Oct. 4, 2018
Issue SpotlightCongress passes new opioid package
Congress has reached agreement on legislation to address the opioid epidemic. The House passed H.R. 6, the "SUPPORT for Patients and Communities Act," by a vote of 393 to 8, and the Senate followed suit, passing H.R. 6 by a vote of 98 to 1. President Donald Trump is expected to sign the bill into law. The legislation touches on almost every aspect of the epidemic. It includes numerous provisions supported by the AMA that will expand access to substance-use disorder (SUD) prevention and treatment programs. Some of the significant AMA-supported provisions would:
- Expand existing programs and create new programs to prevent SUDs and overdoses, including reauthorization of the Office of National Drug Control Policy.
- Expand programs to treat SUDs, including medication-assisted treatment (MAT); partially lift (for five years) a current restriction that blocks states from spending federal Medicaid dollars on residential addiction treatment centers with more than 16 beds by allowing payments for residential substance-use disorder services for up to 30 days; and allow Medicare to cover MAT, including methadone, in certain settings, to treat SUDs.
- Increase funding for residential treatment programs for pregnant and postpartum women; and require the Centers for Disease Control and Prevention (CDC) to develop educational materials for clinicians to use with pregnant women for shared decision making regarding pain management during pregnancy.
- Authorize an alternative payment model demonstration project developed by the American Society of Addiction Medicine, with support from the AMA, to increase access to comprehensive, evidence-based outpatient treatment for Medicare beneficiaries with opioid-use disorders.
- Authorize CDC grants for states and localities to improve their Prescription Drug Monitoring Programs (PDMP), collect public health data, implement other evidence-based prevention strategies, encourage data sharing between states, and support other prevention and research activities related to controlled substances, including education and awareness efforts.
- Expand the use of telehealth services for Medicaid and Medicare SUD treatment.
- Provide loan repayment for SUD-treatment professionals, including physicians, who agree to work in mental health professional shortage areas (HPSAs) or counties that have been hardest hit by drug overdoses, and clarify that mental and behavioral health providers participating in the National Health Service Corps can provide care at a school or other community-based setting located in a HPSA as part of their obligated service requirements.
- Help stop the flow of illicit opioids into the country by mail, especially synthetic fentanyl and its analogs.
- Provide funding to encourage research and development of new non-addictive painkillers and non-opioid drugs and treatments.
- Require the U.S. Department of Health and Human Services (HHS) to study and report to Congress on the impact of federal and state laws and regulations that limit the length, quantity, or dosage of opioid prescriptions.
The final bill also retained some provisions with which the AMA raised concerns, primarily related to mandates on physicians and duplicative requirements in state and federal programs. These provisions would:
- Create a federal mandate for physicians to electronically prescribe controlled substances (EPCS) by January 2021 for Schedule II, III, IV, and V controlled substances covered under a Medicare Part D Prescription Drug Plan or Medicare Advantage (MA) prescription drug plans. The final language did, however, include the requirement that the Drug Enforcement Administration update its regulations pertaining to how prescribers authenticate prescriptions using biometrics to keep up with changing technology.
- Require the HHS Secretary to establish a standard, secure electronic prior authorization system (ePA) for covered Part D and MA drugs but allow plans to continue to operate their individual proprietary online portals.
- Require the U.S. Food and Drug Administration (FDA) to develop prescribing guidelines for the indication-specific treatment of acute pain where such guidelines do not exist. However, the AMA is pleased that a provision was retained that requires the FDA Commissioner to publish a clear statement of intent to accompany the guidelines stating that they are intended to inform clinical decisions by prescribers and patients and are not intended to restrict, limit, delay or deny coverage or access by individual health care professionals.
One proposal that is not in the final legislation would remove patient privacy protections under federal law related to the confidentiality of SUD records. The AMA opposed the efforts to include this proposal partly out of concern that allowing more access to such records could discourage patients from seeking treatment for SUD. However, the AMA is committed to working with Congress and other stakeholders to develop a solution that balances the need for health professionals to have the information they need to provide appropriate treatment to patients with SUD, while ensuring appropriate privacy protections for patients.
