Dec. 8, 2016
Issue SpotlightCongress passes 21st Century Cures bill
The Senate this week completed consideration of the "21st Century Cures Act," approving the bill by a vote of 94 to 5. The House last week passed the bill 392 to 26. After several years of hearings, meetings and negotiations, and with bipartisan support from Congress and the White House, the $6.3 billion medical innovation package is intended to accelerate the discovery, development and delivery of new therapies, including $1 billion to assist states in addressing the opioid epidemic.
As with any legislative package of this size, there are provisions which have the support of physicians and provisions that raise some concerns. However, in the interest of advancing the many positive elements of the final bill, the AMA is in support of the final product.
One AMA-supported provision that would have clarified Sunshine Act reporting obligations for medical reprints and continuing medical education, for example, was struck during final negotiations.
Some of the elements in the bill are supported by AMA policy. It includes $4.8 billion in funding for the National Institutes of Health (NIH) and additional funding for Vice President Biden's Cancer Moonshot initiative. The Precision Medicine Initiative and the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) programs also received funding in the wide-ranging package.
Importantly, $1 billion will be distributed to states over two years to assist in addressing the epidemic of opioid misuse and abuse. Significant funding is also included for many elements of the Helping Families in Mental Health Crisis Act, intended to make improvements to the nation's mental health system.
Other provisions in the bill include:
- Funding for the U.S. Food and Drug Administration (FDA) to meet its various priorities and obligations.
- More protections for human participants in clinical research and provisions to streamline and simplify Institutional Review Board (IRB) requirements.
- Requiring that Medicare Advantage and Medicare Part D plans provide beneficiaries with an option to change plans during the first three months of the benefit year.
- New authority for the U.S. Department of Health and Human Services (HHS) Office of the Inspector General to investigate and penalize acts of information blocking—the first financial penalties that can be directed at electronic health record (EHR) developers and vendors.
The AMA supports a provision excluding those who furnish most of their Medicare services at ambulatory surgical centers from penalties under the EHR Meaningful Use program and from the Merit-Based Incentive Payment System (MIPS) under the Quality Payment Program.
Addressing physician reporting burdens, the bill also allows physicians to delegate certain EHR documentation requirements to non-physician staff. Key interoperability problems were also tackled in the bill by establishing a directory of health professionals so that physicians can easily contact each other.
National UpdateAMA-supported Project ECHO legislation headed to president
The Senate on Nov. 29 passed the Expanding Capacity for Health Outcomes (ECHO) Act (S. 2873/H.R. 5395), which was introduced by Sens. Orrin Hatch (R-Utah) and Brian Schatz (D-Hawaii), by a vote of 97 to 0. The legislation, which was introduced in the House by Reps. Michael Burgess (R-Texas) and Doris Matsui (D-Calif.), was passed by the House Dec. 6 on a voice vote.
Project ECHO is an innovative model that harnesses the power of new technologies to ensure that patients in hard-to-reach regions have access to high-quality health care by connecting health care professionals with specialists for case-based learning, dissemination of best practices and outcomes evaluation.
The bill would direct HHS to study the potential of the technology to address workforce challenges, implement public health programs and deliver care in rural and underserved areas.
Last week, the conference agreement for S. 2943, the "National Defense Authorization Act for Fiscal Year 2017" (NDAA), was released. Language that was included in the Senate-passed version of the bill, which would have altered the location of the practice of medicine for certain telemedicine services provided to TRICARE beneficiaries from the location of the patient to the location of the physician, was not included in the final version of the NDAA.
The earlier proposed change would have allowed health care services to be provided to patients at locations where the provider was not licensed to provide care. The AMA, along with the Federation of State Medical Boards and state and national physician specialty medical societies, strongly opposed this provision and worked to ensure its deletion from the final bill. The House passed the NDAA Dec. 2, and the Senate is expected to approve the measure this week.
Many physicians have experienced frustration with the EHR Meaningful Use program. Members have noted that two of the measures that directly contribute to workflow problems are the requirements for computerized physician order entry (CPOE) and clinical decision support (CDS). These measures focus on the number of orders entered into an EHR, mandate who may enter the orders and arbitrarily demand that physicians implement CDS tools without assurance of relevance or utility.
Following years of advocacy by the AMA, the Centers for Medicare and Medicaid Services (CMS) has removed the CPOE and CDS measures from the Meaningful Use program and the Advancing Care Information (ACI) component of the Quality Payment Program (QPP).
While CPOE and CDS functionality will still be included in EHRs, CMS will no longer require a certain number of orders, that a physician enter the orders, and that physicians implement a certain number of CDS tools. This means that as of Jan. 1, physician practices are free to develop policies around CPOE and CDS in ways that blend with their workflows and improve care.
