This Week: The Affordable Care Act turned 6 years old on March 23... Four in ten voters say health care is extremely important when picking a President, according to a Kaiser Family Foundation’s new tracking poll... Congressional Budget Office says in 2026, the number of Americans covered by employment-sponsored insurance will be 152 million, a slight decrease from 155 million today.

1. Congress

House of Representatives

House Small Business Committee Holds Hearing on Small Business Health Insurance Tax Credit

On March 22, the House Small Business Committee held a hearing to examine the efficacy of the Affordable Care Act’s (ACA) small business health insurance tax credit.

The National Federation of Independent Business (NFIB) testified at the hearing that the health tax credit is not working. “For the same reason that no one buys a new car because of an air freshener, no one is buying very expensive health insurance because of a small, temporary and hard-to-qualify-for tax credit,” said NFIB research director Holly Wade.

Government Accountability Office (GAO) Director of Strategic Issues James McTigue, Jr., also testified at the hearing and released a report on the health tax credit. According to the report, relatively few employers are claiming the small business health insurance tax credit. GAO found that claims of the health tax credit have continued to be lower than projected to be eligible by government agency and small business group estimates, limiting the effect of the credit on expanding health insurance coverage through small employers.

Just 181,000 small businesses claimed the ACA’s health tax credit in 2014, down from about 188,303 claims in 2010. These numbers are relatively low compared to the number of employers eligible for the credit. In 2012, GAO estimated between 1.4 million and 4 million employers were eligible. GAO cited multiple reasons for the lack of use, including the cost and complexity involved in claiming the tax credit that employers can use for only two consecutive years.

For more information or to view the hearing, click here.

House Telehealth Working Group Asks CMS to Include Telemedicine in Implementation of MIPS and APMs

House Energy and Commerce Telehealth Working Group members sent a letter to the Centers for Medicare and Medicaid Services (CMS) Acting Administrator Andy Slavitt asking that CMS incorporate telemedicine in its implementation of the Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs).

In the March 15 letter members said MIPS will evaluate Medicare Part B providers based on quality, resource use, clinical practice improvement activities and meaningful use of certified electronic health record (EHR) technology. They argued that the incorporation of telemedicine data should also be considered a meaningful use of EHRs.

Also, remote synchronous face-to-face video visits between providers and patients or remote patient monitoring of chronic conditions should be outlined as a clinical practice improvement activity. The working group also urged CMS to not subject eligible APMs to telehealth restrictions. For example, telemedicine could be identified within the Patient-Centered Medical Home model.

Reps. Greg Walden (R-OR), Doris Matsui (D-CA), Peter Welch (D-VT), Robert Latta (R-OH), Gregg Harper (R-MS), Bill Johnson (R-OH) and Markwayne Mullin (R-OK) signed the letter.

House Judiciary Committee Holds Markup on Medical Malpractice Legislation but the Bill Gets Derailed

On March 22, the House Judiciary Committee held a markup on the tort reform bill — the Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act — to be included in the House GOP budget package. The bill establishes a $250,000 cap on compensation for non-economic damages because of medical malpractice, limits the contingency fees lawyers can charge, exempts firms whose drugs and devices are FDA approved, and implements a three-year statute of limitations after the manifestation of an injury. It applies to both health care providers and makers of FDA-approved drugs and devices. The Congressional Budget Office (CBO) estimates the tort reform bill would reduce spending by $44 billion over ten years.

Republicans have been unable to pass the HEALTH Act for more than a decade. At the markup, the legislation met the same opposition from states’-rights conservatives as it did in 2011 when the GOP previously tried to pass the bill. Reps. Ted Poe (R-TX) and Louie Gohmert (R-TX) argued against the bill as an infringement of states’ rights in 2011 and both opposed the bill again on March 22.

Judiciary Chair Robert Goodlatte (R-VA) said committee Republicans modeled H.R. 4771 after tort reform laws in California and Texas. He argued that it is well within Congress’s power to impose federal caps on non-economic damages. Referring to the Federalist Papers, Goodlatte said that Congress may pass legislation that supersedes state tort laws when state laws pose barriers to free enterprise.

