Assignment 4……no plagarism…..due

July 22, 2016

David J. Shulkin, MD

Under Secretary for Health

Department of Veterans Affairs

810 Vermont Ave. NW, Room 1068

Washington, DC 20420

Re: RIN 2900–AP44-Advanced Practice Registered Nurses; Proposed Rule (May 25, 2016)

The undersigned physician organizations representing national specialty and state medical societies are

writing to provide comments on the Veterans Health Administration’s (VHA) Advanced Practice

Registered Nurses (APRNs) Proposed Rule which, if finalized, would permit all VHA-employed APRNs to

practice without the clinical supervision of physicians and without regard to state law.

Nurses are an integral part of physician-led health care teams that deliver high quality care to patients.

They are often the first and last person to interact with a patient during an episode of care, and, in the case

of APRNs, they are well equipped to play advanced roles in the health care team. However, APRNs are no

substitute for physicians in diagnosing complex medical conditions, developing treatment plans that take

into account patients’ wishes and limited health care resources, and ensuring that the treatment plan is

followed by all members of the health care team. Nowhere is this more important than in the VHA, which

delivers highly complex medical care to disabled veterans, including those with traumatic brain injuries and

other serious medical and mental health issues. Our nation’s veterans deserve high quality health care that

is overseen by physicians. For the reasons below, the undersigned organizations strongly oppose the

Proposed Rule and urge the VHA to consider policy alternatives that prioritize team-based care

rather than independent nursing practice.

Education and Training Matter

The key difference between medical and nursing education and training is the fact that medical students

spend four years focusing on the entire human body and all of its systems—organ, endocrine, biomedical,

and more—before undertaking three to seven years of residency training to further develop and refine their

ability to safely evaluate, diagnose, treat, and manage a patient’s full range of medical conditions and

needs. And, by gradually allowing residents to practice those skills with greater independence, residency

training prepares physicians for the independent practice of medicine. Combined, medical school and

residency training total more than 10,000 hours of clinical education and training.

In contrast, a nurse generally must complete either a two- or three-year masters or doctoral degree program

to become an APRN. While all baccalaureate nursing programs require a minimum 800 hours of patient

care, advanced nursing degree programs have different patient care hour requirements with no common

minimum standard. It has been estimated, for example, that nurse practitioners’ training includes 500-720

patient care hours, and that nurse anesthetists complete approximately 2,500 hours of patient care. APRN

education and training simply does not provide the same experience, and as such, independent practice is

not appropriate.

David Shulkin, MD
Page 2

The Proposed Rule Goes Against State Law and Trends

The VHA’s proposal would undermine the 28 states that require nurse practitioners to collaborate with or

be supervised by physicians. Currently only 22 states
1
and the District of Columbia allow nurse

practitioners to practice completely independently, seven
2
of which allow nurse practitioners to practice

independently only after the nurse practitioner has completed a certain amount of hours/years of clinical

practice in collaboration with a physician. Another eight states
3
allow nurse practitioners to diagnose and

treat independently, but require a collaborative agreement for purpose of prescribing. The remaining 20

states
4
require physician involvement for nurse practitioners to diagnose, treat, and prescribe. Even states

that have granted independent practice in recent years have required transition periods that maintain the

physician’s oversight role for a certain amount of time.
5
Some states also created joint regulatory bodies

(composed of members of the boards of medicine and nursing) that advise nursing boards on such issues as

formularies and collaborative practice agreements or review nurse practitioner applications for independent

practice. Taken together, these laws are a further indication that the Proposed Rule is misguided and out of

step with state law and trends.

The Proposed Rule is also in conflict with the 21 states
6
that require nurse midwives to collaborate with or

practice under the supervision of a physician, and six states
7
that require collaborative practice for purposes

of a nurse midwife’s prescriptive authority. Finally, the Proposed Rule is significantly out of step with 45

states and the District of Columbia, which require nurse anesthetists to practice with or be supervised by

physicians.
8

The Proposed Rule’s Preemption Language Does not Accord with Federalism Policy

The Proposed Rule asserts that state or local laws relating to the practice of APRNs in the context of VHA

employment are “without any force or effect,” and that state and local governments “have no legal

authority to enforce them.” While the undersigned understand the Supremacy Clause justification cited in

the preamble, the VHA’s proposed regulatory preemption language is startlingly aggressive in light of both

federal policy and the lack of underlying statutory preemption language in 38 U.S.C. 7301.

