News and Updates for Healthcare Professionals

Heart attacks and strokes can be catastrophic, life-changing events that are all too common. Heart disease and stroke are preventable, yet they remain leading causes of death, disability, and healthcare spending in the US. Alarmingly, many of these events happen to adults ages 35-64—over 800,000 in 2016. Million Hearts® is a national initiative with a network of partners focused on preventing one million heart attacks, strokes, and other cardiovascular events by 2022. Coordinated actions by public health and healthcare professionals, communities, and healthcare systems can and will keep people healthy, optimize care, and improve outcomes within priority populations.

Key points:

• About 16 million heart attacks, strokes, and related heart-threatening events* could happen by 2022.
• 1 in 3, of these life-changing cardiovascular events happened in adults 35-64 years old in 2016.
• 80% of premature heart disease and strokes are preventable.

The Centers for Disease Control & Prevention (CDC) launched two new opioid trainings that support providers in safer prescribing of opioids for chronic pain. The modules are part of a series of interactive online trainings that feature recommendations from the CDC Guideline for Prescribing Opioids for Chronic Pain, clinical scenarios, tools, and resource libraries to enhance learning. The modules offer free continuing education.

Proposed regulation for Medicare Parts C & D would strengthen negotiations with prescription drug manufacturers to lower costs and increase transparency for patients

Today, the Centers for Medicare & Medicaid Services (CMS) proposed polices for 2020 to strengthen and modernize the Medicare Part C and D programs. The proposal would ensure that Medicare Advantage and Part D plans have more tools to negotiate lower drug prices, and the agency is also considering a policy that would require pharmacy rebates to be passed on to seniors to lower their drug costs at the pharmacy counter.

President Trump is following through on his promise to bring tougher negotiation to Medicare and bring down drug costs for patients, without restricting patient access or choice, said HHS Secretary Alex Azar. By bringing the latest tools from the private sector to Medicare Part D, we can save money for taxpayers and seniors, improve access to expensive drugs many seniors need, and expand their choice of plans. The Part D proposals complement efforts to bring down costs in Medicare Advantage and in Medicare Part B through negotiation, all part of the President’s plan to put American patients first by bringing down prescription-drug prices and out-of-pocket costs.

In the twelve years since the Part D program was launched, many of the tools outlined in today’s proposal have been developed in the commercial health insurance marketplace, and the result has been lower costs for patients. Seniors in Medicare also deserve to benefit from these approaches to reducing costs, so today CMS is proposing to modernize the Medicare Advantage and Part D programs and remove barriers that keep plans from leveraging these tools.

In designing today’s proposal, foremost in the agency’s mind was the impact on patients, and the proposal is yet another action CMS has taken to deliver on President Trump and Secretary Azar’s commitment on drug prices, said CMS Administrator Seema Verma. Today’s changes will provide seniors with more plan options featuring lower costs for prescription drugs, and seniors will remain in the driver’s seat as they can choose the plan that works best for them. The result will be increasing access to the medicines that seniors depend on by lowering their out-of-pocket costs.

Private plan options for receiving Medicare benefits are increasing in popularity, with almost 37 percent of Medicare beneficiaries expected to enroll in Medicare Advantage in 2019, and Part D enrollment increasing year-over-year as well. The programs are driven by market competition; plans compete for beneficiaries’ business, and each enrollee chooses the plan that best meets his or her needs. Consumer choice puts pressure on plans to improve quality and lower costs. Premiums in both Medicare Advantage and Part D are projected to decline next year.

Today’s proposed changes include:

• Providing Part D plans with greater flexibility to negotiate discounts for drugs in “protected” therapeutic classes, so beneficiaries who need these drugs will see lower costs;
• Requiring Part D plans to increase transparency and provide enrollees and their doctors with a patient’s out-of-pocket cost obligations for prescription drugs when a prescription is written;
• Codifying a policy similar to the one implemented for 2019 to allow “step therapy” in Medicare Advantage for Part B drugs, encouraging access to high-value products including biosimilars; and
• Implementing a statutory requirement, recently signed by President Trump, that prohibits pharmacy gag clauses in Part D.

