Life Science Compliance Update

May 25, 2016

Veterans Affairs Committee Hearing on VA-Established CME

On Tuesday, May 24, 2016, the United States Senate Committee on Veterans' Affairs held a hearing on pending legislation before the Senate. One of the bills discussed was Senate Bill 2049, a bill introduced by Senator Sherrod Brown (D-OH).  S. 2049 is a bill to "establish in the Department of Veterans Affairs a continuing medical education program for non-Department medical professionals who treat veterans and family members of veterans to increase knowledge and recognition of medical conditions common to veterans and family members of veterans, and for other purposes." There is also a companion bill in the house HR 2850 sponsored by Congressman Patrick Tiberi (R-OH).

Panel I Testimony

Department of Veterans Affairs Deputy Secretary Sloan D. Gibson, offered testimony on the bills and what kind of effect he felt they would have on the VA and its operations. Of S. 2049, however, he spoke highly of it. He mentioned that the "VA supports efforts to share continuing medical education (CME) programs for non-VA medical providers who treat Veterans and their family members under laws administered by VA, and runs several programs of the type referenced in S. 2049." He mentioned the VA-established VHA Training Finder Real-time Affiliate Integrated Network (TRAIN), which is an external learning management system that provides Veteran-focused, accredited CME at no cost to community healthcare providers. VHA TRAIN reports more than 7,600 completions from healthcare and public health providers.

Panel II Testimony

Carlos Fuentes, a Senior Legislative Associate for Veterans of Foreign Wars (VFW), testified as to his opinion on the effectiveness of some of the proposed bills as well. He and VFW both support S. 2049. In his testimony, he stated that passage of such bill would "ensure community care providers who care for veterans and their families understand how to provide veteran-centric care." He further mentioned that more than two thirds of all physicians in the country have received some form of training through the VA healthcare system and that this bill would ensure that the VA is able to continue training both our current, and future, healthcare workforce.

Lou Celli, the National Director of Veterans Affairs and Rehabilitation at The American Legion also spoke positively about the legislation, stating that this bill would "ensure effective treatment for veterans who seek their health care outside the VA health care system." He noted that programs created under this legislation would enhance non-VA medical professionals' knowledge of the "medical, mental and physical conditions veterans experience based on their military service, which can represent a unique spectrum when compared to non-veterans."

Adrian Atizado, the Deputy National Legislative Director for Disabled American Veterans (DAV), expressed some concern with the bill as currently written. He is concerned that currently the VA does not provide continuing education credits for its own professional workforce and that current law provides "a discretionary authority for VA to reimburse VA physicians not more than $1,000 per year for obtaining continuing education credits, but does not do so for other professional disciplines." He believes that prohibiting VA professionals from being able to participate in the program laid out in the bill "raises an equity and fairness question in policy." He also mentioned concerns that if thousands of practitioners participate in the proposed program, that it could "become the source of a significant shift in funding from the direct care provided to veterans within the VA, while placing substantial new pressure on VA's already overburdened information technology system." While he did not mention DAV's opposition to the bill, he asked the Committee to address those issues.

Carl Blake, the Associate Executive Director of Government Relations at Paralyzed Veterans of America (PVA), spoke on behalf of the organization in support of the bill. He noted that veterans suffer from a wide range of medical issues that are not experienced by the vast majority of the American population and that continuing medical education geared toward veterans' issues would help to prepare medical professionals to provide more effective care for veterans.

Overall there was favorable testimony for the VA to dedicate resources towards education of community based clinicians on the needs of Veterans and their families.

May 20, 2016

Senator Durbin Asks Medical Associations to Endorse Mandatory Opioid CME – AMA Shows Interest

Following last month's letter to the Pharmaceutical Research and Manufacturers of America (PhRMA), asking the group to "take financial responsibility for the drug industry's role in curtailing the opioid overdose epidemic," United States Senator Dick Durbin sent a letter to four physician associations asking them to endorse mandatory CME programs.

