Ongoing studies focus on many different diseases, including colon cancer, chronic pain and kidney failure.
News and Updates for Healthcare Professionals
NIH expands program that conducts large-scale clinical trials in real-world settings
Can 'Social Determinants' Data Really Improve Patient Care?
- 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.
MS Proposes Historic Changes to Modernize Medicare and Restore the Doctor-Patient Relationship
Proposed changes to the Medicare Physician Fee Schedule and Quality Payment Program would streamline clinician billing and expand access to high-quality care
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
To view the CY 2019 Physician Fee Schedule proposed rule, please visit: https://www.federalregister.gov/public-inspection/
For a fact sheet on the CY 2019 Quality Payment Program proposed rule, please visit: https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/2019-QPP-proposed-rule-fact-sheet.pdf
To view the CY 2019 Quality Payment Program proposed rule, please visit: https://www.federalregister.gov/public-inspection/
For a fact sheet on the Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration, please visit: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2018-Fact-sheets-items/2018-07-12.html
Final Recommendation Statement: Risk Assessment for Cardiovascular Disease With Nontraditional Risk Factors
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.
Final Recommendation Statement: Screening for Peripheral Artery Disease and Cardiovascular Disease Risk Assessment With the Ankle-Brachial Index
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 Takes Action to Modernize Medicare Home Health
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.
For a fact sheet on today’s proposed rule, please visit: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2018-Fact-sheets-items/2018-07-02.html
For additional information about the Home Health Prospective Payment System, visit https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/index.html and https://www.cms.gov/center/provider-Type/home-Health-Agency-HHA-Center.html.
For additional information about the Home Health Value-Based Purchasing Model, visit https://innovation.cms.gov/initiatives/home-health-value-based-purchasing-model.
For additional information about the Home Health Quality Reporting Program, visit https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HomeHealthQualityInits/Home-Health-Quality-Reporting-Requirements.html
Final Recommendation Statement: Screening for Osteoporosis to Prevent Fractures
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.
Sodium and Potassium Intake: Effects on Chronic Disease Outcomes and Risks
- 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
21st Century Cures Act: 2018 Mid-Year Update
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.
EHC Program Update: Chronic Pain Final Report
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.