Democrats spent their time arguing against the policies in the bill. Ranking Democrat John Conyers (MI) said women, children and the poor are hurt the most when non-economic damages are capped because they are less likely to be able to demonstrate economic damages due to lost wages.

The committee adjourned without voting on the bill.

Additionally, 29 groups — including the Center for Justice and Democracy and Consumer Watchdog — have signed a letter protesting the bill. To read the letter, click here.

Oversight Subcommittees Hold Joint Hearing on Health Information Technology

On March 22, two Oversight subcommittees — Information Technology and Health Care, Benefits, and Administrative Rules — held a hearing on standardizing and modernizing health information technology. Members focused on policies ranging from those that affect wearable devices and apps to electronic health records (EHRs). There were calls for new or improved legislation to fill in the gaps in current cybersecurity law. Rep. Ted Lieu (D-CA) noted that ransomware attacks against health care institutions are not covered in the Health Information Technology for Economic and Clinical Health Act (HITECH), which promotes the adoption of EHRs.

Witnesses:

Karen DeSalvo, M.D.
National Coordinator for Health Information Technology
U.S. Department of Health and Human Services (HHS)

Jessica Rich
Director, Bureau of Consumer Protection
U.S. Federal Trade Commission

Matthew Quinn
Federal Managing Director
Intel Healthcare and Life Sciences

Neil DeCrescenzo
Member, Executive Committee
Healthcare Leadership Council

Mark Savage
Director of Health IT Policy and Programs
National Partnership for Women and Families

For more information or to view the hearing, click here.

Energy and Commerce Committee Holds “Conversation on Child Cures”

On March 23, Energy and Commerce Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) led an event entitled “Conversation on Child Cures.” The Who front man and co-founder of Teen Cancer America, Roger Daltrey, headlined the event. Featured patients and advocates included the following:

Sarah Kennedy, mother of Brooke and Brielle Kennedy, sisters battling spinal muscular atrophy (SMA) in Mattawan, Michigan, and the inspiration behind the Cures effort

Walter Whitt, senior at Bishop O’Connell High School in Arlington, Virginia, who has cystic fibrosis (CF)

Joel Wood, co-founder (with his wife, Dana) of the Foundation to Eradicate Duchenne

The event came just a week after Upton, DeGette and other members of the Energy and Commerce Committee met with Vice President Joe Biden at the White House to discuss the 21st Century Cures legislative effort, which is seeking to spur safer cures and treatments for patients, especially children and young adults.

The House passed the Cures bill in July 2015 and a companion bill is currently being negotiated in the Senate by Sens. Lamar Alexander (R-TN) and Patty Murray (D-WA).

To see a related press release, click here.

House Oversight Committee Holds Hearing on Opioid Abuse

On March 22, the House Oversight Committee held a hearing to examine the strategies of the Office of National Drug Control Policy and the Substance Abuse and Mental Health Services Administration to address opioid abuse. Members highlighted the increase in abuse of illegal opioids, such as heroin and fentanyl, as well as controlled prescription opioids like hydrocodone and oxycodone. Key takeaways from the hearing are as follows:

• Drug overdoses are the leading cause of accidental death in the United States
• Experts believe the current epidemic of opioid abuse has contributed to an increase in heroin deaths as opioid consumers move toward heroin use
• In recent years, opioid-related overdoses have started to decrease while heroin-related overdoses have severely increased
• According to the DEA, Mexican-based criminal organizations are the principal suppliers of heroin in the United States. Members emphasized a need to stop the flow of heroin across the southern border
• Primary and secondary prevention programs are in place to decrease the use of potential gateway drugs in youth and others vulnerable to heroin use
• In 2015, $400 million was appropriated to address the opioid epidemic — an increase of $100 million. To date, none of the money has been spent

For additional information or to view the hearing, click here .

