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New Federal Health Claims & Appeals Laws & Regulations

for 193 Million Americans

Effective 09-23-2010

©2010, Jin Zhou, ERISAclaim.com

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ERISA for Medical Device Makers & Surgeons

after FDA Approval &

for Legitimate Reimbursement

As the Last and Integral Step of

New Medical Device Making

by Jin Zhou, 07/06/2005

© 2005, Jin Zhou, ERISAclaim.com

 

 

Please e-mail for further details

630-736-2974

 

  1. FDA Approval Is Not Enough for Reimbursement by Insurers and health Plans, ERISA Controls and Regulates Final Reimbursement

  2. An Unanimous US Supreme Court: Regardless of FDA approval, ERISA controls and regulates reimbursement

  3. Federal Court Of Appeals: No Other Way around ERISA, Regardless How Artfully and Creatively in Patient Lawsuit, ERISA Preempts All State Laws If You Want Money from ERISA Plans

  4. Newly FDA Approved Medical Device Will Be Denied under ERISA Regardless of FDA Approval

  5. ERISA Provides Specific Protections for Medical Claim Denials and Appeals

  6. No ERISA Appeals, No Acceptance of Scientific Papers and FDA Approvals

  7. ERISA Pre-Service Claim Regulation Provides The Best Protections for Any Claims with Requirement of Pre-Certifications, Prior-Authorizations or Any Prior-Approvals

  8. ERISA Compliance/Approval must be integral and final step of any FDA approved medical device for medical device makers and health-care providers

  9. Medical Necessity for The Federal Employees Health Benefit Plan (FEHBP)

  10. ERISA For Medical Device Makers Power Guides

 

 

 

Dr. Jin Zhou Will Speak at This 2007 National Conference



 

World Research Group has also organized two in-depth workshops conducted by the industry’s thought leaders that will drill down into the solutions you need to prevent, reduce and overturn denials. Register for both to maximize your on-site learning experience.

 

Don’t Miss these Must-Attend, In-Depth Workshops!

links to registration: http://worldrg.com/showConference.cfm?confcode=HW765
 

For a brochure, click here 

 

 

I. FDA Approval Is Not Enough for Reimbursement by Insurers and health Plans, ERISA Controls and Regulates Final Reimbursement;

 

When F.D.A. Says Yes, but Health Insurers Say No to Medical Devices (The New York Times; one-time registration required)

 

Excerpt: "Medical device makers devote years and millions of dollars to winning regulatory approval for new products. But all that work does not necessarily produce the kind of data that persuades insurers to pay for the products once they hit the market."

 

New back procedure a sore spot for insurers: Some patients denied coverage for devices fresh on the market (FLORIDA TODAY, October 11, 2005)

 

"According to industry officials, other sources. Federal approval constitutes only a first step in payment-coverage decisions, they said.

 

"In and of itself, it's not sufficient," said Dr. Walter Hollinger, Blue Cross & Blue Shield of Florida's senior medical director."

Getting an FDA approval for medical device makers for their new medical devices is the beginning instead of final step of reimbursement for their medical device related medical claims, after millions of dollars and years of time in research, clinical trials and final FDA approval. Due to national health care crisis and critics claim that new technology is the core driver of rising health-care costs, insurers and health care plans are increasingly scrutinizing new technologies and resisting rapid adaptation of new technologies with significant costs to the plan.

 

While medical device makers assert that new technology will eventually save health-care dollars in long-run, health insurers and plans certainly do not feel the same way when they have to pay the claims right now. Health-care providers and consumers are caught in between. Plan sponsors and employers do not know who to believe.

 

So who is right?

 

That is a very expensive question, because if you are right, you get paid as providers and device makers, or do not have to pay as health plans; if you are wrong, you're in trouble. Bottom line is if it costs nothing, no one cares who's right or wrong, if it costs anything, it's important to find out as early as possible and as much as possible on how to be on the right side instead of wrong side.

 

Medical device makers and health-care providers thought an FDA approval is good enough for the burden of proof, the health insurers and plans insisted on that's not quite yet, FDA approval is useless if ERISA disapproves it.

 

 

II. An Unanimous US Supreme Court: Regardless of FDA approval, ERISA controls and regulates reimbursement.

 

FDA for reimbursement? Not Quite Yet, What Does the Unanimous US Supreme Court Say?

 

On June 21, 2004, an unanimous US Supreme Court ruled that claim processing and denials of benefits under the employer-sponsored health plans, ERISA-regulated benefit plans, for both self-insured and fully-insured (through purchase of insurance) health plans, are completely governed by federal law ERISA, that supersedes and invalidates state laws.

 

ERISAclaim.com: "employer-sponsored group health plans" = ERISA-"regulated benefit plans", both self-insured and fully-insured (through purchase of insurance) health plans, (ERISA - Title 29, Chapter 18.  Sec. 1002.)

 

 

ERISAclaim.com - Supreme Court Managed Care ERISA Watch

 

An Unanimous U.S. Supreme Court Ruling in

Managed Care and Medical Malpractice

 

Aetna Health Inc. v. Davila

06/21/04

Opinion of the Court

 

"Held: Respondents’ state causes of action fall within ERISA§502(a)(1)(B), and are therefore completely pre-empted by ERISA §502 and removable to federal court. Pp. 4–20."

 

"We hold that respondents’ causes of action, brought to remedy only the denial of benefits under ERISA-regulated benefit plans, fall within the scope of, and are completely pre-empted by, ERISA §502(a)(1)(B), and thus removable to federal district court. The judgment of the Court of Appeals is reversed, and the cases are remanded for further proceedings consistent with this opinion.7 It is so ordered."

 

 

III. Federal Court Of Appeals:

No Other Way around ERISA, Regardless How Artfully and Creatively in Patient Lawsuit, ERISA Preempts All State Laws If You Want Money from ERISA Plans.