President Obama’s preemption memorandum of May 20, 2009 specifically noted with approval that “state

and local governments have frequently protected health [and] safety more aggressively than has the

national government.” The President’s memorandum, therefore, announced that “preemption of state law

1
AK, AZ, CO, CT, HI, IA, ID, MD, ME, MN, MT, ND, NE, NH, NM, NV, OR, RI, VT, WA, WV, WY.

2
CT, MD, MN, NE, ME, VT, WV.

3
AR, KY, MA, NJ, OK, TX, UT.

4
AL, CA, DE, FL, GA, IL, IN, KS, LA, MO, MS, NC, NY, OH, PA, SC, SD, TN, VA, WI.

5
See CT Governor’s Bill 36 (Session Year 2014); MD House Bill 999 (2015 Regular Session); MI Senate File 511 (88th Session); NB

Legislative Bill 107 (2015-2016 Session); NV Assembly Bill 170 (77th Session); NY Assembly Bill 4846 (2013-2014 Regular Session);

and WV House Bill 4334 (2016 Regular Session).
6
AL, AR, CA, FL, GA, IL, IN, KS, LA, MD, MS, MO, NE, NM, NC, OH, PA, SC, SD, VA, WI.

7
DE, KY, MI, OK, TN, TX, WV.

8
Only ID, MT, NH, OH, and UT allow CRNAs to practice independently. While 18 states have “opted out” of the federal

requirement that physicians supervise anesthesia care for purposes of Medicare repayment, opting out of this requirement does

not supersede state scope of practice laws.

David Shulkin, MD
Page 3

by executive departments and agencies should be undertaken only with full consideration of the legitimate

prerogatives of the states and with sufficient legal basis for preemption.”
9

Moreover, Executive Order 13132 of August 4, 1999 requires that “any regulatory preemption of state law

shall be restricted to the minimum level necessary to achieve the objectives of the statute pursuant to which

the regulations are promulgated.”
10

We do not support the VHA’s assertion in the preamble of the

Proposed Rule that it complied with this requirement. Executive Order 13132 requires the VHA to

“consult with state and local officials early in the process of developing the proposed regulation.” While

the VHA solicited input from state boards of nursing, there is no mention of any outreach to the state

boards of medicine. We urge the VHA to consult with state boards of medicine and other physician

stakeholders that do not support the Proposed Rule for legitimate patient safety reasons before adopting a

policy that would subvert states’ rights.

Comparison to DoD policy

The VHA tries to make the case that the Proposed Rule is neither “novel [n]or unexpected” by referring to

other agencies, such as the Military Health Service, that “employ APRNs in independent practice without

oversight from physicians.” However, the VHA does not cite specific policies to support this claim and the

Proposed Rule, which would permit all APRNs to practice “without the clinical supervision or mandatory

collaboration of physicians,” is significantly and qualitatively different from employment policies that

allow some APRNs to practice independently.

For example, the Air Force Medical Service (AFMS) states that privileged CRNAs “may act independently

in areas of demonstrated competency within their designated scope of practice.” However, the AFMS also

explicitly states that (1) “CRNAs will consult with an anesthesiologist or any other medical specialty for

patients who require such medical consultation based on acuity of the health condition or complexity of the

surgical procedure;” (2) “a collaborative relationship is a key component for safe, quality healthcare;” (3)

“CRNAs granted MTF [military treatment facility] privileges must have physician consultation (privileged

to the same scope of practice) available either in person or by phone when they are performing direct

patient care activities;” and (4) all privileged APRNs “must have a physician supervisor available for

consultation and collaboration.” Nowhere does the AFMS use language antithetical to team-based care

like that employed in the Proposed Rule (e.g., “without the clinical supervision or mandatory collaboration

of physicians”). In fact, the AFMS expressly requires the opportunity and availability for physician

collaboration.
11

The VA Under Secretary for Health was correct when he stated that “part of what any good health care

professional does is know when it is time to seek help from more experienced professionals.”
12

However,

these best practices need to be built into policies and structures so that the framework for support is

available when health care professionals need it. In its current iteration, the Proposed Rule stands in stark

contrast to the team-based model by explicitly eschewing supervision and collaboration.

