Dear Mr. Bodin:

On behalf of OrthoVirginia, I would like to provide public comment on the periodic review of the Virginia Medical Care Facilities Certificate of Public Need (COPN) Rules and Regulations, 12VAC5-220. We believe these regulations are burdensome and serve as a barrier to patients receiving high-quality, affordable health care in the Commonwealth.

These regulations limit what kinds of services we can offer our patients. If we see a need with our patients to have a Magnetic Resonance Imaging (MRI) machine in our office, we must apply for permission to do so. Our application may be rejected based on outdated requirements and our patients will never benefit from this service. As a result, we would have to refer patients to a hospital to receive a MRI. This can be both inconvenient and will cost more money for our patients. At OrthoVirginia, we can offer this service for approximately a third of what a hospital will charge. At the end of the day, our patients are paying more out-of-pocket because of COPN regulations.

It is my understanding that the periodic review also includes a small business impact review. Physician practices are small businesses and are directly harmed by COPN regulations. They limit our ability to grow our businesses and expand the services offered. If a business does decide to apply for a COPN, they will go through an extremely costly and lengthy process. Many businesses cannot afford to take this risk and do not even attempt.

The COPN regulations are outdated and no longer appropriate for our evolved health care system in Virginia. Patients and small businesses in the Commonwealth are negatively impacted by these regulations. We hope you will consider our comments during your review. Thank you for the opportunity to provide comment.

Sincerely,

William Andrews, MD

OrthoVirginia

On behalf of the Medical Society of Virginia (MSV), thank you for the opportunity to provide feedback to the Virginia Department of Health regarding the periodic review of Virginia Medical Care Facilities Certificate of Public Need (COPN) Rules and Regulations [12VAC5-220].

The current COPN program in Virginia is outdated; it was adopted in 1973, in part because of a federal requirement. The requirement was later repealed due its inability to control cost, regulate quality, or increase access to care. Fourteen states have discontinued their COPN programs because the they have been proven ineffectual at the program’s original aim.

These fundamental flaws are still prevalent as we assess the outcomes of Virginia’s current COPN program. The Federal Trade Commission has noted COPN can limit consumer choice and stifle innovation, while our own All Payer Claims Database (APCD) shows that most services are cheaper in non-hospital outpatient settings (MRI $1797 hospital; $406 doctor’s office) and nationally, studies have shown that hospitals in states with COPN have higher costs than those without COPN. Finally, numerous studies have shown that COPN is irrelevant when it comes to quality; for example, Minnesota doesn’t have COPN and is ranked in the top 10 for quality in the country, whereas Virginia is in the middle 30.

MSV believes Virginians deserve access to modern high-quality healthcare. As such, MSV supports the deregulation of COPN, while maintaining regulatory oversight to ensure newly deregulated services maintain patient safety and quality standards, accreditation, and strong enforceable charity care. MSV welcomes the opportunity to work with the Administration to develop a modern program that meets the needs of patients and providers in the Commonwealth.

Thank you for the opportunity to provide comment.

I am writing to express my support for businesses and to consider meaningful reform of the Certificate of Public Need (COPN). These laws restrict opportunities for our practice to invest and expand care for our patients.
There are advancements in technology and medical care which will now allow our physicians to offer more services outside the hospital setting at a great savings to patients and increase access to them. I personally support removing imaging services, such as MRI's and ambulatory surgical centers from the COPN process. Virginians will be better served and allowed more access to quality patient care as a result.
Please support legislation that will reform COPN and expand access to care for patients in Virginia.

Sincerely,
Cindy Free, LPTA, CDE II
Atlantic Orthopaedic Specialists

I would like to express my support for reform of the COPN Law.

With few exceptions of a minor nature, the Commonwealth's COPN law has remained substantially unchanged following it's inital conception in 1973.

I feel the law has been outpaced by a rapidly evolving healthcare system and it is unable to succesfully further the Commonwealth's ability to incentivize value based market competition. In fact, the practical effect of the COPN law is to stifle competition and ensure a healthcare monopoly owned by the hospitals. 

In this environment of rapidly increasing health care policy premiums and deductibles, COPN reform is an urgent need to decrease costs and increase acess to care.

Thank you, 

Daniel R. Cavazos,MD

The current COPN system is archaic and clearly designed to protect the interests of hospitals, not patients.  No one is fooled by protestations to the contrary; we are all well aware this system is kept in place by a cadre of hospital lobbyists haunting Richmond.  Physicians have dedicated their lives to helping our patients, and letting us direct the care of said patients in physician-controlled facilities will immeasurably improve both quality and cost of care.  It might even stem the increasingly torrential tide of patients traveling over the border to Maryland to have surgery at one of the dozens of new centers physicians have opened there to solve this issue the only way we can.

