PCORI announces $6.5 million in grants to implement ‘shared decision making’

The Patient-Centered Outcomes Research Institute (PCORI) will release of $6.5 million in grant funding to organizations willing to implement shared decision making strategies for patients and care providers. According to the institute, the funding is designed to address concerns by doctors and other care providers that implementing the programs will cost too much time or “interfere with their routine clinical workflow.”

Shared decision making, research around which PCORI has provided nearly $200 million in funding, is an umbrella term for strategies that help patients better understand their treatment options in a given healthcare situation, particularly when the right choice is not clear or could be impacted by a patient’s preferences.

“PCORI recognizes that for many clinical situations, patients and clinicians need to work together to consider all available treatment options, informed by the patients’ preferences,” PCORI Executive Director Joe Selby said in a statement. “For a variety of reasons, shared decision making isn’t as widely used in practice as it should be.”

Examples of the research conducted includes a $1.6 million research project out of the Mayo Clinic, highlighted by PCORI in January of this year, looking at the implementation of “Chest Pain Choice.” The materials were developed in light of concerns that patients at a low-risk for heart attacks who reported chest pain in an emergency room were suffering unnecessary anxiety, as well as possibly increasing healthcare costs, after being transferred to the hospital for further testing. Another $1.4 million project from the University of Texas MD Anderson Cancer Center looked at the development of a video to help heavy smokers between the ages of 55 and 77 understand the risks and benefits of the CT lung cancer screenings, which were recently authorized by Medicare.

Grants are currently available only to those institutions that have served as past recipients of PCORI grants for shared decision making project, which they have completed, or new applicants working closely with one of those institutions to implement one of the research-based strategies. Clinicians have until October 2 of this year to submit their letters of intent for consideration, with an implementation start date of October 2018, at the earliest.

PCORI said it had funded $164 million in research on shared decision making projects as of September 2016. The initial funding comes with a commitment to authorize another $6.5 million to $8 million per cycle, with up to two cycles per year, for continued implementation.

Trump administration disperses $485M in opioid fight

The Trump Administration announced $485 million in grants to assist states with combating opioid addiction. The funding is the first part in two rounds of opioid-focused state grants provided for by the 21st Century Cures Act (Cures Act) (P.L. 114-255). The funds will be administered by the Substance Abuse and Mental Health Services Administration (SAMHSA).

The funding will be received by all 50 states, the District of Columbia, American Samoa, Micronesia, Northern Marianas, Palau, Puerto Rico, and the Virgin Islands. The allocation of the $485 million was determined according to need. The largest grants were awarded to states with the highest rates of overdose deaths and unmet need for opioid addiction treatment. Some of the highest awarded states include: California ($44,749,771), Florida ($27,150,403), Ohio ($26,060,502), Pennsylvania ($26,507,559), and Texas ($27,362,357).

In a letter to governors, HHS Secretary Price called the opioid crisis alarming, noting that “opioids were responsible for over 33,000 deaths in 2015.” He also admonished governors that “we cannot continue to lose our nation’s citizens to addiction.” Price cautioned that “while I am releasing the funding for the first year immediately, my intention for the second year is to develop funding allocations and policies that are the most clinically sound, effective and efficient.”

HHS finalizes regulations prohibiting state discrimination against abortion providers

Recipients of Title X Grants for Family Planning Services making subawards cannot restrict participating entities for any reason other than the entity’s ability to provide Title X services, under a new Final rule that will publish on December 19, 2016. The regulatory change was motivated by recent state-imposed restrictions and prohibitions against entities that provide abortions from receiving Title X funds. By statute, Title X funds cannot be used by programs that allow abortion as a method of family planning (42 U.S.C. §300a-6); such programs also cannot be required to perform or assist in the performance of an abortion, nor discriminate against an employee who performs or assists or refuses to perform or assist in the performance of an abortion (42 U.S.C. §300a-7). The regulations will be effective on January 18, 2017, two days before the inauguration of President-elect Donald Trump (R).

Title X

Title X of the Public Health Service Act (42 U.S.C. §§300–300a-8) created the Family Planning Program, which provides funding to nearly 4,000 community-based clinics that provide high quality, affordable, and cost-effective family planning and related preventive health services for women and men, with priority given to low-income patients. In 2015, more than 4 million individuals received services from Title X Family Planning Clinics.

