Goal 1: Reform, Strengthen, and Modernize the Nation’s Healthcare System
In 2019, the Department of Health and Human Services (HHS) delivered on President Trump’s promise to protect what works and fix what’s broken in our healthcare system. That included delivering on President Trump’s vision for a personalized, affordable, patient-centric healthcare system that has you, the patient, in the center, puts you in control, and treats you like a human being, not a number.
HHS’ work delivering on this vision focused on facilitating patient-centered markets in healthcare, especially through 1) reforms to how HHS finances care—through protecting and improving Medicare and Medicaid and expanding options in the individual health insurance market and 2) efforts to deliver better value in healthcare through equipping patients with price and quality transparency, providing patients with control of their health records, unleashing data, removing regulatory burdens, paying for outcomes, lowering drug prices, and accelerating drug and device approval and reimbursement.
On this page:
- Protecting and Strengthening Medicare
- Lowering Prescription Drug Costs
- Increasing Options and Lowering Costs for Health Insurance
- Transforming Medicaid and Making It Sustainable
- Paying for Outcomes
- Delivering Transparency around Price and Quality
- Provide Patient Control of Health IT and Unleash Data
- Removing Regulatory Burdens
- Committing to High-Quality Care in the Indian Health Service
Protecting and Strengthening Medicare
Executive Order on Protecting and Improving Medicare for Our Nation’s Seniors: In October 2019, President Trump signed an executive order directing HHS to take steps to deliver more options and benefits and lower costs for beneficiaries including to:
- Open up new options for plans within Medicare Advantage and test out new benefits.
- Accelerate Medicare’s ability to pay for the latest medical technology.
- Pay doctors for the time they spend with patients, rather than procedures or paperwork.
- Cut waste, fraud, and abuse in Medicare that undermines the program.
- Help healthcare professionals like nurses practice to the top of their license.
New, lower-cost settings of care: As part of responding to the Executive Order (EO), the Centers for Medicare & Medicaid Services (CMS) has given Medicare beneficiaries more choices on where to obtain care, improved access and convenience, and lowered out-of-pocket expenses, by adding 20 new procedures payable when furnished in either the ambulatory surgery centers or outpatient hospital departments.
Supporting access to the latest technology for Medicare beneficiaries: CMS streamlined the process for supporting innovative treatments by providing an alternative new technology add-on payment pathway in which Breakthrough Devices are no longer required to demonstrate evidence of “substantial clinical improvement” to qualify for new technology add-on payments. This will provide additional Medicare payment for these technologies while real-world evidence is emerging, giving Medicare beneficiaries timely access to the latest innovations in treatment. In addition, CMS increased the maximum new technology add-on payment from 50 percent of the cost of the new technology to 65 percent.
New Medicare Advantage supplemental benefits: CMS delivered modifications designed to help keep seniors safe in their homes and to provide respite care for caregivers, non-opioid pain management alternatives like therapeutic massages, and transportation, as well as more in-home support services and assistance.
New virtual care coverage: In Medicare and Medicare Advantage, doctors can now receive compensation for a much broader range of services delivered virtually, like phone or video check-ins.
Lowering Medicare Advantage premiums: Through strengthening negotiation and maximizing competition, CMS delivered lower average Medicare Advantage premiums and increased plan choices for beneficiaries in 2019 and 2020.
- This work has helped lower Medicare Advantage premiums by 23 percent and added 1,200 plan options since 2018.
- For 2020, the average MA premium is $23 a month – the lowest in 13 years.
Paying for time with patients rather than paperwork: Starting in 2021, CMS will place more emphasis in calculating compensation based on the time healthcare providers spend treating the growing number of patients with greater needs and multiple medical conditions, through increasing the value of evaluation and management (E/M) codes for office/outpatient visits and providing enhanced payments for certain types of visits.
Coverage for CAR T-cell therapy: CMS began covering the first FDA-approved Chimeric Antigen Receptor T-cell, or “CAR T-cell,” cancer therapy, which uses a patient’s own genetically modified immune cells to treat some people with specific types of cancer.
Lowering Prescription Drug Costs
Historic price decrease: CMS National Health Expenditure data released in 2019 showed that, for the first time in more than forty years, the retail price of prescription drugs fell in 2018.