The AMA will continue to strongly advocate its policy priorities to address SUD at the federal and state levels as the numerous provisions in H.R. 6 are implemented.
The FDA released a revised draft guidance document on Sept. 25 that proposes significant changes from its previous proposals for oversight of preparation of sterile drug products in physician offices. The guidance, "Insanitary Conditions at Compounding Facilities," was originally issued in draft form in 2016. That version had included physician offices in the definition of "compounding facilities," which would have subjected physicians preparing sterile drug products in their offices to significant environmental and quality controls akin to those found in compounding pharmacies. However, after significant work by the AMA and physician specialty organizations, the FDA has changed course and has proposed to exempt physicians from federal requirements, noting that they generally do not intend to take enforcement action against physicians who are compounding products for administration to their own patients.
While this move represents a significant shift from earlier FDA thinking and would limit the federal regulatory burdens on practices, physicians will still be subject to possible state regulation of drug compounding. Regulation of these activities at the state level is generally overseen by boards of pharmacy and possible boards of medicine, so physicians preparing sterile drug products in their offices should pay close attention to regulatory activities in their states. Many states have adopted United States Pharmacopoeia (USP) Chapter 797 standards for sterile compounding. USP is currently in the process of revising those standards and the AMA continues to work closely with USP to ensure that physicians can continue to prepare sterile drug products in their offices.
The AMA has formed a Current Procedural Terminology (CPT®)/Relative Value Scale Update Committee (RUC) Workgroup to develop an alternative to a provision in the 2019 Medicare Physician Fee Schedule/Quality Payment Program proposed rule that would collapse the current five levels of evaluation and management (E/M) office visits for new and established patients down to two. The Workgroup has convened five meetings, four two-hour conference calls in August/September and one five-hour meeting on Sept. 29. More than 200 individuals have participated in each meeting. Several CMS staff, CMS medical officers and medical contractors have attended each meeting. The Workgroup has solicited feedback, via a formal survey mechanism, throughout the process to ensure that maximum input is acquired to achieve consensus. More than 60 national specialty societies and national health care professionals have responded to these surveys. The Workgroup continues to make progress and will submit a coding application to the CPT® Editorial Panel in November. All national medical specialty societies will have the opportunity to comment on the CPT® proposal via their CPT® Advisor. The CPT® Editorial Panel will consider this proposal in February 2019. If adopted, the modifications will be implemented in CPT® 2020. The next meeting of the Workgroup will take place via conference call the evening of Oct. 23.House approves ban on pharmacy "gag clauses"
The House passed by voice vote S. 2554, the "The Patients Right to Know Drug Prices Act of 2018," and S. 2553, the "Know the Lowest Price Act," on Sept. 25. The Senate had previously approved both bills, and President Trump is expected to sign them into law. S. 2554, which was introduced by Sen. Susan Collins, R, Maine, and supported by the AMA, would prohibit health insurers and pharmacy benefit managers from using "gag clauses" that prevent pharmacists from sharing with patients the lower-cost options when they are purchasing medically necessary medication. In addition, the legislation would ensure that the Federal Trade Commission will have the necessary authorities to combat anti-competitive pay-for-delay settlement agreements between manufacturers of biological reference products and follow-on biologicals. S. 2553 would apply similar "gag clause" protections to Medicare and MA plans.2019 HHS appropriations bill signed into law
President Trump signed HR 6157 into law on Sept. 28, which provides appropriations for HHS, the Department of Defense (DOD) and the departments of education and labor. To move the appropriations process through the regular order, an agreement was reached by all parties to avoid controversial amendments and riders and to provide additional funding for nondefense accounts in the same amount and spending increases provided for the DOD. The resulting bill, which also provides continued funding for much of the rest of the government through Dec. 7, 2018, increased spending for HHS by $2.3 billion for FY 2019 at a level of $90.5 billion for nonmandatory spending accounts.
Significant increases were included for National Institutes of Health (NIH), including increased funding for the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative and an increase for Alzheimer's disease research of $425 million, meaning there was a total funding increase of $2.34 billion. Several CDC offices, including the Office of Public Health Preparedness and Response and the National Center for Chronic Disease Prevention and Health Promotion, received increases as well.
