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President Signs Bills Lifting Pharmacist ‘Gag Clauses’ on Drug Prices

President Signs Bills Lifting Pharmacist ‘Gag Clauses’ on Drug Prices

Earlier this week, President Trump signed two bipartisan bills into law that will allow pharmacists to tell patients they can save money on drugs by paying cash or trying a lower-cost alternative. At issue was the “broken” drug pricing system in the U.S. that was forcing patients to make decisions, which could have negatively impacted their health.

The bills, the Patient Right to Know Act and the Know the Lowest Price Act, 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 ensures 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. The Patient Right to Know Act would apply similar “gag clause” protections to Medicare and MA plans.

Under the new legislation, pharmacists will be allowed, though not required, to tell patients about lower-cost options. If pharmacists don’t tell, then patients will have to ask about the cost of the medication. However, some pharmaceutical industry experts say although eliminating the gag clause is a step toward consumer transparency, it doesn’t address the issue of lowering actual drug costs, making it unclear how much of a tangible effect the legislation will have.

According to research published in JAMA in March, people with Medicare Part D drug insurance overpaid for prescriptions by $135 million in 2013. Copayments in those plans were higher than the cash price for nearly 1 in 4 drugs purchased in 2013. For 12 of the 20 most commonly prescribed drugs, patients overpaid by more than 33 percent.

Yet some critics say eliminating gag orders doesn’t address the causes of high drug prices. “As a country, we’re spending about $450 billion on prescription drugs annually,” said Steven Knievel, who works on drug price issues for Public Citizen, a consumer advocacy group. The modest savings gained by paying the cash price “is far short of what needs to happen to actually deliver the relief people need.”

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Congress Passes New Opioid Package; Awaiting Presidential Signature

Congress Passes New Opioid Package; Awaiting Presidential Signature

Earlier this week Congress reached agreement on legislation to address the opioid epidemic with the passage of the “SUPPORT for Patients and Communities Act,” which President Donald Trump is expected to sign. The legislation touches on almost every aspect of the epidemic and includes numerous provisions to expand access to substance-use disorder (SUD) prevention and treatment programs.

Below are some of the legislations significant provisions:

  • 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 an 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 which may cause some concerns in the medical community, 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. 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 not in the final legislation would remove patient privacy protections under federal law related to the confidentiality of SUD records. The Medical Association, AMA and other health care groups 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, we are 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.

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After EMR Implementation, Surgeons Spend Less Time Interacting with Patients

After EMR Implementation, Surgeons Spend Less Time Interacting with Patients

Implementing an electronic medical records (EMR) system at an orthopaedic clinic may have unanticipated effects on clinic efficiency and productivity – including a temporary increase in labor costs and a lasting reduction in time spent interacting with patients, reports a study in September 19, 2018, issue of The Journal of Bone & Joint Surgery. The journal is published in the Lippincott portfolio in partnership with Wolters Kluwer.

Even after an initial learning period, introducing a new EMR system may affect several aspects of clinic workflow, according to the paper by Daniel J. Scott, MD, MBA, of Duke University, Durham, N.C., and colleagues. They write, “Healthcare systems and policymakers should be aware that the length of the implementation period is approximately six months and that implementation may alter the time that providers spend with patients.”

Introducing EMRs Could Have ‘Negative Trade-Off’ for Patient Care

The researchers used time-driven activity-based costing methods to evaluate how a new EMR system affected costs and productivity at two outpatient orthopaedic arthroplasty (joint replacement) clinics. The analysis included detailed observations of 143 patient visits before implementation of the EMR system, and again at two months, six months, and two years after implementation.

At two months after EMR implementation, total labor costs had increased significantly, from $36.88 to $46.04 per patient visit. The cost increase was related to increases in the time that attending surgeons spent per patient, from 9.38 to 10.97 minutes, and in the time that certified medical assistants spent on patient assessment, from 3.4 to 9.1 minutes. For surgeons and medical assistants combined, the time spent documenting patient encounters more than doubled: from 3.3 to 7.6 minutes.

By six months after implementation of the EMR system, total labor costs were similar to costs in the pre-implementation period. From six months to two years, labor costs remained stable. Average weekly patient volume decreased for one of the surgeons studied, but remained stable for the other surgeon.

However, the increases in time spent on documentation persisted, even after the initial learning period. This was accompanied by a significant reduction in time spent interacting with patients, from 14.65 to 10.03 minutes.

Electronic medical records systems are rapidly being adopted throughout the US healthcare system, in part due to increased regulation. “EMR implementation can be costly and typically requires workflow redesign,” Dr. Scott and coauthors write. The study is the first to assess the impact of EMR systems in orthopaedic practice.

