organized medical staff) and the governing body.

The main revisions to Standard MS.1.20 are as follows:

  • The Introduction was revised to include a discussion of the relationship between the organized medical staff and the medical staff executive committee, and the definitions of “process” and “procedural detail.”
  • A note was added referring the organization to Standard LD.2.40 for guidance on managing conflict that might arise concerning the medical staff bylaws, rules and regulations, and policies.
  • A note was added to explain the revised structure of the standard.
  • Lead-in sentences to groups of EPs were added to clearly delineate what must be in the medical staff bylaws, and what must be either in the bylaws, or in rules and regulations or policies.
  • Two new EPs were added to align the standard with the Centers for Medicare and Medicaid Services’ requirements regarding medical staff bylaws.
  • An EP was added to underscore the organized medical staff’s ability to propose medical staff bylaws, rules and regulations, and policies directly to the governing body.
  • A requirement was added that the medical staff bylaws must indicate the authority delegated to the medical staff executive committee by the organized medical staff to act on its behalf, and how that authority is delegated and removed.

The revised standard seeks to resolve several important issues.  First, it addresses situations in which a medical staff believes that its medical staff executive committee is not representing its views on issues of patient safety and quality of care.  The revised standard now states that the medical staff bylaws must indicate what authority the medical staff has delegated to the medical staff executive committee, and how that authority is delegated and removed.  Also, the revised standard now states that the medical staff has the ability to adopt medical staff bylaws, rules and regulations, and policies and propose them directly to the governing body, even if the subject matter had been delegated to the medical staff executive committee.  While the revised standard does not state what a medical staff should do if it does not agree with an action taken by its medical staff executive committee, the Introduction to the standard urges the medical staff to consider in advance what action it would take if such a situation occurred.

The revised standard also seeks to allow for an efficient process, for the hospital and its medical staff, for creating and maintaining medical staff bylaws, rules and regulations, and policies.  To do this, the standard indicates what must appear in the medical staff bylaws, and what must appear either in the bylaws, or in rules and regulations or policies.  The requirements in Elements of Performance (EPs) 9 through 33 must appear in the medical staff bylaws.  However, the procedural details associated with the processes listed in EPs 26 through 33 must appear either in the medical staff bylaws, or in rules and regulations or policies (see text of standard below).  The organized medical staff may, if it desires, delegate to its medical staff executive committee approval of the procedural details associated with the processes listed in EPs 26 through 33, when these procedural details are placed in rules and regulations or policies.

To understand these requirements, the difference between “process” and “procedural detail” needs to be explained.  A process is a series of steps taken to accomplish a goal.  A procedural detail describes in detail how each step in the process is to be carried out.  For example, the process for credentialing licensed independent practitioners (see EP 26) can be stated in several steps such as collecting information on a physician, evaluating the information, and making a decision about the information.  That process will be contained in the medical staff bylaws.  The procedural details associated with this process might include who collects the information, how files are kept, what organizations need to be contacted to collect all the necessary information, etc.  For EPs 26 through 33, the medical staff decides whether such procedural details will be retained in the medical staff bylaws (which must be approved by the entire organized medical staff), or in rules and regulations or policies (whose approval may be delegated to the medical staff executive committee).

Revised Standard MS.1.20 becomes effective July 1, 2009.  The Joint Commission is allowing two years for the field to make any changes to medical staff bylaws that may be necessary to bring organizations into compliance with the revised standard.  In the meantime, the current version of Standard MS.1.20 will be in effect.

STANDARD MS.1.20

Effective July 1, 2009

Introduction for Standard MS.1.20 (CAH, HAP)

The (HAP: organized) medical staff and the governing body work together, reflecting clearly recognized roles, responsibilities, and accountabilities, to enhance the quality and safety of care, treatment, and services provided to patients.  To support this work, the (HAP: organized) medical staff creates a written set of documents that describes the organizational structure of the medical staff and the rules for its self-governance.  These documents are called medical staff bylaws.  The medical staff bylaws create a system of rights, responsibilities, and accountabilities between the (HAP: organized) medical staff and the governing body, and between the (HAP: organized) medical staff and the medical staff members.   