Not surprisingly, the Substance Abuse and Mental Health Services Administration (SAMSHA) substance-abuse programs were funded at $3.82 billion, an increase of more than $555 million. Of that total, $1.5 billion would go to State Opioid Response Grants. Other opioid-related funding included $500 million for NIH, $475 million for CDC overdose prevention and surveillance, and $5 million to address opioid-related infectious diseases.
HHS would have to submit a reunification plan for migrant children to Congress by Nov. 15 or face restrictions on accessing nonrecurring expenses funds until the plan in submitted. The bill did not include any new restrictions on family planning funding, though Hyde-amendment abortion restrictions remain, as do Dickey-amendment prohibitions on advocating for gun control.
On education, the bill would provide an additional $350 million to cancel loans under the Public Service Loan Forgiveness Program.
On the Defense side of the bill, provisions were included for a Government Accountability Office review of the implementation of the DOD's new electronic health record system. The bill would also require two reports back to Congress to ensure that the DOD is taking the necessary steps to ensure that full and accurate information is provided to databases used by the National Instant Criminal Background Check System for firearms purchases.
The AMA submitted a comment letter to the Centers for Medicare & Medicaid Services (CMS) regarding the proposed rule for calendar year (CY) 2019 for the Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System.
The Sept. 24 letter expresses appreciation for CMS proposals that encourage care in the lowest-cost setting. However, it points out that the current OPPS payment policies and proposed policies in the rule are complex, confusing and not truly site neutral because the policies do not apply equally to all hospital outpatient clinics. Furthermore, payment differentials stem in part from inadequate Medicare physician payment rates and any savings from site-neutrality proposals derived from OPPS should be reinvested in improvements elsewhere in Medicare Part B, including payments to physicians.
Positive elements of the proposed rule include that it:
- Replaces the Consumer Price Index for Urban Consumers with the hospital market basket as the annual update mechanism for ASC payments
- Revises the definition of surgery for 2019 to account for "surgery-like" procedures in ASCs
- Improves patient access to non-opioid treatments for pain management by separating their payment out from other services in the ASC setting
There are also policies included in this proposed rule that concern the AMA. These include:
- Site-neutrality policies that do not adequately accomplish the goal of encouraging care in the lowest-cost setting
- Insufficient actions to prevent the unnecessary shift of Medicare services from physician offices to hospital outpatient departments
- Potentially using prior authorization as a method for controlling overutilization of services;
- Rescaling the ASC relative weights to achieve a perceived budget neutrality objective instead of applying the OPPS relative weights
- Delaying the immediate removal of the Communication about Pain composite measure from the Hospital Consumer Assessment of Healthcare Providers and Systems and from public reporting
AMA's complete comments can be read here.2017 MIPS targeted review deadline closes Oct. 15
CMS recently released the 2017 Merit-based Incentive Payment System (MIPS) performance feedback and opened the targeted review process. Based on the AMA flagging calculation-error concerns and the initial targeted review requests CMS received, CMS has revised the scoring logic and reissued the 2017 MIPS final scores for the physicians who were impacted. In addition, to ensure CMS maintains the budget neutrality that is required by law under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), some physicians will see slight changes in their payment adjustment because of the reapplication of budget neutrality.
The revisions were made to the performance feedback on the Quality Payment Program (QPP) website on Sept. 13. The AMA encourages physicians and groups to sign in to the QPP website as soon as possible to review their performance feedback. If an error still exists with any 2019 MIPS payment adjustment calculations, the targeted review process is available, but claims must be filed by Oct. 15.
CMS has several resources available in the QPP Resource Library to help physicians and practices understand their performance feedback and the targeted review process. For assistance, please reach out to the Quality Payment Program Service Center at 1-866-288-8292, (TTY) 1-877-715-6222 or at QPP@cms.hhs.gov.
The election period is now open to form a virtual group for the 2019 Merit-based Incentive Payment System (MIPS) performance year. To form a virtual group, first there is an election and then the election must be submitted to CMS via e-mail by Dec. 31. Forming a virtual group provides the opportunity to effectively and efficiently coordinate resources to meet requirements under each MIPS performance category, and potentially increase performance. Virtual groups may be formed based on location, specialty, or shared patient population and can be a variety of sizes and compositions.