The current COPN system is archaic and clearly designed to protect the interests of hospitals, not patients.  No one is fooled by protestations to the contrary; we are all well aware this system is kept in place by a cadre of hospital lobbyists haunting Richmond.  Physicians have dedicated their lives to helping our patients, and letting us direct the care of said patients in physician-controlled facilities will immeasurably improve both quality and cost of care.  It might even stem the increasingly torrential tide of patients traveling over the border to Maryland to have surgery at one of the dozens of new centers physicians have opened there to solve this issue the only way we can.

On behalf of the Virginia Orthopaedic Society (VOS), I am submitting public comments on the periodic review of the Virginia Medical Care Facilities Certificate of Public Need (COPN) Rules and Regulations, 12VAC5-220. VOS believes these regulations should be repealed because they are harmful to patients in Virginia and place an undue burden on small business physician practices.

The review specifically seeks public comment on whether the regulations are necessary for the protection of public health, safety and welfare. VOS believes they are not necessary and furthermore, do harm by serving as a barrier to low-cost, high-quality health care services. COPN regulations require physicians to receive permission from a state agency in order to provide new services for our patients or expand our current services. It directly impacts the kind of care we can provide and the setting in which we are able to provide it.

Virginia’s COPN process prevents competition and limits the services physicians can offer. For example, an orthopaedic surgeon must obtain a COPN in order to have a MRI (Magnetic Resonance Imaging) machine at his or her office. Many physicians are denied by the COPN process and not allowed to have this service at their practice. Instead, they must refer a patient to a hospital for this service, which can be more expensive and time-consuming for the patient.

In addition, these regulations place an undue burden on our practices, which we operate as small businesses. In order to remain as an independent practice and maintain patients, a physician must offer the services patients need. By requiring procedures and services be performed at hospitals (at a much higher cost), the state is directly hurting physician practices.

Virginia’s COPN regulations are outdated and ineffective. They increase out-of-pocket health care costs for our patients, limit access to the services they need and stifle competition within the health care field.

Thank you for the opportunity to provide comments on this critical issue.

Quanjun Cui, MD

President, Virginia Orthopaedic Society

The Virginia Society of Eye Physicians and Surgeons (VSEPS) appreciates the opportunity to provide public comment on the periodic review of the Virginia Medical Care Facilities Certificate of Public Need (COPN) Rules and Regulations, 12VAC5-220. VSEPS is a statewide, non-profit organization comprised of medical doctors and doctors of osteopathy (ophthalmologists). Our mission is to advocate for the best quality eye care through education, legislative efforts and community service.  

We believe Virginians should have access to high-quality, affordable health care, and eye care is an integral part of a person’s overall health. Virginia’s COPN regulations are not only burdensome to small businesses like those physician practices of many ophthalmologists throughout the Commonwealth, but they are also a barrier to health care access.

Eye surgery is a special case study. Ophthalmology is a unique medical specialty in that almost no eye surgery occurs in the hospital setting. According to Virginia Health Information’s data “Ophthalmologic Surgery Service Line in Virginia Hospitals Year: 2015,” of the 97 hospitals in Virginia, including the teaching hospitals and other hospitals at which ophthalmology residents perform surgeries, 81 had zero (0) eye surgery cases. Among the non-teaching hospitals, eye surgery cases represented only .04% of the case load at the facility with the highest number of those cases.

Having a robust supply of ambulatory and outpatient surgery facilities for eye care is therefore even more important so that patients have access to a variety of eye care options in their area. Many hospital systems argue that deregulating COPN will result in lost revenue. However, because eye surgery represents insignificant hospital case load, deregulating ophthalmology would have minimal impact.

Ophthalmology practices are small businesses. Current COPN regulations interfere with small business decision-making and expansion of patient services. When pursuing a COPN, applicants experience a costly and lengthy process which dissuades many others from considering a project. Deregulating COPN regulations for ophthalmology will introduce positive competition that could drive down costs for patients and employers. Virginia’s evolving health care system demands expanded outpatient options for an aging population. Let ophthalmology be a specialty that can respond.

We hope you will consider our comments during your review.

Thank you,

Suzanne Everhart, DO, President,

Virginia Society of Eye Physicians and Surgeons (VSEPS)

As the Practice Administrator for several Orthopaedic Surgeons providing care to constituents in Virginia,  I am writing to urge your support of meaningful reform of the Certificate of Public Need (COPN) laws. These laws restrict opportunities for health care providers to invest in their businesses to expand care for patients. Virginia’s laws are among the most restrictive in the country. Advancements in technology and medical care allow us to offer more services outside the hospital setting at great savings to patients and insurance payors. We have found that the execution of the Patient Protection and Affordable Care Act (Obamacare) has placed significant financial burden on patients who require medical care and surgery  (in the form of increased co-payments, co-insurance and deductibles).  Offering lower cost solutions (with equal quality and efficiency) is essential at this juncture in our history.  

