1. Congress

House of Representatives

House Passes Three Health Bills

The Continuing Access to Hospitals Act (H.R. 5613) exempts small rural hospitals and critical access hospitals from rules that require direct physician supervision for outpatient therapeutic service. Congress has made the same exemption in the past.

The Sustaining Healthcare Integrity and Fair Treatment Act (H.R. 5713) would delay the “25-percent” rule for long-term care hospitals. It also narrowly exempts four types of long-term care hospitals from site-neutral payment efforts.

The Expanding Seniors Receiving Dialysis Choice Act (H.R. 5659) permits Medicare beneficiaries with end-stage renal disease to enroll in Medicare Advantage plans beginning in January 2020.

House Oversight Committee Holds Hearing on Rising Price of EpiPens

On Sept. 21, the House Oversight and Government Reform Committee held a hearing concerning EpiPen and its cost to consumers. Mylan CEO Heather Bresch testified.

To watch the hearing, click here.

Energy and Commerce Committee Launches Review of FDA’s Office of Criminal Investigations

On Sept. 21, the House Energy and Commerce Committee announced it is investigating the FDA’s Office of Criminal Investigations, following reports of morale and management problems there.

In a letter to the FDA, Chairman Fred Upton (R-MI) and Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA) point to reports by the GAO in 2010 and the HHS OIG in 2012 that flagged concerns about the office, including a lack of performance standards and the use of law enforcement agents for non-criminal investigations, among other problems.

The letter also notes that the FDA let the director of the Office of Criminal Investigations relocate a field office in Miami, FL, and that this raises questions about the current management model for the OCI. The lawmakers are also seeking answers by Oct. 12 to a long list of questions about what FDA has done in response to the GAO’s and HHS OIG’s recommendations on the matter.

House Energy and Commerce Republicans Warn Against Using DOJ Funds to Settle Risk Corridors

On Sept 20, the House Energy & Commerce Republicans warned HHS Secretary Sylvia Burwell that the department would circumvent Congress if it draws from a Justice Department judgment fund to settle insurers’ lawsuits over the lower-than-expected risk corridor payments. CMS told insurers in a Sept. 9 memo it was open to settling the suits but didn’t elaborate. The lawmakers also want to know how CMS will follow through on its stated obligation to make insurers “whole” under the corridor program.

The members, House Energy and Commerce Chairman Fred Upton (R-MI), health subcommittee Chairman Joseph Pitts (R-PA), oversight & investigations subcommittee Chairman Tim Murphy (R-PA), Rep. Leonard Lance (R-NJ) and Rep. Morgan Griffith (R-VA) said CMS appeared to signal it is eyeing Congress’ Judgment Fund—which has a permanent appropriation—as a means to repay insurers through a settlement. Such action would circumvent congressional action to block funding for risk corridors, they say. It is also unclear whether use of the Judgment Fund would even be allowed in this situation. DOJ guidelines say that the fund is not supposed to become available just because an agency does not have the funds to pay a judgment.

The lawmakers also raised concern with Acting CMS Administrator Andy Slavitt’ s testimony during a hearing on Sept. 4 that the agency is obligated to pay the risk corridor money.

“During the joint hearing, U.S. Rep. Morgan Griffith asked Mr. Slavitt if CMS takes the position that insurance plans are entitled to be made whole on risk corridors payments, even if there is no congressional appropriation to do so. Mr. Slavitt responded under oath: ‘Yes, it is an obligation of the federal government.’ Mr. Slavitt also testified that the DOJ had reviewed the Sept. 9, 2016, CMS memorandum that invited insurance companies to settle with CMS,” the lawmakers wrote.

The GOP lawmakers said Slavitt agreed to give the names of individuals at CMS and HHS who have spoken to the Department of Justice about insurance companies’ lawsuits about risk corridor payments, a list of insurance companies that have sued CMS or the United States or intend to, and a list of insurance companies that have asked about settlements to risk corridor payment lawsuits, including those CMS referred to the DOJ.

However, the lawmakers stated that CMS only provided a list of companies that have sued the United States over risk corridor payments. They demanded that CMS provide by Oct. 4 Slavitt’ s explanation of how CMS intends to pay for its stated obligation to pay insurers, whether the agency thinks it legal to use the Judgment Fund to pay settlements, and the data missing from the first request.

House Judiciary Subcommittee Holds Hearing on Treating the Opioid Epidemic

The House Judiciary Subcommittee on Regulatory Reform, Commerce and Antitrust Law held a hearing concerning competition in the market for addiction medicine. Witnesses were:

Anne McDonald Pritchett, Ph.D., Vice President, Policy and Research, Pharmaceutical Research and Manufacturers of America

David Gaugh, R.Ph., Senior Vice President for Sciences and Regulatory Affairs, Generic Pharmaceutical Association

Mark Merritt , President and Chief Executive Officer, Pharmaceutical Care Management Association

Eric Ketcham, M.D., Medical Director, Emergency Department and Urgent Care, American College of Emergency Physicians; Co-Medical Director , EMS San Juan Regional Medical Center

Prof. Robin Feldman, Esq. , Harry and Lillian Hastings Professor of Law; Director of the Institute for Innovation Law, UC Hastings College of Law

For more information, click here.


