Rumblings Spring 2018

Spring 2018

www.pasg.org

PSG

INSIDE

President’s Message

The PSG and I Need Your Help Richard E. Moses, DO, JD In my inaugural RUMBLINGS President’s Message, I briefly mentioned some of the tasks the PSG needs to accomplish to continue meeting the needs of our membership and thrive as an organization. The practice of medicine in general, and the practice of gastroenterology and hepatology in particular, is changing nationally and in Pennsylvania in particular. We need to keep pace.

Private practice and academic gastroenterology are threatened. Giant retail pharmacy corporations are buying health insurance companies.

Hospital systems are merging, buying and controlling physician practices, thereby limiting access to out-of-network physician GI services. The government and insurance carriers are continually decreasing reimbursement for the important preventative and curative health care services we provide, while practice overhead continues to increase largely due to the restrictions they impose.

Venture capitalists have entered the health care arena; striving to own physicians and practices. There are many other examples of the affront to medicine and gastroenterology that I will address in future communications.

My goal today is to advise you what your PSG has done, and is doing, to address these and other issues as they arise at multiple levels. Since my winter 2017 RUMBLINGS message, we sent a letter of opposition to Geisinger Health Care opposing its two-step medication policy for prescribing biologics for our IBD patients. This issue came to our attention during Dr. Ralph McKibbin’s presidency and followed PSG’s challenge to Highmark on the same policy. We sent a letter to the Honorables Robert W. Godshall and Thomas R. Caltagirone of the Pennsylvania legislature to support Pennsylvania HB 2113 to amend Pennsylvania’s Unfair Insurance Practices Act. HB 2113 prohibits commercial health insurers from making coverage changes during the policy year that deny or increase the cost of a treatment, service, or prescription that a patient is already receiving.

A letter was sent to Mr. Paul Staudenmeier at Independence Blue Cross (IBC) as a follow-up to his notification to IBCparticipating Gastroenterologists that IBC will be changing its Office-Based Pathology Services Policy. Effective April 1, 2018, IBC has stopped reimbursement of the high-quality pathology services we provide to our IBC-insured patients.

Congress and the U.S. Department of Health and Human Services clearly continued on page 11

Annual Scientific Meeting Contractor Advisory Committee DDNC Update Membership Benefits Risk Management Report FIT Corner

PRESIDENT Richard E. Moses, DO, JD Phila.Gastroenterology Consultants, Ltd. 700 Cottman Ave., Suite 201 Philadelphia, PA 19111-3062 remoses@mosesmedlaw.com PRESIDENT-ELECT Ravi Ghanta, MD Digestive Disease Associates, Ltd. 1011 Reed Ave., Suite 300 Wyomissing, PA 19610-2002 rghanta@hotmail.com SECRETARY David L. Diehl, MD 801 Mount Zion Drive Danville, PA 17821-8613 dldiehl@geisinger.edu TREASURER Karen Krok, MD 425 Elm Avenue Hershey, PA 17033-1752 kkrok@pennstatehershey.psu.edu ADMINISTRATIVE OFFICE ASSOCIATION EXECUTIVE Robbi-Ann M. Cook 777 East Park Drive, P.O. Box 8820 Harrisburg, PA 17105-8820 (717) 909-2688 rcook@pamedsoc.org RUMBLINGS EDITOR Manish Thapar, MD Manish.Thapar@jefferson.edu

2 Annual Scientific Meeting Neilanjan Nandi, MD, FACP Program Chair This year’s 2018 Annual Scientific Meeting will be held at The Hershey Hotel, September 14-16, 2018.

In this new era, we have become more cognizant that food is medicine. In this light, we will have a healthy focus on nutrition management to approach challenging disorders such as Celiac and six food reintroductions for Eosinophilic Esophagitis.

Breakthrough techniques utilizing magnetic sphincter augmentation to manage chronic GERD will be elucidated.

Complementing this, the latest medical and ablative capabilities for Barrett’s esophagus will be reviewed.