“This could suggest that providers ultimately were able to spend less time with patients as documentation requirements increased,” Dr. Scott and coauthors write. “If so, this could represent a negative trade-off for patient care and leave patients less satisfied, a trend worthy of further study.”

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Medical Association, AMA, Others Take a Stand on New CMS Rule

Medical Association, AMA, Others Take a Stand on New CMS Rule

The Medical Association joined with the American Medical Association and more than 170 other organizations to support some components of CMS’ “Patients Over Paperwork” initiative, and say three of its components need to be enacted immediately to reduce “note bloat” redundancy, yet also to oppose a proposal to collapse payment rates for physician office visit services over concern about unintended consequences included in the proposed 2019 Medicare Physician Fee Schedule and Quality Payment Program rule.

Read the letter here.

The AMA and other organizations called for the immediate adoption of these proposals:

  • Changing the required documentation of a patient’s history to focus only on the interval since the previous visit.
  • Eliminating requirement for physicians to redocument information that has already been documented in the patient’s record by practice staff or by the patient.
  • Removing the need to justify providing a home visit instead of an office visit.

However, the CMS proposal to “collapse” payment rates for five evaluation and management (E/M) office visit services into two has the potential to create unintended negative consequences for patients.

“We oppose the implementation of this proposal because it could hurt physicians and other health care professionals in specialties that treat the sickest patients, as well as those who provide comprehensive primary care, ultimately jeopardizing patients’ access to care,” the letter states. The AMA and the other organizations joining the letter also oppose a proposed policy that would cut payments for multiple services delivered on the same day.

The organizations note their willingness to work with CMS to resolve issues connected with calculating the appropriate coding, payment and documentation requirements for different levels of E/M services. They also declare their support for the workgroup the AMA created of coding experts who would “arrive at concrete solutions” in time for CMS to implement in the 2020 Medicare physician fee schedule.

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U.S. House Passes SUPPORT for Patients and Communities Act

U.S. House Passes SUPPORT for Patients and Communities Act

In a 396-14 vote, the U.S. House of Representatives passed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, or H.R. 6 —bipartisan opioid legislation that aims to curb drug abuse.

Sponsored by Greg Walden, R-Oregon, the package of legislation contains more than 50 individually approved bills to address what Pres. Donald Trump has called a health emergency.

The SUPPORT bill is intended to fight the opioid crisis by advancing treatment and recovery programs, improving prevention efforts, providing resources to communities and fighting drugs like Fentanyl. The legislation also calls for a review of current opioid prescriptions, development and usage of non-addictive painkillers, making a patient’s addiction history as part of their medical records to prevent relapse and reducing the trafficking of Chinese fentanyl into the country. Additionally, the legislation will expand Medicare and Medicaid-related services to combat drug abuse.

Opposition votes came from 13 Republicans and a lone Democrat. Alabama’s Rep. Mo Brooks voted against the legislation, which is now headed to the Senate for review and passage.

In short, the bill makes several changes to state Medicaid programs to address opioid and substance use disorders. Specifically, the bill:

  • modifies provisions related to coverage for juvenile inmates and former foster care youth,
  • establishes a demonstration project to increase provider treatment capacity for substance use disorders,
  • requires the establishment of drug management programs for at-risk beneficiaries,
  • establishes drug review and utilization requirements,
  • extends the enhanced federal matching rate for expenditures regarding substance use disorder health home services, and
  • temporarily requires coverage of medication-assisted treatment.

The bill also alters Medicare requirements to address opioid use. Specifically, the bill:

  • exempts substance use disorder telehealth services from specified requirements,
  • requires the initial examination for new enrollees to include an opioid use disorder screening,
  • modifies provisions regarding electronic prescriptions and post-surgical pain management,
  • requires prescription drug plan sponsors to establish drug management programs for at-risk beneficiaries, and
  • requires coverage for services provided by certified opioid treatment programs.

The bill also addresses other opioid-related issues. Specifically, the bill:

  • establishes and expands programs to support increased detection and monitoring of fentanyl and other synthetic opioids, and
  • increases the maximum number of patients that health care practitioners may initially treat with medication-assisted treatment (i.e., under a buprenorphine waiver).

Additionally, the bill temporarily eliminates the enhanced federal matching rate for Medicaid expenditures regarding specified medical services provided by certain managed care organizations.

The Medical Association is closely monitoring the status of this legislation, but we encourage you to read more about the legislation here.