Government Funding or Shut Down?

With the end of the government’s fiscal year on Sept. 30, Republicans released the text of the Continuing Resolution designed to fund the government through Dec. 9. Although the CR contains funding to tackle the Zika virus, it does not contain funding to address the lead contamination crisis in Flint, Michigan, and continues a prohibition on the SEC’s ability to require corporations to disclose political spending. As a result, not all Democrats are on board. A few senators have announced they will break ranks with their party – Florida Democrat Bill Nelson will back the CR since it includes Zika money; South Carolina Republican Lindsey Graham will oppose it, since it does not fully revive the Export-Import Bank. The Senate is scheduled to hold a cloture vote on the bill Sept. 27 at 2:15 pm.

Senate Finance Republicans Ask for OIG Review of EpiPen Medicaid Rebates

Senate Finance Committee Republicans are asking HHS’s Inspector General to review CMS’s oversight of Medicaid rebates, specifically the ones Mylan paid for its EpiPen. “Manufacturer rebates play an important role in helping to offset the ever-increasing costs of prescription drugs to the Medicaid program,” the letter says. “The recent controversy surrounding Mylan’s prescription drug product EpiPen raises questions about the controls in place to ensure that drug manufacturers are paying appropriate rebates.”

CMS may have known since 2014 that EpiPen was incorrectly classified as a generic. The letter notes that Mylan has previously been subject to enforcement for misclassifying a brand drug as a generic. It was one of four companies that in October 2009 entered into a $124 million settlement agreement to resolve claims it violated the False Claims Act by failing to pay appropriate rebates to state Medicaid programs.

Republicans on the House Energy and Commerce Committee have also requested HHS OIG oversight on the issue.

Senate Passes Short-term Reauthorization of FDA Pediatric Review Voucher Program

On Sept. 22, the Senate used its hotline process to pass a reauthorization of FDA’s pediatric review voucher program until the end of the calendar year, leading Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-TN) to call for quick House passage of the short-term authorization.

Sens. Bob Casey (D-PA) and Johnny Isakson (R-GA) attempted to push their bill to reauthorize the program for five years through the same process late Wednesday (Sept. 21), but Sen. Bernie Sanders (I-VT) objected and the debate shifted to drug pricing and 21st Century Cures funding for the National Institutes of Health and FDA.

  1. Administration

CMS Says Medicare Advantage Premiums to Decrease

On Sept. 22, the Centers for Medicare and Medicaid Services announced the average Medicare Advantage monthly premium will slightly decrease to $32.59 in 2017. That’s $1.19 less than the average premium this year, a 4 percent decrease. The average premium for private Medicare enrollees has decreased by 13 percent since passage of the Affordable Care Act, CMS said. The share of Medicare beneficiaries choosing private plans over the traditional fee-for-service program continues to soar. Medicare Advantage enrollment is projected to hit 18.5 million next year, accounting for roughly one-third of all beneficiaries.

For more information, click here.

FDA Announces Competition to Develop Mobile App for Opioid Antidote Naloxone

On Sept. 19, FDA announced a competition for development of a mobile phone app that can connect opioid users experiencing an overdose with nearby carriers of the prescription drug naloxone—the antidote for an opioid overdose.

The FDA, along with the National Institute on Drug Abuse (NIDA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) announced the 2016 Naloxone App Competition in order to bring together computer programmers, public health advocates, clinical researchers, entrepreneurs and innovators to help combat the opioid crisis. The contest was unveiled as part of the White House’s Prescription Opioid and Heroin Epidemic Awareness Week, which is being used by the White House to ratchet up pressure on Congress to approve the $1.1 billion in mandatory funding for opioid treatment, as proposed in the president’s 2017 budget.

For more information, click here.

FDA Approves First Drug to Treat Duchenne Muscular Dystrophy

On Sept. 19, FDA granted accelerated approval to Sarepta’s Duchenne muscular dystrophy treatment after receiving mounting political pressure by lawmakers and patient advocates. FDA’s drug center Director Janet Woodcock, with the help of Commissioner Robert Califf, overruled the drug’s review team, which had raised concerns about the drug’s effectiveness. This Duchenne muscular dystrophy treatment, eteplirsen, is now the first drug approved for the rare genetic disease that usually causes death in patients in their 20s or 30s.

This approval comes after FDA advisers voted against FDA approval of the drug in April. The advisers said Sarepta had not provided “substantial evidence” that the drug effectively treats the disease. FDA’s briefing documents issued ahead of the panel also indicated the agency was not convinced the drug warranted approval.

The accelerated approval means FDA concluded eteplirsen is reasonably likely to improve patients’ lives or longevity. Sarepta will have to conduct an additional clinical trial as a condition of full approval to confirm the drug’s clinical benefit. If that fails, FDA can withdraw the drug’s approval.