CMS is also considering for a future plan year, which may be as early as 2020, a policy that would ensure that enrollees pay the lowest cost for the prescription drugs they pick up at a pharmacy, after taking into account back-end payments from pharmacies to plans.

Medicare Advantage and Part D will continue to protect patient access, as both programs are embedded with robust beneficiary protections. These include CMS’s review of Part D plan formularies, an expedited appeals process, and a requirement for plans to cover two drugs in every therapeutic class.

CMS looks forward to receiving comments on these proposals and other policies under consideration.

NIH-supported studies aim to reduce the burden of COPD.

Federal physical activity guidance updated for the first time since 2008

(Chicago) – Today, Adm. Brett P. Giroir, M.D., assistant secretary for health, announced the release of the U.S. Department of Health and Human Services’ second edition of the Physical Activity Guidelines for Americans at the American Heart Association’s Scientific Sessions meeting. The second edition provides evidence-based recommendations for youth ages 3 through 17 and adults to safely get the physical activity they need to stay healthy. There are new key guidelines for children ages 3 through 5 and updated guidelines for youth ages 6 through 17, adults, older adults, women during pregnancy and the postpartum period, adults with chronic health conditions, and adults with disabilities.

You might consider “giving the axe” to these 11 drug classes, particularly in older patients, to increase safety and reduce pill burden.

Get resources and guidance on how to implement effective team-based opioid management strategies in primary care by participating in the AHRQ-funded “Six Building Blocks” project. Selected practices will implement the Six Building Blocks toolkit to improve opioid prescribing and collect metrics to monitor progress. An anticipated 15 participating practices will each receive technical assistance and a $2,500 honorarium to offset costs of producing metrics required for program evaluation The estimated start date for practices is January 2019.

Jeff Brady, M.D., M.P.H., director of AHRQ’s Center for Quality Improvement and Patient Safety, and Karen Chaves, M.H.S, Director of AHRQ’s National Healthcare Quality and Disparities Report Program, highlight data in the newly released Chartbook on Patient Safety. The Chartbook, based on AHRQ’s recently released 2017 National Healthcare Quality and Disparities Report, shows that the nation’s efforts to improve the safety of health care resulted in some encouraging overall gains between 2000 and 2016. However, there is much room for improvement, particularly for people of color and people in poor households. The Chartbook findings also identify ongoing safety concerns. Quantifying these challenges provides essential information to inform future quality improvement efforts.

New definition enhances ability to research and treat chronic pain.

A major challenge in pain care is to prevent chronic pain from developing after an initial painful event.

“Diabetes in America” sheds light on national burden of diabetes.

“Diabetes in America” sheds light on national burden of diabetes.

NIH-funded study shows clinicians reduced prescriptions following behavioral “nudge”.

Ongoing studies focus on many different diseases, including colon cancer, chronic pain and kidney failure.

– Population-level research supports the concept, but benefit for individual patients less clear

Fictional TV doctor Gregory House routinely ordered his team to break into patients’ homes to find clues to their mystery ailments, perhaps revealing behaviors their patients failed to share.

“Everybody lies,” House often said.

In what some suggest is another ethically questionable version of medical sleuthing, companies are now scanning public records that provide clues to individuals’ “social determinants of health,” or SDOH — such as arrest records, bankruptcy filings, voter registration, address changes, and marriages and divorces — that, in combination with traditional prognostic tools, may predict an individual’s likelihood of future healthcare needs and costs.

Today, the Centers for Medicare & Medicaid Services (CMS) proposed historic changes that would increase the amount of time that doctors and other clinicians can spend with their patients by reducing the burden of paperwork that clinicians face when billing Medicare. The proposed rules would fundamentally improve the nation’s healthcare system and help restore the doctor-patient relationship by empowering clinicians to use their electronic health records (EHRs) to document clinically meaningful information, instead of information that is only for billing purposes.

