Life Science Compliance Update

October 28, 2014

Physician Payments Sunshine Act: Medical Societies Express Strong Support for H.R. 5539 To Exclude Education Materials From Reporting


Last month we wrote about a bipartisan effort in Congress to exempt medical textbooks and journals, as well as indirect payments that pharmaceutical and device manufacturers offer to CME providers, from Sunshine Act reporting requirements. Click here for the text of H.R. 5539. Now, the AMA and dozens of physician organizations representing both national specialty societies and state medical societies have expressed their support of the bill. "H.R. is needed to ensure patients benefit from the most up-to-date and relevant medical knowledge," the letter states.

View the medical societies' letter to Representative Michael Burgess (R-TX), who introduced the bill. Allyson Schwartz (D-PA) co-sponsored. 

Congress outlined 12 specific exclusions from Sunshine Act reporting, including “[e]ducational materials that directly benefit patients or are intended for patient use.” In its interpretation of the statute, CMS concluded that medical textbooks, reprints of peer reviewed scientific clinical journal articles, and abstracts of these articles are not directly beneficial to patients, nor are they intended for patient use. "This conclusion is inconsistent with the statutory language on its face, congressional intent, and the reality of clinical practice where patients benefit directly from improved physician medical knowledge," states the letter.

The American Medical Association and other physician organizations have repeatedly stressed the importance of up-to-date, peer reviewed scientific medical information as the foundation for patient care. "Scientific peer-reviewed journal reprints, supplements, and medical text books have long been considered essential tools for clinicians to remain informed about the latest in medical practice and patient care," the letter states. "Independent, peer reviewed medical textbooks and journal article supplements and reprints represent the gold standard in evidence-based medical knowledge and provide a direct benefit to patients because better informed clinicians render better care to their patients."

Furthermore, the letter states that FDA's reprint guidance underscores the “important public health and policy justification supporting dissemination of truthful and non-misleading medical journal articles and medical or scientific reference publications.” H.R. 5539 clarifies that the Sunshine Act was designed to support the dissemination of this type of educational material.

The letter also addresses the Centers for Medicare and Medicaid Services (CMS) proposal to eliminate the continuing medical education exemption from the Act. "[This] proposal is inconsistent with the legislative history of the Sunshine Act and will further erode support of independent medical education," the societies note. "There is widespread consensus that the agency’s proposal will harm the dissemination of clinically relevant and critical medical knowledge that improves and enhances patient care. We strongly support the provisions in H.R. 5539 which would clarify that CME that meets the standard for independence must be exempt from Sunshine Act reporting." 

Click here for our article on the outpouring of support in favor of keeping the CME exemption. 


H.R. 5539 revises the Sunshine Act in the following way: 

Transparency Reports and Reporting of Physician Ownership or Investment Interests, Sec. 1128G. [42 U.S.C. 1320a-7h]

(B) Exclusions.—An applicable manufacturer shall not be required to submit information under subsection (a) with respect to the following:

(iii) Educational materials that directly benefit patients or are intended for patient use, including peer-reviewed journals, journal reprints, journal supplements, and medical textbooks;

(xiii) A transfer of anything of value to a covered recipient who is a physician if the thing of value is intended solely for purposes of providing continuing medical education to the physician.


November 04, 2013

AAFP Postpones NP and PA Membership

The American Academy of Family Physicians (AAFP) recently announced its intent to study whether nurse practitioners (NPs) and physician assistants (PAs) should -- or would want to -- become nonvoting members. AAFP's Congress of Delegates decided not to create a new dues-paying membership category for NPs and PAs.

According to Medpage Today, AAFP's Reference Committee on Organization and Finance believed the number of allied health professionals that belong to other primary care physician organizations is small and that "the implementation cost would be significant for the small number of members that join the AAFP." The Committee also expressed concern "about the divisiveness of the issue for the physician-based organization, and noted the difficulty of tracking NPs and PAs to ensure they are working with an active AAFP member," Medpage reported.

Ultimately, the reference committee recommend the resolutions be referred to the AAFP Board of Directors for further study. The Congress of Delegates agreed.

