By:  David M Jackson

Attention to detail often becomes more central to success when dealing with an issue or idea, rather than a tangible product or service.  Historic American Author Louis L’Amour said “There will come a time when you believe everything is finished. Yet that will be the beginning.” This can be applied to politics in the sense that many corporations, small businesses, and associations may believe the work stops within the legislature or with campaigns. While keeping a pulse on legislative action can play a major role in all market sectors, many battles can be lost in the administrative rules process as well.  There are 187 state agencies in Missouri that write rules and regulations to implement the laws in Missouri Revised Statutes (RSMo) passed by the General Assembly or through initiative petition.

Twice a month, Missouri’s Secretary of State publishes the Missouri Register. This contains proposed rulemakings by departments and agencies that are then subject to public comment and a hearing.  With 24 editions and over 1200 pages of proposed rules and regulations over the course of one year, it is easy to see why attention to detail is so important. A major component of the rulemaking process is the role of the Small Business Regulatory Fairness Board (SBRFB), which is charged with ensuring state agency rules and regulations do not create an unfair burden for small businesses.

A recent example of this can be seen in a rule published in November of 2008 by the Department of Social Services (DSS) that required all MO HealthNet providers to contract with a Patient Safety Organization (PSO) at the request of the Center for Medicare & Medicaid Services (CMS).  On January 3, 2012, the Department of Social Services proposed to rescind this rule after the Missouri Ambulatory Surgery Center Association (MASCA) filed suit for not properly engaging the SBRFB to analyze the impact this would have on small businesses.  Ambulatory surgery centers (ASCs) add considerable value to Missouri’s economy, with a 2009 statewide economic impact of $841.5 million, including more than $42 million in tax payments and employment of 1,800 full time workers. Additionally, for every dollar spent in the ASC sector of the state economy, $2.35 worth of economic value is created in the state.¹

Patient safety and convenience is the centerpiece of the ASC business model, as surgery centers strive to provide high quality medical care at lower costs with lower infection rates.  A recent national study found that seven-day mortality rates were 25 per 100,000 outpatient procedures at ASCs, compared to 50 per 100,000 in hospital outpatient departments. ¹ Therefore, a regulatory mandate by the Department of Social Services for ASCs to contract with PSO’s could be a cost burden with little to no added value to the quality of care. Most importantly, the Department of Social Services skipped a vital step when they bypassed the SBRFB and neglected the impact this mandate might have on ASCs in Missouri.

This recent victory by the Missouri Ambulatory Surgery Center Association gives new meaning to free enterprise and quality health care in our state.  With a strong lobbying voice and regulatory oversight, all corporations, small businesses, and associations can prevent state and federal government from implementing costly requirements that could be passed on to consumers.  It is MASCA’s mission to continue advocating for free enterprise and competition in the legislative and regulatory environment that will lead to lower costs and high quality care for Missouri patients.

Link to January 3, 2012 edition of Missouri Register:

http://www.sos.mo.gov/adrules/moreg/current/v37n1/v37n1.asp

Source: [1] Oxford Outcomes (2010). ASC Impact Analysis.

The two physicians in the General Assembly, Sen. Rob Schaaf (R-St. Joseph) and Rep. Keith Frederick (R-Rolla), are teaming up on an effort to ensure providers can be fairly reimbursed for the cost and labor used to retrieve medical records.  The House Health Care Policy Committee heard HB 580 this week, which allows providers to charge a fee for medical records that are stored at an off-site location.  Amendments are being drafted to cap the fee at $30 and increase other fees for copying and postage to adjust for inflation.  Under current law, providers can charge up to $17.67 for copying and costs of labor or supplies.  Sen. Schaaf has identical legislation in the Senate under SB 62, which was voted out of committee on February 22^nd.

Pictured Above (Left to Right): Cindy Young, John Blanck, Michelle Lehew, Michelle Dickison, Harry Eggleston MD, Lori Meltner, Diana Carr-President, Denice Morrison, David Lewis, Nancy Sturgeon, Michael Ladevich, Kim Nitsche

Surgical Technologists Legislation Sits Still: Neither SB 178 or HB 526 moved further in the legislative process this week, as both have yet to have a hearing in the House or Senate chamber.  Identical in language, these bills would require all surgical technologists and hospitals and ASCs to be certified through the National Board of Surgical Technology and Surgical Assisting (NBSTSA).   It has come to our attention that this legislation is in fact being pushed by the NBSTSA.  This is an opportunity for ASCs to further educate Missouri’s legislators on the safety measures and training used for your staff.  Please provide feedback on any information available regarding the training program used for your surgical technologists.  Distribution of this information related to low infection rates will provide substantial evidence to the validity of your current process.