First-Ever safe drug importation action plan: For the first time ever, the FDA issued a proposed rule that, if finalized, would allow states to submit plans for the importation of certain prescription drugs from Canada in order to lower Americans’ drug costs, and also issued draft guidance for industry to facilitate importation of prescription drugs, including biological products, that are manufactured abroad, authorized for sale in a foreign country, and originally intended for sale in that foreign country, which could give drug companies new flexibility to lower drug prices.
Lowering Part D premiums: For the third year in a row, the average basic premium for Medicare Part D prescription drug plans is projected to decline. Over the past three years, average Part D basic premiums have decreased by 13.5 percent, from $34.70 in 2017 to a projected $30 in 2020, saving beneficiaries about $1.9 billion in premium costs over that time.
Real-Time Pharmacy Benefit Tool: Starting in 2020, Part D plan sponsors will be required to make available a real-time benefit tool that provides prescribers with information about what drugs are covered by a patient’s insurance coverage, what cost-sharing may be, and other information.
Historic generic drug approvals: For the third year in a row, the FDA approved a record number of generic drugs in FY 2019, approving or tentatively approving a record 1,171 generic drugs, including 125 applications for first generics of medicines that had no generic competition.
Historic biosimilar approvals: While implementing several facets of its Biosimilars Action Plan (BAP), the FDA approved 10 biosimilar products in calendar year 2019, an increase from seven in 2018 and five in 2017. FDA also witnessed an increase in the number of biosimilars marketed to consumers, including products for treating cancer, neutropenia, Crohn's disease and arthritis.
Draft Guidance to advance insulin competition: To inform product developers who intend to seek FDA approval of proposed insulin products that are biosimilar to, or interchangeable with, an approved insulin product, FDA issued a draft guidance to clarify what data and information may or may not be needed to demonstrate biosimilarity or interchangeability.
Increasing Options and Lowering Costs for Health Insurance
Lower premiums, more options on HealthCare.gov: For the second year in a row, average benchmark premiums for plans offered on HealthCare.gov dropped, declining by 4 percent from 2019 to 2020, while the number of issuers participating in the Exchanges increased by 20, giving consumers more coverage choices.
Improving the enrollment experience: In 2018, CMS developed a new enhanced direct enrollment pathway for consumers to enroll in an Exchange plan directly through an approved issuer or web-broker without the need to be redirected to HealthCare.gov or to contact the Exchange Call Center. In 2019, for the first time, Enhanced Direct Enrollment was made available through the entire Open Enrollment period. In addition, for the first time, consumers were able to “window shop” and preview plan options ahead of the Open Enrollment period.
Health Reimbursement Arrangements: With the Departments of Labor and Treasury, HHS issued a rule that will expand the use of two new types of Health Reimbursement Arrangements beginning January 2020, giving millions of American workers more options for health insurance coverage.
Providing state flexibility: Since 2017, HHS and the Department of the Treasury approved twelve Section 1332 waivers authorizing state reinsurance programs to lower premiums, ranging from an estimated 6 percent reduction in Rhode Island to a 30 percent reduction in Maryland. Hawaii was also issued a waiver in 2016 to avoid having to establish a Small Business Health Insurance Program (SHOP) as part of its Exchange.
Transforming Medicaid and Making It Sustainable
Reducing potential for improper payments: CMS continued its work to ensure sound fiscal stewardship and oversight of the Medicaid program by proposing a comprehensive update to Medicaid’s regulations that ensure the program operates in a sound fiscal manner, consistent with statutory requirements. This proposal would clamp down on abusive financing arrangements by reducing the potential for inappropriate payments so that federal Medicaid dollars are being spent on Medicaid beneficiaries, not state projects that do not benefit Medicaid beneficiaries, or to supplement or supplant the state’s required share of Medicaid financing.
Protecting the integrity of Medicaid and CHIP: CMS issued a new proposed rule to ensure the integrity of the Medicaid and the Children’s Health Insurance Program (CHIP) eligibility and enrollment process by aiming to improve the accuracy and consistency of eligibility determinations across states.
Supporting research on improving Medicaid: For the first time, CMS released a robust repository of research-ready Transformed Medicaid Statistical Information System (T-MSIS) data files. Researchers and others can now use this data to answer questions about Medicaid and CHIP enrollment, services and payment.