CLEGHORN V BLUE SHIELD OF CALIFORNIA

 

9th Cir., 05/23/2005

 

OPINION

CANBY, Circuit Judge:


"We are presented once again with a question concerning the degree to which the federal Employee Retirement Income Security Act (ERISA) preempts state law. Douglas D. Cleghorn is a participant in his employers ERISA health plan offered by Blue Shield of California (doing business as Care-America) (Blue Shield). On one occasion he sought and received emergency medical services and Blue Shield denied reimbursement. Cleghorn sued Blue Shield in California state court, asserting state-law causes of action and alleging that Blue Shield had violated an emergency care provision in section 1371.4(c) of the California Health and Safety Code. Blue Shield removed the case to federal court and the district court held that Cleghorns claims were preempted by ERISA. When Cleghorn declined to amend his complaint to allege an ERISA claim, the district court dismissed his complaint for failure to state a claim. We affirm the judgment of the district court."

 

IV. Newly FDA Approved Medical Device Will Be Denied under ERISA Regardless of FDA Approval

 

When F.D.A. Says Yes, but Health Insurers Say No to Medical Devices (The New York Times; one-time registration required)

 

Excerpt: "Medical device makers devote years and millions of dollars to winning regulatory approval for new products. But all that work does not necessarily produce the kind of data that persuades insurers to pay for the products once they hit the market."

In general, a health-care plan may deny a claim involving new medical device, either based on specific policy exclusion of experimental and investigational status of the medical device or lack of medical necessity.

 

When F.D.A. Says Yes, but Health Insurers Say No to Medical Devices (The New York Times; one-time registration required)

 

"Charité needs to show substantial improvement in the patients' quality of life and clinical outcomes," said Michael Chee, a spokesman for Blue Cross Blue Shield of California, a unit of WellPoint that is one of many large Blue Cross insurers that has denied coverage for Charité.

If a plan denies a claim based on policy specific exclusion or investigational and experimental exclusion, the plan bears burden of proof, to establish that specifically the relevant plan provision has particularly identified such medical device as noncovered, or FDA has not classified such device for general medical use. If this is the case, claim dispute is determined solely based on policy exclusion and FDA classification of medical device at issue, regardless of clinical outcome or medical merits of the case, because the policy, the plan provision has specific limitation or exclusion regardless of each individual case scenario

 

In policy exclusion or specific limitation denial, the relevant plan provision is controlling document, any external, outside or unofficial document may not be acceptable by a court under ERISA.

 

In a medical necessity denial involving specific medical condition and medical device, ERISA requires the plan administrator to consult with an appropriate health care professional, to make individual and specific medical necessity determination based on specific fact he driven analysis and sounding medical guidelines, in compliance with state laws in utilization review, or if applicable, external review. More specifics from ERISA regulation will be discussed in the next section and relevant pages of ERISAclaim.com.

 

 

Schneider, Janet M. v. Sentry Group

7th Cir. 09/07/2005

 

Oral Argument

Opinion

 

"The notice that Sentry afforded Ms. Schneider was indefensible as a matter of statute, regulation and case law."


Claim Denial Found Arbitrary and Capricious for Utterly Failing to Consider Plan Language (EBIA)

 

Wheeler v Aetna

MEMORANDUM OPINION
 

ERISAclaim.com Comments:

 

  1. Faulty Denial Notice:

    Initial Denial Notice/EOB from an ERISA plan by an insurer, Aetna in this case, must refer to specific and actual plan provisions (Summary Plan Description, SPD), instead of Aetna online "Coverage Policy Bulletin" on the web site, to include specific reasons for claims denials, "rational connection between the issue to be decided, the evidence in the case, the text under consideration, and the conclusion reached".

      In this case, a court found that Aetna's initial denial and subsequent two level appeals inadequate because “they utterly fail to consider the actual language to the plan at issue", "largely fail to connect Aetna's denial benefits to the specific situation and Bryce’s diagnoses. And Aetna's is cursory and simply states that claim/therapy is not covered without explaining why.
     

  2. "Necessary" and "Appropriate" Treatment Must Be Individually and Actually Determined:

     After reviewing the plan's definitions of "necessary" and "appropriate" treatment from the Summary Plan Description, the Court concludes:

     “It  is   clear   from  the   terms  of  the  plan   that  the necessary/appropriate determination will involve an individualized determination,  considering the particular circumstances,   medical condition,  and  health   condition, of the  possible outcome  of  a certain  treatment  relative  to alternative  treatments.   No such determination was made here with respect to Bryce.   Aetna does not state that the sensory integration therapy was not as  likely to produce a significant positive outcome as and no more likely to produce a negative outcome than any alternative    treatments,  nor does  Aetna  state  what the  possible  alternative treatments  are. Moreover,  there  was no  individualized determination of what  was necessary or appropriate treatment in light of Bryce's particular situation.    instead,  Aetna  refers   (in its briefs,  not  in its letters to the Wheelers)   to its "Coverage Policy Bulletin," which states that Aetna will not cover sensory integration therapy.
     

  3. Summary Plan Description (SPD), instead of Online "Coverage Policy Bulletin", Controls Coverage and Exclusion, Necessary and Appropriate Definitions:

     The court finds that the specific and actual plan's language must be referenced in benefits determination and be included in initial claim denial notice/EOB (Explanation of Benefits) instead of "Coverage Policy Bulletin" referenced and referred on Aetna's web site, which is a popular practice by Aetna and more and more health insurers, in the course of settling physician class actions and "compliance with" ERISA claim regulation.  SPD supersedes and invalidate any other "Coverage Policy Bulletin" and other company policy and internal guidelines if they are conflicted with the individual plan's SPD (Summary Plan Description).

