21 May May 21, 2018

Major Changes Coming to Pharmaceutical Pricing and Policy

HHS Secretary Alex Azar and other Administration officials are beating the drum of pharmaceutical reform, promoting the President’s “Blueprint for Lower Drug Prices” since it was introduced May 11th. Azar highlighted the need for Medicare to have the ability to negotiate drug prices and suggested “merging” Parts B and D as a move towards lower prices for seniors. “We are going to make negotiation dramatically more effective than it is today in our retail drug program, Part D, and bring negotiation to where it doesn’t exist, in physician-administered drugs, Part B,” Azar said. To read Azar’s remarks from May 14th, click here, and on May 16th, click here.

• CMS announced an updated drug pricing dashboard to show the public drug prices and how they have increased. Click here for the drug dashboard.
• According to a Memorial Sloan Kettering report, nine percent of 340B hospitals would become ineligible under the Trump 340B proposal in the drug plan, click here.  The Administration is proposing to tie 340B eligibility to a hospital’s charity care amount.
• HHS issued a formal request for information to offer feedback on drug pricing proposals in the Administration’s  plan, click here.
• FDA launched a website listing the names of brand name drugs and their makers who have stood in the way of generic drug companies trying to make more affordable alternatives, click here
• In 2018, three Medicare Part D plan sponsors – UnitedHealth, Humana, and CVS Health – accounted for more than half of the program’s 43 million Part D enrollees and two-thirds of all stand-alone drug plan enrollees, click here.
• CMS sent letters to Medicare Part D plans stating ” that CMS finds any form of “gag clauses” unacceptable and contrary to our efforts to promote drug price transparency and lower drug prices.” So-called gag-clauses prevent pharmacists from talking to patients about cheaper drug alternatives, click here.
• Click here for a very good NYTimes article on Azar, the “Joyful Regulator.”

GAO, OIG Call for Changes to 340B; 60 Groups Urge Congress To Reject 340B Cuts

The Senate Health Committee heard from the Government Accountability Office and the HHS Inspector General last week in a hearing where both called for changes to the 340B drug discount program through regulations and guidance documents.  Some of the changes had previously been proposed by the Health Resources Services Administration that oversees the 340B program but retracted before making final. Republican Senators concentrated on the purpose of the program that the GAO official stated is to help covered entities “stretch scare federal resources.” Democratic senators, raised concerns about the lack of required regulations on drug ceiling prices that would allow auditors determine whether manufacturers are providing accurate 340B prices. Click here for the OIG testimony. Click here for the GAO testimony.

• About 60 patient and consumer advocates sent a letter to House and Senate leadership urging them to reject proposals that would make cuts to 340B program, though the groups offer support for more program transparency, For the letter, click here.

House Committees Pass Opioid Legislation

Two House Committees passed bipartisan legislation aimed at combating the country’s opioid crisis. The House Ways & Means Committee approved six bills aimed at reducing opioid abuse through the Medicare program. The package would expand coverage for medication-assisted treatment, promote non-opioid therapies for pain management, and require prescription drug plan sponsors under Medicare to establish drug management programs for at-risk beneficiaries. The House Energy and Commerce Committee passed 30 bills to curb the opioid epidemic, this is in addition to the 25 bills that they had voted on the previous week. Most bills were bipartisan and included policies to increase access to addiction treatment for Medicaid beneficiaries, to help build up the provider workforce as well as ways to encourage non-opioid treatments for pain. For the Ways and Means Committee markup and list of bills, click here, for the Energy and Commerce Committee markup information, click here.  Strategic Health Care clients may request a copy of our detailed summary.

House Votes to Broaden Veterans Health Care Access and Create Prompt Payment Process

The House has passed legislation, the VA MISSION Act, that would broaden veterans’ access to health care services,  consolidating the Veterans Choice Program with other community care programs that provide medical care to veterans outside of the VA system. The bill also authorized $5.2 billion in funding to keep it running through fiscal year 2019. The bill creates a prompt payment process that requires VA to process payment within 30 calendar days of receipt of a clean electronic claim or within 45 calendar days of receipt of a clean paper claim. Finally, it establishes a new commission to review VA medical facility realignment and provisions seeking to help recruit and retain health care professionals, plus aid to caregivers. Click here for the bill, and here for the section-by-section summary of the bill.

• President Trump announced Friday that his new nominee for Secretary of Veterans Affairs is the current Acting Secretary, Robert Wilkie.  Click here for more on the nominee from ABC news.

CMS Requests Proposals for Medicare Promoting Interoperability Program

CMS is calling for proposals on measures for the Medicare Promoting Interoperability Program. Specifically, the agency is looking for involvement in the process from stakeholders on the evolution of the program and to further advance meaningful use of certified electronic health record technology (CEHRT) by Medicare eligible hospitals and critical access hospitals participating in the Medicare PI Program. CMS states that they are particularly interested in adding measures to the program that:

• Utilize the 2015 Edition CEHRT;
• Increase CEHRT health information exchange and interoperability;
• Continue improving program efficiency, effectiveness, and flexibility;
• Measure patient outcomes; and
• Emphasize patient safety.

Proposals submitted by June 29, 2018 will be considered for inclusion in rulemaking in CY 2019. Click here for more on the request from CMS.