Updated Medicaid scorecards: CMS released an updated Medicaid and CHIP Scorecard – an innovative public-facing federal dashboard that includes additional data points, measures, and enhanced functionality.
Substance Use Data Book: CMS produced the first ever Substance Use Data Book, with information about diagnosis and treatment. These and other efforts helped to ensure that states have the flexibility to best serve their residents.
Paying for Outcomes
New models that pay for value: HHS continued to work to realign incentives in how we pay for healthcare, and developed over a dozen new innovative payment models that allow reimbursement to be tied to value, rather than merely volume of services.
- Kidney care:As part of the President’s Advancing American Kidney Health Initiative, the Kidney Care Choices Models and the proposed ESRD Treatment Choices Model add financial incentives for providers and suppliers to better manage care for Medicare beneficiaries to delay the onset of kidney disease and incentivize kidney transplantation and home dialysis.
- CMS Primary Cares Initiative: The Direct Contracting and Primary Care First models are the next step in transforming how Medicare pays primary care providers. These models align up to a quarter of Medicare beneficiaries to primary care entities participating in payment arrangements based on outcomes rather than volume.
- Emergency Triage, Treat and Transport (ET3) model: Traditionally, Medicare has paid for patients who call 911 and are picked up by emergency medical services to go to the hospital, which can be unnecessary and expensive. The ET3 model will allow ambulance suppliers and providers to partner with qualified health care practitioners to deliver treatment at the site of a medical emergency (either on-the-scene or through telehealth) and to bring patients to alternative destination sites (such as primary care doctors’ offices or urgent-care clinics) that may represent lower cost, more appropriate options than a hospital.
More Accountable Care Organizations taking on risk: CMS revamped the Medicare Shared Savings Program in the Pathways to Success final rule to put ACOs on a quicker path to taking on real risk. By January 2020, almost 37 percent of ACOs will be on the path to take on risk—doubling the number of ACOs taking on downside risk.
Delivering Transparency around Price and Quality
Delivering on President Trump’s Executive Order on Improving Price and Quality Transparency in Healthcare:
- Finalized a rule so that, starting January 2021, hospitals will have to disclose publicly their negotiated rates for services and the discounted cash price they’re willing to take.
- Proposed a rule to require that most health insurance insurers provide patients, upon request, cost-sharing data, similar to an advance explanation of benefits, delivering transparency around all healthcare prices.
- Launched the HHS Quality Summit to convene federal and private stakeholders to produce a health quality roadmap that will align quality measures across federal departments.
Modernized and redesigned Medicare Plan Finder: For the first time in a decade, CMS launched a modernized and redesigned Medicare Plan Finder, which provides users with a mobile friendly and easy-to-read design.
First official Medicare app: CMS launched its first app, “What’s Covered,” that delivers accurate cost and coverage information on mobile devices so users can quickly see whether Medicare covers an item or service.
Qualified Health Plan Five-Star ratings: For the first time, CMS is requiring the display of the Five-Star Quality Rating System nationwide for qualified health plans offered through Exchanges, to offer consumers more information to help them compare plans.
Provide Patient Control of Health IT and Unleash Data
Proposed historic interoperability rule: CMS and the Office of the National Coordinator for Health Information Technology (ONC) proposed rules on interoperability to help allow individuals to quickly and easily access their health information electronically. ONC’S proposed rule requires the healthcare industry to adopt standardized application programming interfaces (APIs) to help patients securely and easily access their electronic health information using smartphones and other mobile devices.
Blue Button 2.0: Through Blue Button 2.0, Medicare beneficiaries can now securely connect their data to apps and other tools developed by innovative companies. The apps can help them organize and share their claims data, find health plans, make care appointments, and check symptoms. As of December 2019, 54 applications are in production and over 2,400 developers from 1,456 organizations are working on development of applications.
Helping clinicians access claims data: The “Data At the Point of Care” API Pilot is making a patient’s Medicare A, B, and/or D claims data available to the clinician directly in their workflow to support treatment decisions.
