November 4, 2019

Final CMS OPPS Payment Rules:
Defy Court Rulings on 340B, HOPD Site Neutral
— Postpone Price Transparency Rules
— Revise E/M Coding
— Remove More Procedures from Inpatient-Only List

CMS has released its final rules for the FY2020 hospital outpatient prospective payment system (OPPS) and physician fee schedule. The only major surprise was the decision to pull the price transparency proposal from the rules with an assurance that they would be coming soon (click here for details.)  Under the OPPS rule, CMS is finalizing a policy that will pay doctors the same amount for a clinic visit whether it takes place in a hospital outpatient facility or a regular doctor’s office – even after a recent federal judge’s decision that this policy was unlawful. HHS Secretary Azar also fully endorsed site neutral payment policies in a statement.  Click here. The OPPS also keeps the 28.5% rate cut under Medicare to 340B drugs – even though a sesparate Court said CMS acted outside its legal authority. Under the physician rule, CMS is aligning its evaluation and management coding with changes adopted by the American Medical Association CPT Editorial Panel for office/outpatient E/M visits by retaining 5 levels of coding for established patients, and reducing the number of levels to 4 for office/outpatient E/M visits for new patients. CMS also updated the regulation of physician supervision of physician assistants to give PAs greater flexibility to practice. For the OPPS fact sheet, click here, and the rule, click here. For the physician fee schedule fact sheet, click here, and the rule, click here.  Ambulatory Surgery Centers seemed to fair well in the new rule.  Click here for the ASC association’s summary analysis.

  • Rural hospitals and safety net hospitals are bracing for a $4 billion cut in the Medicaid Disproportionate Share Hospital program this year and are expecting twice that next year due to a provision in the Affordable Care Act that Congress has postponed for years, click here.  The cut takes effect November 21, unless Congress acts to postpone.
  • Healthcare experts predict an increase in private equity firms moving into deals for orthopedic services as federal regulators push to move orthopedics from hospitals into outpatient settings as more of the population ages, click here.

CMS Allows for Home Infusion Therapy in Final Home Health Payment Rule
The Centers for Medicare and Medicaid Services released late last week the home health payment final rule that will give a 1.3-percent ($250 million) payment increase. Included in the final rule is a provision that will allow for new home infusion therapy – the administration of certain types of medication, through a durable medical equipment pump, in the patient’s home. The new home infusion therapy benefit includes: professional services, including nursing; patient education and training; and patient monitoring for the provision of home infusion therapy. Additionally, the final rule will move payments away from paying for volume of services to payments based on patients’ clinical characteristics through a new system called the Patient-Driven Groupings Model based on a 30-day episode of care. Click here for the CMS fact sheet and here for the final rule.

CMS Issues Final Rule Updating End-Stage Renal Disease Payment System
A final rule updating payment policies and rates under the End-Stage Renal Disease Prospective Payment System  was released last week by CMS. Some of the changes include a $4.06 increase in the PPS base rate, updated wage indexes, decreases in fixed-dollar lost and Medicare Allowable Payment amounts, new eligibility criteria for the Transitional Drug Add-on Payment Adjustment, an add-on payment adjustment for new and innovative dialysis equipment, and more. Most notable was updates that align with the President’s kidney initiatives to make changes to support the development and use of innovative technologies, and provide greater access to new treatments in kidney care. To read the CMS fact sheet, click here, and the rule, click here.

FDA Sends Report to Congress on Drug Shortages, Recommends Penalties on Drug Manufacturers
The inter-agency Drug Shortage Task Force led by FDA sent a report to Congress last week saying the rate of drug shortages increased between 2013 and 2017. It  identified three primary causes for the problem – lack of incentives for manufacturers to produce less profitable drugs; the market does not recognize and reward manufacturers for “mature quality systems” that focus on supply chain issues; and logistical and regulatory challenges that make it difficult for the market to recover from a disruption. The report found that the shortages affect several treatments for T-cell acute lymphoblastic leukemia, the most common childhood cancer. Among the recommendations was one to provide financial incentives, including penalties and higher prices, to make certain that manufacturers, especially of older generic drugs, continue to produce essential drugs. To read the report, click here.