“Today’s reforms proposed by CMS bring us one step closer to a modern healthcare system that delivers better care for Americans at a lower cost,” said HHS Secretary Alex Azar. “Such a system requires empowering American patients by giving them price and quality transparency and control over their own interoperable health records, goals supported by CMS’s proposals. These proposals will also advance the successful Medicare Advantage program and accomplish a historic regulatory rollback to help physicians put patients over paperwork. Further, today’s proposed reforms to how CMS pays for medicine demonstrate the commitment of HHS to implementing President Trump’s blueprint for lowering drug prices. The ambitious reforms proposed by CMS under Administrator Verma will help deliver on two HHS priorities: creating a value-based healthcare system for the 21st century and making prescription drugs more affordable.”

“Today’s proposals deliver on the pledge to put patients over paperwork by enabling doctors to spend more time with their patients,” said CMS Administrator Seema Verma. “Physicians tell us they continue to struggle with excessive regulatory requirements and unnecessary paperwork that steal time from patient care. This Administration has listened and is taking action. The proposed changes to the Physician Fee Schedule and Quality Payment Program address those problems head-on, by streamlining documentation requirements to focus on patient care and by modernizing payment policies so seniors and others covered by Medicare can take advantage of the latest technologies to get the quality care they need.”

The proposals, part of the Physician Fee Schedule (PFS) and the Quality Payment Program (QPP), would also modernize Medicare payment policies to promote access to virtual care, saving Medicare beneficiaries time and money while improving their access to high-quality services no matter where they live. Such changes would establish Medicare payment for when beneficiaries connect with their doctor virtually using telecommunications technology (e.g., audio or video applications) to determine whether they need an in-person visit. Additionally, the QPP proposal would make changes to quality reporting requirements to focus on measures that most significantly impact health outcomes. The proposed changes would also encourage information sharing among health care providers electronically, so patients can see various medical professionals according to their needs while knowing that their updated medical records will follow them through the healthcare system. The QPP proposal would make important changes to the Merit-based Incentive Payment System (MIPS) “Promoting Interoperability” performance category to support greater EHR interoperability and patient access to their health information, as well as to align this clinician program with the proposed new “Promoting Interoperability” program for hospitals.

If today’s proposals were finalized, clinicians would see a significant increase in productivity – leading to substantially more and better care provided to their patients. Removing unnecessary paperwork requirements through the PFS proposal would save individual clinicians an estimated 51 hours per year if 40 percent of their patients are in Medicare. Changes in the QPP proposal would collectively save clinicians an estimated 29,305 hours and approximately $2.6 million in reduced administrative costs in CY 2019.

Proposed CY 2019 Physician Fee Schedule Key Changes

The Physician Fee Schedule establishes payment for physicians and medical professionals treating Medicare patients. It is updated annually to make changes to payment policies, payment rates and quality-related provisions. Extensive public feedback the agency has received has highlighted a need to streamline documentation requirements for physician services known as “evaluation and management” (E&M) visits, as well as a need to support greater access to care using telecommunications technology.

The proposed changes to the Physician Fee Schedule would reinforce CMS’ Patients Over Paperwork initiative focused on reducing administrative burden while improving care coordination, health outcomes, and patients’ ability to make decisions about their own care.

Streamlining Evaluation and Management (E&M) Payment and Reducing Clinician Burden

CMS and the Office of the National Coordinator for Health Information Technology (ONC) have heard from stakeholders that CMS’s extensive documentation requirements for Evaluation and Management codes have resulted in unintended consequences. To meet these documentation requirements, providers have to create medical records that are a collection of predefined templates and boilerplate text for billing purposes, in many cases reflecting very little about the patients’ actual medical care or story.

Responding to stakeholder concerns, several provisions in the proposed CY 2019 Physician Fee Schedule would help to free EHRs to be powerful tools that would actually support efficient care while giving physicians more time to spend with their patients, especially those with complex needs, rather than on paperwork. Specifically, this proposal would:

• Simplify, streamline and offer flexibility in documentation requirements for Evaluation and Management office visits — which make up about 20 percent of allowed charges under the Physician Fee Schedule and consume much of clinicians’ time;
• Reduce unnecessary physician supervision of radiologist assistants for diagnostic tests; and
• Remove burdensome and overly complex functional status reporting requirements for outpatient therapy.