 

"No ERISA Appeals, No Science"

 

JO ORTLIEB v UNITED HEALTHCARE

8th Cir., 10/28

 

"....Thereafter, Ortlieb contested the denial of coverage by filing her case in the district court. The district court reviewed the benefit determination using an arbitrary and capricious standard of review. In opposing United HealthCare’s motion for summary judgment, Ortlieb submitted four technical documents discussing TPN, none of which were included in the administrative record. The district court declined to consider the new evidence. Based on the administrative record, the district court determined United HealthCare reasonably relied on the assessments of multiple doctors that TPN was an unproven therapy for Ortlieb’s medical conditions. The district court rejected Ortlieb’s argument that United HealthCare had failed to consider the “life-threatening condition” exception to the unproven service exclusion. The court granted summary judgment in favor of United HealthCare. Ortlieb now appeals......"

 

ERISAclaim.com Comment:

 

         "No ERISA Appeals, No Science"

 

If healthcare providers didn't appeal under ERISA in a timely fasion, the federal court may not consider these new evidence at trial, even they could truly scientifically persvasive, as they are not considered as these new scientic eveidence are not part of administrative records the court will exam under ERISA.

 

Timely ERISA appeal is more important than "true science" under ERISA, as federal law and rules are also important things to follow.

 

This will help all of us here in recent denials crisis.


 

Krodel v. Bayer Corporation

(10/12/2005, D. Mass.)

 

Page 17 of 20

"Here, the Court holds only that where 1) a participant applies for coverage of a benefit which 2) is apparently covered under the language of an SPD and 3) the plan administrator thereafter re-interprets it in a more restrictive fashion and denies coverage 4) in contravention of the conclusions of all of the medical experts involved, that decision is arbitrary and capricious. The decision of the Plan Administrator will be reversed."

 

 


 

 

Krodel v. Bayer Corporation

(11/19/2004, D. Mass.)

 

Self-Insured Employer Simply Rubber Stamped the Decision of CIGNA and Violated New ERISA Claim Regulations

 

Bayer’s Denial of Dr. Krodel’s Claim

 

"1. Bayer violated ERISA by failing to "afford a reasonable opportunity to any participant whose claim for benefits has been denied for a full and fair review by the appropriate named fiduciary of the decision denying the claim." 29 U.S.C. §1133(2); 29 C.F.R. § 2560.503-1(h)(1). Under that provision, a plan administrator is required to provide a review that "does not afford deference to the initial adverse benefit determination".29 C.F.R. § 2560.503-1(h)(3)(ii)."

 

"2. Bayer also violated 29 C.F.R. § 2560.503-1(h)(3)(iii) which provides that:

In deciding an appeal of any adverse benefit determination that is based in whole or in part on a medical judgment, including determinations with regard to whether a particular treatment, drug, or other item is . . . medically necessary or appropriate, the appropriate named fiduciary shall consult with a health care professional who has appropriate training and experience in the field of medicine involved the medical judgment. Id. § 2560.503-1(h)(3)(iii) (emphasis added).

As far as the record shows, Defendants failed to seek any medical advice in making their determination with respect to Dr. Krodel’s claim. Thus, a clear violation of the regulation occurred.

 

"3. Upon notifying Dr. Krodel of the denial of his claim, Bayer violated 29 C.F.R. § 2560.503-1(g)(1)(v)(A) which provides that, if a specific internal rule is relied on in making a determination, that rule must be provided or a statement made that it will be made available to the claimant free of charge. Id. § 2560.503-1(g)(1)(v)(A)."

 

"4. Bayer also violated 29 C.F.R. § 2560.503-1(g)(1)(v)(B), which states that:

If the adverse benefit determination is based on a medical necessity . . . either an explanation of the scientific or clinical judgment for the determination, applying the terms of the plan to the claimant’s medical circumstances, or a statement that such explanation will be provided free of charge upon request [will be provided to the claimant]. Id. § 2560.503-1(g)(1)(v)(B).

 

"5. Finally, Bayer violated its own internal rule by failing to inform Dr. Krodel that he might qualify for a different prosthesis."

 

"Second, Plaintiff contends that he is entitled to statutory penalties of approximately $40,000 (i.e. up to $100 per day for 400 days) based upon Defendants’ alleged failure to provide information to Dr. Krodel as required by ERISA. See 29 U.S.C. §1132(c). Specifically, Dr. Krodel alleges that the non-provision of the SOP constituted such a failure. His argument has merit because the SOP contained the underlying basis for his exclusion from coverage."

 

Therefore, it is extremely important for medical device makers and health-care providers to distinguish pure policy exclusion from medical necessity denials, and to understand appropriate actions and steps to be taken to prevail benefits claims under ERISA, the federal governing Law for your reimbursement from any employer-sponsored health-care plans.

 

FDA approval is only the beginning of medical device marketing, ERISA claims practice is the real challenging steps for medical device claims to be reimbursed legitimately under federal laws and specific health plan provisions.

 

V. ERISA Provides Specific Protections for Medical Claim Denials and Appeals

 

What You Should Know about Filing Your Health Benefits Claim

New Federal Claim Regulation, effective January 1, 2003, is the best and the most powerful protection for improper medical necessity denials:

 

  1. "Plans must consult with appropriate health care professionals in deciding appealed claims involving medical judgment." [70268-70269, CFR § 2560.503-1(h)(3)(iii)]

  2. "The term `health care professional' means a physician or other health care professional licensed, accredited, or certified to perform specified health services consistent with State law." [page 70271 CFR § 2560.503-1(m)(7)]  

  3. A Full and Fair Review with new definitions and protection requires De Dovo reviews on two appeals by at least four (4) different people, two (2) different fiduciaries with ERISA plan, and two (2) different Health-care professionals independent to the ERISA plan. [Page 70252-70253, 70268-70269, CFR § 2560.503-1(h)(3)]

  4. Plan must disclose all the "secrets" under new definitions of relevant documents with better disclosure obligations, no more medical necessity secrets, UCR fee schedules are no longer confidential. [Page 70252 & 70271, CFR § 2560.503-1(m)(8)  (DOL FAQ B-5, C17)]

 

 

 

VI. No ERISA Appeals, No Acceptance of Scientific Papers and FDA Approvals

 

When F.D.A. Says Yes, but Health Insurers Say No to Medical Devices (The New York Times; one-time registration required)

 

"Charité needs to show substantial improvement in the patients' quality of life and clinical outcomes," said Michael Chee, a spokesman for Blue Cross Blue Shield of California, a unit of WellPoint that is one of many large Blue Cross insurers that has denied coverage for Charité."