  • The Senate Health Committee advanced several public health bills including one to boost FDA oversight of the burgeoning over-the-counter drug market, to reauthorize nursing program grants, and fund research into the causes of sudden death in infants, click here.
  • The House unanimously passed a bill last week that would require more public disclosure of the discounts drug companies give to pharmacy benefit managers, click here for H.R. 2115.
  • A bipartisan group of Representatives led by Rep. Diana DeGette (D-CO) introduced legislation that would legally ban drug makers from giving insurers rebates for insulin if they agree to keep the price for products at or below 2006 list prices, click here.
White House Unveils Website to Streamline Search for Drug Treatment
The Trump administration released a new program to help individuals struggling with addiction connect with treatment resources. The website – – is connected with more than 13,000 facilities and offers telehealth treatments. Individuals can review these facilities by the type of treatment offered, payment options, age, and language. To read the full briefing, click here.
Bipartisan Bill Introduced to Expand Telehealth Access Through Medicare
A bipartisan group of senators led by Brian Schatz (D-HI), Roger Wicker (R-MS) introduced last week the Creating Opportunities Now for Necessary and Care Technologies (CONNECT) for Health Act of 2019 that aims to improve access to telehealth services, mental health services, and emergency services to patients, particularly in rural areas. The legislation would allow rural health clinics and other community-based health care centers to provide telehealth services, something that is not allowed under current CMS guidance documents. The bill has bipartisan support as well as support from more than 100 medical organizations including the American Hospital Association. The organizations believe that telehealth is the future of health care and increasing access is crucial. To read the bill language, click here, and for a summary from the sponsor, click here.
CMS Announces Plan to Expand Coverage for Testing in Breast and Ovarian Cancer Patients
CMS announced a plan to expand coverage for next-generation sequencing in breast and ovarian cancer patients. The decision was based on evidence that supports testing in patients. NGS testing is not currently approved by the FDA; however, patients with a family history – or patients who do not know their family history – and are at a great risk of cancer are eligible and generally benefit from the testing. To read more, click here. To read the proposed decision memo from CMS, click here.
Increasing Deaths from Heart Failure Contribute to Worsening Life Expectancy
A JAMA Cardiology study found that death resulting from heart failure rose 20.7 percent after being measured in 2011 and 2017. This increase in heart failure deaths is in part due to the growing over-65 population; however, the study also finds that individuals younger than 65 years are also dying from heart failure. The study notes that the aging population is increasing and by 2030 73.1 million Americans will be 65 years and older. The lead author of the study states that the influx of aging individuals will place a greater burden on society as it figures out how to care for them. Heart failure cost the United States $30.7 billion in 2012 and is projected to increase to $70 billion by 2030. To read the entire WSJ article, click here. For the study click here.
  • Apple hired its second prominent cardiologist, David Tsay, to join its team and work with other physicians at the company increasing the company’s focus on heart health – in addition to the new feature on the Apple Watch that tracks irregular heart rates through the use of an electrocardiogram, click here.
Bipartisan Bill Puts Focus on Medicare Beneficiaries’ Loneliness
After increased reports of the issues contributing to ill health of seniors, Representatives David Trone (D-MD) and Tim Walberg (R-MI) introduced a bill to reduce problems of loneliness among seniors on Medicare. The new bill would amend the Older Americans Act by supporting screenings for beneficiaries that test for social isolation as well as providing services to address loneliness. These services include having the Assistant Secretary for Aging increase the focus on social isolation as people age and giving states the opportunity to conduct grant-funded projects for addressing isolation. Click here for the full summary, and here for the bill language.
U.S. Employers Shift to Innovative Strategies to Make Healthcare More Affordable
According to the 2019 National Survey of Employer-Sponsored Health Plans, the average benefit costs over $13,000 and employers predict that the following year’s health benefit cost will also increase. This has led to employers searching for more affordable healthcare for their employees. The Mercer survey reports that 58 percent of large and midsize employers and 78 percent of employers with over 20,000 employees offer one or more of the innovative tech-enabled programs. Likewise, nine out of ten employers offer a telemedicine service to reduce the out-of-pocket expenses from office visits. To read the Mercer report, click here.
Facebook Promises Privacy Safeguards as it Introduces its Preventative Health Tool
Facebook introduced its new set of preventative-health tools including those that remind users to get a flu shot and screenings for cancers and heart health. As these tools are launched, Facebook reports that it used “strict safeguards” to protect users’ privacy in response to previous controversies regarding privacy; the company promises that users’ data will not be shared with third parties, other members on Facebook, or advertisers who might target ads based on the information a person provides. Several high-profile partners including the American Cancer Society, American Heart Association, and the CDC helped to relay accurate messages on the preventative health technology. Facebook members can access this tool by typing “preventative health” in their search bar. To read the full article, click here.
Obesity and Related Healthcare Costs Continue to Rise in the US