Senate

Senate Activity on Drug Abuse and Mental Illness

In the past few weeks, the Senate has addressed legislation to curb drug abuse and treat mental illness:

• The Senate Health, Education, Labor and Pensions Committee unanimously passed the Mental Health Reform Act of 2016 (S. 1945) on March 16
• Senate Democrats introduced on March 7 the Behavioral Health Coverage Transparency Act (S. 2647) to strengthen parity in mental health and substance use disorder benefits
• The Senate passed the Comprehensive Addiction and Recovery Act (S. 524) on March 10 — the bill would let the attorney general give out grants to those fighting the prescription opioid epidemic

2. Administration

CMS Announces Final Round of Applications for the Next Generation ACO Model

On March 21, the Centers for Medicare and Medicaid Services (CMS) announced the second and final round of applications for the Next Generation Accountable Care Organization (ACO) Model. The model will begin its second performance year on Jan. 1, 2017. Details on model parameters are included in the Request for Applications, which is now available on the Next Generation ACO Model web page .

Available below are links and dial-in information to newly scheduled Open Door Forums:

• Open Door Forum: 2017 Letter of Intent Overview (March 22, 2016)
• Open Door Forum: 2017 Application Overview (March 29, 2016)
• Open Door Forum: 2017 Financial Methodology (April 5, 2016)
• Open Door Forum: 2017 Participating Provider List (April 12, 2016)
• Open Door Forum: 2017 Benefit Enhancements (April 19, 2016)

All organizations interested in applying to the Next Generation Model must first submit a letter of intent (LOI), which is now available on the Next Generation ACO Model web page. The LOI due date has been extended to May 2, 2016.

CMS Signals Interest in a Home Care Prior Authorization Demo

The Centers for Medicare and Medicaid Services (CMS) signaled interest in subjecting home health claims in some states to prior authorization through a demonstration. CMS plans to test whether prior authorization would work in a Medicare Part B environment. The agency released a Paperwork Reduction Act notice that said it is developing a prior authorization demonstration for home health in high-risk fraud states including Florida, Illinois, Michigan, Massachusetts and Texas. Beneficiary advocates say the demonstration would hurt home health access.

White House Asking Medical Schools to Require Prescriber Education

The White House is asking medical schools to pledge to make prescriber education a graduation requirement, and that the coursework be consistent with the Centers for Disease Control and Prevention’s (CDC) opioid prescribing guidelines.

This could confirm the medical community’s fear that there would be an effort to force people to strictly follow the guidelines once released. Others worry this type of pledge could open the doors for outside influence on the education curriculum.

Tannaz Rasouli, senior director of public policy and strategic outreach at the Association of American Medical Colleges (AAMC), said the group thinks it is up to the Liaison Committee on Medical Education (LCME) — an accrediting body recognized by the Department of Education — to set standards for medical education. The AAMC has not taken a position on the CDC guidelines.

The CDC released its final guidelines on March 15. The recommendations include: considering non-opioid medications as an initial therapy; starting patients with chronic pain on immediate-release opioids instead of extended-release/long-acting opioids; starting patients with the lowest effective dosage; and prescribing no greater quantity than needed for the expected duration of pain.

Outside stakeholders and government officials, including U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, have raised concerns about the evidence supporting the guidelines and the process used to develop them.

CMS Office of the Actuary Certifies Diabetes Prevention Program Saves Money, Improves Health

On March 23, the Centers for Medicare and Medicaid Services (CMS) Office of the Actuary certified that an intervention program preventing diabetes saves the government money. Specifically, the office certified that expansion of the Diabetes Prevention Program — a model funded by the Affordable Care Act (ACA) — would reduce net Medicare spending. The expansion was also determined to improve the quality of patient care without limiting coverage or benefits. This is the first time that a preventive service model from the CMS Innovation Center has become eligible for expansion into the Medicare program.

The three-year pilot program run by YMCA succeeded in its efforts to prevent high-risk enrollees from fully developing type 2 diabetes. In the first year, the average enrollee lost about 5 percent of body weight, and Medicare saved $2,650 for each enrollee over a 15-month period, determined by a comparison of participants’ costs to otherwise similar enrollees.