HHS and House Settle Lawsuit Over ACA Payments, Other ACA Developments

The House of Representatives, HHS, and several states settled a lawsuit over funding for the Affordable Care Act’s cost-sharing reduction subsidies. The U.S. Court of Appeals for the D.C. Circuit dismissed an appeal of an earlier ruling, which found that the Obama Administration had been illegally spending money under the ACA without an appropriation from Congress. This settlement confirmed lower Court’s ruling and left open the question of whether the House has standing to sue the executive branch. Click here for the ruling.

• Insurers in the ACA Marketplace had the best year financially in 2017 according to new Kaiser report, click here.
• New analysis by the UnitedHealth Group shows Medicaid coverage costs 43 percent less than insuring individuals through the ACA Marketplace, click here.

Bundled Payments the Path To Price Competition: Analysis

Accountable Care Organizations have not resulted in the level of spending reductions that the government had expected, according to numerous recent studies.  However, some researchers believe the answer may be bundled payments, as they are more likely to allow for more price competition among providers since the products can be more easily compared.  Click here for this interesting analysis in Health Affairs.

31 Senators Urge FCC to Increase Funding of Rural Health Care Program
A bipartisan group of 61 Senators joined together to call on the Federal Communications Commission to increase the funding cap for their Rural Health Care (RHC) program. The program’s current $400 million dollar cap is insufficient to meet the demand from rural health care providers seeking funds for telecommunications and broadband expansion. Without this increase in funds, the FCC has informed providers that their funding will be reduced by 15 percent for individual participants and 25 percent for consortia participants. Click here for the Senator’s letter.

• Cuts in funding for the RHC program has left Cordova Community Medical Center, a Critical Access Hospital in Alaska, with a $964,370 bill to be paid by June 30th to retain telecommunications services. Hospital leaders say it is impossible for them to pay that bill up front.  Read the letter sent to Cordova Community Medical Center here.
• The Critical Access Hospital Coalition represents the needs of CAHs and is also advocating for an increase in the RHC programs funding. Read more about the CAH Coalition here.

For Every Woman Who Dies In Childbirth In America 70 More Come Close
NPR and ProPublica teamed up to investigate why American mothers die in childbirth at a higher rate than in other developed countries. During their reporting they found that for every American woman who dies from childbirth, 70 nearly die. That adds up to more than 50,000 women who suffer “sever maternal morbidity” from childbirth each year. In the U.S. the rate of severe complications from childbirth has been rising faster than the rate of women who died. A report in the American Journal of Obstetrics and Gynecology found the cost of caring for mothers suffering from pre-eclampsia is more than a billion dollars each year. The CDC points to risk factors: American women are giving birth at older ages and are more likely to have problematic conditions like obesity, high blood pressure and diabetes. For the full article, click here.

• Energy and Commerce Committee Democrats sent a letter to the Committee Chairman to request a hearing on maternal mortality, click here.
• New data from the CDC shows that the U.S. fertility rate fell to 60.2 births per 1,000 women, down from the record low of 62.0 births per 1,000 women in 2016, click here.

Children’s Hospital GME Funding Expires This Year, Congressional Renewal Is Uncertain

The House Energy and Commerce Health Subcommittee has scheduled a hearing for Wednesday this week on legislation to reauthorize the Children’s Hospital Graduate Medical Education Program. The program, which expires on Sept. 30th of this year, is designed to help pediatric hospitals, which because of their low Medicare patient volume do not receive significant Medicare direct graduate medical education (DGME) and indirect medical education (IME) payments. H.R. 5385, the Children’s Hospital GME Support Reauthorization Act of 2018 will reauthorize the program for an additional 5 years. Click here for more from the Subcommittee.

GAO: Patients Still Struggle To Get Their Records

The Government Accountability Office’s May audit showed that fees charged to patients to access their medical records vary by request type and across the four US states reviewed, with Rhode Island being the only state that sets $100 as the maximum allowable fee charged to those requesting copies of medical records if the provider processes requests using an EHR. Having information stored on EHRs and in paper records or on multiple, disparate EHR systems presents challenges in fulfilling patient requests.  Click here for the GAO report.

1980 Is the Year American Health Care Prices Began Their Upward March.  Why?

It’s not news that health care prices in the United States exceed those of the rest of the modern world, but this hasn’t always been the case.  In fact, until about 1980, American health care costs were generally comparable to those of other advanced nation’s.  What happened?  The NY Times has an excellent story on the reasons why our country diverged from the path of the rest of the world.  Click here.

New Wellness Report Focuses on Top Initiatives Across U.S.
The Harkin Institute at Drake University released its first annual Harkin on Wellness Report that highlights the work of top wellness and nutrition initiatives across the country.  Many of the featured organizations use cross-sector collaboration in order to help their communities achieve better health outcomes. Click here for the full report.

• A new interactive tool developed by NYU and the Robert Wood Johnson Foundation shows how healthy 500 cities are across the U.S., based on health-related statistics, click here.

CDC Says – Stay Out of the Pool!

According to a Centers for Disease Control study released last week, hotel pools, hot tubs and water parks are breeding grounds for parasites and bacteria. The report details how these public pools are responsible for one-third of swimming-related diseases and illnesses. From 2000 to 2014, the agency recorded 493 outbreaks, which caused eight deaths and at least 27,219 people getting sick. One of the most common diseases is caused by a parasite called Cryptosporidium, or “Crypto,” which is responsible for 58 percent of outbreaks and 98 percent of illnesses and is strong enough to survive even when pools are cleaned properly. Click here for the study.