In 2018, rapidly changing IBD treatment paradigms have inspired an in-depth review of practical topics on management of post-operative Crohn’s, proactive therapeutic drug monitoring, biosimilars in clinical practice, and the latest insights into precision medicine.

Dysmotility disorders may be difficult to manage, but our panel will provide real world recommendations to optimize treatment of cyclic vomiting syndrome, gastroparesis, and fecal incontinence.

New insights into revolutions in endoscopic drainage of abdominal collections, treatment of today’s fatty liver, and approach to ethanol induced hepatitis.

We will also provide an introductory ‘how-to’ on social media to improve your community and professional engagement. Rounding out our exceptional line-up of topics and speakers will be our annual GI jeopardy tournament.

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3 Contractor Advisory Committee F. Wilson Jackson, MD

representative seat.

The Contractor Advisory Committee (CAC) met at the Novitas Camp Hill, PA office on February 22, 2018. The CAC serves as a forum for Novitas, the Medicare administrator for our jurisdiction to receive input on new and revised local coverage determinations. New and updated CMS initiatives are also presented for discussion.

Your PSG society has a

There were no policies presented that had direct impact on gastroenterology or hepatology. Updated policies on facet joint injections for pain management were reviewed with thoughtful input from our colleagues from pain management. Novitas also presented their reimbursement for a new drug, nusinersen (Spinraza). This therapy was admittedly new to me. It received FDA approval in December 2016 and is used to treat the rare (1:11,000 live births) autosomal recessive disorder, spinal muscular atrophy. The specific gene mutation, SMN1, is known and the drug, an antisense oligonucleotide medication, delivered intrathecally. The list price of the drug is $125,000 and one-year of treatment is estimated at $750,000.

Other topics covered included the scheduled rollout of the new Medicare cards. The Medicare Beneficiary Identifier card will be mailed out in April 2018. The new cards have an alphanumeric number unique to the Medicare beneficiary and devoid of their social security number. The gender and signature line are re-moved. The deadline to have all Medicare beneficiaries converted is December 31, 2019. Both old and new Medicare numbers will be accepted during the transition phase. Since claims are processed with the old number, there will be prompts in the system to migrate Medicare patients to their new number. Those of you who manage your own billing and patient registration operations will want to stay current with the conversion.

More info can be found here.

2018 Part A Hospital Insurance will have a deductible of $1,340. Coinsurance for 61st to 90th day of hospitalization is $335 a day, rises to $670 a day for 91st to 150th day (lifetime reserve days). Skilled nursing facility coinsurance is $167.50 a day for days 21 through 100 days. Medicare Part B deductible is $183 for 2018 with a 20% coinsurance.

Reference for further information is here.

An ongoing focus remains to correct and police fraud and abuse in the Medicare system through the CERT (Comprehensive Error Rate Testing) program. Novitas Jurisdiction JL has an overall error rate of 6.6% compared to a national rate of 9.5%. Projected national improper payments project to about $33 billion dollars. JL makes us $2.3 billion of that national estimate. Common error areas include adequate demonstration of medical necessity and incorrect coding. Correcting insufficient documentation is an area of focus for 2018. Skilled nursing facilities (SNF), dialysis and hospital-based care documentation, and coding are the areas with the largest projections of improper payment and the focus of action. Corrective areas are documentation of prognosis on the care plan, progress notes (these are most often missing when an error is identified), and physician signatures. Hospital outpatient claims also have high error rates around insufficient documentation. In many ways, the implementation of digital health records should improve these efficiencies though they do require a fresh examination of the workflow. Some specific HCPCS codes under closer review as it may pertain to PSG members include subsequent hospital care (99233 and 99232), initial hospital care (99223), and office visit (99203). Those of you who work with an advanced practitioner will want to be certain your attestation statements are captured along with your e-signature.

As always, your PSG organization will continue to advocate and best represent on behalf of our members and patients. Please pass on any thoughts or concerns.