In addition to the medical staff bylaws, the (HAP: organized) medical staff may create other medical staff governance documents such as rules and regulations and policies. In doing so, the (HAP: organized) medical staff may recommend that the procedural details of those requirements listed in Elements of Performance 26-33 of this standard be retained in the medical staff bylaws, or in rules and regulations or policies, in accordance with applicable law and regulation. 

In developing its bylaws, the (HAP: organized) medical staff may include within the scope of responsibilities of the medical staff executive committee the authority to adopt, on the behalf of the entire (HAP: organized) medical staff, any procedural details associated with Elements of Performance 26-33 appearing in rules and regulations or policies.  The (HAP: organized) medical staff can also propose medical staff bylaws, rules and regulations, and policies, and amendments thereto, directly to the governing body.

When approval of procedural details associated with Elements of Performance 26-33 appearing in rules and regulations or policies is delegated to the medical staff executive committee, it is to represent to the governing body the organized medical staff’s views on issues of patient safety and quality of care.  The organized medical staff can take action to revise the authority it has delegated to the medical staff executive committee to act on its behalf.  The organized medical staff is urged to determine what steps it will take if it does not agree with an action taken by the medical staff executive committee.  Such steps might include a process that would allow the organized medical staff, at its discretion, to extract and consider an action by the medical staff executive committee prior to the action becoming effective.

To understand these requirements, the difference between “process” and “procedural detail” needs to be explained.  A process is a series of steps taken to accomplish a goal.  A procedural detail describes in detail how each step in the process is to be carried out.  For example, the process for credentialing licensed independent practitioners (see EP 26) can be stated in several steps such as collecting information on a physician, evaluating the information, and making a decision about the information.  That process will be contained in the medical staff bylaws.  The procedural details associated with this process might include who collects the information, how files are kept, what organizations need to be contacted to collect all the necessary information, etc.  For EPs 26 through 33, the medical staff decides whether such procedural details will be retained in the medical staff bylaws (which must be approved by the entire organized medical staff), or in rules and regulations or policies (whose approval may be delegated to the medical staff executive committee).

The significance of the medical staff bylaws cannot be overstated.  For this reason, the medical staff leaders should assure that all medical staff members understand the content and purpose of the bylaws, and the bylaws adoption and amendment processes.

Note: If conflicts regarding the medical staff bylaws, rules and regulations, or policies arise between the governing body and the (HAP: organized) medical staff, the organization’s conflict management process is implemented, as set forth in Standard LD.2.40.

Standard MS.1.20 (CAH, HAP)

Medical staff bylaws address self-governance and accountability to the governing body.

Note regarding Elements of Performance 9-33: All requirements appearing in Elements of Performance 9-33 must be in the medical staff bylaws.  These requirements may have associated procedural details.  Any procedural details associated with the requirements in Elements of Performance 9-25 must also be in the medical staff bylaws.  Any procedural details associated with Elements of Performance 26-33 must be either in the medical staff bylaws, or in rules and regulations or policies.  All requirements and procedural details addressed in the medical staff bylaws must be adopted and amended by the whole of the (HAP: organized) medical staff and approved by the governing body.  All procedural details addressed in rules and regulations or policies must be adopted and amended by either the whole of the medical staff or the medical staff executive committee, if so delegated by the (HAP: organized) medical staff, and approved by the governing body.

Elements of Performance for Standard MS.1.20

  1. (CAH, HAP) The (HAP: organized) medical staff develops medical staff bylaws, rules and regulations, and policies.
  2. (CAH, HAP) The (HAP: organized) medical staff adopts and amends, and the governing body approves, medical staff bylaws.
  3. (CAH, HAP) The (HAP: organized) medical staff, or the medical staff executive committee as delegated by the (HAP: organized) medical staff, adopts and amends, and the governing body approves, any rules and regulations and policies that address procedural details of the requirements in Elements of Performance 26-33.
  4. (HAP) Regardless of whether the medical staff executive committee is empowered to act on behalf of the organized medical staff, the organized medical staff as a whole has the ability to adopt medical staff bylaws, rules and regulations, and policies, and amendments thereto, and propose them directly to the governing body.