Advancement of Patient Medical Records Legislation:  HB 528 filed last week by Rep. Caleb Jones (R-California) to require health care providers to provide medical records within 15 business days was referred to the Health Insurance Committee on Thursday.  The Senate Health Committee also voted out SB 62 this week, which would allow health care providers to charge a retrieval fee for outsourced records.  Rep. Keith Frederick, M.D. (R-Rolla) has identical language filed under HB 580, which was referred to the Health Care Policy Committee on Thursday.

Prompt Credentialing Hearing on Wednesday: The House Professional Registration and Licensing Committee will hear HB 347 on Wednesday relating to the Prompt Credentialing of Physicians.   This will require health carriers to credential providers within 60 days or be subject to certain penalty provisions. Sen. Rob Schaaf M.D. (R-St. Joseph) has an identical version (SB 212) that is currently in the Senate Health, Mental Health, Seniors and Families Committee.  Please notify our team by next Monday if you are interested in testifying on behalf of this legislation.

CON Repeal Inches Forward: By a narrow vote of 4-3, the Senate Health, Mental Health, and Seniors Committee passed SB 86 to repeal Missouri’s Certificate of Need requirement for health care facilities.  In addition, Rep. Todd Richardson (R-Poplar Bluff) filed HB 685 in the House this week to repeal the CON requirement.  The only difference between the Senate version and the House is that HB 685 leaves nursing home facilities under CON regulation.  As always with the legislative session, that provision is open to change as the bill moves forward.

Tort Legislation Hits Rules Committee: The Missouri Association of Trial Attorneys appears to be alone in fighting legislation that would require a defendant to pay only the percentage at which he or she is found to be guilty.  HB 364, sponsored by Rep. Mark Parkinson (R-St. Charles), prevents a defendant from paying 100% of the damages solely because they are 51% or more at fault.  The bill was voted out of committee last week and reported to the Rules Committee on Tuesday.  Once voted out of the Rules Committee, HB 364 is eligible for debate on the House Floor.

ID Badge Bill Passes 18-0 with Consent Status: On Wednesday, the House Professional Registration and Licensing Committee passed HB 287 by a vote of 18-0 with consent status.  This legislation, sponsored by Rep. Ellen Brandom (R-Sikeston), will ensure providers are easily identified and highly transparent for patient satisfaction.  Under the House Committee Substitute version, all physicians licensed under RSMO 334 will have the title “PHYSICIAN” in bold letters on the bottom one half inch of their ID Badge and nurses will carry their title as defined in RSMO Chapter 334, such as “REGISTERED NURSE.”  Nothing in this bill shall prohibit a provider from putting additional credentials after their name on their badge, such as “M.D., D.O., or APRN.”  If passed, all other titles will be promulgated in the rules process by the Department of Health.  The Senate version, SB 137, was voted out of the Senate Health, Mental Health, Seniors and Families Committee last week by a vote of 6-2 and is sponsored by Sen. Dan Brown (R-Rolla).  Read more HERE in an article by the Missourinet.

Any Willing Provider and Hospital Privileges on Deck for Senate Health Committee: The Senate Health Committee will hear SB 111 sponsored by Sen. Rob Schaaf, M.D. (R-St. Joseph) on Tuesday, March 1, which contains any willing provider language and internet access to a health carrier’s standard fee schedule.  The Committee also plans to hear SB 136, which prohibits hospitals from making patient referrals a condition of receiving medical staff privileges.  SB 136 also prevents a hospital from denying privileges to a provider who has ownership interest in another health care facility, such as an Ambulatory Surgical Center.

(FROM: http://online.wsj.com/article/SB10001424052748703422904575039110166900210.html?mod=WSJ_hpp_MIDDLENexttoWhatsNewsForth )

It wasn’t just an educated guess: Dr. Bussell used a new risk calculator that handicaps an individual patient’s chances of surgical complications based on personal medical history and physical condition. It also helps doctors and patients make tough decisions about procedures.

For Ms. Rivard, who is 67 years old, factors including her age, blood pressure and weight lifted her risks—though the surgeon was able to reassure her that they weren’t out of line, and that any complication would be manageable.

Risk calculators, used by heart surgeons for several years, are now being developed for other surgical specialties. The American College of Surgeons recently introduced calculators for surgery of the colon and pancreas, and is designing similar tools for 18 other procedures, including gastric bypass, hernia repair and prostate surgery. The calculators use data from more than one million patient records gathered as part of the group’s National Surgical Quality Improvement Program, which works with hospitals to reduce surgical errors and complications.