After months of deliberation and work with key stakeholders, including the AMA, the FDA recently announced an indefinite delay in releasing final guidance for the regulation of laboratory-developed testing services (LDT). If finalized, the guidance would significantly change the way many clinical tests are regulated, requiring many to go through a time-intensive and financially burdensome FDA approval process.
The AMA has been working closely with the FDA, Congress and other stakeholders to determine the appropriate oversight structure for these important tests and has strongly advocated for oversight to remain with the Centers for Medicare and Medicaid Services (CMS), which regulates laboratory testing under the Clinical Laboratory Improvement Amendments (CLIA).
For now, oversight of these tests will remain with CMS-CLIA until further action either by Congress or the FDA to regulate testing services. No such action is pending.
State UpdateRegister now for the State Legislative Strategy Conference in January
Join physician leaders and medical society staff at the 2017 AMA State Legislative Strategy Conference at the Ritz-Carlton in Amelia Island, Fla.
This year's conference will include sessions on:
- Provider networks
- Prior authorization
- Gun violence
- Health care consolidation
- Rising drug costs
- Opioid-related laws
The conference begins Thursday, Jan. 5, at 2 p.m., and concludes noon, Saturday, Jan. 7. Saturday will feature two interactive state advocacy strategy workshops focused on prescription drug costs and new opioid laws and policies. Please consider the schedule when making your travel plans to ensure that you can stay for the duration of Saturday's program.
Thursday will offer a series of strategy workshops where you can hone your advocacy skills and strategies with colleagues, state legislators, pollsters and grassroots directors.
Don't miss this opportunity to share your organization's priorities, concerns and tactics with advocacy leaders from across the country, and to discuss the challenges and opportunities likely to be part of your upcoming legislative sessions.
Register today and make your hotel reservation. With a new president about to enter the White House, this year's event promises to be especially relevant and helpful in expanding your understanding of what 2017 may hold.
The AMA and the Medical Association of the State of Alabama have released a physician-focused toolbox of data, education and other resources to aid physicians in their continued fight against Alabama's epidemic of prescription drug misuse, overdose and death. The toolbox was made possible, in part, by a Providers' Clinical Support System for Opioid Therapies grant from the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA).
"Although Alabama is no longer the top prescriber of opioids in the country, we still have a very long way to go as far as educating our physicians and other prescribers how to properly handle the prescription of opioid pain medication and those patients that require that medication," said Medical Association of the State of Alabama Executive Director Mark Jackson. "This toolbox will help physicians not only educate patients about pain, but also provide resources for overdose prevention and treatment."
"This toolbox contains the types of data and resources that physicians can rely on to help improve their practices for their patients," said Gerald Harmon, MD, chair-elect of the AMA Board of Trustees, who joined the Medical Association of the State of Alabama in Birmingham to release the toolbox.
"We recognize that we have much more to accomplish," he said, "but physicians in Alabama and across the nation already have made important strides to reverse the nation's opioid epidemic, and using these resources will help physicians continue that progress."
Alabama, along with Rhode Island, are the only two states in this grant. These states were chosen due to many factors, including high rates of opioid-related harm as well as diverse demographic, socioeconomic, geographic and other characteristics. The characteristics offer excellent opportunities to study the implementation of the toolbox, refine it and potentially use it as a model for other states that want to undertake similar efforts.
The Alabama toolbox has been added to Alabama's Smart and Safe website, and the toolbox can be found on the Web.
Other NewsNew FAQs on ACA Section 1557 compliance
Following the release of the final rule implementing Section 1557 of the Affordable Care Act (ACA), the AMA has been working with the HHS Office of Civil Rights (OCR) to communicate physician concerns and questions.
Five new FAQs (Nos. 21 – 25) on Section 1557 were recently posted by OCR. The questions relate to posting requirements, examples of "small-sized" documents, examples of documents not considered "significant publications and communications," and information about whether a Notice of Privacy Practices (as required under the Health Insurance Portability and Accountability Act, or HIPAA) and a written Summary of Benefits and Coverage and its addendum are considered "significant" under Section 1557.
The AMA has developed materials related to Section 1557's requirements, including information about how a language access plan can assist physicians with limited English proficiency (LEP) compliance and clarifications about misunderstandings of the rule's sex discrimination prohibitions.
The HHS OCR recently issued a listserv announcement warning covered entities and their business associates about an email that disguises itself as an official communication from HHS. The email, commonly known as a "phishing" email, prompts recipients to click a link regarding possible inclusion in the HIPAA Privacy, Security, and Breach Rules Audit Program and directs individuals to a nongovernmental website marketing a firm's cybersecurity services.