    Note: Please see the Introduction to this standard for further discussion of the organized medical staff’s relationship to the medical staff executive committee.
  5. (CAH, HAP) The governing body acts in accordance with those medical staff bylaws, rules and regulations, and policies that are adopted by the (HAP: organized) medical staff or, as delegated by the (HAP: organized) medical staff, the medical staff executive committee, and approved by the governing body.
  6. (HAP) The organized medical staff enforces the medical staff bylaws, rules and regulations, and policies.
  7. (HAP) The medical staff bylaws, rules and regulations, and policies and the governing body bylaws do not conflict.
  8. (CAH, HAP) The organized medical staff and its members comply with the medical staff bylaws, rules and regulations, and policies.
     

    The medical staff bylaws must include the requirements and any associated procedural details in Elements of Performance 9-25.
  9. (CAH, HAP) The structure of the (HAP: organized) medical staff. 
  10. (CAH, HAP) The process for privileging licensed independent practitioners. 
  11. (CAH, HAP) Qualifications for appointment to the (HAP: organized) medical staff. 
  12. (HAP) Indications for automatic suspension of a practitioner’s medical staff membership or clinical privileges.
  13. (HAP) Indications for summary suspension of a practitioner’s medical staff membership or clinical privileges.
  14. (HAP) Indications for recommending termination or suspension of medical staff membership, and/or termination, suspension, or reduction of clinical privileges.
  15. (HAP) The composition of the fair hearing committee. (See also EP 32.)
  16. (CAH, HAP) The roles and responsibilities of each category of practitioner on the medical staff (active, courtesy, etc.). 
  17. (CAH, HAP) Requirements for performing medical histories and physical examinations. 
  18. (HAP) Those practitioners who are eligible to vote on the medical staff bylaws and their amendments.
  19. (HAP) A list of all the officer positions for the organized medical staff.
  20. (HAP) The medical staff executive committee’s function, size, and composition; the authority delegated to the medical staff executive committee by the organized medical staff to act on its behalf; and how such authority is delegated or removed.  (See also Standard MS.1.40.)
  21. (HAP) The process for selecting and removing the medical staff executive committee members.
  22. (HAP) That the medical staff executive committee includes physicians and may include other practitioners as determined by the organized medical staff.
  23. (HAP) That the medical staff executive committee acts on the behalf of the organized medical staff between meetings of the organized medical staff, within the scope of its responsibilities as defined by the organized medical staff.  (See also Standard MS.1.40.)
  24. (HAP) The process for adopting and amending the medical staff bylaws.
  25. (HAP) The process for adopting and amending medical staff rules and regulations, and policies.


    The medical staff bylaws must include the requirements in Elements of Performance 26-33.  The procedural details, if any, associated with Elements of Performance 26-33 must appear either in the medical staff bylaws, or in rules and regulations or policies (see Elements of Performance 1-4).
  26. (CAH, HAP) The process for credentialing licensed independent practitioners. 
  27. (HAP) The process for appointment to membership on the organized medical staff.
  28. (HAP) The process for selecting and removing the organized medical staff officers.

    Corrective Actions

  29. (HAP) The process for automatic suspension of a practitioner’s medical staff membership or clinical privileges.
  30. (HAP) The process for summary suspension of a practitioner’s medical staff membership or clinical privileges.
  31. (HAP) The process for recommending termination or suspension of medical staff membership and/or termination, suspension, or reduction of clinical privileges.

    Fair Hearing and Appeal
  32. (HAP) The fair hearing and appeal process (see also EP 15), which at a minimum shall include:

    - The process for scheduling hearings
    - The process for conducting hearings
    - The appeal process

    Qualifications and Roles and Responsibilities of the Department Chair

  33. (HAP) If departments of the organized medical staff exist, the qualifications and roles and responsibilities of the department chair, which shall include the following:

    Qualifications:
  • Certification by an appropriate specialty board or comparable competence affirmatively established through the credentialing process.