Removing Regulatory Burdens
Freeing clinicians to spend more time with patients: In 2019, CMS eliminated reams of overly burdensome and unnecessary regulations and sub-regulatory guidance, to allow clinicians and providers to focus on their primary mission – improving their patients’ health. These efforts are estimated to save $6.6 billion through 2021—with a reduction of 42 million burden hours, giving that time back to clinicians and providers to spend with their patients and not on needless paperwork.
Simplifying Participation in Pay-for-Performance Program: CMS established an approach for simplifying ways for clinicians to participate in the pay-for-performance program Merit-Based Incentive Payment System (MIPS) called the MIPS Value Pathways (MVPs).
Regulatory Sprint to Coordinated Care: HHS continued work under the direction of Deputy Secretary Eric Hargan on the Regulatory Sprint to Coordinated Care to benefit patients and providers through regulatory reforms that allow for commonsense, value-based, patient-centered innovations.
- Anti-Kickback Statute: The HHS Office of Inspector General (OIG) proposed a rule that, if finalized, would remove unnecessary regulatory obstacles to value-based healthcare arrangements, giving more options for providers to work together in innovative ways to better coordinate care, while maintaining strong safeguards to protect patients and programs from fraud or abuse. For instance, under the proposed rule, a doctor could provide a patient who’s taking a large number of medications with a free smart pillbox to help him or her keep medications organized and alert the physician of any missed doses.
- 42 CFR Part 2: SAMHSA proposed reforms for 42 CFR Part 2 to decrease burden for practitioners and ultimately increase access to care for those with substance use disorders.
- Stark Law: CMS proposed to modernize and clarify the regulations that interpret the Medicare physician self-referral law, also called the “Stark Law,” to open additional avenues for physicians and other healthcare providers to coordinate the care of the patients they serve. As one example, under the proposal, a hospital could donate cybersecurity software to physicians who refer patients to it, ensuring security of patient records sent between the hospital and doctors’ offices without encouraging consolidation of providers.
- In December 2018, the Office for Civil Rights (OCR) published a Request for Information seeking input from the public on how the HIPAA Rules could be modified to further Secretary Azar’s goal of promoting coordinated, value-based healthcare. OCR reviewed the comments and developed a proposed rule, which will be issued in the coming months.
Deputy Secretary’s Innovation’s and Investment Summit (DSIIS): HHS Deputy Secretary Hargan convened four meetings with healthcare leaders focused on innovation and investment, identifying and discussing critical issues that affect innovation in healthcare This was the first department-wide effort of its kind that HHS had ever undertaken to understand and accelerate innovation in healthcare. The ideas, insights and information gathered from DSIIS helped to ensure that HHS understands the perspective of those focused on innovation.
Committing to High-Quality Care in the Indian Health Service
Establishing an IHS Office of Quality: The Indian Health Service formally established the IHS Office of Quality in 2019, to provide national leadership and promote consistency in health care quality across the agency. The IHS has made significant strides in addressing priority areas for quality improvement, including implementing credentialing and privileging software agency-wide; hiring an IHS credentialing program manager at headquarters; and awarding a new contract for an adverse events reporting and tracking system.
New steps toward tribal self-governance: In 2019, the Ak-Chin Indian Community in Arizona, the Rolling Hills Clinic of the Paskenta Band of Nomlaki Indians in California, and the Iowa Tribe of Kansas and Nebraska entered into self-governance compacts and funding agreements. The IHS has now entered into a total of 104 compacts and 130 funding agreements with the participation of over 370 federally recognized tribes and tribal organizations.
Supporting ambulatory facilities in Indian Country: IHS awarded $15 million for eight tribal health facilities to eight tribes and tribal organizations as part of the competitive Small Ambulatory Program to fund construction, expansion or modernization of small ambulatory health care facilities, which are an important part of the Indian health system and can expand access to various outpatient services
Delivering results through the Special Diabetes Program for Indians: The Assistant Secretary for Planning and Evaluation published an Issue Brief, The Special Diabetes Program for Indians: Estimates of Medicare Savings. The Issue Brief reported that a 54 percent decrease in the incidence of diabetes-related end-stage renal disease in American Indian and Alaska Native populations from 1996 (the year before the Special Diabetes Program began) through 2013, likely resulting in thousands of fewer cases and hundreds of millions of dollars in savings to Medicare. Improvements in related outcomes in this population far surpass those observed in other races.