4 DDNC Update

DDNC Will Continue to Advocate for the Digestive Disease Patients Ralph D. McKibbin, MD PSG Representative and DDNC President

The Digestive Disease National Coalition (DDNC) met in Washington, DC on March 4th and 5th for its 28th Public Policy Forum.

Representatives from more than 40 gastrointestinal patient and provider organizations, as well as institutional members, met to advocate for a unified agenda.

The DDNC is an advocacy organization comprised of the major national voluntary and professional societies concerned with digestive diseases. DDNC focuses on improving public policy and increasing public awareness with respect to diseases of the digestive system. Its mission is to work cooperatively to improve access to and the quality of digestive health care to promote the best possible outcome and quality of life for current and future patients. The legislative agenda represents a consensus agenda regarding budget, regulatory, and legislative issues which is developed through a series of focused meetings.

The public policy forum allows representatives and patients to meet directly with their own federal legislative representatives to express these goals.

On March 4th an educational session was held focusing on “Patient Access in a New Era of Health Care.” The initial research and patient care panel was Adam Cheifetz, MD, Director of the Center for Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center. Dr. Cheifetz presented an Overview of Biologics in Digestive Diseases and their Role in Patient Care; Therapeutic Drug Monitoring. Madelaine Feldman, MD, Government Affairs representative for the Rheumatology Alliance of Louisiana, Vice President, Coalition of State Rheumatology Organizations and Chair, Alliance for Safe Biologic Medicines presented on Access to Biologics for Patients.

Stephen James, MD, Director, Division of Digestive Diseases and Nutrition, National Institute for Diabetes, Digestive and Kidney Diseases presented on Emerging Research at NIDDK. The patient access panel followed with Samir A. Shah, MD, Professor of Medicine, Brown University Gastroenterology Associates, Inc. and Secretary, American College of Gastroenterology. Dr. Shah spoke about a Report from the Front Lines on Step Therapy/Preauthorization and Disruption of Care. Ms. Brittany Ricci, a patient and second year medical student at Brown University spoke on her personal experience regarding How Step Therapy Affected My Care.

Timothy Morck, PhD, Founder and President of Spectrum

Dr. Ralph McKibbin, PSG Immediate Past President and DDNC President (third from right) and Pennsylvania patient advocates meet with Congressman Ryan Costello (R – PA 6th District) (fifth from left) during the DDNC Policy Forum. Rep. Costello received the Congressional Distinguished Public Service Award from DDNC for his efforts to advocate for the digestive disease patient community. He also serves as co-chair of the Crohn’s and Colitis Caucus.

5 Nutrition, LLC spoke on industry experiences with Patient Access to Medical Foods. Scott Winiecki, MD Lead Medical Officer, Center for Drug Evaluation and Research at the Food and Drug Administration spoke on an Overview of the Product Review Process and what that means for patients.

Finally, an industry and insurance perspective panel closed the educational session. Joseph Adedokun, MS, RPh, Associate Director of Clinical Pharmacology, Janssen Research and Development updated on Therapeutic Drug Monitoring. John Kelton, PharmD, US Medical Director of Biosimilars-Inflammation, Pfizer, Inc., gave an update on the current Role of Biosimilars.

On March 5th, attendees met with federal senators and representatives to deliver the legislative agenda.

Both Pennsylvania senators and many representatives cooperated. A luncheon was held in the Senate building allowing attendees to network and discuss their successes.

During the luncheon, awards were presented for past efforts. A Lifetime Achievement Award was given to Dr. Stanley Benjamin. Dr. Benjamin is a graduate of the University of Pittsburgh Medical School and served 13 years in the US Navy before becoming Chief of Gastroenterology at the National Naval Medical Center. He then served as Chief of Gastroenterology at Georgetown University Hospital. Dr. Benjamin also served on the board of the American College of Gastroenterology and the American Society for Gastrointestinal Endoscopy, as well as serving as President of the DDNC. Pennsylvania’s Congressman Ryan Costello, representing the 6th District of Pennsylvania, was also recognized as the Congressional Distinguished Public Service Awardee in recognition of his efforts to advocate for the digestive disease patient community, including co-chairing the Crohn’s and Colitis Caucus. The Congressman has been a champion for individuals with chronic health conditions and continues to work to ensure their protection.