The federal agency’s endorsement of expanding the Medicare diabetes program nationwide could mean that tech firms and community centers will soon obtain federal funding to keep patients thin. With certification from the CMS actuary, Medicare can begin the process of reimbursing providers for diabetes prevention efforts — which it could do in Medicare’s physician fee schedule update this summer.

If CMS expands the diabetes prevention program, it will be a victory for startup Omada Health and YMCA, which already serve tens of thousands of prediabetics.

Omada executive Mike Payne estimates CMS reimbursement could drive up the numbers served by various programs nationwide to 6 million within the next few years, with roughly 22 million Medicare beneficiaries potentially eligible.

Community YMCAs that participated in the pilot program saw enrollment increase almost 1,100 percent compared to its typical diabetes prevention program, which may be reimbursed by private companies or require enrollees to pick up the cost. The YMCA’s Matt Longjohn attributed the huge enrollment jump to the Medicare pilot program’s easing costs for participants.

The large numbers of potential new customers could create an atmosphere in which some unethical or ineffective providers are paid for their prevention services. The Centers for Disease Control and Prevention (CDC) and CMS will need to create an effective oversight structure to prevent this from happening. The expansion could also strain existing infrastructure.

To see a related press release, click here.

CMS Releases Risk Adjustment Methodology White Paper

On March 24, the Centers for Medicare and Medicaid Services (CMS) released the Risk Adjustment White Paper, which provides a summary of the Health and Human Services (HHS) risk adjustment methodology, as it applies to health insurance issuers in the individual and small group markets, including detailed explanations of the risk adjustment models and payment transfer formula, as well as the updates to the models CMS has made since the initial 2014 calibration. The white paper also explores potential areas of improvement for the 2018 benefit year and beyond.

CMS is looking at ways to incorporate prescription drug data, better account for partial-year enrollments and adjust the population set it uses to create the payment formula. Some small health plans have said they have no way to reliably forecast how much they will have to receive or pay out under the risk adjustment program. They argue that major insurers are better able to manipulate their data and qualify for payments.

The potential changes outlined in the white paper largely track suggestions made by Avalere Health in a report also issued on March 24. The consulting firm identifies flaws in the methodology used by CMS to create the payment formula. For example, CMS uses data from the employer-based insurance market to create the methodology, but there are substantial differences between that population and the individual and small group markets.

This white paper will inform the discussion at the CMS risk adjustment meeting on March 31, which is open to the public. CMS is seeking feedback on the topics described in the paper, as well as other improvements that should be made to its risk adjustment models and the payment transfer formula, including with respect to how the various changes will interact. Comments should be submitted on the proposals discussed in this paper through hhshccraops@cms.hhs.gov or REGTAP at https://www.REGTAP.info, by April 22, 2016.

CMS Launches New Payment Model to Improve Care for Nursing Facility Residents

On March 24, the Centers for Medicare and Medicaid Services (CMS) announced it will test a new payment model for nursing facilities and practitioners that is intended to further reduce avoidable hospitalizations, lower combined Medicare and Medicaid spending and improve the quality of care received by nursing facility residents.

This next phase of the Initiative to Reduce Avoidable Hospitalizations among Nursing Facility Residents seeks to reduce avoidable hospitalizations among beneficiaries eligible for Medicare and/or Medicaid by providing new payments to practitioners for engagement in multidisciplinary care planning activities. In addition, the participating skilled nursing facilities will receive payment to provide additional treatment for common medical conditions that often lead to avoidable hospitalizations.

Medicare currently pays physicians less for a comprehensive assessment at a skilled nursing facility than for the same assessment at a hospital. This model would equalize the payments between the sites of care. Removing potential barriers to effective treatment within a facility can improve the residents’ care experience and mitigate the need for disruptive and costly hospitalizations. For example, participating skilled nursing facilities will be expected to enhance their staff training and purchase new equipment to improve their capacity to provide intravenous therapy and cardiac monitoring.