Download the 2019 Virtual Groups Toolkit to learn more about the election process and how to participate in MIPS as a virtual group. The toolkit also contains sample templates for the submission e-mail and the virtual group formal agreement.
The AMA submitted a letter to the FDA in response to the agency's Biosimilar Action Plan and subsequent public meeting on facilitating biosimilar competition. In the Sept. 21 letter, the AMA stated its strong support for FDA efforts aimed at enhancing competition in the generic drug space, including biosimilars, and urged the agency to continue its work to limit anticompetitive actions by brand manufacturers. The AMA also stated its support for a robust biosimilar marketplace and urged the FDA to take action to ensure biosimilars are quick to market and that no regulatory actions are taken that may hinder physician and patient uptake of these products. The AMA continues to work with FDA to ensure the success of biosimilars in the market and to educate physicians on these important products.Back to Top
State UpdateRead the new Surgeon General's Spotlight on Opioids
Medical students, residents, academic or physicians in clinical practice, can all benefit from reading the Surgeon General's Spotlight on Opioids. Here are five reasons to do so.
- Ending the epidemic requires a comprehensive, patient-centered focus. The report provides the evidence base that provides important support for comprehensive care rather than a one-size-fits-all approach
- Medication-assisted treatment works for treating substance-use disorders. All patient populations can be treated with MAT, including mental health patients, pregnant women and criminal justice populations.
- There are multiple harm-reduction strategies to pursue. In addition to naloxone access, strategies to reduce opioid-related harms include needle or syringe exchange which reduce transmission of infectious disease.
- Recovery requires ongoing care and removing stigma. Improving access to care and helping ensure high-quality evidence-based treatment requires medical oversight and effective integration of prevention, treatment and recovery services across the health care continuum. SUDs can and should be treated like any other chronic condition.
- It's a quick read. The report will take less than one hour to read, and it will almost certainly increase your knowledge about the epidemic.
Seventy percent of neurosurgeons need to use a separate website to access their state PDMP, according to a new study published in the October issue of Neurosurgery. Sponsored by the Council of State Neurosurgical Societies, the study looked at neurosurgeons' use of PDMPs in states with—and without—mandates to use PDMPs. Among the other findings:
- Who checks the PDMP? Fifty-three percent of respondents in states with mandates checked the PDMP themselves compared to 31 percent of respondents in states without mandates.
- Does checking the PDMP add time to workflow? Almost one quarter percent of respondents in states with—and without—mandates said that checking the PDMP adds time to the workflow of their practice, but it is worth it. Almost one third of respondents in mandate states said that it creates workflow disruptions compared to only 13 percent of non-mandate respondents.
- How do patients react? Half of respondents in mandate states said that patients "often" or "sometimes" respond with anger or denial when the neurosurgeon discusses the patient's PDMP data compared to only 39 percent of respondents in nonmandate states.
- Does the PDMP help with prescribing decisions? More than one third of respondents in mandate states "strongly agreed" or "agreed" that the PDMP helped in prescribing pain medications for patients with 31 percent "neutral," compared to 28 percent of respondents in non-mandate states "strongly agreed" or "agreed" that the PDMP helped in prescribing pain medications for patients with 40 percent neutral.
The authors noted that "while the PDMP plays an important role in identifying patients with potentially problematic opioid use, the impositions on day-to-day neurosurgical clinical workflow and barriers to accessibility can limit the widespread use and efficacy of the PDMP."Virginia governor to headline medical society opioid summit
The Medical Society of Virginia (MSV) and Gov. Ralph Northam, MD, are partnering to host a Health Care Provider Opioid Summit on Oct. 20 in Roanoke, Va. It will include officials from Virginia, South Carolina, Maryland and the Appalachian Regional Commission as well AMA President-elect Patrice A. Harris, MD, MA. The summit will focus on how states, stakeholders, health care providers and physicians can partner together "the next phase of overcoming the crisis."
The summit also will include options for physicians to take buprenorphine-waiver training and a two-hour training focused on pain management for continuing medical education (CME) credit.
More information can be found here.
