14 Oct October 14, 2019

HHS Reg Changes Would Allow for New Relationships Between Docs, Hospitals and Others
Long-awaited regulatory changes to the physician-self referral and anti-kickback statute regulations were released jointly last week by CMS and the HHS Inspector General. The proposed rules are the result of a CMS request for information on potential changes to the Stark Law over a year ago, and a separate RFI from the HHS Office of Inspector General on potential changes to the anti-kickback statute.  CMS’ proposed rule would create new, permanent exceptions to the physician-self referal “Stark Law” for providers in value-based payment arrangements. The anti-kickback proposal from HHS’ OIG includes several new safe harbors, such as for care coordination to improve quality, health outcomes and efficiency, for value-based care initiatives with substantial downside or full financial risk, and for providers participating in CMS payment models. Comments are due Dec. 31st. Click here for the CMS fact sheet, and here for the proposed rule. Click here for the OIG fact sheet, and here for the proposed rule.

Pelosi Rx Reform Bill Would Save $345 Billion: CBO
House Speaker Nancy Pelosi’s Rx pricing reform bill would save the government $345 billion over an eight-year period, according to a partial Conressional Budget Office analysis of the bill released late last week The savings would come from lower drug costs in a provision of the bill allowing the government to negotiate the cost of at least 25 drugs per year, with the maximum price no more than 1.2 times that paid in other wealthy countries, which typically pay lower prices for medicines than the United States. The CBO analysis assumes most companies would cooperate with negotiations, thereby avoiding the large tax penalties that would come from failing to lower the prices of their medicines. The House could include Pelosi’s bill, or portions of it, in a year-end package now under negotiation.  Click here for the CBO review.

• The National Association of Manufacturers will spend at least $1 million on an ad campaign opposing price controls on prescription drugs to run nationally on cable, in print and online, click here.

$5 Billion in Higher Costs for 7 Major Drugs in 2 Years: ICER
Drug costs increased by $5 billion over two years for seven drugs with no evidence the drugs’ actual value had increased, according to a new study by the Institute for Clinical and Economic Review. The cost-effectiveness group, known as ICER, released its first annual report focused on seven pharmaceuticals on “unsupported price increases” for price hikes that are not associated with new clinical research or other innovation that would indicate a drugs had additional worth that contributed to the largest increase in drug spending in 2017 and 2018.  The report based findings on net sales revenue and price hikes. Of the seven, AbbVie’s Humira was the largest as the autoimmune medicine’s average net price increased by 15.9 percent, costing consumers and insurers an additional $1.86 billion over the two-year period. The other six drugs in the study were Roche Genentech’s Rituxan, Pfizer’s Lyrica, Gilead’s Truvada, Amgen’s Neulasta, Eli Lilly’s Cialis and Biogen’s Tecfidera. The drug companies have pointed out that they sent along hundreds of studies for ICER to consider in its analysis and the group rejected almost all of them.  To read the study, click here.

25 Percent of Health Care Spending Is Waste: JAMA
About one quarter of all health care spending in the U.S. is waste, according to a new study released in JAMA last week. The estimated cost ranged from $760 billion to $935 billion from January 2012 to May 2019.  What is drivng the numbers?  Waste is mostly due to failure of care delivery, failure of care coordination, overtreatment or low-value care, pricing failure, fraud and abuse, and administrative complexity. The lead author was William Shrank, Humana’s chief medical officer. He and his colleagues say the waste is paid for through higher premiums, out-of-pocket spending, and taxes. Click here for the study.  Click here for a NYT report.

• The expansion of telemedicine has enabled new forms of Medicare fraud, in the past year. HHS OIG and the Justice Department have uncovered at least five health care fraud schemes that involved telemedicine, click here.

HHS Announces New Guidelines for Opioids
The Department of Health and Human Services recently published a new Guide for Clinicians on the Appropriate Reduction or Discontinuation of Long-Term Opioid Analgesics. The guide shares that both individual patients and the public’s health benefit only when opioids are prescribed so that the benefits outweigh the risks. Additionally, the new guidelines give advice to medical staff who are contemplating or initiating changing opioid dosage. Click here for more.

CDC:  Vaping Lung Injuries Jump to 1299
The Centers for Disease Control announced last week that they now have 1,299 reported lung injury cases associated with the use of e-cigarette, or vaping products, as of Oct. 8, 2019. The CDC also confirmed 26 deaths mostly due to THC-containing products, which most findings suggest is the biggest cause of the problem. However, no single product or substance has been linked to all lung injury cases, and the specific chemicals causing lung injuries associated with e-cigarette use, or vaping, remains unknown at this time according to the CDC. Click here for the latest from the CDC.

• The New York Times reports on the youngest known vaping-related death of a 17-year-old Bronx teen, click here.
• Prudential Financial will now classify e-cigarette users as smokers under the life insurance plans, making those customers subject to higher insurance rates for individual coverage, click here.
• The House Energy and Commerce Health Subcommittee will hold a legislative hearing on the youth tobacco epidemic, click here for more on the legislation and here to watch the hearing on Wednesday at 10:30 EST
• School districts across the U.S. filed lawsuits against e-cigarette companies last week in response to the growing epidemic among students. Click here for a report on the filings.

Ransomware Attacks Increasing on Small Providers
Cyber attacks going after doctors, dentists, and community hospitals around the country are causing some providers to turn away patients, while others have had to close permanently. Experts claim that health care providers, in particular smaller types, are attractive to hackers as the data can be sold for insurance-fraud purposes and/or can be locked-up to extort money. Additionally, these facilities and practitioners are at greater risk because they usually do not have resources for significant security tools and might not have dedicated cybersecurity specialists on staff to monitor their systems. To read the WSJ article, click here. An Alabama hospital chain that quit accepting new patients after a malware attack crippled computer systems said it has resumed normal operations after paying a ransom demand. Click here.