Outgoing AAFP President Jeffrey Cain, MD, told MedPage Today the NP/PA-membership issue has come up previously.

Thomas Weida, MD, of Hershey, Pa., the delegate who introduced the resolutions on NPs and PAs, said he wanted to provide the allied health professionals access to AAFP's continuing medical education (CME) opportunities. "The academy has been founded on CME, and I think our CME is a high quality," Weida told MedPage Today. "We can then start working together on developing solutions to the challenges that face patients in care delivery and patient-centered medical homes."

This idea is increasingly important as many of the pillars of healthcare reform include team-based care, collaboration, and integration among healthcare providers—whether through the patient centered medical home (PCMH) or Accountable Care Organizations.

Moreover, the significant increase and influx of patients that will have health insurance over the next few years coupled with an unaddressed physician shortage leaves the possibility that NPs and PAs will fill those gaps—making interprofessional CME even more appealing.

Interprofessional CME is already a reality on the CME stakeholder side, with several CME providers receiving dual accreditation for physicians, nurses and/or pharmacists. Thus, the framework to offer interdisciplinary CME is already in place and can only be enhanced and improved as physicians, NPs and PAs work closely together to use the skills and knowledge they can gain from such education. Moreover, interprofessional CME may also offer unique opportunities for these healthcare providers to interact and exchange ideas and best practices for managing patient care.

The head of the American Academy of Physician Assistants strongly supported the measure, Weida said. He added that he was pleased with the result of Tuesday's action. Weida said that he did expect the resolution "to be accepted this first time around" but "the pendulum will swing as we realize the value of working together." Despite the resolution not being adopted, the AAFP maintained that NPs and PAs must work in teams with physicians and not independently.

Incoming AAFP President Reid Blackwelder, MD, told the Congress of Delegates in an address Monday that family physicians must work together -- not against -- NPs and PAs to meet patients' needs.

"Perhaps one of the most important aspects of this discussion is to recognize that ultimately the scope-of-practice issue is not a battle, it's not us against them, it's not good or bad, it's not right or wrong, even though this is often how the discussion is framed," Blackwelder said. "The truth is that each member of the team is critical and has important roles to play, but we are not interchangeable."


October 11, 2013

Electronic Health Records: Physician Organizations Requesting One Year Delay in Meaningful Use Stage 2 Requirements and Penalties

As both congressional chambers debate reopening of the goverment, budgets and whether to defund all or pieces of the Affordable Care Act (ACA), healthcare reform continues to be implemented in various areas, such as electronic health records (EHRs) and the meaningful use program. Over the last several weeks, various healthcare stakeholders and groups have expressed their concerns over the implementation deadlines of the Meaningful Use stages as well as other aspects of the program that may be burdensome to physicians and their staff.

As a brief refresher: Under the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act (part of the Recovery Act), hospitals and healthcare providers must be able to demonstrate by 2015 that their EHR systems are capable of certain tasks that constitute "meaningful use."

Currently, to receive a payment, providers must meet 19 of 24 "meaningful use" objectives that include electronically tracking patients' medications and allergies, sending reminders, sharing lab test results and producing summaries of a patient's office visit. The Centers for Medicare& Medicaid Services (CMS) oversees the incentive program.

More than 3,750 hospitals have received a total of $8.8 billion in "meaningful use" incentive payments as of July, according to the CMS website.

Concerns About Meaningful Use

For example, FierceEMR reported that the American College of Physicians recently sent a letter addressed to federal health officials saying that the "very aggressive" timeline and "overly ambitious" objectives of Meaningful Use Stage 2 threaten to limit the success of the overall program.

In the letter—sent to U.S. Department of Health & Human Services (HHS) Secretary Kathleen Sebelius, Centers for Medicare& Medicaid Services (CM) Administrator Marilyn Tavenner and National Coordinator for Health IT Farzad Mostashari—ACP Medical Informatics Committee Chair Peter Basch added that relying on "evolving and draft standards" and untested technology could create "unintended consequences" and "additional costs" for physicians.