Roles and responsibilities:

  • Clinically related activities of the department.
  • Administratively related activities of the department, unless otherwise provided by the hospital.
  • Continuing surveillance of the professional performance of all individuals in the department who have delineated clinical privileges.
  • Recommending to the organized medical staff the criteria for clinical privileges that are relevant to the care provided in the department.
  • Recommending clinical privileges for each member of the department.
  • Assessing and recommending to the relevant hospital authority off-site sources for needed patient care, treatment, and services not provided by the department or the organization.
  • Integration of the department or service into the primary functions of the organization.
  • Coordination and integration of interdepartmental and intradepartmental services.
  • Development and implementation of policies and procedures that guide and support the provision of care, treatment, and services.
  • Recommendations for a sufficient number of qualified and competent persons to provide care, treatment, and services.
  • Determination of the qualifications and competence of department or service personnel who are not licensed independent practitioners and who provide patient care, treatment, and services.
  • Continuous assessment and improvement of the quality of care, treatment, and services.
  • Maintenance of quality control programs, as appropriate.
  • Orientation and continuing education of all persons in the department or service.
  • Recommending space and other resources needed by the department or service.

Prohibited Mark-up of Diagnostic Tests: Text of Proposed 2008 Medicare Regs

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

24.       The authority citation for part 414 is revised to read as follows:

Authority:       Secs. 1102, 1871, and 1881(b)(1) of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(1)).

Subpart B--Physicians and Other Practitioners

25.       Section 414.50 is revised to read as follows:

§414.50 Physician billing for purchased diagnostic tests.

(a)        General rule.  (1) For services covered under section 1861(s)(3) of the Act and paid for under part 414 of this chapter (other than clinical diagnostic laboratory tests paid under section 1833(a)(2)(D) of the Act, which are subject to the special rules set forth in section 1833(h)(5)(A) of the Act), if a physician or medical group bills for the technical or professional component of a diagnostic test that was performed by an outside supplier, the payment to the physician or the medical group (less the applicable deductibles and coinsurance) for the technical or professional component of the test may not exceed the lowest of the following amounts:

(i)         The supplier's net charge to the physician or medical group.

(ii)        The physician's or medical group's actual charge.

(iii)       The fee schedule amount for the test that would be allowed if the supplier billed directly.

(2)        This provision applies regardless of whether the test or its interpretation was purchased by the physician or medical group billing for the test or the interpretation, or whether the right to bill for the test or its interpretation was reassigned to the physician or medical group billing for the test or the interpretation.

(3)        For purposes of paragraph (a) of this section--

(i)         The physician's or other supplier's net charge must be determined without regard to any charge that is intended to reflect the cost of equipment or space leased to the outside supplier by or through the billing physician or medical group.

(ii)        An outside supplier is someone other than a full-time employee of the billing physician or medical group.

(b)        Restriction on payment. (1)  The physician or medical group must identify the supplier and indicate the supplier's net charge for the test. If the physician or medical group fails to provide this information, CMS makes no payment to the physician or medical group and the

physician or medical group may not bill the beneficiary.

(2)        Physicians and medical groups that accept Medicare assignment may bill beneficiaries for only the applicable deductibles and co-insurance.

(3)        Physicians and medical groups that do not accept Medicare assignment may not bill the beneficiary more than the payment amount described in paragraph (a) of this section.

26.       Section 414.65 is amended by revising paragraph (a)(1) to read as follows:

§414.65 Payment for telehealth services.

(a) *   *   *

(1)        The Medicare payment amount for office or other outpatient visits, consultation, individual psychotherapy, psychiatric diagnostic interview examination, pharmacologic management, end stage renal disease related services included in the monthly capitation payment (except for one visit per month to examine the access site), individual medical nutrition therapy, and neurobehavioral status exam furnished via an interactive telecommunications system is equal to the current fee schedule amount applicable for the service of the physician or practitioner.

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Medicare IDTF Proposals: Regs and Staff Comments Text

The text of both of the discussions of the Independent Diagnostic Testing Facility (IDTF) regulations and of the specific regulations themselves are posted below in full. The fundamental changes from the earlier proposals are as follows:

1.      IDTF must maintain comprehensive general professional liability insurance in the amount of $300,000 per location.

2.      There will no longer be retroactive enrollment. The enrollment date will be the later of the completion of the application or the date the IDTF actually begins services, and enrollments will be processed through an online application.