We have an AAAHC accredited office-based surgical suite that we built in 2009 to serve our patients.  Our goal was to reduce the cost of orthopaedic surgery in our general service area (Harrisonburg and Rockingham County).  We have made great headway toward this endeavor, but continue to be significantly obstructed by the current Virginia state COPN laws.   As we strive to make care more affordable through innovation, integration, and competition, we need to be able to provide a wider array of services. Virginia’s COPN laws only serve as a barrier to this effort and stomp out any opportunity to use competition to allow choice and drive down costs.   Our story is just one example of this barrier.  

We are in support of legislation that will strategically deregulate certain components of COPN and expand access to care for patients in Virginia. 

Respectfully,
Lindsay A. McHone

Administrator, Hess Orthopaedic Center and Sports Medicine, PLC and Valley Outpatient Services, LLC

I believe COPN for ASCs in particular should be repealed in the state of Virginia.  Lack of free market competition drives costs up and legislaters should begin placing the best interests of constituent patients and their ability to afford healthcare above the interests of powerful lobby groups.

Winchester, Virginia and Valley Health System are examples of why the COPN should be repealed.  Here is the history:

Winchester Medical Center (Valley Health) opened an ambulatory surgery center (ASC)  in the mid 1980's.  A new hospital was then constructed around the ASC in 1990. The ASC operated independently until 2014 when VHS/WMC incorporated it into the "Main OR"  to increase costs  Hospital OR rates.  There was only a change in "name only" and my patients saw staggering increase in costs.

In 2014, physicians attempted to get a COPN to re-open an ASC in Winchester.  It was challenged by VHS/WMC and due to the process of COPN in Virginia,  the VA Dept of Health issued a new COPN to VHS/WMC to open an ASC when in fact VHS/WMC had just closed an ASC.  Please explain how this system works?  How this benefits the community?  How maintaining monopoly control of health care services/facilities benefits the community?  How can the COPN process be shown to control health care costs?

Please repeal the entire COPN process.  Thanks

Curtis A. Winter, MD

Winchester, Virginia

Virginia must change its COPN laws in favor of improving access and lower cost for surgical services and imaging services.  Last night, I operated on two patients with obstructing kidney stones.  One patient had been sitting in the emergency department of a large hospital system for 7 hours prior to me being called.  The patient had been to the emergency department twice in one week.  He had labs and two CT scans during those visits.  As a result of not having any competition or better access to an independent surgical center/ imaging center, this patient will have two bills in EXCESS of 25,000 dollars for those two visits.  If a facility existed which was owned by a NONHOSPITAL entity, the CT scan would have been less than 400 dollars, labs less than 250 dollars and his surgical procedure would have been less than 2000 dollars.  He would have NEVER waited for 7 hours in an emergency department. The second patient has nearly an identical story.  Finally, did you know that hospitals who have hired physicians prior to last October, can use provider based billing to bill a facililty fee (even if just a doctors office during a patient visit) and a professional fee for all services rendered by that physician as long as it is within 35 miles of an existing facility.  Said another way, a patient gets at least two bill from a hospital when seeing a doctor employed by the hospital - one for the facility (at least 200 dollars) and one for the physician's professional services.  If a procedure is done in the physician's office, they bill as if it were done in the hospital (could be ten times the cost of the same procedure done in an independent physician office).  

Physicians treat more self pay or "inability to pay" patients on a percentage basis than any hospital system. Moreover, hospital systems get to balance bill their unpaid care under CMS/Medicare law, collecting a significant amount of that "loss" back. Physicians and physician owned centers cannot do such activity and moreover cannot write losses off or get any breaks yet we continue to treat and take care of all patients.  Our two largest health systems have over 7 BILLION dollars of cash and assets on hand and pay no Federal, State, or Local taxes.   Isn't it time for Virginia to stop supporting such activity?  

I urge to to phase out the COPN laws for emergency services, imaging (CT, MRI), radiation services, and surgical services.  You will see competition lowering the prices of services, a shift of services from the MOST expensive to most economical.  You will see no change in employment as hospitals will still remain open and more hiring will occur by these independent centers.  Finally, you will see a vast improvement in the Healthcare of Virginians.

Thank you.