The phishing email originates from the email address OSOCRAudit@hhs-gov.us and directs individuals to a URL at www.hhs-gov.us. This is a subtle difference from the official email address for the HIPAA audit program, OSOCRAudit@hhs.gov. Such deviousness is typical in phishing scams.
In no way is the firm associated with HHS or OCR. In the event that you or your organization has a question about the legitimacy of an apparently official communication from the agency regarding a HIPAA audit, please contact OCR via email OSOCRAudit@hhs.gov.
Physicians who see Medicare patients have until Dec. 31 to make changes to their participation status for 2017. Updated information describing Medicare participation options and frequently asked questions is available for download.
Although many physicians are appropriately focused on preparing for the new Quality Payment Program (QPP) in 2017, the QPP will not affect physicians' Medicare payment rates and participation decisions until 2019. Rather, for 2017, payment adjustments will be determined by physicians' 2015 participation in the existing Medicare payment programs: the Physician Quality Reporting System, EHR Meaningful Use and the value-based modifier.
Those facing penalties in 2017 due to these programs may want to review the AMA's "Know Your Options" guide options before the deadline.
For those physicians who are using an eClinicalWorks (eCW) EHR in their practice, an announcement was sent out by eCW regarding the need to update your EHRs as a matter of patient safety. Just like the software you use on your personal computers or mobile devices, occasionally EHR updates are required.
If you have not done so lately, check your EHR version number against your vendor's most recent software update. If you are unsure of your version number, check with your EHR vendor. Any physician experiencing safety issues or unexpected software functions should notify their EHR vendor.
The Office of the National Coordinator for Health Information Technology (ONC) has also created a website where you can report EHR safety issues. More information on eCW's announcement can be found on the eClinicalWorks website. The ONC's website offers a chance to share your health IT concerns or complaints.
In a move that closely follows advice offered by the AMA, Medicare officials have modified an earlier list of patient relationship categories they are constructing to improve their ability to accurately attribute costs of care to particular physicians and then compare costs among physicians.
The AMA suggestions were developed with assistance of a joint CPT/RUC workgroup that was formed to evaluate potential patient relationship categories that the Centers for Medicare and Medicaid Services (CMS) offered for comment in April. They laid out four broad categories of physician-patient relationships based on whether the care is continuous or episodic and whether it is broad or focused along with a potential fifth category for physicians providing care ordered by another physician.
CMS's revised document adopts these recommendations along with another AMA suggestion that the categories could be indicated on claims forms using a modifier rather than a new code. Comments should be sent to email@example.com by Jan. 6.
Development of these categories along with new patient condition categories and cost measures based on episodes of care was required under the Medicare Access and Chip Reauthorization Act (MACRA), which gives physicians the option of participating in a qualified alternative payment model or a Merit-Based Payment Incentive System (MIPS) that will replace current value-based payment program. Under MIPS, physicians will be judged based on a composite score that includes four categories: quality, costs, practice improvement activities and use of electronic records. The score will first affect payments in 2019 but will be based on performance in 2017.
The AMA has called for pilot testing of all of the new cost measures and tools prior to their use in MIPS. CMS responded by eliminating cost as part of the composite performance scores in the first year of MIPS. The AMA continues to push for pilot tests prior to making costs part of the composite score.
The AMA and California Medical Association will host an additional MACRA educational seminar similar to the Atlanta seminar that took place in November. The event will take place in San Francisco at the Marriott Marquis, Nob Hill Ballroom, 780 Mission St., at 9:30 a.m. PST. This seminar is also available to stream or via webinar. Register and learn more.
Jan. 5 – 7, 2017:
The AMA State Legislative Strategy Conference, described earlier, is where physician leaders and medical society staff meet to discuss state-related legislative issues. The meeting will take place at the Ritz-Carlton in Amelia Island, Fla., and feature keynote speaker Mike Leavitt, former HHS secretary and former administrator of the Environmental Protection Agency. Leavitt was governor of Utah from 1993 – 2003. Learn more and register.
Feb. 19 – 21, 2017:
Whether you want to run for public office or campaign for a candidate who supports issues that are important to medicine, AMPAC (the AMA's bipartisan political action committee) offers the hands-on training you need. The Candidate Workshop is designed to help you make the leap from the exam room to the campaign trail and give you the skills and strategic approach you will need to make a run for public office. Excluding travel, AMPAC covers all expenses for AMA members who are accepted. Learn more or apply today.
Feb. 27 – March 1, 2017:
The 2016 National Advocacy Conference will take place in Washington, D.C. Participants in this year's conference will gain important insights from industry experts, political insiders and members of Congress. Conference participants will leave more well informed and empowered to advocate for patients, the medical profession and the future of health care. Learn more and register today.