3.      The IDTF will be required to provide updated information regarding any changes contained in the enrollment application regarding ownership, location, general supervision or adverse legal actions within 30 days of occurrence.

4.      The IDTF must have a documented complaint process. 

5.      The physician responsible for general supervision will not be ultimately responsible for the operations of the IDTF. The regulations will clarify that these responsibilities remain the responsibilities of the owners/shareholders.

6.      A physician may be responsible for only three IDTF sites, whether they be fixed or mobile. The responsibility clarification will not change the existing requirements for direct or personal supervision of tests.

7.      The sharing of facilities at fixed sites will be prohibited.

The specific requirements regarding these changes are listed in the proposed regulations and discussed in the comments below.

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Proposed 2008 Medicare Changes: Diagnostic Test Mark-Up Prohibited

2008 MEDICARE CHANGES:

PHYSICIAN BILLING FOR PURCHASED DIAGNOSTIC TESTS

CMS is proposing to revise the rules on prohibited mark-ups for purchased diagnostic tests. Revised proposed Section 414.50 will state that “if the physician or medical group bills for the technical or professional component of a diagnostic test that was performed by an outside supplier, the payment to the physician or the medical group (less the applicable deductible and coinsurance) for the technical or professional component of the test may not exceed the lowest of the following amounts:

            (i)         The supplier’s net charge to the physician or medical group.

(ii)        The physician’s or medical group’s actual charge.

(iii)       The fee schedule amount for the test that would be allowed if the supplier billed directly.

This provision applies regardless of whether the test or its interpretation was purchased by the physician or medical group billing for the test or the interpretation, or the right to bill for the test or its interpretation was reassigned to the physician or medical group billing for the test or the interpretation.

For purposes of this provision, the physicians’ or other suppliers’ net charge must be determined without regard to any charge that is intended to reflect the cost of equipment or space leased to the outside supplier, buyer or through the billing physician or medical group, and an outside supplier is somewhat other than the full-time employee of the billing physician or medical group.

CMS Proposes to Close Stark Loopholes

CMS has issued regulations within the intent of closing what it perceives to be loopholes in the Stark regulations. The major initiatives are as follows:

1.         The definition of the term “entity” will be expanded to include both sole practitioners as well as other types of entities. The definition will state that an entity will include a physician’s sole practice or a practice of multiple physicians or any other person, sole proprietorship, public or private agency or trust, corporation, partnership, limited liability company, foundation, non-profit corporation or unincorporated association that furnishes DHS. An entity will not include the referring physician himself or herself, but does include his or her medical practice.

2.         In order for compensation to be considered as “set in advance” and compliant, it may not be based on any percentage of revenue other than compensation based on revenues directly resulting from personally performed physician services. Compensation will be considered “set in advance” if the aggregate compensation, a time-based or per unit of service based (whether per use or per service) amount, or a specific formula for calculating the compensation is set in an agreement between the parties before the furnishing of the items or services for which the compensation is to be paid. The formula for determining the compensation must be set forth in sufficient detail so that it can be objectively verified, and the formula may not be changed to modify during the course of the agreement in any manner that reflects the volume or value of referrals or other business generated by the referring physician.

3.         Per unit, rental arrangements will not be allowed to the extent that such charges reflect services provided to the patients referred by the lessor to the lessee

4.         The burden of proof on billing arrangements will be shifted to the billing entity. The proposed regulations will require that, when payment for a designated health service is denied on the basis that the service was furnished pursuant to a prohibited referral, the burden will be on the entity submitting the claim to establish that the service was not furnished pursuant to a prohibited referral.