Advancing Virtual Care

“CMS is committed to modernizing the Medicare program by leveraging technologies, such as audio/video applications or patient-facing health portals, that will help beneficiaries access high-quality services in a convenient manner,” said Administrator Verma.

Getting to the doctor can be a challenge for some beneficiaries, whether they live in rural or urban areas. Innovative technology that enables remote services can expand access to care and create more opportunities for patients to access personalized care management as well as connect with their physicians quickly.

Provisions in the proposed CY 2019 Physician Fee Schedule would support access to care using telecommunications technology by:

• Paying clinicians for virtual check-ins – brief, non-face-to-face appointments via communications technology;
• Paying clinicians for evaluation of patient-submitted photos; and
• Expanding Medicare-covered telehealth services to include prolonged preventive services.

Lowering Drug Costs

President Trump is putting American patients first and lowering prescription drug costs, and CMS is committed to advancing this effort. CMS is today proposing changes as part of the continued rollout of the Administration’s blueprint to lower drug prices and reduce out-of-pocket costs.

The changes would affect payment under Medicare Part B. Part B covers medicines that patients receive in a doctor’s office, such as infusions. CMS is proposing a change in the payment amount for new drugs under Part B, so that the payment amount would more closely match the actual cost of the drug. This change would be effective January 1, 2019, and would reduce the amount that seniors would have to pay out-of-pocket, especially for drugs with high launch prices. This is one of many steps that CMS is taking to ensure that seniors have access to the drugs they need.

Proposed CY 2019 Quality Payment program Key Changes

To implement the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), CMS established the Quality Payment Program (QPP), which consists of two participation pathways for doctors and other clinicians – the Merit-based Incentive Payment System (MIPS), which measures performance in four categories to determine an adjustment to Medicare payment, and Advanced Alternative Payment Models (Advanced APMs), in which clinicians may earn an incentive payment through sufficient participation in risk-based payment models.

The proposed changes to QPP aim to reduce clinician burden, focus on outcomes, and promote interoperability of electronic health records (EHRs), including by:

• Removing MIPS process-based quality measures that clinicians have said are low-value or low-priority, in order to focus on meaningful measures that have a greater impact on health outcomes; and
• Overhauling the MIPS “Promoting Interoperability” performance category to support greater EHR interoperability and patient access to their health information, as well as to align this performance category for clinicians with the proposed new Promoting Interoperability Program for hospitals.

Under the requirements of the Bipartisan Budget Act of 2018, CMS is continuing the gradual implementation of certain MIPS requirements to ease administrative burden on clinicians. The proposed changes to the Quality Payment Program reflect feedback and input from clinicians and stakeholders, and we will continue to offer free and customized support from CMS’s technical assistance networks.

Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration

Aligning with the agency’s goals of improving quality of care and responding to the feedback we have received from clinicians, CMS also proposes waivers of MIPS requirements as part of testing a demonstration called the Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) demonstration. The MAQI demonstration would test waiving MIPS reporting requirements and payment adjustments for clinicians who participate sufficiently in Medicare Advantage (MA) arrangements that are similar to Advanced APMs.

Some Medicare Advantage plans are developing innovative arrangements that resemble Advanced APMs. However, without this demonstration, physicians are still subject to MIPS even if they participate extensively in Advanced APM-like arrangements under Medicare Advantage. The demonstration will look at whether waiving MIPS requirements would increase levels of participation in such MA payment arrangements and whether it would change how clinicians deliver care.

Price transparency: Request for information

Finally, as part of its commitment to price transparency, CMS is seeking comment through a Request for Information asking whether providers and suppliers can and should be required to inform patients about charge and payment information for healthcare services and out-of-pocket costs, what data elements would be most useful to promote price shopping, and what other changes are needed to empower healthcare consumers.