The DDNC will continue to advocate for the digestive disease patients. The complete legislative agenda can be accessed on the website www.ddnc.org.

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6 The Benefits of Your PSG Membership Annual Meeting • Free to members. The non-member meeting physician registration fee is $175 and $100 for physicians’ assistants and nurses. (Pending members who have a completed application on file are entitled to free registration.)

• The 2018 Annual Meeting will be held September 4-16 at the Hotel Hershey in Hershey, PA. • The annual meeting provides an excellent opportunity to earn CME credits.

Interaction with Other State and National Medical Societies • PSG is a member of the Digestive Disease National Coalition and is represented at their meetings.

• PSG maintains a regular dialogue with the AGA, ACG, and ASGE on national issues that impact Pennsylvania gastroenterologists.

• PSG has a seat on the PA Medical Society (PAMED) Specialty Leadership Cabinet and a vote at their House of Delegates. Together, PSG and PAMED advocate for gastrointestinal issues on a state level.

• The two PA regional governors for ACG are now members of the PSG board and we will closely collaborate with them on matters of common interest.

Representation by GI Fellows In Training • Four FITs sit on the PSG Board.

• PSG hosts a FIT poster competition at the annual meeting. Those who submit a poster and attend the meeting receive generous stipends.

Reimbursement and Health Care Issues

• PSG routinely corresponds with carriers to convey gastroenterology concerns and clarify questions.

• PSG sends a gastroenterology representative to the PA Medicare Carrier Advisory Committee.

• PSG actively voices concerns affecting gastroenterology and patient care to the PA legislature and insurers.

PSG Website The PSG Website (www.pasg.org) has many features that benefit our physician members and their patients.

Website features include: • Membership information – online join/renew opportunities; • Meeting information; • Legislative and payor relations updates; • Fellows in training details; and • Electronic copies of the PSG newsletter, Rumblings.

Rumblings Newsletter • Contains reimbursement news and updates • Alerts members of pending issues and problems relative to gastroenterology • Informs members of state and federal legislative issues effecting Pennsylvania gastroenterologists • Provides helpful information for GI fellows and new practitioners

If you received this issue of RUMBLINGS as a non-member, PSG invites you to consider membership benefits such as free registration for the PSG Annual Scientific Meeting, representation in physician advocacy activities, and opportunities for dialogue with other GI professionals across Pennsylvania. To learn more about the Society, visit www.pasg.org.

Join us today! A membership application is enclosed in the following pages.

9 Risk Management Report

Informed Consent Richard E. Moses, DO, JD

Physicians are introduced to the doctrine of informed consent by the start of their clinical training.

It arises from the concept that a physician and patient are entering into a contract. Validation of any contract requires that both parties understand and agree upon the nature of the procedure and the expected and unexpected results. The physician must inform the patient of the facts, risks, complications, and alternatives. All information that the physician possesses does not have to be disclosed.

Conveying a clear understanding of the procedure to the patient is the responsibility of the physician. Informed consent is a process designed to protect the welfare and rights of the patient. Specific requirements vary among the states.

Under Pennsylvania Act 135, also known as the Medical Care Availability and Reduction of Error (MCARE) Act of 2002, it is the: Duty of Physicians. Except in emergencies, a physician owes a duty to a patient to obtain the informed consent of the patient or the patient’s authorized representative prior to: • Performing surgery, including the related administration of anesthesia • Administering radiation or chemotherapy • Administering a blood transfusion • Inserting a surgical device or appliance • Administering an experimental medication, using an experimental device, or using an approved medication or device in an experimental manner

Description of procedure. Consent is informed if the patient has been given a description of any procedure set forth above and the risks and alternatives that a reasonably prudent patient would require making an informed decision as to that procedure. The physician should present evidence of the description of that procedure and those risks and alternatives that a physician acting in accordance with the accepted medical standards of medical practice would provide.