"As Meaningful Use has become more prescriptive of certain workflows, it has become less relevant to internal medicine subspecialists," Basch writes. "We are concerned that subspecialists may not adopt and fully realize the potential of certified [electronic health record] products if the requirements of the program do not allow for the unique workflows required by some subspecialists." The letter outlines five areas of concern for ACP members, including:

  • The Stage 2 timeline: ACP recommends an extension of at least one year or "perhaps even longer" for Meaningful Use Stage 2. "The implementation of software by a practice does not mean that the practice is prepared to use it appropriately or to make the care process changes needed to accomplish the objectives," Basch says.
  • Clinical quality measures: ACP believes that the clinical quality measures reporting process won't be ready in time for Stage 2. According to Basch, there hasn't been "sufficient time either for the new e-measures to be tested and validated, or for a determination if the output of the EHR systems is an accurate representation of the performance of the [eligible providers]."
  • ICD-10 and physician quality reporting systems: The implementation of the former means that physicians will need new or updated EHR systems on Jan. 1, 2014, to comply with data collection requirements for the latter.
  • Scoring Meaningful Use measures: ACP calls the "pass-fail" requirements "counter-productive." Basch says that a "partial scoring" or "tiered" system would be more fair and representative of what providers can realistically accomplish. "Not every measure is absolutely appropriate and of equal value to every practice situation," he adds.
  • Planning for Stage 3: ACP believes that "deeming" should be the "preferred pathway" for most providers in achieving Stage 3 of Meaningful Use. "There are better ways for EPs to prepare for and to deliver better outcomes than logging activities that may or may not have direct impact on the quality, safety or value of care," Basch says.

In addition to the ACP's latter, the Medical Group Management Association (MGMA) asked HHS last month to extend reporting for Stage 2 by at least one year and delay the penalties to be imposed on providers who are not meeting the Meaningful Use requirements, as reported by FierceEMR. The CEO of MGMA, Susan Turney, told Secretary Sebelius that while there are more than 2,200 products and almost 1,400 "complete EHRs certified under the 2011 criteria for ambulatory eligible providers, there are only 75 products and 21 complete EHRs for Stage 2 criteria."

"This lack of vendor readiness has significant implications for EPs," and "without the appropriate software upgrades and timely vendor support, EPs will be unable to meet the Stage 2 requirements and thus will be unfairly penalized starting in 2015," Turney wrote. MGMA also called for an extension for providers on the reporting period for Stage 2 incentives from 90 days to one year, as well as an extended reporting period for Stage 1 incentives for providers whose EHR has not been re-certified by January 2015 for the Stage 2 criteria.

The American Academy of Family Physicians (AAFP), also asked federal health officials for a one-year extension to the time frame for compliance with Meaningful Use Stage 2, saying that the current time frame "will outstrip the capacity" of both vendors and family doctors. AAFP Board Chair Glen Stream, M.D., said that such an extension would create "three distinct cohorts:"

  • Cohort 1, which would include eligible professionals attesting to Meaningful Use in 2014 as their first payment year;
  • Cohort 2, which would include EPs attesting to Meaningful Use in 2014 as their second payment year, and;
  • Cohort 3, which would comprise EPs attesting to Meaningful Use as their third or fourth payment year

As reported by FierceEMR, EPs in each of the cohorts under AAFP's proposal would be required to follow specific but distinct timelines for Meaningful Use reporting to receive their bonus payments.

"This modified timeline would allow exemplar practices to implement Meaningful Use Stage 2 requirements early in 2014 and for their experience and learnings to be leveraged by vendors, implementers and other providers to optimize subsequent transitions," Stream said. "Pressure would be kept on vendors to be ready for Meaningful Use Stage 2 by Jan. 1, 2014, while distributing the strain of conversion of vendor product and physician workflow over a 21-month period rather than a nine-month period."

In addition to these letters, Seventeen Republican senators urged HHS to extend the deadline Stage 2 of the Meaningful Use Incentive Program.

The senators—led by John Thune (S.D.), chair of the Senate Republican Conference, and Lamar Alexander (Tenn.), ranking member of the Health, Education, Labor and Pensions Committee--sent a letter Sept. 24, to Secretary Sebelius, asking for a one-year extension "for providers who need extra time to meet the new requirements." The senators expressed three key concerns with the current timeline:

  • Significant timeline pressure
  • A widening of the "digital divide" for small and rural providers 
  • Serious unintended consequences of the rush, such as stifling innovation and increasing medical errors

The senators asked Sebelius to respond by October 8th.