Public comments on the proposed rules are due by September 10, 2018.

For a fact sheet on the CY 2019 Physician Fee Schedule proposed rule, please visit: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2018-Fact-sheets-items/2018-07-12-2.html

The U.S. Preventive Services Task Force released today a final recommendation statement on risk assessment for cardiovascular disease (CVD) with nontraditional risk factors. The Task Force found insufficient evidence on whether additional methods of risk assessment provide more information than traditional measures of risk and help prevent heart attack or stroke. To view the recommendation and the evidence on which it is based, please go here. The final recommendation statement can also be found in the July 10 online issue of JAMA.

The U.S. Preventive Services Task Force released today a final recommendation statement on screening for peripheral artery disease (PAD) and cardiovascular disease risk assessment with the ankle-brachial index (ABI). The Task Force found insufficient evidence on use of the ABI as a screening tool for PAD. To view the recommendation and the evidence on which it is based, please go here. The final recommendation statement can also be found in the July 10 online issue of JAMA.

CMS Action for Home Health Agencies Puts Value Over Volume and Advances MyHealthEData Initiative

WASHINGTON DC – Today, the Centers for Medicare & Medicaid Services (CMS) proposed significant changes to the Home Health Prospective Payment System to strengthen and modernize Medicare, drive value, and focus on individual patient needs rather than volume of care. Specifically, CMS is proposing changes to improve access to solutions via remote patient monitoring technology, and to update the payment model for home health care.

“Today’s proposals would give doctors more time to spend with their patients, allow home health agencies to leverage innovation and drive better results for patients,” said CMS Administrator Seema Verma. “The redesign of the home health payment system encourages value over volume and removes incentives to provide unnecessary care.”

CMS’s proposed changes promote innovation to modernize home health by allowing the cost of remote patient monitoring to be reported by home health agencies as allowable costs on the Medicare cost report form. This is expected to help foster the adoption of emerging technologies by home health agencies and result in more effective care planning, as data is shared among patients, their caregivers, and their providers. Supporting patients in sharing this data will advance the Administration’s MyHealthEData initiative.

As required by the Bipartisan Budget Act of 2018, this proposed rule would also implement a new Patient-Driven Groupings Model (PDGM) for home health payments. The current system pays for 60-day episodes of care and relies on the number of therapy visits a patient receives to determine payment. The PDGM would eliminate the use of “therapy thresholds” in determining payment and changes the unit of payment to 30-day periods of care. The improved structure would move Medicare towards a more value-based payment system that puts the unique care needs of the patient first while also reducing the administrative burden associated with the HH PPS. The PDGM would be implemented in a budget-neutral manner on January 1, 2020.

The proposed rule also includes information on the implementation of home infusion therapy temporary transitional payments as required by the Bipartisan Budget Act of 2018. In addition, the proposed rule solicits comments on elements of the new home infusion therapy benefit category and proposes standards for home infusion therapy suppliers and accrediting organizations of these suppliers as required by the 21st Century Cures Act.

Physicians who order home health services for their patients would also see administrative burden reduced under this rule. CMS is proposing to eliminate the requirement that the certifying physician estimate how much longer skilled services would be needed when recertifying the need for continuing home health care, as this information is already gathered on a patient’s plan of care.

The proposed rule helps advance the Trump Administration’s Meaningful Measures Initiative. CMS is proposing changes to the Home Health Quality Reporting Program (HH QRP). The cost impact related to updated data collection processes as a result of the proposed implementation of the PDGM and proposed changes to the HH QRP are estimated to result in a net $60 million in annualized cost savings to HHAs, or $5,150 in annualized cost savings per HHA, beginning in CY 2020.

In the proposed rule CMS is releasing a Request for Information to welcome continued feedback on the Medicare program and interoperability. CMS is gathering stakeholder feedback on revising the CMS patient health and safety standards that are required for providers and suppliers participating in the Medicare and Medicaid programs to further advance electronic exchange of information that supports safe, effective transitions of care between hospitals and community providers.