 

"Johnson is hoping to gain more support after the publication on July 15 of two articles on the F.D.A. trial data in Spine, a peer-reviewed medical journal. "We expect that will lead to a new round of policy reviews," said John Argiro, director of reimbursement for DePuy Spine, the Johnson subsidiary that makes the disk."

If healthcare providers fail to appeal under ERISA in a timely fashion, the federal court may not consider these new evidence at trial, as medical device makers have hoped, even if they could be truly scientifically pervasive, as ERISA judicial review standards will generally only allow a court to review administrative records developed through appeals, and preclude these peer-reviewed articles not submitted by ERISA appeals from being introduced as a part of administrative records that a court will exam under ERISA.

 

Timely ERISA appeal is more important than "true science" under ERISA, as federal law and rules are also important things to follow, as prerequisites of any of the scientific evidence, that would support medical necessity for these new medical devices.

 

JO ORTLIEB v UNITED HEALTHCARE

 

8th Cir., 10/28/2004 

"....Thereafter, Ortlieb contested the denial of coverage by filing her case in the district court. The district court reviewed the benefit determination using an arbitrary and capricious standard of review. In opposing United HealthCares motion for summary judgment, Ortlieb submitted four technical documents discussing TPN, none of which were included in the administrative record. The district court declined to consider the new evidence. Based on the administrative record, the district court determined United HealthCare reasonably relied on the assessments of multiple doctors that TPN was an unproven therapy for Ortliebs medical conditions. The district court rejected Ortliebs argument that United HealthCare had failed to consider the life-threatening condition exception to the unproven service exclusion. The court granted summary judgment in favor of United HealthCare. Ortlieb now appeals......"

And there is no other way around ERISA if any one is expected to get paid by an employer sponsored health plan, regardless of its shape, HMO, POS, PPO & P4P: CLEGHORN V BLUE SHIELD OF CALIFORNIA  and Aetna Health Inc. v. Davila, in accordance with unanimous US Supreme Court ruling.

 

VII. ERISA Pre-Service Claim Regulation Provides The Best Protections for Any Claims with Requirement of Pre-Certifications, Prior-Authorizations or Any Prior-Approvals

When F.D.A. Says Yes, but Health Insurers Say No to Medical Devices (The New York Times; one-time registration required)

 

Excerpt: Eight months later, though, most private insurers still refuse to cover the cost of the procedure, which is generally $30,000 to $45,000 for a single disk. And while Medicare does provide some coverage, its reimbursement level for hospitals is far less than the cost of the disk, which Johnson lists at $11,500 but sells at discounts of as much as 20 percent to its high-volume customers.

 

""About 80 percent of my patients who could be candidates for the disk aren't covered for it by their insurance," said Dr. Scott G. Tromanhauser of the Boston Spine Group."

ERISA Claims Procedure.§2560.503-1(m)(2)

"(2) The term “pre-service claim” means any claim for a benefit under a group health plan with respect to which the terms of the plan condition receipt of the benefit, in whole or in part, on approval of the benefit in advance of obtaining medical care."

Benefit Claims Procedure Regulation

DOL > EBSA > Frequently Asked Question

"A-3: Does the regulation apply to a request for a determination whether an individual is eligible for coverage under a plan?

 

The regulation applies to coverage determinations only if they are part of a claim for benefits. The regulation, at § 2560.503-1(e), defines a claim for benefits, in part, as a request for a plan benefit or benefits made by a claimant in accordance with a plan’s reasonable procedure for filing benefit claims. A claim for group health benefits includes pre-service claims (§ 2560.503-1(m)(2)) and post-service claims (§ 2560.503-1(m)(3)). If an individual asks a question concerning eligibility for coverage under a plan without making a claim for benefits, the eligibility determination is not governed by the claims procedure rules. If, on the other hand, the individual files a claim for benefits in accordance with the plan’s reasonable procedures, and that claim is denied because the individual is not eligible for coverage under the plan, the coverage determination is part of a claim and must be handled in accordance with the claims procedures of the plan and the requirements of the regulation. See 65 FR at 70255."

Therefore, if a surgery, such as with Charité disk, is required by the plan to obtain a prior-approval, and such request is denied, the patient and doctor can appeal the denial even if the surgery was never performed yet, because it is a pre-service claim under ERISA, ("no money-down appeal", as Dr, Zhou calls it). A pre-service claim under ERISA is also entitled to "ERISA Prompt Pay" protections.
 