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Association’s New Task Force to Address Health Care Manpower Shortage

Association’s New Task Force to Address Health Care Manpower Shortage

In response to a resolution passed by the House of Delegates during the 2018 Annual Meeting in Montgomery in April, the Board of Censors formed a new task force to develop and restore adequate health care manpower in all geographic areas in order to provide quality local health care for all Alabama citizens.

The resolution, submitted by the Pickens County Medical Society, stands as a reminder that Alabama ranks in the last five of 50 states in health status categories, and while primary care medicine is effective in raising health status, supporting hospitals and improving the economic status of disadvantaged communities, the state’s aging population is causing an escalation in need for primary care physicians.

The task force had its first meeting the week of July 23 and will meet again on Aug. 14. We will post details as they become available.

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Association’s Board to Evaluate Prior Authorization Process

Association’s Board to Evaluate Prior Authorization Process

The Medical Association recently received information from a consortium of health care providers, which included the American Hospital Association, America’s Health Insurance Plans, the American Medical Association, the American Public Health Association, Blue Cross Blue Shield Association and the Medical Group Management Association, who have partnered to identify opportunities to improve the prior authorization process. The Board of Censors during its last meeting tasked the Council on Medical Services to further investigate the consortium’s report.

The consortium’s goals are to promote safe, timely and affordable access to evidence-based care for patients; enhance efficiency; and reduce administrative burdens. However, according to a 2012 Kaiser Family Foundation estimate, physicians spend 868.4 million hours annually on prior authorizations. In a 2011 study by Health Affairs, the average annual per-doctor cost of interacting with insurance plans to complete prior authorizations was about $83,000.

The consortium has targeted five areas that offer improvement in prior authorization programs that can bring meaningful reform:

  • Selective application of prior authorizations
  • Prior authorization program review and volume adjustment
  • Transparency and communication regarding prior authorization
  • Continuity of patient care
  • Automation to improve transparency and efficiency

Once the Council on Medical Services concludes its investigation, more information will be available.

Read the Consensus Statement on Improving the Prior Authorization Process from the consortium.

Read the Medical Association’s feature article from Alabama Medicine Magazine, Between Doctors & Patients: Prior Authorizations

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With Net Neutrality Gone, What’s in the Future for Physicians?

With Net Neutrality Gone, What’s in the Future for Physicians?

Net neutrality changed the digital landscape for millions of Americans, specifically physicians and health care professionals, but these changes may diminish due to the repeal of net neutrality. In December, the Federal Communications Commission voted to repeal the net neutrality rules set in place by the Obama Administration in 2015, and on June 11, 2018, net neutrality was officially repealed leaving many questions for Americans. Previously, most professionals were unfazed by the net neutrality rules, and many are still unaware of the positive impact net neutrality had in areas of the health care profession, such as telemedicine and technology education since it passed in 2015. Despite these technological advancements, many doctors still do not understand net neutrality or the effect the repeal could have on their practice or their financial bottom lines.

What is net neutrality?

Net neutrality is the concept that Internet Service Providers (ISPs) like Verizon, AT&T, Comcast and Spectrum are required to handle all data equally. The previous net neutrality rules protected against blocking, throttling and prioritization — meaning ISPs were not able to slow down or block some websites but speed up others. Net neutrality required all websites to load at equal speeds and treated all online content fairly. It also protected the consumer from paying more for slower internet speeds. In other words, all internet users were on a level playing field with the same rights to equally fast internet, and all websites were available at the same speed and quality.

What does life look like without net neutrality rules?

Without net neutrality, non-profit and educational websites and databases could be de-prioritized in lieu of commercial websites, meaning the importance of educational materials and research would be left up to the internet service providers. Allowing ISPs the ability to decide the importance of internet content leaves the potential for the medical and academic community to suffer because their content could potentially load at slower speeds or worse, blocked. Additionally, slower internet speeds will affect the ability to live-stream, upload and download promptly. Finally, many worry ISPs could offer multiple plans with different options on internet speed, leaving consumers paying more for high-speed internet. Overall, a divide will form between those who can afford faster internet service options and those who are stuck with slower bandwidth.

What does this mean for physicians?

For physicians and health care professionals, the repeal of net neutrality leaves the potential for devastating effects. First, medical professionals could be forced to pay significantly more for high-speed internet capable of downloading, uploading, sending and receiving digital medical records. Also, all the advancements made in telemedicine could become stagnant. Despite recent advancements, the future of telemedicine remains uncertain even if a physician can afford the high-speed internet to treat patients, many patients may not be able to afford the high-speed internet capable of live-streaming with their physician. Additionally, the repeal could be detrimental for physicians practicing in rural areas or with patients living in rural areas reliant on telemedicine.