The letter, which was sent to the American Medical Association (AMA), the American Academy of Family Physicians (AAFP), the American College of Emergency Physicians (ACEP), and the American Dental Association (ADA), noted several steps the Senator feels as though the associations can take to address the opioid epidemic. While the letters all had the same goal and the same roadmap to get there, each one was individually focused on the addressed association, using their mission statements to reach out and personalize his prayer for support.

Sen. Durbin believes that "the increased frequency with which prescription opioids have been prescribed in recent years has played a major factor in our nation's escalating heroin epidemic, including an alarming increase in opioid-related emergency room visits, opioid-related treatment admissions for abuse, and opioid-related overdose deaths." He cited statistics, including the statistics that the United States accounts for almost 100% of the world total consumption of hydrocodone and 81% of the world total consumption of oxycodone.

He believes that the best way to reduce the number of Americans who suffer from opioid addictions is to ensure that patients never become addicted in the first place.

Senator Durbin believes that the associations each can address the opioid and heroin crisis by "supporting evidence-based interventions." In part, he recommended that the AMA could prioritize helping physicians be more judicious in their prescribing patterns, while working to protect access for those who need opioids to manage their pain.

Several of the steps Senator Durbin mentioned in his letters to the associationswere: endorsing mandatory continuing medical education programs for opioid prescribers; supporting initiatives that require physicians to check prescription drug monitoring programs before prescribing painkillers to patients; and supporting increased transparency in physician prescribing practices and proper intervention for those who may be outliers.

Senator Durbin, in his letter, does acknowledge that there are "many patients suffering from acute and chronic pain" and that "doctors face a challenge in evaluating its existence or severity," since pain is always subjective.

Durbin HealthExec Interview

After publishing his letters, Senator Durbin participated in an interview with HealthExec, where he was asked whether or not he had heard from doctors that what he's asking of the associations would actually help. He responded, saying that he has heard from doctors in both directions. He believes that doctors who say it isn't their fault, that they try to keep their patients happy and satisfied, aren't providing a good answer, or doing their job. He believes that they "have to make certain they're doing what's medically necessary, number one, and do no harm to the patient."

In the interview, Senator Durbin did not appreciate the idea of training new professionals to not prescribe opioids en masse, though. He feels as though there should be some responsibility taken by current physicians, and some actions to rectify the current situation.

AMA Response

Following receipt of the letter from Senator Durbin, AMA President Steven Stack, MD, penned an open letter to medical professionals to "play a lead role" in reversing the rise in opioid addiction, but did not endorse the standards that were advocated in Sen. Durbin's letter.

Instead of endorsing mandatory continuing education programs, however, Stack endorsed ideas such as: avoiding prescribing opioids for new patients who have chronic pain unrelated to cancer; to register and use Prescription Drug Monitoring Programs (PDMPs); and work on reducing opioid exposure to patients who are already on chronic opioid therapy when the risks exceed the benefits.

Interestingly, on May 17, 2016, Inside Health Policy reported that the AMA is starting to warm up to the idea of mandatory opioid prescriber education tied to DEA registration. This is a huge change from before, when the AMA tended to focus on an alternative approach because they felt as though mandatory CME was too "one size fits all."

May 18, 2016

E&C Committee Hearing on CMS Medicare Part B Demonstration

The United States House Committee on Energy and Commerce, Subcommittee on Health held a hearing on Tuesday, May 17, 2016, on the Centers for Medicare & Medicaid Services (CMS) proposed rule for Part B reimbursement rates. The hearing, titled "The Obama Administration's Medicare Drug Experiment: The Patient and Doctor Perspective," heard from witnesses including Debra Patt, MD, MPH, MBA; Marcia Boyle, the President and Founder of the Immune Deficiency Foundation; Michael Schweitz, MD, FACP, MACR National Advocacy Chair for the Coalition of State Rheumatology Organizations (CSRO); Heather Block, a patient advocate; and Joe Baker, the President of the Medicare Rights Center.