The AMA Opioid Task Force strongly supports removing barriers that stand between patients and MAT for opioid-use disorder (OUD). Prior authorization for MAT has potentially dangerous consequences for patients who are forced to delay care or are denied treatment because of administrative barriers.
Yngvild Olsen, MD, MPH, who is a member of the Maryland State Medical Society (MedChi) Opioid Task Force and co-chair of the MedChi Addiction Committee, recently spoke with the AMA about the devastating effects these prior authorization policies can have.
"Patients would go to the pharmacy only to be told that their [buprenorphine] prescription couldn't be filled," Dr. Olsen said. "I would get frantic calls from patients after they'd been denied their medication. I had one woman say, 'What am I supposed to do today?' She was on her last dose of medicine." Ninety-nine percent of the time prior authorization requests are approved, so the delay is a senseless bureaucratic hurdle that can be the difference between continued recovery and relapse for vulnerable patient populations.
Medicaid took the initiative to drop prior authorization for MAT, she said, but this still left barriers in place for commercially insured patients. To address the problem the Maryland-DC Society of Addiction Medicine partnered with MedChi and proposed a bill to have prior authorization requirements for MAT lifted for commercial insurers.
"There was no opposition to this bill," said Dr. Olsen. "The commercial payer lobbyist was so excited that they were doing this, he went in and hugged the lobbyist from the state medical society. Medicaid was the driver of change in the commercial market, and they did that by setting the precedent."
Gene M. Ransom, the chief executive officer of MedChi, agreed.
"We think that everyone got on board because of the focus on supporting high-quality, evidence-based medical treatment," Ransom said. "Working with policymakers and others, we all agreed that it was time to put aside any differences we might have and support patients getting the care they need. This is a common-sense solution that doesn't cost any money, and it should be this easy to do this everywhere."
House Bill 887 prohibits carriers that provide coverage for prescription drugs from applying a preauthorization requirement for medication used for treatment of an OUD. It was signed into law on May 25, 2017. Dr. Olsen has seen the difference this change has made in her practice almost immediately. No longer does she have to spend hours a week answering panicked phone calls from patients at the pharmacy, and then making calls to the insurer and pharmacists to try and straighten it out. But the biggest change was removing the fear of "will I be able to fill my prescription?" for her patients.
To see what other progress is being made in battling the opioid epidemic across the country, read the latest AMA Opioid Task Force progress report.
For support in eliminating prior authorization burdens for MAT at the state level, contact Daniel.Blaney-Koen@ama-assn.org, senior legislative attorney, AMA Advocacy Resource Center.
The AMA recently announced the release of the latest series of Geographic Mapping Initiative maps, or "Geomaps." Geomaps illustrate the practice location of physicians and non-physicians in all 50 states and the District of Columbia. New to this version are maps illustrating the location of dermatologists, and of physician assistants. The maps are a powerful tool in legislative or regulatory advocacy related to scope of practice and the health care workforce.
For access to AMA Geomaps for your state or specialty, please contact Kristin Schleiter, senior legislative attorney, at the AMA Advocacy Resource Center.
Other NewsNew Medicare card: MBI available on remittance advice
From Oct. 1 through Dec. 31, CMS will return both the new Medicare Beneficiary Identifier (MBI) and Health Insurance Claim Number (HICN) on remittance advice when physicians submit a claim with a valid and active HICN. CMS will report the MBI in the same place the "changed HICN" is shown today.
Physicians can also access the MBI by using their Medicare Administrative Contractor's MBI look up tool through their portal. Practices can sign up here if they do not have access to the portal. The AMA was instrumental in successfully urging CMS to create a look-up tool for patients' new MBIs if patients do not bring their new cards with them to office visits.
To ensure Medicare patients continue to receive care, physicians can use either the HICN or MBI for all Medicare transactions through Dec. 31, 2019. More information about the MBI is available on the AMA's New Medicare Card page and the CMS New Medicare Card website.