ERISA “Prompt Pay” Time Limits

 © 2003 - 2004  Jin Zhou, ERISAclaim.com

 


ERISA §2560.503-1

Claims Procedure

 

New Rules
 Effective on 01/01/2003 for all ERISA plans

  self-insured and fully-insured, §2560.503-1(a)

Old Rules

Urgent Care Claim

Preservice Claim

Post-Service Claim

Disability Claims

ERISA Claims

Claim Beginning Time

Beginning at a Time a Claim Is Filed, Regardless of Clean Claim or Not, In Accordance With Plan Procedures, § 2560.503-1(f)(4)

Decision Maximal Time Limits

In No Event Exceeding 90 Days Period, §2560.503-1(f)

< 180 days

"Not Clean" Notification Time

24 hours

5 days

N/A

N/A

N/A

Claimant Claim Cleanup Time

48 hours

45 days

45 days

45 days

N/A

Plan Initial Determination

ASAP,
<48 hours (clean claim)
< 72 hours (cleaned up claims)

 

15 days

30 days

45 days

90 days

 

Claimant Appeal Deadline

180 days

180 days

180 days

180 days

60 days

Plan 1st Level Appeal Response Time


72 hours

15 days

30 days

45 days

60 days

Plan 2nd-Level Appeal Response Time

15 days

30 days

90 days

120 days with extensions

Plan Extension Time

48 hours

15 days

15 days

75 days

120 days

Review/Appeal Maximal Limit

72 hours

30 days (one Appeal)

15 days (two appeals)

30 days (two appeals)
60 days (one Appeal)

105 days

180 days

Initial Determination/EOB by:


"The Plan Administrator", § 2560.503-1(g)

Appeal Delay & Denial to:

"An Appropriate Named Fiduciary of the Plan", § 2560.503-1(h)

Review/Appeal Decision by:

"The Plan Administrator", § 2560.503-1(j)

 

VIII. ERISA Compliance/Approval must be integral and final step of any FDA approved medical device for medical device makers and health-care providers.

After millions were spent by medical device makers for research, clinical trial and FDA approval, market share and earnings for the new devices will be surprisingly disappointing to health-care providers, their patients and investors if increasing claim denials for new technology, even FDA approved are not appealed or effectively appealed.
 

Medical device makers must include ERISA claim compliance and appeals in their standard marketing programs to health-care providers in order for their patients to receive benefits reimbursement that each patient is legally entitled to under federal law and specific benefits plan provisions.


 

IV. Medical Necessity for The Federal Employees Health Benefit Plan (FEHBP)

 

Under5 U.S.C. § 8901, the Federal Employees Health Benefit Plan (FEHBP) provides health care coverage to more than nine million Federal employees and their dependents. The U.S. Office of Personnel Management (OPM) is enforcement Federal agency for administration of benefits claims, but OPM contracts with health plans to serve Federal employees, administers the FEHBP.

 

There is no specific definition for "medical necessity" or medical necessity review standards for both initial and administrative appeal process in both federal statute and administrative regulations, except for "FEHB Plan Brochures" drafted by health plans or insurers but published by OPM.

 

Federal Employees Health Benefit Plan does offer appeal process similar to ERISA appeal process although ERISA regulation does not directly regulate federal employee benefit plans.

 

OPM does retain level to appeal jurisdiction but delegates discretionary authority to each individual health plan contractor.

 

Most health-care plan contractors voluntarily adopt ERISA claim regulation and state law regulated utilization review and ex-con review programs even though neither ERISA or state law directly apply to the federal employee health pogrom.

 

After exhausting to levels of appeal with OPM, and a claimant may commence lawsuit only in federal court and against OPM, Federal Government, instead of health plan and its contractors for a possible recovery similar to ERISA remedies, no punitive damage.

 

For OPM appeal process and each individual plan brochures, the following hyperlinks will be extremely authoritative and helpful, especially each individual plans appeal process and OPM second-level appeal guidelines.

 

 

 

For better understanding of relevant federal law on medical necessities, the following information from HHS web site will be extremely helpful:

 

Medical Necessity in Private Health Plans

Sara Rosenbaum
Brian Kamoie
D. Richard Mauery
Brian Walitt

U.S. Department of Health and Human Services
Substance Abuse and Mental Health Services Administration
Center for Mental Health Services

 

View the PDF version

Table of Contents
  Acknowledgments
I. Executive Summary
II. Introduction
  Research Methods
  Structure and Organization of the Review
III. Medical Necessity and the Published Literature
IV. Industry Practices in the Managed Care Industry
  Analysis of the Structure of Medical Necessity Definitions
  Interviews With Managed Care Officials on the Processes of Medical Necessity Determinations
  Managed Care Accreditation Organizations
  Judicial Case Law, Official Investigations, and Legal Actions
  Judicial Case Law
  Investigations and Official Legal Actions
     New York
     Maine
     Connecticut
V. State Law Regulation of Medical Necessity
  Laws That Regulate the Content of Insurance Contracts
  Independent Review Statutes
VI. Relevant Federal Laws Pertaining to Medical Necessity Reviews
  ERISA
  Office of Personnel Management Standards: FEHBP
VII. Synthesis and Implications
VIII. References
IX. Endnotes
Figures
Figure 1: The Five Dimensions of the Medical Necessity Definition: Industry Practice
Figure 2: NCQA and JCAHO Utilization Management Standards
Figure 3: NCQA and JCAHO External Appeals Standards
Figure 4: Common Procedural Problems in Medical Necessity Determination Processes Noted in Investigations, Litigation, and Case Law
Figure 5: Medical Necessity Utilization Review and Appeals Procedures
Tables
Table 1. Medical Necessity Definitions in Published Literature (See Also Appendix C)
Table 2. Medical Necessity Definitions: Managed Care Industry
Table 3. Medical Necessity Definitions Identified in Case Law (Sorted by Case Name)
Table 4. Medical Necessity Definitions Contained in State Statutes and Regulations
Table 5. State Independent Review Statutes and Regulations
Table 6. Medical Necessity Definitions: State Insurance Laws and IRO Statutes
Table 7. State Independent Review Statutes With Specific Behavioral Health Provisions
Table 8. Qualifications of External Reviewer in State IRO Statutes
Table 9. Independent Reviews: Standard of Review for Medical Necessity Determinations
Appendixes
Appendix A. Selected Published Literature on Medical Necessity (Sorted by Year)
Appendix B. NCQA and JCAHO Utilization Management and External Appeals Standards
Appendix C. Litigation Regarding Medical Necessity Definitions and Procedures (Sorted by Case Name)
Appendix D. State Investigations and Legal Actions Regarding Medical Necessity Issues