The Centers for Disease Control and Prevention announced that 18.5 percent of children in the U.S. are obese, and so are 40 percent of adults. The CDC said it is likely this trend will continue. Additionally, with the rise of obesity, rates of comorbid diseases, such as type 2 diabetes and hypertension, will likely increase as well. These growing health issues will result in even greater health costs. Last year, diabetes cost the U.S. over $245 billion. Click here for the CDC’s report.
  • A new study from JAMA Surgery finds that bariatric surgery may not be associated with lower healthcare costs in the long-term, finding that among the U.S. veterans who were severely obese, those who opted for the surgery saw around $25,900 more in total healthcare expenditures in the ten years following, click here.
Americans Split on US Healthcare Model
A new survey, from the New York Times, the Commonwealth Fund, and the Harvard T.H. Chan School of Public Health, asked 2,005 adults to pick their top preference of three U.S. Healthcare models. The plans included one that resembled a Medicare for all model, another was similar to more incremental Democratic proposals, and the other was like plans proposed by congressional Republicans. Each plan was equally supported, at around 30 percent each.  This suggests that while more Americans favor Democratic proposals, they are equally split between the changes. To read more, click here.
CMS Releases Qualified Health Plan Report for Plan Year 2020
CMS released its Qualified Health Plan report to give information to states using for enrollment as a part of plan year 2020. The report includes state and national metrics from 2014-2019 and findings include the following categories: average premiums, subsidy effects, issuer participation, consumer options, cost sharing, and more. According to the report, Wyoming has the highest average benchmark plan premium for 27-year-olds and Alaska is the only state with a decrease in the average 27-year-old benchmark plan premium. To view the full report, click here.
  • Since 2016, the percentage of uninsured children has risen from 4.7 percent to 5.2 percent in 2018, causing the number to increase from a low of 3.6 million in 2016, to a high of 4.1 million uninsured children, click here.
Trump to Nominate Texas Doctor to Head FDA
President Trump announced he is nominating Dr. Stephen Hahn, Chief Medical Executive at The University of Texas MD Anderson Cancer Center, to run the Food and Drug Administration. According to a statement from the White House, Dr. Hahn specializes in lung cancer and sarcoma and is board-certified in medical oncology and radiation oncology. To read the statement from the White House, click here.
FDA Committee Recommends Withdrawal of Preterm Birth Preventative Medication
An advisory committee from the Food and Drug Administration has recommended the standard treatment for preventing preterm birth should be removed from the market. The drug, Makena, approved in 2011, is used with women who have had prior spontaneous preterm births. Several studies have suggested that this progesterone medication is not always successful at reducing the risk for preterm birth. Due to the results of studies, the committee reached a decision with a 9-7 vote. To read more, click here.
  • Mylan Pharmaceuticals issueed a nation-wide recall of the anxiety drug Alprazolam, also known as the Brand name of Xanax due to a potential presence of a foreign substance in the drugs, click here.
  • Study shows that there is little evidence that cannabinoids can improve mental disorder symptoms, because while pharmaceutical THC improved anxiety symptoms, it worsened psychosis symptoms and increased number of adverse episodes in the other examined disorders, click here.
New Data from CDC Details State of US Health
The Centers for Disease Control new chartbook report on US healthcare says that within the last ten years deaths from drug overdoses have increased by 82 percent. Personal healthcare expenditures grew from $1.92 trillion to $2.96 trillion from 2007 to 2017. Additionally, while overall tobacco usage among adults dropped from 19.7 percent to 14.1 percent, between 2007 to 2017, electronic cigarette usage among high school aged adolescents grew from 1.5 percent in 2011, to 20.8 percent in 2018. Click here to read the report.
Report Finds Nursing Home Quality “Average” 
The latest U.S. News & World Report nursing home rankings found that most facilities only delivered “Average” quality care as opposed to “High Performing” care. This level of care was seen in nursing homes regardless of providing long-term or short-term care. Only 420 facilities out of the 16,000 U.S. News ranked performed well enough to receive a top grade for both long-term and short-term care. To read the full report, click here.
  • End-of-life support often depends on family members being the primary point of care for their family members, according to various government studies and surveys, click here.
New Report on Antibiotic Policies for Most Popular Fast Food Restaurants
A study, from several public interest groups recently published, shared the details of antibiotic policies amongst 25 of the top fast food and fast casual dining chains in the US. More than half of the top 25 chain restaurants have taken steps to restrict the use of the antibiotics in the production of the chicken they serve. The report graded establishments, such as Chipotle and IHOP, from A to F. 11 out of the 25, almost half, received an F rating, while only 2, Panera Bread and Chipotle, received an A grade. To learn more, click here. For the full report, click here.
Measles Virus Will Diminish the Body’s “Immune Memory” for Other Illnesses
New research that studied unvaccinated children who had measles and measured the number of antibodies they had after the virus found that in a sample of 77 unvaccinated children tended to lose up to 70 percent of their antibodies for other diseases after having the measles virus. They found that participants could recover the antibodies they lost after having measles if they were re-exposed to the natural pathogens that caused an immune reaction. Click here for the study.
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