Since 2012, CMS has funded Enhanced Care and Coordination Providers (ECCPs) to test a model to improve care for long-stay nursing facility residents through clinical and educational interventions. The ECCPs currently collaborate with 143 long-term care facilities to provide on-site staff for training and preventive services and to improve the assessment and management of medical conditions. Early results from the first phase of the Initiative are promising, according to an independent evaluation. All seven sites generally showed a decline in all-cause hospitalizations and potentially avoidable hospitalizations, with four sites showing statistically significant reductions in at least one of the hospitalization measures. In addition, all sites generally showed reductions in Medicare expenditures relative to a comparison group in 2014, with statistically significant declines in total Medicare expenditures at two sites. This first phase of the Initiative will continue through 2016.

This new four-year payment phase of the Initiative, slated to begin fall 2016, will be implemented through cooperative agreements with six ECCPs. The six awardees are:

• Alabama Quality Assurance Foundation – Alabama
• HealthInsight of Nevada – Nevada and Colorado
• Indiana University – Indiana
• The Curators of the University of Missouri – Missouri
• The Greater New York Hospital Foundation, Inc. – New York
• UPMC Community Provider Services – Pennsylvania

The new model will be subject to an independent evaluation to determine the effects on cost and quality of care. ECCP awardees will implement the payment model with both their existing partner facilities, where they provide training and clinical interventions, and in a comparable number of additional facilities to be recruited over the next several months.

For more information on this Initiative, including both current activities and this new phase, click here.

FDA Issues Draft Guidance for Abuse-Deterrent Opioid Generics

On March 24, the U.S. Food and Drug Administration (FDA) issued draft guidance to help generic drug companies make abuse-deterrent versions of brand-name opioid drugs. The guidance recommends studies, including comparative in vitro studies, which should be conducted by the potential abbreviated new drug application (ANDA) applicant and submitted to FDA to show that the generic drug is no less abuse-deterrent than its reference listed drug (RLD).

The FDA will evaluate generic copies of brand-name drugs that are formulated to make the pills harder to crush, dissolve or otherwise more difficult to abuse. The majority of opioids available are not abuse-deterrent, and the technology requires a big investment on the part of generic companies. These companies have not had any guidance from FDA on how to get the drugs approved.

There is still uncertainty about whether abuse-deterrent drugs will have a large impact on the prescription opioid epidemic. The drugs are still just as addictive, but would be more difficult to snort or inject.

Comments regarding the draft guidance must be submitted within 60 days of publication in the Federal Register.

3. State Activities

California: Insurance Exchange Proposing to Drop Poorly Performing Hospitals

California’s health insurance exchange is proposing to drop hospitals from its networks based on poor performance or high costs. The move is being suggested as a way to improve the delivery system to make it more cost effective and higher quality. If approved, insurers would have to rate hospitals on cost and quality starting in 2018 and doctors in later years. The proposal is facing widespread opposition from the health care industry, with doctors, hospitals and insurers accusing the exchange of overstepping its authority. The exchange’s five-member board is slated to vote on it next month.

Louisiana: Gov. Edwards’ Medicaid Expansion Plan Taking Shape

Louisiana Gov. John Bel Edwards is receptive to instituting new copays, providing premium assistance, requiring work referrals and providing health behavior incentives into the state’s Medicaid expansion program. One of the copay proposals would charge for inappropriate usage of the emergency room. Lawmakers are discussing potential legislation for this session but the Edwards administration maintains that expansion is still on track for a July 1 rollout. More than 300,000 additional Louisiana residents — mainly the working poor — will gain coverage under expansion. Adults who make up to 138 percent of the federal poverty level would become eligible.

New Jersey: Gov. Christie Releases Transition to Fee-for-Service Proposal

New Jersey Gov. Chris Christie is proposing to change the way the state pays for behavioral health treatment for Medicaid patients. According to his proposal, Christie wants $127.8 million for increasing reimbursements for mental health and substance abuse treatment. Success of the plan — from a state affordability and budget perspective — hinges on fully leveraging federal Medicaid resources.

To see the full proposal, click here.