More than 30 million operations are performed in the U.S. annually to remove deadly cancers, repair diseased organs and replace worn-out joints. Yet going under the knife can be risky, leading to serious infections, blood clots, heart attacks and pneumonia. Those risks increase with age and for patients who are obese, smoke, abuse alcohol or have medical conditions such as diabetes and hypertension.

The nonprofit Institute for Healthcare Improvement, which works with hospitals to improve the quality of care, estimates that 2.5 million to 3.5 million surgical patients each year experience unintended harm resulting from or contributed to by surgical care. While some complications are unavoidable, surgical teams often make mistakes, such as leaving a surgical sponge in a patient, or fail to take steps known to prevent complications, such as delivering antibiotics to a patient within one hour before beginning surgery, which can dramatically cut infection rates.

Complications are also costly. The Centers for Disease Control and Prevention estimates that there are more than 290,000 surgical-site infections each year, and the cost to treat them ranges from about $12,000 to nearly $35,000 per patient—or as much as $10 billion annually.

The American College of Surgeons’ quality-improvement program is one of several efforts to help reduce such risks. It was adapted from a program originally used by the Veterans Health Administration and shown to reduce deaths at VA hospitals from surgery by 27% and complications by 45%.

Since its launch in non-VA hospitals in 2005, 250 hospitals have signed on. The program costs hospitals about $35,000 annually to participate. But a study published last September in the Annals of Surgery found that it helped 118 hospitals prevent from 262 to 524 complications per year, saving each an average of $3 million.

Preventing Complications

“If these results were translated across all U.S. hospitals, we would have the potential to prevent millions of complications a year, save potentially billions of dollars a year and provide evidence to health-care reformers that higher-quality care can cost less,” says Clifford Ko, a colorectal surgeon at the University of California, Los Angeles, and director of research and optimal patient care for the American College of Surgeons.

The calculators allow surgeons to enter a patient’s risk variables and in a matter of minutes receive a customized report outlining the risk of death and specific complications. For example, using data from 28,863 patients who underwent colorectal surgery at 182 hospitals from 2006 to 2007, the colorectal risk calculator has 15 variables to help predict complications and death within 30 days of surgery, including age, body mass index, the extent of disease—whether it is cancer or a digestive disease—and how much of the colon must be removed.

David Bentrem, a surgeon at Northwestern University’s cancer center who has used the colorectal surgery calculator, says it not only helps assess whether a patient is a good candidate for surgery, but also helps him make sure patients understand what they are getting into—the process known as “informed consent.”

Patients often don’t read or understand the documents they sign prior to surgery, studies show, and after meeting with a surgeon they may be anxious and confused, making it hard to process and remember information key to deciding whether to go ahead with surgery or not.

“The more information we can offer surgeons to give their patients that are specific to their own individual case, the better,” says Dr. Ko. If the surgery isn’t urgently needed, Dr. Ko says he may delay it until a patient loses weight or stops smoking to lessen the risks. Patients may also decide to delay surgery after learning of the risks.

Patients considering any kind of surgery should ask if their hospital participates in surgical-quality improvement programs, and whether risk calculators are available. For example, the Society of Thoracic Surgeons offers heart surgeons a calculator to predict the risk of death and complications from heart-bypass and other cardiac surgeries.

While generally surgical risk calculators are not designed for use by consumers, patients can visit euroscore.org to calculate their risks for cardiac surgery, using a free program from the European System for Cardiac Operative Risk Evaluation, widely used in European hospitals.

Hospitals in the American College of Surgery quality-improvement program can also compare their performance against a national benchmark, and tell patients whether their complication rates are lower than the national average.

‘An Easy Recovery’

At Danbury Hospital, Dr. Bussell was also able to reassure Ms. Rivard that the facility has among the lowest infection rates among hospitals in the American College of Surgery’s quality-improvement program, and because her results were comparable to the average low-risk patient, he expected her procedure to be “uneventful and dull” with “an easy recovery.”

“Telling a patient there is a risk of dying from a cancer surgery is not an easy conversation to have,” says Pierre Saldinger, a surgeon who oversees the quality-improvement program at Danbury Hospital and was also in the room when Ms. Rivard heard about her surgical risks. “The calculator is a tool you need to use in a judicious way, so as not to scare the patients, but to make them feel more comfortable that you are being honest and open with them.”

Ms. Rivard says she had already determined that she needed the surgery before learning of the risks, but she and her two daughters, who accompanied her to the consultation, wanted to hear the doctor put the calculator data in perspective.

The last time she had surgery—on her hip, nine years ago—no one discussed risks with her. While hearing about the risks of complications and infections was “a little overwhelming,” she says, “I want to know everything that might happen.”