Recipient restrictions

Section 2303 of 2010’s Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) expanded family planning services for certain Medicaid beneficiaries. Soon thereafter, however, family planning organizations began facing funding challenges. According to the Final rule, 13 states have taken action since 2011 to restrict funding to abortion providers, and entities which do not provide abortion services but are affiliated with organizations—such as Planned Parenthood—which provide abortions at some facilities. These restrictions have affected family planning clinics both as subrecipients of Title X grants and as Medicaid providers, leading to decreased access to providers and limitations in the geographic distribution of services.

These restrictions led to litigation (see, e.g., (see Court grants preliminary injunction reinstating Planned Parenthood’s provider agreement with Alabama, Health Law Daily, October 29, 2015; Medicaid termination denied because Planned Parenthood is qualified, Health Law Daily, November 4, 2015; Patients’ provider choice rights violated by exclusion without cause, Health Law Daily, April 19, 2016), and HHS action telling states to end such restrictions (see States warned not to exclude qualified providers, especially family planning, Health Law Daily, April 20, 2016; No limits on choice of provider, contraceptive method for Medicaid enrollees, Health Law Daily, June 16, 2016). HHS also began granting Title X funding directly to providers as sole source replacement grants following the imposition of state restrictions (see Direct award Title X grant documentation properly withheld by HHS, Health Law Daily, February 5, 2015).

Regulatory changes

Earlier this year, HHS’ Office of Population Affairs published a Notice of proposed rulemaking in the Federal Register, declaring its intent to amend current Title X regulations to preclude project recipients from using criteria in their selection of subrecipients that are unrelated to the ability to deliver services to program beneficiaries in an effective manner (81 FR 61639, September 7, 2016). Approximately 91 percent of the 145,000 comments the agency received on the proposed regulations were in favor of the amendment.

In response to negative comments, the Final rule explained that there is no evidence that certain Title X funding recipients—Planned Parenthood, specifically—have engaged in Medicaid fraud, and pointed to research finding that every grant dollar spent on family planning saves an average of $7.09 in Medicaid-related expenditures. The Final rule similarly responded to commenters concerned that Title X service providers would use Title X funding to fund abortion by reiterating the statutory and regulatory requirements that prevent Title X funds from being used for abortions, and said that family planning services help prevent abortions by preventing unintended pregnancies.

Will the change last?

The Final rule was promulgated in accordance with notice-and-comment requirements under the federal Administrative Procedure Act, and its changes were announced months ago, which may prevent it from being considered a “Midnight Rule.” According to the New York Times, repealing these regulations would require either a new comment-and-notice rulemaking process, or a joint resolution of disapproval by the House and Senate, with concurrence by the new president. Both supporters and opponents of family planning services are preparing to fight for or against the regulations, while President-elect Trump, who has promised to repeal many of the Obama Administration’s regulatory actions, offered contradictory messages on Planned Parenthood and abortion during his presidential campaign.

$2.3B awarded to fund HIV/AIDS care, medications in 2016

Cities, states, and community organizations have received a total of almost $2.3 billion in Ryan White HIV/AIDS program grants. The program is overseen by the Health Resources and Services Administration (HRSA), and serves over 50 percent of people diagnosed with HIV in the United States. The program retained over 80 percent of those who received care in 2014, and over 81 percent of program clients were virally suppressed. All organizations receiving grants are working toward the goals found in the National HIV/AIDS Strategy.

Grants

To further these efforts, Part A of the program awarded about $627 million to 24 metropolitan areas and 28 transitional grant areas. These areas have the highest number of residents with HIV/AIDS or have an increased number of cases. Part B of the program awarded about $1.3 billion to allow states and territories to provide core medical and support services, and for the AIDS Drug Assistance Program (ADAP). Part B also issued Emerging Community and Minority AIDS initiative grants.

Part C Early Intervention Services (EIS) awarded about $186 million to local organizations that provide core services to HIV patients. Part C Capacity Development grants were also awarded to about 48 organizations. Part D awarded $66.6 million in grants to 115 organizations to fund family-centered care. Part F awarded several grants to fund dental care, as well as technical assistance and clinical training.