Tennessee: Birth Control Bill Passes Senate, Advances in House

On March 15, a House Health subcommittee approved legislation allowing women 18 or older to obtain birth control directly from pharmacists. The bill — sponsored by Sen. Steve Dickerson — has already cleared the Senate. If passed, it would make Tennessee one of a handful of states that allow women to obtain birth control from pharmacists without a doctor’s prescription. Under the Tennessee legislation, pharmacists would have to enter into collaborative agreements with physicians to prescribe the medication directly.

4. Regulations Open for Comment

Food and Drug Administration (FDA) Issues Final Rule to Phase Out Trans Fats

FDA issued a final rule June 16 that gives the food manufacturers three years to phase out partially hydrogenated oils (PHOs), which are still used in a wide variety of food products from microwave popcorn to cake frosting. The decision finalizes an agency determination that PHOs, the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” or GRAS for use in human food. Since 2006, manufacturers have been required to include trans fat content information on the Nutrition Facts label of foods. Between 2003 and 2012, the FDA estimates that consumer trans fat consumption decreased about 78 percent and that the labeling rule and industry reformulation of foods were key factors in informing healthier consumer choices and reducing trans fat in foods. Comments on the final rule are due by June 18, 2018.

More information on FDA’s decision can be found in the agency’s press release.

HHS Posts Guidance for State Innovation Waivers

On Dec. 11, the Department of Health and Human Services (HHS) posted guidance for states interested in seeking a State Innovation Waiver under Section 1332 of the Affordable Care Act (ACA). State Innovation Waivers allow states to receive federal funding to implement alternative models of health care coverage that provide affordable coverage to their residents. The notice clarifies that the minimum length of public notice and comment periods for waiver applications is 30 days.

To see the guidance, click here.

CMS Issues Proposed Rule Expanding Access to Medicare Claims Data

The Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled “Medicare Program: Expanding Uses of Medicare Data by Qualified Entities.” The rule would expand access to Medicare information by permitting certain organizations to buy and share claims data. Created under Obamacare, Medicare’s qualified entity program allows providers, employers and others access to Medicare data to analyze the performance of providers and suppliers. The rule aims to help qualified entities make business decisions that reduce costs and improve quality of care. These changes were mandated in the Medicare Access and CHIP Reauthorization Act and CMS thinks the expansion of data sharing will stir more interest in the program. If the proposal is finalized, CMS estimates the number of qualified entities will go from 13 to 20. Comments will be accepted on the proposed rule until 5 p.m. on March 29, 2016.

CMS Releases Proposed Rule for Provider Enrollment Process

On Feb. 25, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule to implement additional provider enrollment provisions of the Affordable Care Act (ACA) to help make sure that entities and individuals who pose risks to the Medicare program are kept out of it or removed for extended periods. This rule is part of CMS’s effort to prevent questionable providers and suppliers from entering the Medicare program.

If finalized, the regulations would allow CMS to remove or prevent enrollment of those who try to circumvent enrollment requirements through name and identity changes or through inter-provider relationships. It will also address vulnerabilities such as when providers and suppliers avoid paying their Medicare debts by reenrolling as a different entity.

Major provisions of the proposed rule include:

• Disclosure of Affiliations: Would require health care providers and suppliers to report affiliations with entities and individuals that: (1) currently have uncollected debt to Medicare, Medicaid or CHIP; (2) have been or are subject to a payment suspension under a federal health care program or subject to an Office of Inspector General (OIG) exclusion; or (3) have had their Medicare, Medicaid or CHIP enrollment denied or revoked. CMS could deny or revoke the provider’s or supplier’s Medicare, Medicaid or CHIP enrollment if CMS determines that the affiliation poses an undue risk of fraud, waste or abuse.
• Different Name, Numerical Identifier or Business Identity: CMS could deny or revoke a provider’s or supplier’s Medicare enrollment if CMS determines that the provider or supplier is currently revoked under a different name, numerical identifier or business identity.
• Abusive Ordering/Certifying: Would allow CMS to revoke a physician’s or eligible professional’s Medicare enrollment if he or she has a pattern or practice of ordering, certifying, referring or prescribing Medicare Part A or B services, items or drugs that is abusive, represents a threat to the health and safety of Medicare beneficiaries or otherwise fails to meet Medicare requirements.
• Increasing Medicare Program Re-enrollment Bars: Would improve protection of the Medicare Trust Funds and program beneficiaries by: 1) raising the existing maximum re-enrollment bar from three years to 10 years; 2) allowing CMS to add three more years to the provider’s or supplier’s re-enrollment bar if the provider attempts to re-enroll in Medicare under a different name, numerical identifier or business identity; and 3) imposing a maximum 20-year re-enrollment bar if the provider or supplier is being revoked from Medicare for the second time.
• Other Public Program Termination: Would permit CMS to deny or revoke a provider’s or supplier’s Medicare enrollment if: (1) the provider or supplier is currently terminated from participation in a particular Medicaid program or any other federal health care program under any of its current or former names, numerical identifiers or business identities; or (2) the provider’s or supplier’s license is revoked in a state other than that in which the provider or supplier is enrolled or enrolling.
• Expansion of Ordering/Certifying Requirements: Would permit CMS to require that physicians and eligible professionals who order, certify, refer or prescribe any Part A or B service, item or drug must be enrolled in or validly opted out of Medicare.

Comments on the proposed rule must be submitted no later than 5 p.m. on April 25.

For more information, click here.

ONC Releases Proposed Rule Expanding Role in Health IT Certification Program

The Office of the National Coordinator for Health Information Technology (ONC) released a proposed rule that would enable the agency to conduct direct reviews of certified health IT products. Such direct review would also include how certified health IT interacts with other systems. The rule increases ONC’s oversight of health IT testing bodies to improve alignment and more successfully deal with issues, and seeks to increase transparency associated with the surveillance — it plans to make results of surveillance of electronic health records (EHRs) publicly available. The reviews would focus on situations posing health or safety risks. Depending on the findings, the office says it may require corrective action or suspend or terminate certification for an EHR or health IT module.

ONC hopes this move will enhance public confidence in health IT testing and certification. The U.S. Department of Health and Human Services (HHS) said the rule will empower consumers by improving availability of certification information. ONC is proposing a “strict process” for health IT recertification or replacement versions, and a program ban for those that don’t fix problems pointed out by ONC. Comments on the rule will be accepted through May 2.

To see the proposed rule, click here.

CMS Proposes to Test New Medicare Part B Prescription Drug Models

On March 8, the Centers for Medicare and Medicaid Services (CMS) announced a proposed rule to test new models to improve how Medicare Part B pays for prescription drugs and supports physicians and other clinicians in delivering higher-quality care. Medicare Part B covers prescription drugs that are administered in a physician’s office or hospital outpatient department, such as cancer medications, injectables like antibiotics, or eye care treatments. The proposed Medicare Part B Model would test new ways to support physicians and other clinicians as they choose the drug that is right for their patients. The proposed rule is designed to test different physician and patient incentives to do two things: drive the prescribing of the most effective drugs and test new payment approaches to reward positive patient outcomes. Among the approaches to be tested are the elimination of certain incentives that work against the selection of high-performing drugs, as well as the creation of positive incentives for the selection of high-performing drugs, including reducing or eliminating patient cost sharing to improve patients’ access and appropriate use of effective drugs.

Prescription drug spending in the U.S. was around $457 billion in 2015, or 16.7 percent of overall health spending. In 2015, Medicare Part B spent $20 billion on outpatient drugs administered by physicians and hospital outpatient departments. The proposed rule seeks comments on testing six different alternative approaches for Part B drugs to improve outcomes and align incentives to improve quality of care and spend dollars wisely:

1. Improving incentives for best clinical care
2. Discounting or eliminating patient cost sharing
3. Feedback on prescribing patterns and online decision support tools
4. Indications-based pricing
5. Reference pricing
6. Risk-sharing agreements based on outcomes

CMS is accepting comment on the proposed rule through May 9, 2016.