Write to Laura Landro at informedpatient@wsj.com

You may recognize the quote from which the title of this blog was irreverently taken. Most people would incorrectly identify the quote from “The Treasure of the Sierra Madre” (actually used in “Blazing Saddles”), just as the federal government and many states incorrectly believe they don’t need a balanced budget. This is especially true in the bad times when many haughtily believe government spending is the answer to fiscal woes.

California is perhaps the poster child for this type of thinking. They increased spending even though they couldn’t support their current budget and then acted surprised they have to cut the budget! Fortunately, Missouri has a constitutional requirement that a balanced budget must be signed and maintained by the Governor.

Occasionally, despite the best estimates and efforts of the Governor and legislature, the budget is not sustainable given the revenue collections. So, what happens when revenues fail to match spending? Tough choices have to be made and under the state constitution, those choices are left to the Governor to maintain a balanced budget. Three main areas present themselves for reductions; education (principally higher education), hiring freezes and Medicaid reimbursements.

Higher education has the target on its back because it represents approximately $1 billion in spending that is not mandated by constitution or state law. The Missouri constitution does require the state to provide some level of funding to higher education. But unlike elementary and secondary education, the constitution does not mandate a level of spending.

Hiring freezes are somewhat painless and are most readily acceptable to the general public as most of them believe there are too many government employees anyway. There are usually exceptions made for “critical” positions but a significant number of positions can go unfilled. After years of growing the number of state employees, that trend has reversed in the last 4 to 5 years.

Medicaid reimbursements are the trickiest reductions to make. Few Governors want to be known as the one who cut Medicaid recipients. Governor Blunt took appropriate action a few years ago to reduce eligibility and fraud in the Medicaid system and it saved the system for the neediest in the state.

Other Governors have chosen to reduce reimbursement rates for Medicaid providers. After all, if anyone can absorb cuts, it is the “rich” doctors. Unfortunately, “rich” doctors don’t usually accept Medicaid patients. Medicaid providers have payrolls and families to support. Reductions in reimbursement rates leave those providing Medicaid service with the decision of losing even more money, Medicaid reimbursement generally fall short of the cost of the services delivered, or simply closing their practice to any new Medicaid patients. This has the same effect as reducing eligibility.

Budget reductions are never pleasant. They may not be entirely avoidable but they can be reduced by not making unwise spending decisions during the “good times” such as was done in the 1990’s. Spending limitations that allow for reasonable government growth and for putting aside savings for the bad times would be prudent but are not popular with most politicians. Bad times are inevitable. After all they don’t call it a business cycle for nothing!

Q. Are ASCs subject to regulation?

A. Yes, ASCs are some of the most highly regulated health care providers in the country. Medicare has certified 85 percent of the centers. All states except one require ASCs to be licensed. The Missouri Dept. of Health specifies the criteria that Missouri ASCs must meet for licensure. Both the state and Medicare survery ASCs regularly to verify that the established standards are being met. In addition to state and federal inspections, nearly all surgery centers choose to complete a voluntary accreditation process conducted by their peers. ASCs that want to demonstrate a commitment to quality can see accreditation from one of four accrediting bodies. All four are recognizd by Medicare for their rigorous adherence to the highest standards of quality care. All accredited ASCs must meet specific standards that are evaluated during on-site inspections. As a result, patients visiting accredited ASCs can be assured that the centers provide the highest quality care.

Q. Does the federal government sanction ASCs?

A. Yes. Since 1982, when Medicare agreed to pay for surgeries performed in ASCs, the program has saved a significant amount of money. ASCs that receive Medicare payments must meet the programs certification criteria and receive payments only for those procedures that have been approved by Medicare. Today, more than 2,400 ASC procedures have been granted that approval. The Office of Inspector General commented in its 1999 final rule regarding safe harbor provisions that “ASCs can signficantly reduce costs for Federal health care programs, while simultaneously benefiting patients.” CMS has promoted the use of ASCs as cost-effective alternatives to higher cost settings, such as hospital inpatient surgery.

Q. How long have ASCs been in existence?

A. The first ASC opened in 1970. Today, more than 7 million surgeries are performed each year in the more than 3,300 surgery centers across the United States.

Q. What are Ambulatory Surgery Centers?

A. ASCs are facilities were surgeries that do not require hospital admission are performed. They provide a cost-effective and convenient environment that may be less stressful than what many hospitals offer. Particular ASCs may perform surgeries in a variety of specialties or dedicate their services to one specialty, such as eye care. Patients who elect to have surgery in an ASC arrive on the day of the procedure, have the surgery in an operating room, recover under the care of the nursing staff, and go home the same day, all without a hospital admission.