Michael D. Fabrizio MD FACS

Urology of Virginia, PLLC, CEO

Professor of Urology, Eastern Virginia Medical School

Founder, The Atlantic Clinic

I am writing to give an opinion regarding the COPN in Virginia. Having moved from a state that did not have a COPN (Arizona) to one that does (Virginia); I can fully see the advantage of not having a COPN and the detriment to the patients of having one.  I was in practice for 14 years in Tucson, AZ. There was no COPN and therefore many groups had CT scans and MRI scanners as well as surgery centers. From a physician perspective, when I needed a CT scan performed, I could always find a place that could accomodate the patient by the next day. This alleviated anxiety and in many cases was life-saving as well as cost-saving by the patient not ending up in the ER at one of the hospitals to have the test done urgently. Because of the number of scanners around, those that did best were those that accomodated the patient the most. As a result, one could get scans on Saturdays and early mornings or late evenings. The patient 100% benefited and were very happy. We as physicians were very happy with utlizing this care as well. This same held true for surgery centers.  Medical care was much more driven by patient satisfaction in Arizona and less so by unnecessary regulation. There was no evidence that physicians over-utilzed this service because of the increased competition. That should be of no worry these days due to increased cost responsibility on the patient and the patient now being the requlator of their own care due to finances. If I can answer any questions, please feel free to contact me. Thank you for your time.  BAR 

It is time for a dramatic change in the COPN laws in the state of Virginia.   At a time when we are dissecting healthcare in every imaginable way to try and improve quality and value,  these laws  stand in stark contrast to our efforts.   It is only with competition that will ever be able to the lower the extortionate cost  and suboptimal quality of modern healthcare.   The current deficits in healthcare are largely due to the hospital and healthcare system monopolies. Without substantial change in these laws, actually even better repeal, we are just not going to get to these twin goals. It's frankly not in the interest of "big" healthcare.

Please repeal COPN rules. Doing so will make health care costs decrease. This is especially true in rural areas where patients are forced to get specialty care/surgery in the hospital setting for care that could be more efficiently and more economically provided in facilities like outpatient surgery centers, as one example. Thank you. 

COPN rules should be repealed. This would allow physician groups to allow high quality care at a much lower cost compared to hospital systems.  In addition, this would allow for shorter wait times for patients, and improved access to both medicaid and medicare patients. 

I beleive it is very important for the legislature of Virginia to consider CON reform. As an independent physician it is very diffucult to fight with this regulation as we seek to improve access, minimize travel and burden on our patients, and offer innovative treatment options. Coming from a non-CON state I saw patients who didn't have to wait days to weeks for procedures or tests, and where physician groups could offer a progressive practice environment to attract new physicians. The CON rules are unnecessarily restrictive to prohibit the free-market from driving down cost to comsumers so that large hospital corporations can control and profit from the illness of Virginians. It is discouraging to those of us who have committed our lives to serving our patients to see corporate greed put ahead of patient needs in the Commonwealth. 

I believe we should repeal the existing copn law in VA.  Free Competition with hospital systems would allow lower cost, better access for patients, and even improved quality of care.

John S. Liu, MD

The legislature needs to seriously consider changing the state COPN regulations. The hospitals claim they need the COPN regulations to keep financially viable operations due to Medicaid and uninsured patients. Who do they think treats these patients?? The physicians! The hospitals are not the only ones treating patients and not getting paid.

Also, with higher deductibles on health plans the insured patients have to pay more out of pocket. Some competition would lower the costs of diagnostic testing (CT/MRI) that is done in the hospital only. The hospitals can gouge the system with no competition.

Please consider that Virginians are paying higher costs and are experiencing reduced access to care due to the COPN regulations.

I believe the Virginia Certificate of Public Need (COPN) regulation should be repealed.  Doing so would improve patient access, increase competition, lower cost because of the competition in the market place, and increase quality also because of competition.

I am a practicing ophthalmologist in Virginia Beach, specializing in the treatment of retinal disease. Virginia’s COPN regulations are a barrier to the expansion of services that could serve more patients seeking eye and other health care services. Independent medical practices are small businesses that must make decisions on how to best serve our patients. Regulations that unduly prevent or disincentivize these decisions not only hurt small businesses from making investments but ultimately limit choice and raise costs for patients. Please repeal COPN regulations for eye surgery and other medical services. 

Thank you!

I believe repeal of COPN is necessary for Virginians to receive a better and more efficient health care.  Current law creates barrier to entry which stifles competition and allows the parties which are "IN" to operate in a monoplistic fashion.  

These parties mostly consist of hospitals are against repeal of COPN law often plead proverty, which is not true.  In the newspaper, we know most of the Virginian hosptial system are profitable.  How does it make sense when the hospitals which pleads proverty pay their executive exordinary amount of compensation up to $6 million.

We also know hospital system can charge much higher rate usually at 3-4X the going rate of a private practice groups for the same care.  It is time to be true and to work work for the common folks.  Keep a law that is a big part of someone's $6 million paycheck is unethical and un-American.

COPN should be repealed. It limits the growth and offering of cheaper alternatives to hospital based platforms. 

In 2014 I was very active in the HealthVest proposal which would have brought a free standing psychiatric hospital to Prince William County.  This proposal was denied because of, as I understand it, the COPN regulations.