SMA03-3790
07/2003

 

VI: Relevant Federal Laws Pertaining to Medical Necessity Reviews

 

"Relevant Federal Laws Pertaining to Medical Necessity Reviews

This part considers two sources of law relevant to medical necessity determinations. First, two sets of Federal standards governing employee health plans are examined. The first set of standards is embodied in the regulations promulgated by the Department of Labor in 2000 that set forth the "full and fair review" procedural requirements that all ERISA health benefit plans must meet. The second set is embodied in the standards governing medical necessity reviews that are currently in use by the U.S. Office of Personnel Management."

ERISA

"The ERISA statute regulates health and welfare benefits for more than 140 million workers and their families (Rosenbaum, Frankford, Moore, & Borzi, 1999). ERISA requires every health benefit plan within its scope to provide adequate notice in writing to a participant when a claim is denied, "setting forth the specific reasons for such denial, written in a manner calculated to be understood by the participant."29 In addition, ERISA affords a health plan member whose claim has been denied a "reasonable opportunity . . . for a full and fair review by the appropriate named fiduciary of the decision denying the claim."

....

 

With disclosure of protocols and explanations of the application of medical necessity, the Federal full and fair review regulations exceed the reach of State utilization and independent review statutes and regulations."

 

Office of Personnel Management Standards: FEHBP

 

"......Although the ERISA full and fair hearing regulations and the FEHBP provide further procedural safeguards to health plan enrollees, both have important limitations. The ERISA regulations do not contain a right to an external appeal, despite providing important additional access to information and better claims procedures not previously available. The FEHBP, limited to Federal employees, provides a right to appeal outside the health plan to the OPM or to Federal court if necessary, but, as with ERISA plans, monetary damages are limited to payment for the cost of the denied benefit itself (i.e., punitive and "pain and suffering" damages are not available).

 

As a result of the modest reach of Federal law, the definition of medical necessity is still governed by the terms of the contract negotiated between buyers and sellers."

 

"Figure 5 presents the key elements of medical necessity review and compares ERISA procedures with those established by OPM.

Medical Necessity in Private Health Plans

Figure 5: Medical Necessity Utilization Review and Appeals Procedures

Issue ERISA FEHBP
Standards for initial utilization review process X  
Standards for internal appeals of initial denials X  
Timelines X X
Qualifications of reviewer X  
De novo review X  
Evidentiary standards X  
Access by claimant to health plan evidence X  
Treatment guidelines X  
Definition of medical necessity    
External de novo administrative review of health plan decision    

Table of Contents | Previous | Next

 

Executive Summary

"Medical Necessity in Private Health Plans

Executive Summary

This report addresses how the term "medical necessity" is defined in private health insurance coverage decisions. It summarizes a review of the literature, an extensive review of legal cases that challenge insurer decisions, materials prepared by the insurance industry, consultation with experts in the field, a review of investigations conducted by State departments of insurance and attorneys general, and interviews with health care executives regarding the decisionmaking process itself. The report does not explore factors that can affect access to care that might be considered clinically necessary by treating professionals or the effects of medical necessity decisions on therapeutic outcomes.

 

Sources of medical necessity definition: Few regulations address the definition of medical necessity. There is no Federal definition, and only slightly more than one-third of States have any regulatory definition of medical necessity. As a result, the meaning of "medical necessity" is most commonly found in individual insurance contracts that are defined by the insurer and hold primacy in most determinations.

 

Rather than turning simply on whether a proposed treatment meets professional medical standards, the prevailing definition of medical necessity is broadly framed, multidimensional, and controlled by the insurer, not the treating professional. The process of medical necessity determination is rarely public information. Even where a claimant can show that a clinical recommendation is consistent with professional clinical standards, the insurer may reject a proposed treatment if it is inconsistent with other definitional elements such as relative cost and efficiency.

 

The multiple dimensions of the prevailing medical necessity definition: The evidence suggests that the medical necessity definition spans five dimensions:

 

  1. Contractual scope-whether the contract provides any coverage for certain procedures and treatments, such as preventive and maintenance treatments that are not necessary to restore a patient to "normal functioning." This dimension preempts any other coverage decision.
  2. Standards of practice-whether the treatment accords with professional standards of practice.
  3. Patient safety and setting-whether the treatment will be delivered in the safest and least intrusive manner.
  4. Medical service-whether the treatment is considered medical as opposed to social or nonmedical.
  5. Cost-whether the treatment is considered cost-effective by the insurer.

 

Regulation of the medical necessity definition and coverage determination process: Some State external review laws provide appeals procedures that permit reviewers to reject the insurer's medical necessity definition and look at the evidence with a fresh eye. However, many State laws parallel insurers' multidimensional definitional approach. It does not appear that either the State or Federal regulatory process has moved away from the industry's prevailing medical necessity standard."

 

Table of Contents | Previous | Next



Traditional "squeaky wheel" approach by medical device makers are insufficient and practically flawed under new health-care crisis, partially blamed by critics on new technology costs.

 

We offer educational assistant programs to medical device makers and health-care providers on strategy, prevention of denials, and how to effectively use and comply with ERISA claim regulation to achieve maximum reimbursement for what their patients are legally entitled to in accordance with applicable Federal ERISA law, state utilization review and external review laws.

 

 

X. ERISA For Medical Device Makers Power Guides

(Purified Verion)

(Copyright © 2005 by Jin Zhou,  ERISAclaim.com)

ERISAclaim.com - ERISA, Who?