As of June 20, 2017, the Pennsylvania Supreme Court overruled all previous proceedings that presumably allowed a physician to fulfill through an intermediary the duty to provide sufficient information to obtain a patient’s informed consent in MEGAN L. SHINAL AND ROBERT J. SHINAL, HER HUSBAND, Appellants v. STEVEN A. TOMS, M.D., Appellee. 162 A. 3d 429 (Pa. 2017). The Court ruled that the obligation of obtaining informed consent from a patient is solely the duty of the treating physician, and may not be delegated to another individual, regardless of that other person’s qualifications. In addition, the Court overruled any previous law that allowed a physician to fulfill through an intermediary the duty to provide sufficient information to obtain the patient’s informed consent.

The Shinal Court asserted the plain language of MCARE. It interpreted the language to say that the responsibility of obtaining informed consent from a patient falls solely with the physician. The Court further specified the above section also requires the physician to provide the necessary information to obtain an informed consent from the patient.

When a procedure requiring informed consent in Pennsylvania, such as endoscopy, is performed without the patient’s informed consent, the patient may have a legal claim for a “battery” in addition to a potential medical negligence claim. A battery is an uninvited touching.

Unlike most medical malpractice cases, the patient does not have to prove negligence in a battery claim. All that needs to be proven is that the physician performed the procedure without the patient’s informed consent.

Physicians still have no obligation to enlighten the patient with details related to their education and/or experience in performing the procedure. However, if the patient inquires, the physician must provide truthful and accurate answers.

Patients need to be afforded all the time they desire to read and sign the informed consent form. If the patient requests more information, it needs to be provided by the physician.

At this time, the physician performing the procedure must personally obtain informed consent prior to initiating the procedure.

10 Welcome

NEW

Members (October 31, 2017 through April 3, 2018)

Active Marika Bergenstock, DO

Associate Richard P. Denicola, MD Adam Gluskin, MD Kyle R. Kreitman, DO Sunny P. Patel, DO Ankit V. Patel, MD Dhruvan N. Patel, MD Andrew J. Quinn, MD Joseph Spataro, MD Joshua A. Weston, DO Matthew D. Wolcott, MD Stephanie A. Zacharias, MD

Non-Physician Clinician Amy Moss Erin Nomland, PA-C Minal Patel, PA-C

FIT Corner

The Importance of Anxiety and Depression Screening in Patients with Inflammatory Bowel Disease Seyedehsan Navabi, MD Pennsylvania State University, Milton S. Hershey Medical Center Gastroenterologists have all encountered challenges with some of our patients suffering from Inflammatory Bowel Disease (IBD) including Crohn’s Disease (CD) or Ulcerative Colitis (UC).

These challenges could be due to medication compliance, symptom management (pain control) and, sometimes, the patient’s dependence on opioids which is now a concerning epidemic in the United States. Many studies show individuals who are affected by IBD are at increased risk for anxiety and depression in comparison to the unaffected population. Some studies show the prevalence of patients experiencing anxiety and depression can be as high as 45% which is at least two times more than the general population. At the same time less than 20% of affected individuals received appropriate treatment.

Although affective disorders may affect an individuals’ care regarding medication compliance, risk of smoking, risk of opioid dependence, and increased no show rates among these patients, studies also indicate it can affect both clinical remission and endoscopic healing rates in these population.

IBD as a chronic disease currently requires lifelong treatment. Study literature indicates as much as 50% of affected patients may require surgical intervention in life. The increased risk for colon cancer and known side effects of medications, such as infections and some malignancies, would increase the rate of anxiety and chronic pain. Recurrent hospitalization or ED visits would increase the risk of depression like other chronic diseases.