I was shocked back in 2014 and I continue to be so.  Talking with people who live with mental illness and the providers who seek bed space for people looking for help in a psychiatric emergency, there is definitely a lack of available psychiatric hospital beds for people in Prince William County. 

Now, supporters of the COPN process say we do not need beds.  But the reality is simply quite different. 

Our Community Services Board Emergency Services report indicates for 2016, 73% of juveniles and 19% adults were sent out of our area.  But on this report, our CSB counts hospitals in our region as in our area.  But residents in Prince William County do not consider Arlington or Falls Church in our area.  As a person who lives with mental illness and who is a champion for others who live with serious mental illness these numbers are simply unacceptable.

This report is great to see, if you are merely looking at numbers.  But for me and the work I do, I look at people.  Robert (someone living with mental illness) has told his story about having been in handcuffs at the police station for over 6 hours while someone attempted to find a bed for him.  The bed they found was 2 hours away.  There are many people who have been sent over an hour away to find psychiatric care in an emergency.  This is simply unacceptable.

I have personally known people who were sent to Northern Virginia Mental Health Institute.  I very much wanted to visit them and be able to help in any way I could during a very stressful time for them, but was unable to do so because it’s so far away and during rush hour the commute is nearly impossible for someone who works full-time.

We have already overworked CSB Staff who spend literally hours of their time looking for somewhere to send one person.  That is time and tax dollars spent needlessly when they could literally be moving on to the next person helping to make positive change for some of our most vulnerable citizens.

Here in Prince William County I work endlessly attempting to help people in their mental health recovery.  Often, we are able to help people before it becomes an emergency that escalates into needing hospitalization.  But when a hospitalization is necessary, we need appropriate services in our area that can help quickly and in a suitable manner.

In 2014 I collected over 2000 signatures in support of HealthVest’s proposal.  If I had had more time, that number would have been much higher.  The HealthVest proposal had residents, professionals, and organizations supporting it.  Our Board of County Supervisors were in support of the proposal.  I personally am willing to do whatever I need to do for mental health recovery in Prince William County. 

What will it take to be able to create a new psychiatric hospital for Prince William County?  One that can help us with our goal of offering services that work for our most vulnerable citizens before it becomes an out of control alarming crisis.

Please change the COPN process.

Sincerely,

Cynthia Dudley

Executive Director

Trillium Drop-In Center, Inc.

703.763.3865

CynthiaD_va@yahoo.com

we need the copn law abolished to help out pts with limited access to health care.

Not good for healthcare and for physicians.

Thanks for your consideration 

On behalf of the Virginia Hospital & Healthcare Association, thank you for the opportunity to comment on the Virginia Board of Health periodic review and small business impact review of 12 VAC 5-220, Virginia Medical Care Facilities Certificate of Public Need Rules and Regulations.  As discussed in greater detail below, VHHA submits that this regulation should be retained and has provided suggestions for how the regulation could be further improved.

I.The Regulation is Necessary for the Protection of the Public Health, Safety, and Welfare and for the Economical Performance of Important Governmental Functions

Certificate of Public Need (“COPN”) regulations are necessary for the economical performance of important governmental functions and protect the public health and safety in several ways: through ensuring access to care for the indigent; supporting the availability of essential health services across the Commonwealth; limiting duplication of services and overutilization; maintaining competency levels and quality for complex medical services; and supporting graduate medical education and health care workforce development.

Since Virginia does not have an extensive public hospital system and relies heavily on private providers to meet the health care needs of the low-income uninsured and medically needy, charity care conditions are one mechanism by which the Commonwealth is able to maintain an adequate safety net.  Based on information from the Division of Certificate of Public Need, $1.34 billion in direct care in 2013 was reported by providers subject to charity care conditions. An additional $34.8 million in direct cash contributions to safety net providers (free clinics) was reported in lieu of direct care to meet charity care conditions. 

Through the application of the State Medical Facilities Plan standards found in corresponding regulations at 12 VAC 5-230, the COPN regulations also limit the unnecessary duplication of services and help to disperse access to services across geographic regions in the Commonwealth.  In the absence of regulations to ensure the appropriate distribution of medical care facilities, services could cluster around areas of high population, high income, and high rates of commercial insurance, and those smaller communities, rural settings, and inner cities could see access reduced or experience increased drive times to access care.

The COPN regulations also play a role in protecting safety.  Many of the more complex medical services that are regulated by COPN rely on a well-trained and technically competent workforce of physicians, nurses, and other support staff.  To recruit providers and maintain these skills, a certain volume of procedures is necessary in order to provide proficiency, quality and cost-efficient delivery of care.  There are multiple peer-reviewed studies included in medical literature that demonstrate how concentration of these complex medical services to maintain minimum volumes produces improvement in quality outcomes.  The COPN regulations help to achieve this goal.  