Issue Background

On March 8, 2016, CMS issued a proposed rule that has the potential to dramatically change the way many Part B administered drugs are reimbursed. Not only would the program affect the statutorily set reimbursement rate from 6% to 2.5% plus $18, but it would also impose untested purchasing arrangements.

It is also important to note that the changes proposed do not take into account the changes that are being proposed under the Medicare Access and CHIP Reauthorization Act (MACRA).

Representative Larry Bucshon, M.D., has also introduced a bill, H.R. 5122, in an attempt "to prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models," which was also discussed at the hearing.

The hearing showed the true divisiveness of Congress: the Republicans tended to oppose the model (as evidenced by the introduction of Rep. Bucshon's bill), whereas the Democrats were more likely to support the model.

Opening Statements

In his opening statement, Subcommittee Chairman Joseph Pitts expressed concern about unelected officials making decisions behind closed doors to take healthcare away from seniors, as well as concerns about the lack of stakeholder ability to weigh in on Phase II value-based purchasing proposals because they are too vague.

Subcommittee Ranking Member Gene Green, in his opening statement, stated that the loudest voices are the ones that oppose the proposal and that all issues deserve to be thoroughly evaluated before a decision was made. Full Committee Ranking Member Frank Pallone confessed that he thought the proposal was "imperfect," but that he had faith in the administration to listen to concerns prior to finalizing the demonstration.

Witness Testimony

Dr. Debra Patt referred to the model as an "experiment," that it was clinical research without an "opt out" for patients. She believes that this model would prevent patients from having access to treatments with known survival advantages, which would likely lead to higher death rates and lower quality of life for patients suffering severe ailments. She believes that the demonstration would lead physicians to acting in ways contrary to patient's best interests.

Dr. Michael Schweitz believes that the demonstration was ill-considered and that there is no data to support the idea that add-on payments impact prescribing behavior. His concerns did not stop there, however. He also expressed concerns about the model, including: the lack of consideration for sequestration; hardships that smaller practices currently face; and the vagueness of Phase II.

Marcia Boyle was also not too favorable of the proposal, expressing concern that the proposal tested value initiatives without defining what value means, and how to ensure that the initiation of value-based alternatives does not reduce patient access.

Heather Block shared her personal story and background with cancer and voiced support for the demonstration model while voicing skepticism for a model that rewards prescribing medications that cost more money. She noted that one of the proposed value based purchasing tools actually eliminated beneficiary co-payments and hoped that proposition would be included in the rule.

Joe Baker also supported the model, but also noted the importance of preserving access and allowing prescribers to retain control over which medications they feel are right for patients. He stated that his organization had some concerns about the model, but had voiced practical solutions that could be implemented alongside it.

Panel Discussion

Patient Access

A large portion of the hearing focused on the demonstration's impact on patient access. A lengthy list of Representatives expressed concern about the ability of patients to receive needed treatments in areas where the model has pricing reforms preventing doctors from being able to afford the drugs. Ms. Block, a patient advocate, however, made known that she and her personal physician got together and read the regulation; neither one of them felt that any specific part of the demonstration would give rise to issues with patient access.

Stakeholder Engagement

Another contentious issue discussed in the hearing is that of stakeholder engagement. Republican representatives bemoaned the lack of engagement and transparency in the development of the model, and used that oversight and lack of participation as reason to repeal the demonstration. Democrats, on the other hand, didn't find lack of previous engagement as much of a deal breaker, provided going forward, CMS involves stakeholders as it refines the demonstration prior to finalization.

Size/Scope of the Model

Throughout the hearing, Republican lawmakers continued to equate the demonstration to a clinical trial, voicing concerns that for all the similarities, the demonstration did not have adequate beneficiary safeguards the way traditional clinical trials do. Representative Michael Burgess opined that through a national demonstration, seniors would essentially be forced into a mandatory test without their consent. Dr. Pratt also pointed to differences: that the model had no adverse events follow up, no informed consent, and likely would not pass institutional board review.

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