Likewise, educational endeavors could suffer a significant impact. It could cost more for high-speed internet capable of downloading and uploading medical books and research vital to medical education, leaving medical students with the potential for an increase in tuition. Physicians could find it harder to stay up-to-date on the most recent research and studies in their field if educational and non-profit websites become overshadowed by commercial websites paying ISPs. Finally, the competition created between commercial websites and educational and non-profit websites will hinder and slow-down research. Overall, net neutrality created a level playing field on the internet making it possible for technological advancements that empower physicians with the education and tools they need to best care for their patients.

What can the medical community do now?

As of right now, ISPs have not changed their services despite the repeal of the net neutrality rules. In fact, many ISPs have publically stated they will not block or throttle but have left open the potential to charge more for some data transportation. On the contrary, just because an ISP publically states it will continue as if net neutrality is still in place does not mean it is locked into obeying that standard. As time goes on without net neutrality, look out for changes with ISPs. Many predict the changes will start small and add up over time.

How can you make a difference?

The U.S. Senate voted to reinstate the net neutrality rules repealed in December. The legislation is currently in the U.S. House of Representatives where it is given little hope of advancing. Contact your district’s representative and express your concerns over the end of net neutrality and the effects it will have on physicians and health care professionals.

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Alabama Physicians Attend AMA Meeting in Chicago to Discuss State of Health Care

Alabama Physicians Attend AMA Meeting in Chicago to Discuss State of Health Care

Pictured from left in the back are Dr. Buddy Smith Jr., Dr. Jefferson Underwood and Dr. Jerry Harrison. In front from left are Dr. Steven Furr, Medical Student Delegate Hannah Ficarino from the University of South Alabama, Dr. Jorge Alsip and Dr. John Meigs.

During the AMA’s Annual Meeting held June 8-13, 2018, the House of Delegates debated a wide range of issues and adopted policies to expedite the free exchange of key patient data between EHR systems; to make e-prescribing of controlled substances and access to state PDMPs less cumbersome, and to reduce the MIPS reporting burden. The AMA also reaffirmed its strong opposition to the legalization of physician-assisted suicide and euthanasia.

Medical Association President Jefferson Underwood, M.D., joined the delegation in Chicago and represented Alabama physicians at the inauguration of the AMA’s new president, Barbara McAneny, M.D.

“The AMA House of Delegates is much like Congress in that the views of its members vary from region to region, and few members agree with every decision made by the organization. However, a state’s representation in the HOD is based on their number of AMA members, and Alabama along with the other Southeastern states are working vigorously to increase their AMA membership. I encourage our Medical Association members to also join the AMA, so we can have a greater impact on policy and help elect officers who share our views and values.” said Jorge Alsip, M.D., who chairs Alabama’s AMA Delegation.

Pictured are Association President Underwood and his wife, Sara.

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President Trump Signs VA Mission Act

President Trump Signs VA Mission Act

UPDATE JUNE 6, 2018: President Trump signed the VA Mission Act designed to increase veterans’ access to timely and private health care. The new VA law aims to combine and expand existing community care programs during the next year with intentions to roll out one centralized community care program next May.

Building off the positive changes enacted by the Choice Program, which was created in 2014 after two veterans died waiting for appointments, the Mission Act broadens the circumstances for which veterans can receive non-VA health care. Presently, veterans can seek third-party medical care if they live more than 40 miles away from a VA facility or if they must wait over 30 days for an appointment. The Mission Act will also allow veterans access to non-VA health care if they are in need of a service the VA does not offer or if their doctor thinks it is in the best interest of the patient.

With access to non-VA health care becoming more accessible, some lawmakers became fearful the new law would undermine the VA. The Mission Act recognizes this potential and includes incentives and funding to ensure the Act does not drive veterans away from the VA. The order will boost funding to allow the VA to hire more health care professionals in addition to offering scholarships to medical students willing to work for the VA.

Additionally, the new measure will help pre-9/11 veterans by giving them benefits to help cover the cost of in-home caregivers. Post-9/11 veterans already have access to such benefits. These benefits offer an alternative to institutionalized health care and will help take some of the cost of local governments.

While the Mission Act passed overwhelmingly in both the House and Senate with bi-partisan support in May 2018, there is a debate on exactly how the measure will be funded after May 2019. Sen. Richard Shelby (R-Ala.), head of the Senate Appropriations Committee, is working across party lines in both the Senate Appropriations Committee and the Veteran’s Affairs Committee to help establish the best possible funding plan for the VA Mission Act.

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