Cutting Costs, Not Care

POLICY PERSPECTIVE

Cutting Costs, Not Care

Both the government and private sector in the U.S. are struggling to find new ways to limit the rapid rise in healthcare costs. The administration, following the May 2018 Department of Health and Human Services (HHS) blueprint, America Patients First, is introducing several new proposals to lower patient costs for healthcare. However, certain efforts to reduce prices are misguided and put patient care at risk. Reintroduction of step therapy, infamously referred to as “fail first,” by the Center for Medicare and Medicaid Services (CMS) represents one of these dangerous cost saving methods. CMS argues that step therapy will “cut costs and optimize clinical decisions,” however patient groups, including GLI, disagree and signed onto a letter to HHS Secretary Alex Azar opposing the policy.

In the private sector, CVS Caremark has adopted value based drug pricing using quality-adjusted life years guidelines (QALY). This model would allow rejection of expensive drugs that do not meet these QALY thresholds. Patient groups have voiced their opposition to this measure, citing it as a potential barrier to patients who require excluded high cost drugs but which may effectively combat their disease and restore their health or prolong their life.

While reducing healthcare costs is a critical policy concern, broad standardized efforts negatively impact individual patient care and coverage. To solve rising healthcare costs, total cost of care to patients, not just drug pricing, must be addressed. Implementation of alternative payment models (APMs) that incentivize value based care, increasing cost transparency for drug prices and medical services, and reducing surprise out of pocket costs are all viable alternatives that can help stem the rising costs of healthcare.

Efforts to address total cost of care have already been brought forward. Senator Bill Cassidy (R-LA) has sponsored legislation to target balance billing, where patients are billed directly for remainder and surprise out of network medical costs, a practice that plays a significant role in healthcare cost-induced bankruptcies in the U.S. The bill mandates that hospitals and providers must inform patients (and obtain patient consent) that there may be out of network costs, and they can obtain treatment elsewhere if necessary, a policy enhancement, which unfortunately is not always practical for individuals. In addition, two bipartisan bills, Know the Lowest Price and Patient Right to Know Drug Prices, include anti-gag clauses which prevent insurers and pharmacy benefit managers (PBMs) from stopping pharmacies from informing patients of lower cost medication alternatives. Through bipartisan coalitions, new reforms are being advocated to reduce total costs of healthcare while preserving individualized patient care.

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Donna R. Cryer, JD
President & CEO
Global Liver Institute

OPEN ADVOCACY OPPORTUNITIES

GLI has sent a letter to the California governor and State Assembly regarding the State’s “Cancer Screen Week.” GLI asks patients, caregivers, healthcare professionals, and advocates to join us in signing this letter, which advocates the inclusion of liver cancer in its statewide cancer screening awareness campaign.

FDA’s Oncology Center for Excellence is holding its second annual workshop, “Partners in Progress: Cancer Patient Advocates and FDA,” for new cancer patient advocates. This workshop will provide basic training for patient advocates and will provide information about the development and implementation of oncology drugs and treatments. The workshop will take place November 27th at the FDA White Oak campus in Maryland and will be accessible via webinar.

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POLICY DEVELOPMENTS AT GLI

Last month, GLI conducted its first #Octoberis4Livers campaign. Throughout October, GLI generated press releases, news articles and social media content on Facebook and Twitter with important information about the prevalence and risks for liver cancer and what the public and liver patients can do to prevent it or to ensure that they are diagnosed as early as possible. GLI called for a new standard of care for all liver patients who are at the highest risk for liver cancer by urging that they have ultrasound screening every six months to identify liver tumors. During #OctoberIs4Livers, GLI also reviewed new and innovative research, highlighted patient and caregiver stories, and highlighted the work of other organizations in the cancer field.

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STATE ACTION

Midterms

As the 2018 midterm elections approach, healthcare has become an important issue in races across the U.S. In a Kaiser Family Foundation poll, 70% of polled voters say a major factor this election is healthcare, with nearly one third of voters describing it as the most important issue for them. This represents a major election talking point in a year where 16 Senate seats, out of 35 total races, and 79 House seats are considered vulnerable. Additionally 36 states are holding elections for governor with 25 of the gubernatorial races marked as battleground races. Coverage for pre existing conditions stands out as a key issue in many states. Democratic Senators Heidi Heitkamp (ND), Joe Donnelly (IN), Joe Manchin (WV), and Claire McCaskill (MO) are locked in tight races and continue to campaign on maintaining ACA provisions for universal coverage. In Arizona, Senator Martha McSally (R-AZ) is trailing her incumbent opponent due to her focus on repeal and replace of ACA.

Medicaid expansion is another major campaign issue particularly in gubernatorial races. Wisconsin, Florida, Kansas, Maine, and Georgia governor seats are considered vulnerable to Democrat challengers who are seeking to expand state Medicaid programs. If these governorships flip, it could lead to large changes in the Medicaid landscape in these states. Taking matters into their own hands, voters in four states (Idaho, Montana, Nevada, and Utah) have ballot initiatives that decide, not their legislatures, whether to expand Medicaid coverage.

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GLOBAL

World Health Organization (WHO)

WHO announces a new series of 13 steps to reduce rates of non-communicable diseases (NCDs). The effort led by WHO ambassador and former New York City Mayor Michael Bloomberg seeks to reduce global rates of NCD’s by one third before 2030. Local governments and state leaders pledge to pass both legislative and fiscal WHO recommended measures to help combat NCDs through improving air quality, reducing rates of obesity, increasing access to vaccinations, and increased regulation on unhealthy foods or harmful products. GLI is developing a letter to Mr. Bloomberg urging that this initiative also address prevention and treatment of NAFLD and NASH diseases globally.