There is broad consensus among policymakers that Virginia faces current and projected maldistributions and shortages of physicians and advanced practice professionals in the state.  In the absence of a policy to fully fund the costs of undergraduate medical education and ensuring adequate resources to support graduate medical education, the COPN regulations, including provisions that take into consideration the effects on academic medical centers, plays an important role in addressing the workforce shortage.  Private teaching hospitals, which have ongoing relationships with the academic medical centers serve as training sites for medical education and are supported in this role by the COPN regulations.

II .COPN Regulations Minimize the Economic Impact on Small Businesses in a Manner Consistent with the Stated Objectives of Applicable Law

Va. Code § 32.1-102.2 charges the Board of Health with establishing the COPN regulations.  The stated objective of the COPN regulations is “to set forth an orderly administrative process for making public need decisions.” 12 VAC 5-220-30.  Consistent with the underlying authority and objective, the COPN regulations minimize the economic impact on small businesses in several ways.  Limiting economic impact is particularly important for small businesses that comprise a significant percentage of the workforce, yet have fewer employees and tend to be located in rural and medically underserved areas.  

Specific examples of how COPN regulations minimize the economic impact on small businesses include:

1. The COPN regulations provide for a preconsultation process for COPN applicants to assess health resource needs.  This process can help to confirm the feasibility of undertaking COPN projects and potentially eliminate unnecessary expenditures.  12 VAC 5-220-170.
2. The COPN regulations establish concise procedures for organizing applications in batches and the prompt review of applications for certificates, including a process for combined certificates.  12 VAC 5-220-200, 230.
3. The COPN regulations include specific criteria for determining need in rural areas.  Specifically, the Commissioner is granted authority to waive State Medical Facilities Plan (“SMFP”) requirements that are not relevant to a rural locality's needs or are inaccurate, outdated, inadequate, or otherwise inapplicable.  12 VAC 5-220-270.
4. The COPN regulations establish application fees based upon the proposed expenditure on the project with a cap on the total fee.  12 VAC 5-220-180.
5. The COPN regulations include an expedited review process for certain projects. 12 VAC 5-220-280, 290.
6. The COPN regulations allow for alternative plans of compliance for charity care conditions. 12 VAC 5-220-270.

There are, however, areas where COPN regulations or related sub-regulatory guidance or procedures could be improved to further minimize the economic impact of the regulations.  Current application forms required by 12 VAC 5-220-180 request information that is not needed to process applications or evaluate statutory considerations and SMFP requirements.  At the same time, the application form does not include information that is routinely requested by staff for purposes of completeness review.  The 2016 COPN Workgroup established by Secretary of Health and Human Resources William A. Hazel, Jr., M.D. pursuant to Item 278D of the 2015 Appropriation Act (the “Secretary’s Workgroup”) acknowledged this by including in its Final Report, Recommendation 3b. to “evaluate COPN application forms to ensure that only data necessary for review of an application is required to be submitted and that the forms reflect statutory requirements.”

Similarly, the Secretary’s Work Group included Recommendation 5b to implement “a real-time automated/electronic tracking and posting mechanism for Letter of Intent (LOI) filings . . . to make LOIs available to the public as soon as they are received” and Recommendation 5c to create “an online library . . . where all relevant COPN information and documents are posted and easily available to the public.” Making this information available through an online portal should produce cost-savings and greater efficiencies for applicants, as well as, for the state.  

III.COPN Regulations are Clearly Written and Easily Understandable

Generally speaking, the COPN regulations are concise, clearly written and easily understandable.  The COPN process is fairly complex and detail-oriented, yet the COPN regulations describe the process in an organized fashion providing detailed definitions of key terms to assist in interpretation.  There are, however, areas where technical amendments would be appropriate or additional clarification would be helpful:

1. 12 VAC 5-220-10 The definition of “public hearing” could be revised to clarify who conducts the public hearing in health planning regions that do not have a regional health planning agency.
2. 12 VAC 5-220-50 The citation to the Virginia Code section for the Freedom of Information Act is incorrect.  It should be § 2.2-3700 et seq.
3. 12 VAC 5-220-70 The citation to the Virginia Code section for the Administrative Process Act is incorrect.  It should be § 2.2-4000 et seq.
4. 12 VAC 5-220-90 The Virginia Code section referenced in this regulation, § 32.1-102.12, has been repealed.  
5. 12 VAC 5-220-130 The regulations specify that the regional health planning agency reviews the proposed change; however, it is unclear from the regulation by whom this review is completed or if this review is even required for projects in health planning regions that do not have a regional health planning agency.
6. 12 VAC 5-220-160 The Virginia Code section referenced in this regulation appears to be incorrect.  The eight statutory considerations are enumerated in § 32.1-102.3.
7. 12 VAC 5-220-200 The terms “mental hospital” “psychiatric hospital” “intermediate care facility established primarily for the medical, psychiatric or psychological treatment and rehabilitation of alcoholics or drug addicts” and “mental retardation facility” could be defined in the description of Batch Group C to provide further clarification. 
8. 12 VAC 5-220-230 The regulations do not specify who is responsible for holding public hearings in health planning regions that do not have a regional health planning agency.
9. 12 VAC 5-220-270 It appears that the citation to 12 VAC 5-220-230(B) in Section (B) should be to 12 VAC 5-220-230 (C) instead.
10. 12 VAC 5-220-440 Section (D) discusses regional health planning agency review of extension requests, but does not specify who is responsible for review of requests in health planning regions that do not have a regional health planning agency.