To see the press release, click here.

For a fact sheet on the proposed rule, click here.

AHRQ Releases Draft Technology Assessment for Public Comment

The Agency for Healthcare Research and Quality’s (AHRQ) Technology Assessment Program posted a draft technical brief for review on March 11. The draft is entitled “Renal Denervation in the Medicare Population.” The document will be available for review from 9 a.m. on March 11 to 5 p.m. on April 1.

To review the document, click here.

5. Reports

Congressional Budget Office Says ACA Does Not Cost as Much as Anticipated

The Congressional Budget Office (CBO) issued its latest baseline projections on March 24 and provided interesting news related to the Affordable Care Act (ACA).

The ACA will cost 25 percent less between 2016-2019 than CBO’s original estimate because of the ongoing health cost slowdown and slower-than-expected exchange enrollment. By 2026 Medicaid enrollment is expected to grow to 69 million and Medicaid and CHIP will cover one in four people under age 65.

CMS Releases Interim Report to Congress About IVIG Demonstration

The Centers for Medicare and Medicaid Services (CMS) recently posted an interim report to Congress about the Medicare Patient Intravenous Immunoglobulin (IVIG) Demonstration.

For more information, click here.

HHS Credits ACA for Decrease in Rate of Medicare Spending

According to new data from the U.S. Department of Health and Human Services (HHS), Medicare spent $473.1 billion less on personal health expenditures from 2009 to 2014 than it would have spent if the average rate of growth in health care spending between 2000 and 2008 had held steady. This data comes as the administration approaches the Affordable Care Act’s (ACA) six-year anniversary and as it makes the political case for the health care law. HHS also credits Obamacare for the 4.3 percent growth in health care spending in 2014.

To see the report, click here.

Duke Study Investigates the Use of Open Access Platforms for Clinical Trial Data

According to a new study from Duke University, concerns over bias in clinical trial reporting have stimulated calls for more open data sharing — in response, drug companies have created mechanisms for investigators to access patient-level data. However, it is being underutilized. Drug companies are approving most proposals from researchers who want to do their own analysis on company trial data.

The study looked at three open access platforms that include clinical trials from 14 drug companies. Of the 177 requests for trial data that had been processed, 87 percent had been approved and less than 7 percent were rejected. Despite this high approval rate, only 15.5 percent of the available data had ever been requested since the trial platforms became available in 2013.

FDA Releases Final Results From Its Study on Workload and Cost of Biosimilar Review Program

On Feb. 24, the U.S. Food and Drug Administration released the final results of a study on the workload and cost of the biosimilar review program. The study found that the overall cost of FDA’s biosimilar program for its first three years was almost double the amount the agency collected in user fees between fiscal year 2013 and 2015. In total, FDA spent $81.7 million on biosimilars-related work over the first three years, while collecting around $42.8 million in user fees during the same time period. FDA collected $6 million in user fees in fiscal year 2013, $13 million in 2014 and $23.8 million in 2015.

Congress did not appropriate any additional funding for the biosimilar program when it was created, and FDA had to take $20 million from other activities, including over-the-counter monographs and compliance activities. The report, required by the Biosimilar User Fee Act (BsUFA), said the biosimilar program cost $26 million in 2013, $23 million in 2014 and $32 million in 2015.

The amount of time FDA’s drug center spent on biosimilar application reviews increased to 27 percent of its workload in 2015, exceeding the amount of time the agency spent on policy-related work in the biosimilars program. FDA’s Center for Drug Evaluation and Research spent the most time in 2015 on biosimilar development program activities, accounting for 36.3 percent of its full-time equivalents. Overall — for the first three years of the program — these activities accounted for 42.7 percent of the drug center’s time.

FDA spent the least amount of time on outreach activities, such as biosimilar-related education courses, in the first three years. However, FDA launched a continuing education course for health care professionals last month to help them strengthen their understanding of biosimilars. The course also aims to help professionals’ understanding of how a biosimilar can be prescribed and dispensed, and how an interchangeable product can be substituted for another biological product.