 

ERISAclaim.com - ERISA 1-2-3

 

ERISAclaim.com: Appeals  for Commonly Seen
Medical Claim Denials

with Superpower from Federal & State Laws

 

ERISAclaim.com - New! On-site Programs for ERISA & New CMS/Medicare Compliance

 

ERISAclaim.com - HSA &/Or  ERISA? 95% of HSA Are Still ERISA's!

 

ERISAclaim.com - CMS New Appeal Rules: "Overhaul of the Medicare Claims Appeals System"

 

ERISAclaim.com: ERISA Demystified for
Providers, Insurers, TPAs, Patients,
Regulators and Legislators

 

ERISAclaim.com: What's New? You Must Comply with
New Federal Claim Regulations!

 

ERISAclaim.com - Managed Care Court Watch -
Superpower & Protections for Physicians

 

ERISAclaim.com - 950,000 MD's Settled
With Aetna & Cigna on ERISA

 

ERISAclaim.com: Prompt Pay Crisis & ERISA Solutions

 

ERISAclaim.com: How to Appeal
Downcoding & Bundling Claim Denials

 

ERISAclaim.com - "Overpayment" Refund Request
& Recoupment Response & Appeals

 

ERISAclaim.com:  ERISA Certification Programs for
Cost-Saving & Reimbursement by Compliance

 

 

ERISAclaim.com: 50% Savings - Healthcare Crisis Turnaround
for Employers, Insurers & TPA's

 

 

 

 

 

 

DOL Compliance Assistance for Health Plans

 

 

 

 

 

ERISA Not Insurance

Aetna Video Shows ERISA Patients Mistreated

 

"According to the video, when faced with claims for identical medical problems, Aetna separates the claims where no damages are available - those subject to the federal Employee Retirement Income Security Act, or ERISA - from non-ERISA claims, where consumers can sue.1 2"

 

Aetna ERISA Settlemnt with 950,000 MD's

 

 
No ERISA Preemption of BOME Regulation of Medical Decisionmaking ...
Murphy v. Board of Medical Examiners, 949 P.2d 530, 190 Ariz. 441, 247 Ariz. Adv. Rep. 35 (Ariz.App.Div.1 07/15/1997)

 (Edward P. Richards, III, J.D., M.P.H.)

 

"Although Dr. Murphy is not engaged in the traditional practice of medicine, to the extent that he renders medical decisions his conduct is reviewable by BOMEX. Here, Dr. Murphy evaluated information provided by both the patient's primary physician and her surgeon. He disagreed with their decision that gallbladder surgery would alleviate her ongoing symptoms. S.B.'s doctors diagnosed a medical condition and proposed a non-experimental course of treatment. Dr. Murphy substituted his medical judgment for theirs and determined that the surgery was "not medically necessary." There is no other way to characterize Dr. Murphy's decision: it was a "medical" decision."

 

"We affirm the trial court's ruling that BOMEX has jurisdiction to review medical decisions which could affect the health or safety of a patient or the public, including decisions Dr. Murphy renders as medical director for Blue Cross. ...."

 

Law Professor Looks at Criminal Prosecution for HMO Treatment Denial (Prof. John A. Humbach published by the Health Administration Responsibility Project (harp.org))

 

 

Rolando Villazon, etc., v. Prudential Health Care Plan Inc.,

AMNews: May 5, 2003. HMOs liable for actions of their network doctors
Health plans control aspects of physician care and should be held accountable, the Florida high court says.

 

 

Agree to terms and conditions

"Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's benefit plan to determine if there are any exclusions or other benefit limitations applicable to this service or supply."

 

CIGNA - Coverage Positions/Criteria
"The terms of a participant's particular benefit plan document [Group Service Agreement (GSA), Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Positions are based. If these Coverage Positions are inconsistent with the terms of the member's specific benefit plan, then the terms of the member's specific benefit plan always control."

 

UnitedHealthcare Medical Policies

"By clicking "I agree," you agree to be bound by the terms and conditions expressed below, in addition to our Site Use Agreement.

UnitedHealthcare medical policies have been made available to you as a general reference resource. When reading these policies you agree that:

Our Medical Policy is not your patient's Benefit Plan.

Your patient's medical benefits are governed and determined by a benefit document, either a Certificate of Coverage or a Summary Plan Description. You should not rely on the information contained in this Web site section to determine your patient's medical benefits.
 

  1. Federal and state mandates and the patient’s benefit document take precedence over these policies.

  2. The patient’s benefit document lists the specific services that have coverage limits or exclusions.


Our Medical Policy does not address every situation and individuals should always consult their physician before making any decisions on medical care."


Medical Necessity: The Gateway to Meaningful Health Care Access (Rosenfeld & Rafik)

 

The Independent Medical Review Program (insurance.ca.gov)

 

Department of Labor

 
"A group health plan is an employee welfare benefit plan established or maintained by an employer or by an employee organization (such as a union), or both, that provides medical care for participants or their dependents directly or through insurance, reimbursement, or otherwise.

Most private sector health plans are covered by the

 Employee Retirement Income Security Act (ERISA). Among other things, ERISA provides protections for participants and beneficiaries in employee benefit plans (participant rights), including providing access to plan information. Also, those individuals who manage plans (and other fiduciaries) must meet certain standards of conduct under the fiduciary responsibilities specified in the law."

 

 

UCR

Usual, Customary and Reasonable Charges

FALLICK v NATIONWIDE MUTL INS

 

Usual Customary and Reasonable claim denial is almost usual and customary but unreasonable denial for a physician's practice every day in industry.