CMS: More MA Choices in 2020
CMS announced Friday more seniors would have access to more high-quality Medicare Advantage Plan choices in 2020. Approximately 52 percent of Medicare Advantage plans that offer prescription drug coverage will have an overall rating of four stars or higher, compared to approximately 45 percent in 2019. To read more from CMS, click here.

Medicaid Work Requirements Racking Up Millions in Administrative Costs: GAO
The cost to CMS to administer waivers for Medicaid expansions was estimated to be between $10 million to more than $250 million in each of the five states that were reviewed by the GAO. The report recommended CMS should 1) require states to submit and make public their projections of administrative costs for demonstrations including work requirements 2) account for the administrative costs of demonstrations when assessing whether demonstrations are budget neutral and 3) assess the risks of providing federal funds for costs to administer work requirements that are not allowable and respond to risks by improving oversight procedures. Click here for the full report.

• A federal appeals court on Friday sharply questioned the Trump administration’s work requirements for Medicaid recipients, casting doubt on a key part of a government-wide effort to place conditions on low-income people seeking taxpayer-financed assistance. Click here.

Most Providers Do Not Screen for Social Determinants of Health
A new study funded by AHRQ and published in JAMA found that only 16 percent of physician practices and 24 percent of hospitals reported screening for all five factors associated with social determinants of health: food insecurity, housing instability, utility and transportation needs and interpersonal violence. Surveys administered from June 2017 to August 2018 to 2,190 physician practices and 739 hospitals found that while most physician practices and hospitals do not report screening patients for the key social needs, it appears that practices serving more economically disadvantaged populations do report screening at higher rates. The study did show that 75 percent of hospitals and 56 percent of physician practices did screen for interpersonal violence. To read the full study, click here.

• “Ending Senior Isolation: A Summit on Healthy Aging” will look at the social isolation, access to healthcare, limited incomes and other social determinants of health in the U.S. on Oct. 30th, click here to register.
• Robert Wood Johnson Foundation’s first report on the state of childhood obesity found that 15 percent of Americans age 10 to 17 remain obese, and there are dramatic disparities along socioeconomic, racial and ethnic lines, click here.
• HRSA’s newest National Survey of Children’s Health says 15.3% of adolescents ages 10-17 are considered obese with a BMI greater than or equal to 30. The report finds that each state has a different adolescent obesity rate, with Utah having the lowest rate at 8.7% and Mississippi having the highest rate, at 25.4%. To view the interactive data, click here.
• Reps. Lisa Blunt Rochester (D-DE) and Gus Bilirakis (R-FL) introduced H.R. 4621, the Collecting and Analyzing Resources Integral and Necessary for Guidance (CARING) for Social Determinants Act of 2019. It is aimed at a providing guidance for states to address social determinants of health for their Medicaid and CHIP programs, click here. 
• As part of the new ability to cover certain social determinants of health among seniors through Medicare Advantage plans, Devoted Health, a start-up health insurer targeting seniors, says it will be the first to offer the Apple iWatch as a fitness benefit to its members, click here.

Analysis Questions Hospitals’ Charity Care Policies
Under the Affordable Care Act, nonprofit hospitals are expected to provide free or discounted care to patients of meager incomes — or risk losing their tax-exempt status. And yet 45 percent of nonprofit hospitals are routinely sending medical bills to patients whose incomes are low enough to qualify for charity care, according to a Kaiser Health News analysis. Click here for details.

STD Rates Rise to Record High in U.S.
According to the CDC, the number of Americans who were diagnosed with a sexually transmitted diseases rose to a record high with nearly 2.46 million cases of chlamydia, gonorrhea, syphilis and other STDs in 2018. Most notable was the rate of newborn deaths related to congenital syphilis, which increased 22 percent from 2017 to 2018 (from 77 to 94 deaths). Officials point to increased drug use, poverty, stigma, and unstable housing, which can reduce access to STD prevention and care; decreased condom use among vulnerable groups, including young people and gay and bisexual men; and cuts to STD programs at the state and local level. To read the full report, click here.

CMS’ Nursing Home Website To Include Abuse and Neglect Citations
CMS has announced that it will update the information available on the Nursing Home Compare website to display a consumer alert icon next to nursing homes that have been cited for incidents of abuse, neglect, or exploitation. Nursing Home Compare already shows staffing levels, quality measure performance and health and safety compliance, and by adding this new function CMS says that they are “empowering consumers to make the right decisions for themselves and their loved ones.” Beginning October 23 if a facility has been cited for abuse that led to resident harm within the past year, an alert will appear. Additionally, the site will show an icon if they have been cited during past two years for abuse that could have potentially led to patient harm. Click here for more from CMS.

CDC Sounds Alarm for Pregnant Women Not Vaccinated for Flu, Whooping Cough
The Centers for Disease Control has issued a report claiming that an alarming number of pregnant women have not received vaccines for the flu or whooping cough, putting them and their infants at heightened risk of hospitalization and death. The report claims that about 65 percent of expecting mothers did not receive those critical vaccinations last year, despite expert recommendations. The CDC stresses that pregnant women are twice as likely to be hospitalized for the flu than non-pregnant women of childbearing age, and infants who become infected with the flu or whooping cough are at high risk of hospitalization or death. The CDC recommends all expectant mothers get the flu vaccine during any trimester and the Tdap vaccine for whooping cough during the early part of the third trimester. Click here for the report.