A recent research letter in JAMA shows the number of breaches of protected health information (PHI) has been on the rise since 2010. Researchers examined reportable breaches—those that impacted 500 or more medical records—and analyzed their occurrence at health plans, health care providers and business associates. Health care providers were the most common entity breached, with 1,503 breaches compromising 37.1 million records between 2010 and 2017. However, health plans, with 278 breaches, accounted for the largest share of breached records at 110.4 million. Breach location and type have shifted from paper or films to computer networks, servers and email. As the type of data breached has shifted toward electronic records and away from paper records, the nature of breaches has shifted toward electronic means, such as hacking. By 2017, there were more than 132 million breached records because of hacking and other information technology incidents—outpacing both loss and theft combined.
Recent research conducted by the AMA has revealed that over 80 percent of physicians have experienced a cyberattack---increasing the need to better support medical practices. Theft of PHI and loss of access to critical medication lists, diagnoses and lab results are of great concern for physicians. Breaches can also result in physicians experiencing significant practice downtime.
The AMA is advocating for increased support from the federal government to help medical practices bolster their breach resilience. Recently, a bill which the AMA supported was signed into law that directs federal agencies to dedicate cybersecurity resources to small business—including physician practices. The AMA is also seeking exemptions in federal regulations that would allow all large hospitals and health systems to subsidize or donate cybersecurity technology or services to local physician practices. More information on cybersecurity and how physicians can best protect their practices can be found here.
A new report titled, 2018-19 Health Care Trends: Artificial and Augmented Intelligence in Health Care is now available on the AMA Education Hub. In this course, participants will learn the history, definitions and components of AI, and discover how the field of AI may progress, highlighting potential opportunities and challenges for physicians. Possible outcomes of health care AI are also presented. Physicians are eligible to receive 1.0 AMA PRA Category 1 credits™ at no charge and nonphysicians receive a certificate for successfully completing the course.
The latest episode of the AMA's "Making the Rounds" podcast series, "Contracting pt 4: Restrictive Covenants and Termination Clauses," is now available. It covers compensation options and what to look for in benefits package. The series features advice and discussions on the most important topics impacting residents' lives.AMA receives high ranking in study of major national associations
In a study produced by APCO that tackles the question of association public policy effectiveness, the AMA was given top marks in the categories of local impact, coalition building, industry reputation steward and bipartisanship. To conduct the study policymakers and influencers rated associations on both overall effectiveness and a range of detailed areas. The results show in detail areas where associations must excel to enhance their impact.Back to Top
Register now for both 2019 advocacy conferences and save on registration fees
Registration is now open for the 2019 American Medical Association State Advocacy Summit (formerly the State Legislative Strategy Conference) and the National Advocacy Conference. Register for both events today and get 20 percent off. SAS will be held Jan 10-12 in Scottsdale, Arizona and NAC will be held Feb. 11-13 at the Grand Hyatt in Washington D.C.
Oct. 17: M.A.P. blood pressure improvement program webinar
Learn about the Target: BP national initiative to prioritize blood pressure control. M.A.P. is an evidence-based, real-world-proven program to help physicians improve the health of their patients with hypertension. The webinar takes place from noon to 1 p.m. Central time. Register now.
Oct. 24: Prior authorization – overview of AMA advocacy strategy
Register to attend an informative discussion of the AMA's multi-faceted advocacy campaign for prior authorization reform, and learn about resources available to help streamline the prior authorization process. The webinar takes place from noon to 1 p.m. Central time. Register now.
Oct. 24: Panel discussion on the new RAND study results
Register to attend this educational event from 9:30 a.m. to noon on Oct. 24 in Washington, D.C., which will highlight the findings of the AMA-RAND follow-up study on payment models. Panel discussions will cover how the challenges still experienced, improvements realized and strategies implemented affect the shift to value-based care. Opening remarks will be given by AMA President Barbara L. McAneny, MD. Space is limited so reserve your spot now and be the first to hear the research results.
Oct. 30 & Nov. 15: Climate and health emergency medicine perspective webinars
In this webinar series emergency medicine experts will explore the health impacts of climate change and opportunities to advance solutions that address human health and our health system. Participating physicians can earn one CME credit per webinar. Topics are "Preparing for climate emergencies" on Oct. 30 at 1 p.m. Eastern time and "Delivering climate-smart health care" on Nov. 15 at 1 p.m. Eastern time. Register now.