Lastly, we note that in 2015, VHHA developed a series of recommendations for COPN process improvements.  With limited exceptions, those recommendations were consistent with similar recommendations coming out of the Secretary’s Workgroup.  Implementing many of these recommendations would require not only changes to the COPN regulations, but corresponding changes to the related statutory authority as well.  Accordingly, we are not repeating those recommendations here.  Outside of this regulatory review process, VHHA continues to support efforts to streamline the COPN process and improve transparency, accountability, and uniformity in COPN review consistent with those previous recommendations. 

Thank you again for this opportunity to comment.

modifying or abolishing C OPN  regulatory burden will facilitate care and reduce cost of careTmodifying or abolishing to see OPN will facilitate care and reduce cost of care

The way the COPN process is currently constructed and interpreted, it’s really designed to protect current monopolies over growing health care systems, if the COPN process continues to exist in Virginia, then the regulators should evaluate current practices to ensure a consistent and fair approach for every applicant. 

In a recent COPN application, Medarva Healthcare highlighted consistently high utilization of its surgical services and also discussed the need for the population of patients that live in the northern and western portions of the planning district, that application was determined to be unauthorizable as an institutional need-based project by the (state health) commissioner.  The primary objection came from an acute care hospital that has unutilized OR's and has closed ASC's.  Despite evidence being given to the value and costs of a free-standing ASC, the Commissioner ignored these points and chose, instead, to protect the more expensive acute care hospital.

In a second COPN application to relocate 2 OR's from Stony Point Surgery Center (even though Stony Point is the busiest ASC in the State) the staff recommended denying our application.  At the same time, however, two new operating rooms proposed by Bon Secours St. Francis Medical Center were recommended for approval.  The staff person who reviewed the application was upset that the Commissioner had denied the first application and was concerned that Stony Point would request permission to replace the 2 OR's that were being relocated.  This demonstrates that the process is now subject to the personal bias of the COPN staff and is no longer based upon rational thought, data or as implied in the name, "Public Need."

Medarva Healthcare challenged the decision by the Virginia Department of Health’s staff to recommend denying an application to relocate two licensed operating rooms from its Stony Point Surgery Center to West Creek Medical Park and after two years fighting with the state, Medarva Healthcare received approval from the Virginia Department of Health to build its West Creek Surgery Center in Goochland County. In that time, Medarva spent more than 1,000 hours of staff time and in excess of $300,000 in legal and other fees to complete the Certificate of Public Need — or COPN — process.

The current antiquated bureaucratic system favors incumbents by inviting opposition from competitors and considering any impact on a competitor’s patient volume as a basis to deny an application.   A mechanism is needed to ensure even handed application of the process for ever applicant.

Erik Bodin

Director, Office of Licensure and Certification

Virginia Department of Health

9960 Maryland Drive, Suite 401

Henrico, VA  23233

                RE: Public Comment for Periodic Review of 12 VAC 5-220

Dear Mr. Bodin,

Thank you for the opportunity to comment on the Virginia Board of Health periodic review and small business impact review of 12 VAC 5-220, Virginia Medical Care Facilities Certificate of Public Need Rules and Regulations.  I write as President and Chief Executive Officer of Chesapeake Regional Healthcare.  I believe that Certificate of Public Need (COPN) regulations continue to have ongoing benefit to communities like Chesapeake who have invested significant money and effort into building a non-profit hospital system.

Chesapeake Regional Healthcare (CRH) is a unique entity.  Following the 1963 consolidation of the former independent city of South Norfolk with Norfolk County, the citizens and physicians of the newly formed City of Chesapeake began to recognize the need for their own hospital.  In 1966, the Virginia General Assembly agreed and codified into state statute the creation of the Chesapeake Hospital Authority, our governing body.  Today, over 40 years later, Chesapeake Regional Healthcare includes a 310 bed hospital and affiliated acute and long term care services serving residents of the City of Chesapeake and adjacent areas.  We employ over 2,100 people and have an annual total economic impact of nearly $1 billion.