Studies show poorly controlled anxiety and depression may increase the risk of flare-ups in IBD patients regardless of excellent medical management of their IBD. Animal models show there is a correlation between gut inflammatory proteins and increase in neurotransmitters responsible for anxiety and depression. Individuals with anxiety and depression have an increased risk of malnutrition. IBD patients may be at an increased risk of malnutrition due to higher instances of nutritional deficiencies.

A pilot study at Penn State Hershey Medical Center’s IBD clinic, identified individuals with IBD are at greater risk for psychiatric disorders. This has been assessed using simple but proven questionnaires such as HADS and PHQ-9 for screening of depression and anxiety. The study data has been presented at national conferences as well as presented for publication in the Inflammatory

11 Bowel Disease journal. Based on these findings we recruited a dedicated psychiatrist at the IBD clinic who sees patients with positive screening tests. We have received positive feedback from our IBD patients with better clinical response after proper management of their affective disorders.

Screening of depression and anxiety is one of the standard quality of care measures at Hershey Medical Center’s IBD clinic with a follow-up referral a to psychiatrist if needed.

With appropriate screening for affective disorders in IBD patients and optimal treatment of anxiety and depression, we anticipate encountering a reduction in these challenges.

Stay tuned for more data from Hershey Medical Center’s IBD clinic about causes and consequences of anxiety and depression in Inflammatory Bowel Disease.

President’s Message

How many ways can you help?

from page 1

understand the importance of in-office pathology, and hence, included it as an In-Office Ancillary Services Exception (IOASE). We copied the leaders of our national GI organizations (AGA, ASGE, ACG) in addition to highranking government officials. I am proud that our three national organizations agree and have contacted IBC to voice their concerns. Your PSG intends to pursue this issue further as necessary.

The PSG and I need you to do a few things to help:

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Renew your membership ASAP  numbers matter!

Get your partners, associates, and advanced practice providers to join the PSG.

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Encourage your GI fellows and residents to join the PSG (this is free to them).

Governor Wolf included a proposal for a 2.81% provider tax on Pennsylvania ambulatory surgical and endoscopy centers in his current budget proposal. We notified the Governor and our legislators that our PSG members oppose this net profit tax. We are collaborating with our physician colleagues and corporate sponsor, Physicians Endoscopy, who also oppose this tax that will result in decreased access to high quality, cost-efficient communitybased care and increase costs for patients, insurers, employers, and the Commonwealth of Pennsylvania.

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Recruit your colleagues from other GI practices.

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On the non-political front, thanks to countless hours of work by our devoted PSG staff, we have reorganized our Board positions and launched our new website. We have instituted a President’s e-Message so I can keep you more up-to-date with our fast-paced challenges and calls for action. Phase two of the website redesign is underway, thanks to our FIT, Eshan Navabi, MD (more of that in future communications). PSG leaders and staff have met with our corporate sponsors to identify how we can increase service to our patients and arranged an interview about the PSG that was published in the latest issue of EndoEconomics. We have coordinated organized conference calls with our leadership, established FIT responsibilities, increased our social media presence, and continue to work at keeping information on the website timely and up-todate. We are driven to accomplish as much as possible for all of us and our patients.

Contact your pharmaceutical and device reps for corporate sponsorship.

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Contact your pharmaceutical and device reps to support our meeting in Hershey.

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Visit our new PSG website at least weekly for updates.

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Read my President e-Messages.

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Activate your social media  open Facebook and Twitter accounts.

“Like” the PSG on your Social Media accounts.

Follow the PSG on your Social Media accounts.

Contact us if you need help with getting into Social Media (the future is now).

Send us feedback on how we can help you, your practice, and GI in PA.

We are the PSG, your organization, and your professional family. Contact us or me personally, as necessary, or just to be in contact. We look forward to hearing from, connecting with, and working for you in the months ahead.

Richard

PSG 777 East Park Drive PO Box 8820 Harrisburg, PA 17105-8820

Visit www.thehotelhershey.com for destination details.

Watch your mail in June for the registration brochure! www.pasg.org

PRSRT STD U.S. POSTAGE PAID HARRISBURG PA PERMIT NO. 922