CMS Proposes Medicare Changes for 2008

CMS PROPOSES MEDICARE CHANGES FOR 2008

The Centers for Medicare and Medicaid Services (CMS) has issued its proposed rules to revise the Medicare Physician Fee Schedule (MPFS) for 2008. Links to both the CMS press release announcing the proposed rules and to the proposed rules themselves are contained below:

·        Press Release:

http://www.cms.hhs.gov/apps/media/press/release.asp?Counter=2239&intNumPerPage=10&checkDate=&checkKey=&srchType=1&numDays=3500&srchOpt=0&srchData=&keywordType=All&chkNewsType=1%2C+2%2C+3%2C+4%2C+5&intPage=&showAll=&pYear=&year=&desc=&cboOrder=date

·        Medicare Proposed Rule:

http://www.cms.hhs.gov/physicianfeesched/downloads/CMS-1385-P.pdf?agree=yes&next=Accept

The proposed rule implements the update procedure required by the sustainable growth rate (SGR) methodology, which result in a negative 9.9% update, i.e., a decrease, in Medicare payments. CMS notes that Congress has intervened to eliminate the negative update or decrease for each of the last five years.

Med Law Blog will post an article on what we believe to be the items of most interest to physicians over the next several weeks regarding the following items: proposals to close the perceived Stark loopholes, revisions in the enrollment process for independent diagnostic testing facilities (IDTF), and establishment of mark-up prohibitions for both the technical and professional component of diagnostic tests. Following is a description of the provisions in the proposed rule by CMS:

·        Updating the Geographic Practice Cost Indices (GPCI) to reflect more recent data.

·        Revising certain physician payment localities according to one of three proposed options

·        Using the Physician Assistance and Quality Initiative Fund (PAQI), created by TRHCA that provides $1.35 billion for physician payment and quality improvement initiatives, to extend voluntary quality reporting bonus payments into 2008.

·        Requiring that persons furnishing physical and occupational therapy services to people with Medicare meet licensing, registration, or certification requirements in the state in which they practice, and that they complete an approved educational program for the services they are furnishing. The proposed rule would also change the time frames for certifying a plan of care.

·        Updating regulations governing payment of certain services furnished in Comprehensive Outpatient Rehabilitation Facilities (CORF's), to reflect payment under the MPFS. This conforms to a statutory mandate.

·        Adding neurobehavioral status exams to the list of telemedicine services eligible for Medicare payment.

·        Adding certain ophthalmologic imaging procedures to the list of procedures that would be subject to the Deficit Reduction Act of 2005 (DRA) provision that caps payment for the technical component of imaging procedures at the payment amount under the hospital outpatient prospective payment system.

·        Modifying the requirements under the competitive acquisition program (CAP) for Part B drugs for verifying that a drug ordered by a physician has been administered.

·        Requiring the reporting of hemoglobin or hematocrit data on claims for drugs used to treat anemia secondary to anticancer treatment.

·        Modifying a number of physician self-referral provisions to close loopholes that have made the Medicare program vulnerable to abuse.

·        Modifying enrollment standards for Independent Diagnostic Testing Facilities (IDTFs).

·        Eliminating the exemption for computer-generated faxes from the e-prescribing standards.

District Court Rejects Renal Physicians Association Stark Challenge

The United States Court of Appeals has decided that the Renal Physicians Association (RPA), a national professional association, does not have legal standing to challenge the legality of the Stark Regulations.

RPA had asserted that certain of the Stark regulations defining fair market value and personal service arrangements for purposes of establishing exceptions to the statutory  prohibition of referrals to financially related entities were not properly promulgated, and that the regulations were harming its members who had medical director agreements with dialysis facilities. The United States District Court, the trial court below in this matter, had granted the motion of the United States Department of Health and Human Services (HHS) seeking dismissal of the Complaint for lack of standing, i.e., the assertion that RPA by itself had not suffered any direct harm, regardless of any harm to its members, and, therefore, had no legal “standing” to bring this litigation. In upholding the decision of the District Court, the Court of Appeals wrote that standing on behalf of RPA would require that the regulations could be shown to be illegal or that the action requested by RPA had the potential of redressing the harm asserted. The Court concluded that neither element was present, concluding that redress was not available because, even if the action requested by RPA was granted, i.e., the retraction of the regulations, members of RPA would still be confronted with the statutory language of the Stark Act declaring that referrals were prohibited unless one of the statutory acceptance was available.

The case is Renal Physicians Association vs. U.S. Department of Health and Human Services, and it was decided by the United States Court of Appeals for the District of Columbia on June 12, 2007 (No. 06-5133).