9
74 Fed. Reg. 24693-24694 (May 22, 2009).

10
64 Fed. Reg. 43255-43259 (August 10, 1999).

11
Air Force Instruction 44-119, Medical Quality Operations (August 16, 2011).

12
Lisa Rein, Top VA doc: if there aren’t enough doctors, have nurses treat our vets, The Washington Post (June 2, 2016).

David Shulkin, MD
Page 4

Existing data does not support the VHA’s proposal

In September 2014, the VA published an evidence brief entitled, “The Quality of Care Provided by

Advanced Practice Nurses.”
13

The authors of this evidence synthesis found “scarce long-term evidence to

justify” the position that “a large body of evidence shows that APRNs working independently provide the

same quality of care as medical doctors.”
14

The authors conclude that “strong conclusions or policy

changes relating to the extension of autonomous APRN practice cannot be based solely on the evidence

reviewed [in the brief.]” While the VHA cites this brief in supporting documents for the Proposed Rule,

the evidence brief’s conclusions do not support the VHA’s proposal.

The VHA brief finds that APRNs deliver high quality care with a focus on protocol-driven care, thereby

ensuring that physicians on the team can focus on more complex patients which uniquely require their

expertise. However, it does not follow that APRNs should practice independently. The authors

acknowledge as such, noting that studies that “do not explicitly define that autonomy of the nurses,

compare non-autonomous nurses with physicians, or evaluate nurse-direct protocol-driven care for patients

with specific conditions” are often used to support claims regarding the care independent APRNs provide

compared to physicians.
15

The evidence brief also found insufficient evidence to draw conclusions on APRN effect on quality of life

and hospitalizations. The authors concluded that insufficient evidence exists to support “strong conclusions

or policy changes relating to extension of autonomous APRN practice.”
16

Patients want and expect physician-led health care teams

Research shows patients value and rely upon the additional education and training that physicians receive

and they want a physician in the decision-making process.
17

Patients understand the benefits of team-based

care delivery which is why, according to a 2012 survey, patients overwhelmingly want a physician leading

the health care team. Key findings include:

• 91 percent of respondents said that a physician’s years of education and training are vital to optimal

patient care, especially in the event of a complication or medical emergency.

• 86 percent of respondents said that patients with one or more chronic conditions benefit when a

physician leads the primary health care team.

• 4 out of 5 patients prefer a physician to have primary responsibility for leading and coordinating their

health care.

• 78 percent of respondents agreed that nurse practitioners should not be allowed to run their own

medical practices without physician involvement.

13

McCleery E, Christensen V, Peterson K, Humphrey L, Helfand M. Evidence Brief: The Quality of Care Provided by Advanced

Practice Nurses. VA-ESP Project #09-199; 2014.
14

Id. at 1.
15

Id. The authors also found insufficient information on whether the quality of care provided by APRNs varies by the practice

setting or degree of autonomy.
16

Id. at 19.
17

Cite AMA PLT study.

David Shulkin, MD
Page 5

• 79 percent of respondents agreed that nurse practitioners should not be able to practice independently

of physicians, without physician supervision, collaboration, or oversight.