European Association for the Study of Liver (EASL)

In a new six year study focusing on improving lifestyle habits for treatment of NAFLD, web-based interventions prove to be an appropriate alternative to in person group therapies. Current EASL Clinical guidelines recommend a series of lifestyle changes to prevent and manage NAFLD but some patients may have trouble accessing treatment centers or group programs that assist in developing healthy lifestyles. Investigators created a web-based initiative, combined with physical check ups every six months, that would support healthy eating, physical activity, and weight loss in NAFLD patients. In a study of 700 patients, split into group-based and web-based lifestyle interventions, the researchers discovered that both populations showed a similar 10% reduction in fat, increased physical activity, and had reduced liver steatosis and fibrosis.

.GOV NEWS

Food and Drug Administration (FDA)

FDA announced a new effort to advance more generic versions of complex drugs for patients. With increasingly complex drug compounds and intricate methods of delivery, generic drug versions are becoming costlier and more difficult to create. This is leading to a lack of competition for classes of drugs even after their period of exclusivity has ended. Through a series of draft guidances, new policies and legal assistance, a framework will be established intending to expedite and improve the efficient production of generic complex drugs.

U.S. Department of Health and Human Services (HHS)

Secretary of Health Alex Azar has called for pharmaceutical companies to begin disclosing drug prices in televised advertisements. HHS and CMS have announced a series of steps outlining how this proposal would be implemented and how it will help increase transparency for drug pricing. The proposal seeks to make all Medicare/Medicaid covered drugs with a list price of $35 or more (per monthly supply) subject to this rule, with other forms of advertising media possibly included in the future.

US Department of Veterans Affairs (VA)

Of interest to liver patients in the U.S. qualifying for veteran benefits, the VA announced an integrated Electronic Health Records (EHR) system for all VA and Department of Defense (DOD) patients. The joint collaboration seeks to create seamless health information and patient data sharing between the two departments. The effort is planned to help individual patients better transition from active duty to veteran status as well as to improve veteran health outcomes.

Centers for Medicare and Medicaid Services (CMS)

CMS has revised the Affordable Care Act (ACA) 1332 waiver status allowing greater flexibility in the state insurance markets. The new initiative, State Relief and Empowerment Waivers, softens ACA statutory guidelines, permitting states to forgo certain ACA provisions in order to expand the number of eligible state insurance plans. Many groups, such as National Academy for State Health Policy (NASHP), are concerned that this will eliminate safeguards in ACA law and will permit state plans to avoid full care coverage for patients with pre-existing conditions.

In an effort to reduce drug prices, CMS has released its plan for an International Pricing Index (IPI). The IPI model would establish an intermediary vendor between hospitals and practices and the drug distributors that sell Medicare Part B drugs. These vendors would purchase the drugs and bill Medicare based on a “Target Price,” calculated on what international markets pay, not the average sales price (ASP) that drug distributors set. The model intends to bring prices for Medicare Part B drugs in line with international standards.

NGOS

Patient Centered Outcomes Research Institute (PCORI)

PCORI marked its eighth anniversary in October. In a blog, Director Joe Selby lists the multitude of PCORI achievements and outlines its goals for 2019. These new objectives include an additional investment of $400 million in research and expanding information resources regarding research and new technologies in the healthcare landscape.

National Organization for Rare Diseases (NORD)

NORD Director for State Policy Tim Boyd has raised an alarm against a surge of insurers and PBMs adding copay accumulator adjustments into health insurance plans for 2019. This feature denies copay assistance (often provided by drug manufacturers) counting toward beneficiaries’ deductibles or out of pocket maximum costs, which could raise patient prescription costs by thousands of dollars. PBMs and insurers such as Express Scripts, CVS Caremark, and BCBS have instituted these accumulator adjustments already and more than half of private insurers will potentially add them by 2020.

The International Association of Hepatitis Task Forces (IAHTF)

The International Association of Hepatitis Task Forces (IAHTF) has launched its new website. Its mission is to support patients with hepatitis B and C, assist in uniting efforts of regional hepatitis task forces, and to encourage global hepatitis research.

GRANT OPPORTUNITIES

Epidemiologic Research on Emerging Risk Factors and Liver Cancer Susceptibility (R21 Clinical Trial Not Allowed). Funding available from NIH. Application deadlines: November 16, 2018.

Mechanisms of Disparities in Chronic Liver Diseases and Cancer (R21). Funding available from NIH. Application deadlines: April 4th, 2019.

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NAMES TO KNOW

Bill Cassidy: Senator and licensed gastroenterologist (R-LA), who serves on the committee for Health, Education, Labor, and Pensions (HELP).

Joe V Selby: MD, MPH Executive Director of PCORI.

Dan Best: Senior Advisor to the HHS Secretary for Drug Pricing Reform. Leads initiatives aimed at lowering drug prices. Mr. Best was a former CVS Caremark executive prior to joining HHS.

TERMS TO KNOW

PBMs: pharmacy benefit managers; third party administrators that negotiate and manage prescription drug programs for health plans, government or private companies.

PET scan: positron emission tomography; a procedure where a small amount of radioactive material is injected into the bloodstream in order to create a computerized map of the area.

Copay Accumulator Adjustment: a new policy where copayment cards can no longer be used to pay down deductibles or max out of pocket costs. Patients must pay for prescriptions until they reach their max copayment card value and then also pay their plan’s deductible.

FURTHER READING

A proposal from PEW research group seeks to review and change protected classes for Medicare drugs. One of these protected classes includes immunosuppressants, an essential drug for patients who have undergone organ transplants to prevent rejection.

Positron emission tomography (PET) scans have been found to be an effective, non-invasive substitute for patient biopsies of the liver. This technique could give physicians a new tool for diagnosis and treatment management for patients with chronic liver diseases.

Policy UpdatesDonna Cryer