The proposed rule and the Request for Information can be downloaded from the Federal Register at: https://www.federalregister.gov/public-inspection.

The proposed rule announced today is part of a broader effort to put patients over paperwork by improving access to and value of care, and reducing the administrative burden on physicians so that more effective care to patients may be provided. To date, CMS has taken the following notable actions in this year’s rulemaking for Medicare, among others, to advance the Patients Over Paperwork initiative for Medicare beneficiaries:

• The modernizing proposals to advance CMS’ Meaningful Measures Initiative released in five separate fiscal year 2019 proposed rules are projected to save Medicare providers close to four million hours and more than $144 million as they take effect in 2019 and 2020.
• CMS proposed a Patient-Driven Payment Model for the Skilled Nursing Facility Prospective Payment System that ties payment to patients’ conditions and care needs rather than volume of services provided and simplifies complicated paperwork requirements that save facilities approximately $2.0 billion over 10 years.
• CMS finalized a rule that would allow Medicare Advantage plans to offer more tailored plan benefit packages and new types of supplemental benefits.

The U.S. Preventive Services Task Force released today a final recommendation statement on screening for osteoporosis to prevent fractures. The Task Force found that screening for osteoporosis can prevent fractures in women 65 years and older and in women younger than 65 years who are at increased risk. More research is needed for men. To view the recommendation and the evidence on which it is based, please go here. The final recommendation statement can also be found in the June 26 online issue of JAMA.

Key Messages

• Decreasing dietary sodium intake most likely reduces blood pressure in normotensive adults and more so in those with hypertension
• Higher sodium intake may be associated with greater risk for developing hypertension
• Use of potassium-containing salt-substitutes in the diet to reduce sodium intake most likely reduces blood pressure in adults
• Increasing potassium intake most likely decreases blood pressure in adults with hypertension
• All-cause mortality may be associated with sodium intake
• Reduced sodium intake may decrease the risk for combined CVD morbidity and mortality

The 21st Century Cures Act (P.L. 114-255) is landmark, bipartisan legislation that was signed into law on Dec. 13, 2016, and touches virtually all aspects of biomedical research, medical product development and the regulatory approval process. Read what FasterCures has said about 21st Century Cures over the years.

Evidence Review Now Available
Noninvasive Nonpharmacological Treatment for Chronic Pain: A Systematic Review
(Systematic Review, released on June 11, 2018)

Selected Key Messages:

• Interventions that improved function and/or pain for at least 1 month when used for
  • Chronic low back pain: Exercise, psychological therapies (primarily cognitive behavioral therapy [CBT]), spinal manipulation, low-level laser therapy, massage, mindfulness-based stress reduction, yoga, acupuncture, multidisciplinary rehabilitation (MDR).
  • Chronic neck pain: Exercise, low-level laser, Alexander Technique, acupuncture.
  • Knee osteoarthritis: Exercise, ultrasound.
  • Hip osteoarthritis: Exercise, manual therapies.
  • Fibromyalgia: Exercise, CBT, myofascial release massage, tai chi, qigong, acupuncture, MDR.
  • Chronic tension headache: Spinal manipulation.
• Most effects were small. Long-term evidence was sparse.
• There was no evidence suggesting serious harms from any of the interventions studied; data on harms were limited.

App offers easy access to scientifically backed information on herbs and herbal products.

Findings show the impact of chronic pain on the brain and its relation to depression.

The AHRQ National Guideline Clearinghouse (NGC, guideline.gov) Web site will not be available after July 16, 2018 because federal funding through AHRQ will no longer be available to support the NGC as of that date. AHRQ is receiving expressions of interest from stakeholders interested in carrying on NGC’s work. It is not clear at this time, however, when or if NGC (or something like NGC) will be online again. In addition, AHRQ has not yet determined whether, or to what extent, the Agency would have an ongoing role if a stakeholder were to continue to operate the NGC. We will continue to post summaries of new and updated evidence-based clinical practice guidelines until July 2, 2018.