 

'Investigational' Treatments See Cutbacks By Health Insurance Plans (The Kansas City Star via The Foundation for Taxpayer & Consumer Rights)

 

Silent PPO Discount

 

$10,600 ERISA Claim

Recent Federal Court Ruling in a Case with $10,600 medical claim, insurance Co. refused to pay, provider made numerous demand for payment in almost one year, but no appeals filed, the court dismissed the lawsuit because provider failed to exhaust administrative remedy, as required under ERISA, by filing ERISAclaim appeals.  This situation is so popular in health-care community.

 

 

$37,350 ERISA Claim

Health-care provider alleged medical claims submitted to Aetna for reimbursement, Aetna asserted no receipt of medical claims, no written denials.  Health-care provider failed to present proof of claim submission, claim denial and ERISA claim appeals. This case was dismissed. ERISA health-care claims are handled in federal court, state law is generally not applicable.

 

 

 

 

External Review

Patients' Rights: External Review 2000,50 State Comparisons:

 

New Survey: State External Review Programs (Henry J. Kaiser Family Foundation)

 

Prompt Payment

 

Rights Bills

 

$400,00 Fine

Georgia fines Humana again for slow claims payments (insure.com)

   Excerpt: "Georgia has fined Humana Employers Health Care of Georgia   Inc. $400,000 for violating the state's prompt pay law, the second time in as many years that the HMO has been fined for dragging its feet on paying claims." (insure.com)

 

Health Insurance Laws & Benefits Tools from INSURE.com

 

NAIC News Release

 

ERISA Laws/Rules

ERISA in the United States Code: Cross-reference table, table of contents

 

ERISA in US CODE

 

 

 

Peer Review

 

 

Independent Medical Review Experiences in California (California HealthCare Foundation)

 

 

 

 

 

 

 

Office for Civil Rights - HIPAA

OCR Guidance Explaining Significant Aspects of the Privacy Rule- December 4, 2002

 

 

Statutes (United States Code) 
ERISA - Title 29, Chapter 18. 

        Selected links:

Sec. 1002.
Definitions

Sec. 1003.
Coverage

Sec. 1022.
Summary plan description
Sec. 1104.
Fiduciary duties

Sec. 1140.
Interference with protected rights

Sec. 1141.
Coercive interference

part 7
group health plan requirements

 

 

Code of Federal Regulations

Codified in Title 29 of the Code of Federal Regulations:

Regulations

        Selected links:

2520.102-3 Contents of summary plan description.
2560.503-1 

Claims procedure.

 

 

 

 

 

 

 

AMA (PSA)

 

U.S. Department of Health and Human Services

Medical Necessity in Private Health Plans

Sara Rosenbaum
Brian Kamoie
D. Richard Mauery
Brian Walitt


U.S. Department of Health and Human Services
Substance Abuse and Mental Health Services Administration


Center for Mental Health Services

 

View the PDF version
You will need Adobe Acrobat Reader to view this file.

Table of Contents

  Acknowledgments
I. Executive Summary
II. Introduction
  Research Methods
  Structure and Organization of the Review
III. Medical Necessity and the Published Literature
IV. Industry Practices in the Managed Care Industry
  Analysis of the Structure of Medical Necessity Definitions
  Interviews With Managed Care Officials on the Processes of Medical Necessity Determinations
  Managed Care Accreditation Organizations
  Judicial Case Law, Official Investigations, and Legal Actions
  Judicial Case Law
  Investigations and Official Legal Actions
     New York
     Maine
     Connecticut
V. State Law Regulation of Medical Necessity
  Laws That Regulate the Content of Insurance Contracts
  Independent Review Statutes
VI. Relevant Federal Laws Pertaining to Medical Necessity Reviews
  ERISA
  Office of Personnel Management Standards: FEHBP
VII. Synthesis and Implications
VIII. References
IX. Endnotes
Figures
Figure 1: The Five Dimensions of the Medical Necessity Definition: Industry Practice
Figure 2: NCQA and JCAHO Utilization Management Standards
Figure 3: NCQA and JCAHO External Appeals Standards
Figure 4: Common Procedural Problems in Medical Necessity Determination Processes Noted in Investigations, Litigation, and Case Law
Figure 5: Medical Necessity Utilization Review and Appeals Procedures
Tables
Table 1. Medical Necessity Definitions in Published Literature (See Also Appendix C)
Table 2. Medical Necessity Definitions: Managed Care Industry
Table 3. Medical Necessity Definitions Identified in Case Law (Sorted by Case Name)
Table 4. Medical Necessity Definitions Contained in State Statutes and Regulations
Table 5. State Independent Review Statutes and Regulations
Table 6. Medical Necessity Definitions: State Insurance Laws and IRO Statutes
Table 7. State Independent Review Statutes With Specific Behavioral Health Provisions
Table 8. Qualifications of External Reviewer in State IRO Statutes
Table 9. Independent Reviews: Standard of Review for Medical Necessity Determinations
Appendixes
Appendix A. Selected Published Literature on Medical Necessity (Sorted by Year)
Appendix B. NCQA and JCAHO Utilization Management and External Appeals Standards
Appendix C. Litigation Regarding Medical Necessity Definitions and Procedures (Sorted by Case Name)
Appendix D. State Investigations and Legal Actions Regarding Medical Necessity Issues

SMA03-3790
07/2003

 

 

 

 

FDA Logo links to FDA home page

New Super Search

 

 

 

FDA > CDRH > Database Super Search

 

"Device Listing Database

 

Proprietary Device Name:

MASSAGER ( THERAPUTIC, ELECTRIC, WATER

Common/Generic Device Name:

ASOOTHE/AQUAMED

Classification Name:

MASSAGER, THERAPEUTIC, ELECTRIC

Device Class:

1

Product Code:

ISA

Regulation Number:

890.5660

Medical Specialty:

Physical Medicine"

 

Categorization of Investigational Devices

 

"... all FDA-approved IDE's into either Category A (experimental / investigational) or Category
B (nonexperimental/ investigational). An experimental / investigational ..."

 

 
   
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