Back in July 2013, Sen. Orrin Hatch (R-Utah) in called for HHS to pause and reassess the program. Hatch's statement came during a Senate Finance Committee hearing, which focused on health IT. National Coordinator for Health IT Farzad Mostashari, who attended the hearing, defended the program, testifying that the Meaningful Use objectives are "strongly aligned with other policy drivers to help" the healthcare system to become safer and more efficient. When asked by Hatch if a break from the program would be a good idea, Mostashari responded that doing so would interrupt momentum being built, reported FierceEMR.

Patrick Conway, chief medical officer at CMS, agreed with Mostashari, testifying that increased EHR adoption will improve the quality of care for CMS beneficiaries. "EHR data can be used to display information in ways that are beneficial for providers and their patients. … By providing tools and incentives for EHR adoption, quality reporting, e-prescribing and patient engagement in their healthcare, CMS is encouraging clinicians, hospitals and beneficiaries to use HIT as a platform for improved healthcare quality and better health outcomes at lower cost."

In addition to this testimony, four hospital Chief Information Officers (CIOs) representing the College of Healthcare Information Management Executives (CHIME) expressed their concern, about increasingly rigorous demands and shorter deadlines in Meaningful Use Stage 2. The CIOs called for a one year extension for Meaningful Use Stage 2.

FierceEMR noted that a majority of hospital CIOs recently polled by in late May called the Meaningful Use program flawed, agreeing with CHIME's request for a one-year extension. CHIME's proposal came in response to a call in April from six GOP senators to reboot the Meaningful Use incentive program.

"The biggest issue … is that we just don't have enough time to implement and exercise the 2014 certified software," said Pamela McNutt, CIO of Dallas-based Methodist Health System.  "All of the objectives listed as challenges require significant work to implement after upgrading … For example, after delivery of the patient portal we will have to map data elements from the patient record and clinical staff will need to ensure that the data is representing accurately."

Others expressed concern about funding, noting that small and rural hospitals already make ends meet on "razor-thin margins." In fact, Reuters reported on a recent study, which found that small and rural U.S. hospitals are most at risk of not satisfying certain federal requirements for using electronic health record systems.

In this new study, lead author Catherine DesRoches, from Mathematica Policy Research, collaborated with the American Hospital Association (AHA) and analyzed Medicare data to see which types of hospitals were receiving incentive payments indicating progress toward the meaningful use goals.

Between 2011 and 2012, the researchers found, the percentage of hospitals nationwide receiving incentive payments more than doubled from about 17 percent to about 37 percent.

But considerable disparities among hospital types and regions have emerged, the researchers report in the journal Health Affairs. Hospitals in the Northeast were most likely to receive incentive payments, compared to those in other parts of the country, with the West trailing. In 2012, 47 percent of Northeast hospitals got the payments, followed by 41 percent of hospitals in the South, 32 percent in the Midwest and just under 29 percent in the West.

Teaching hospitals were more likely to receive federal incentive payments than nonteaching hospitals, and for-profit hospitals more likely to receive the payments than not-for-profits. Less than 30 percent of government-owned hospitals got the incentives in 2012.

In all categories, as the number of beds at facilities got smaller, the percentage of hospitals receiving payments dropped.

More than half of the hospitals with 200 or more beds received incentive payments, compared to just about 27 percent of hospitals with fewer than 100 beds. And just 10 percent of critical-access hospitals received the incentives in 2012.

These smaller hospitals may have difficulty coming up with the financial resources to implement an EHR system meeting the requirements, they may have trouble attracting the proper support staff to manage the EHRs and they may also have trouble competing with larger clinics for the systems, the study authors point out.

There have been "infrastructure issues" when it comes to smaller and critical-access hospitals, according to Kimberly Lynch, director of the Regional Extension Center (REC) Programs at the Office of the National Coordinator for Health IT in Washington, DC.



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