Enabling APRNs to practice independently dismisses clear patient preference for the physician-led model

of care delivery and the undersigned reiterate their strong opposition to the VHA Proposed Rule. If the

VHA moves forward with this proposal despite our opposition, VA beneficiaries and their surrogates

should have all the information necessary to make informed health care decisions consistent with the

current Administration’s focus on transparency. This includes advance, clear, and conspicuous notification

of whether the beneficiary will be seen by a doctor of medicine or osteopathy or by a non-physician

provider. The right to opt out of the health care appointment and to reschedule with the preferred type of

provider is critical to engaging patients in their health care choices and to providing veterans with the

benefits they have so deservedly earned.

Conclusion

The undersigned believe that policymakers serve patients best by supporting team-based care that makes

the most of the respective education and training of physicians and APRNs as part of a collaborative

framework. Patients deserve to have a physician on their team, whether that is for the treatment and

management of chronic conditions, or for surgery. Nowhere is this more important than in the VHA, which

delivers highly complex medical care to our nation’s veterans. To that end, the undersigned urge the

VHA to preserve the highest quality of care and protect the safety of our nation’s veterans and not

move forward with the proposed rule.

Sincerely,

American Medical Association

Academy of Physicians in Clinical Research

Advocacy Council of the American College of Allergy, Asthma and Immunology

American Academy of Allergy, Asthma and Immunology

American Academy of Child and Adolescent Psychiatry

American Academy of Dermatology Association

American Academy of Family Physicians

American Academy of Otolaryngology—Head and Neck Surgery

American Academy of Otolarynic Allergy

American Academy of Physical Medicine and Rehabilitation

American Association for Geriatric Psychiatry

American Association of Clinical Endocrinologists

American Association of Clinical Urologists

American Association of Neurological Surgeons

American Association of Neuromuscular & Electrodiagnostic Medicine

American Association of Orthopaedic Surgeons

American College of Allergy, Asthma & Immunology

American College of Emergency Physicians

American College of Mohs Surgery

American College of Occupational and Environmental Medicine

David Shulkin, MD
Page 6

American College of Osteopathic Internists

American College of Radiation Oncology

American College of Radiology

American College of Surgeons

American Osteopathic Association

American Psychiatric Association

American Rhinologic Society

American Society for Clinical Pathology

American Society for Dermatologic Surgery Association

American Society for Gastrointestinal Endoscopy

American Society for Surgery of the Hand

American Society of Anesthesiologists

American Society of Cataract and Refractive Surgery

American Society of Dermatopathology

American Society of Echocardiography

American Society of Neuroradiology

American Society of Nuclear Cardiology

American Society of Plastic Surgeons

American Society of Retina Specialists

American Urological Association

American Academy of Ophthalmology

College of American Pathologists

Congress of Neurological Surgeons

National Association of Medical Examiners

Renal Physicians Association

Society for Cardiovascular Angiography and Interventions

Society of Interventional Radiology

Spine Intervention Society

Medical Association of the State of Alabama

Alaska State Medical Association

Arizona Medical Association

Arkansas Medical Society

California Medical Association

Colorado Medical Society

Medical Society of Delaware

Medical Society of the District of Columbia

Florida Medical Association Inc

Medical Association of Georgia

Hawaii Medical Association

Idaho Medical Association

Illinois State Medical Society

Indiana State Medical Association

Iowa Medical Society

David Shulkin, MD
Page 7

Kansas Medical Society

Kentucky Medical Association

Louisiana State Medical Society

Maine Medical Association

MedChi, The Maryland State Medical Society

Massachusetts Medical Society

Michigan State Medical Society

Minnesota Medical Association

Mississippi State Medical Association

Missouri State Medical Association

Montana Medical Association

Nebraska Medical Association

Nevada State Medical Association

Medical Society of New Jersey

New Mexico Medical Society

Medical Society of the State of New York

North Carolina Medical Society

North Dakota Medical Association

Ohio State Medical Association

Oklahoma State Medical Association

Pennsylvania Medical Society

Rhode Island Medical Society

South Carolina Medical Association

South Dakota State Medical Association

Tennessee Medical Association

Texas Medical Association

Utah Medical Association

Vermont Medical Society

Medical Society of Virginia

Washington State Medical Association

West Virginia State Medical Association

Wisconsin Medical Society

Wyoming Medical Society