COPN is a vital component of state health care policy that helps hospitals and other providers balance their mission to provide high quality, affordable health care to all patients regardless of their ability to pay and meet other community and social needs.  Last year CRH ranked 1st in South Hampton Roads and 4th out of 22 Eastern Region hospitals in Charity Care (as a percentage of total expenses) while at the same time contributing to more than 45 community organizations with various causes.  Without COPN, many providers would not be required to provide charity care.  By tying project approval to charity care, the state is assured that there are providers within all geographic areas that will treat indigent and uninsured patients.

Healthcare is not a free market.  Hospitals are subject to a number of unique regulatory requirements and market inequities not borne by other providers.  For example:

• EMTALA – hospitals must treat all patients regardless of their ability to pay 24/7/365

• Hospitals have a higher payer mix of Medicare and Medicaid patients typically paying less than 80 cents on the dollar of costs

COPN helps address these inequities.  COPN regulations also preserve quality of services offered by specialized staff.  Absent some check on whether a service is needed in a community, the available skilled workforce is often not able to meet the staffing needs of competing providers, driving up the costs of services to bring in and train new staff and, to the extent skilled staff are not available, diluting the quality of care.  As currently recognized in the companion State Medical Facilities Plan regulations, some procedures also have volume thresholds so that staff can maintain proficiency and provide better care.

Please understand that Chesapeake Regional Healthcare’s interest in preserving the current COPN law is not based on limiting “competition” and “protecting a monopoly.”  COPN does not prevent competition; it is a safeguard against healthcare over-expansion.  The current review process applies rules equally across the board.  Rather than repealing or amending the existing regulations, the Department of Health’s focus in implementing the existing COPN law should be on the process improvements outlined in Secretary Hazel’s COPN Workgroup Report dated November 25, 2015.  Many of those changes would increase transparency and improve the efficiency of COPN reviews.  Until there is a legislative statement to the contrary, the projects subject to COPN review should continue as is.  The goal of any COPN reform should be to improve public health and welfare and to prevent the financial ruin of independent systems like Chesapeake Regional Healthcare.

Thank you again for this opportunity to comment.

Sincerely,

Reese Jackson, President & CEO

Chesapeake Regional Healthcare

COPN laws should be repealed.  Repealing the outdated and outmoded COPN laws will allow more competition in the health care market, allowing for lower cost options for outpatient imaging and surgery, shorter wait times, improved quality of care, and improved access for Medicaid and Medicare patients.

On behalf of the Virginia Spine Institute PLC, thank you for the opportunity to provide feedback to the Virginia Department of Health regarding the review of Virginia Medical Care Facilities of Public Need (COPN) Rules and Regulations.

The current COPN program is obsolete, increases the cost of care, reduces the quality of care and negatively impacts innovation.  These facts are well known by physicians and other providers, and the reason 14 states have eliminated their COPN programs.  The program has created healthcare monopolies at the expense of patients, physician practices and other small businesses.  As a result, patients have reduced access to quality care at an increased cost.  Physician practices applying for a COPN are required to spend enormous amounts of capital, over an extended period of time, with a low probability of success.  Furthermore, these regulations push patients into hospitals and other facilities when it is not necessary.  In the current world of high premiums and high deductibles, this results in another significant burden for the average consumer.

As one specific example, many procedures/services could be more efficiently and effectively performed in an office based surgical center at lower cost, with less stress on the patient all while achieving improved outcomes.  Surprisingly, the current regulatory environment is not friendly to patients and obstructs physicians ability to utilize this approach. 

It is essential that the COPN Rules and Regulations are repealed.  Creating a fair marketplace would be significant win for Virginia consumers and have no material impact on the current healthcare monopolies.  This fact can be validated by looking at many states that have already implemented successful COPN repeals. Thank you for reaching out and asking for comments. 

Sincerely,

Thomas C. Schuler, M.D., F.A.C.S.

Virginia Spine Institute CEO and Founder

Spinal Surgeon

COPN law need to be repealed. The Mercatus Center has numerous references and studies of the harmful consequences of COPN Laws. A recent article A Baby Dies in Virginia by Eric Boehm unfortunately illustrates a recent lethal consequences of COPN laws. The Federal Government realized COPN laws had negative effects on patient care and repealed the law in 1986.  Thirty one years later it is past time that Virginia repeal COPN laws and regulations . 

To Whom It May Concern:

The current COPN Regulations in Virginia are antiquated and no longer serve a purpose in our state. The current systems favors the dominance of the hospital's in our medical system. The COPN law is increasing the cost to the individual patient as well as their freedom to choose where they can be treated. Market forces if allowed to take place will increase choices for the patients and certainly drive down cost. The principle of capitalism prevalent throughout our society should not be artificially restricted in the field of health care. Other states without COPN regulation have shown that market forces will drive competition there by lowering cost and promoting freedom of choice.