  1. Courts

Federal Judge Denies HHS an Extension to Reduce Medicare Billing Appeals Backlog

On Sept. 19, a D.C. federal judge refused to give government officials more time to reduce a million-claim backlog of Medicare billing appeals lodged by hospitals, calling proposed fixes either inadequate or unlikely to materialize. The ruling from U.S. District Judge James E. Boasberg rejected a request from the U.S. Department of Health and Human Services to pause litigation brought by the American Hospital Association. HHS wanted to put things on hold until October 2017 to see if administrative and legislative fixes would produce results, but Judge Boasberg concluded that the fixes are not sufficient and therefore waiting does not make sense.

The judge scheduled a hearing for Oct. 3 to discuss next steps. In a Sept. 19 statement, AHA Assistant General Counsel Lawrence Hughes said that the association is “very pleased with the decision” and “will have concrete recommendations to offer the administration at the upcoming status hearing.”

  1. State Activities

Colorado: ACLU Sues Colorado Medicaid Over Hepatitis C Treatment Restrictions

On Sept. 19, the American Civil Liberties Union (ACLU) of Colorado filed a federal class action lawsuit against the state’s Medicaid agency over restrictions on hepatitis C treatments. The Colorado Department of Health Care Policy and Financing recently relaxed its policy to allow Medicaid enrollees with a liver fibrosis score of F2 to receive the drug—previously it only included the sickest patients, with a score of F3 or F4—but the ACLU argues the new policy still is not inclusive enough. Other states facing a lawsuit over access to hepatitis C treatments include Indiana, Massachusetts, Pennsylvania and Washington.

Iowa: Iowa Supreme Court Asked to Overturn Gov. Branstad’s Closure of Mental Health Institutions

On Sept. 14, the Iowa Supreme Court was asked to decide if Gov. Terry Branstad violated state law last year by using his line-item veto authority to close two state mental health institutions. Branstad was sued by 25 state lawmakers and the American Federation of State, County and Municipal Employees following his decision. The plaintiffs’ attorneys argue the governor should have asked the state legislature to modify the statute. But a lower court sided with the Republican governor, saying that his authority to veto spending bills supersedes a section of state law requiring the state to operate four mental hospitals.

Minnesota: State Regulators Fail to Recruit Insurers to Join the MNsure Health Exchange

State regulators have come up short in their efforts to recruit more insurers to join the MNsure health exchange ahead of the 2017 open enrollment season. Officials made a concentrated effort after Blue Cross Blue Shield of Minnesota announced it would drop many of its individual market plans—though it will continue to sell individual HMO plans. The Minnesota Department of Health said it will continue to seek out more insurers but that it is unlikely coverage options will come together for the upcoming enrollment period.

Missouri: State Legislature Overrides Veto

The Missouri legislature recently overrode a veto on a bill that allows for Medicaid patients to be billed for missed appointments if they do not cancel within 24 hours. Gov. Jay Nixon vetoed the bill in July, writing at the time, “While these kinds of market-based reforms and incentives may be acceptable in the context of an expanded Medicaid population that includes more working Missourians, they are cruel and punitive when imposed solely on some of our very poorest and most vulnerable citizens.” Gov. Nixon is the most overridden governor in state history.

Nevada: Head of Nevada Health Exchange Leaving for New Job

Bruce Gilbert has resigned as the executive director of Nevada’s exchange to take a position with TriHealth, a health system in Ohio. The state exchange board met Sept. 20 to discuss appointing a successor.

New York: AG Files Lawsuit Claiming Anticompetitive Practices by Suboxone

According to a federal lawsuit filed by New York Attorney General Eric Schneiderman and 35 other attorneys general, the maker of Suboxone, a blockbuster drug that helps people control their opioid addiction, engaged in anticompetitive business practices, coercing patients to use an oral strip because the tablets were set to face generic competition. The tablets were first approved in 2002 and the Food and Drug Administration granted the pills orphan drug status, which protected the company’s market exclusivity through 2009.

The lawsuit alleges Indivior switched to a dissolvable film strip to prevent other companies from providing a generic form of the pill. The company also told the FDA the pill might be dangerous because it could wind up in the hands of children. At the time, FDA officials were skeptical of this argument but ordered the manufacturer and any generic manufacturers to participate in a shared Risk Evaluation and Mitigation Strategy. Invidior then asked the FDA to delay approving a generic until it could be proven there was no risk to children. This was all in a way to delay approval of generic versions of the drug, according to the lawsuit.

The FDA denied this petition and approved generic versions in 2012. By then, according to the lawsuit, Indivior had already gotten out of the pill market and switched to manufacturing the strips.

The company is also facing an investigation by the Federal Trade Commission over Suboxone and multi-district litigation by purchasers of the drug, accusing the company of similar deceptions.

Oregon: Oregon, Oracle Reach Settlement Over Botched Rollout of Oregon’s Exchange

On Sept. 15, Oregon and Oracle reached a $100 million settlement related to the botched rollout of Oregon’s exchange. Per the agreement, Oracle will give Oregon $60 million in free customer service support; a $10 million grant for science, technology, engineering and math programs in Oregon schools; and $25 million to reimburse the state for litigation costs. The two entities had been locked in a legal battle for years after the ACA marketplace failed to launch in 2013. A year later, Oregon switched to HealthCare.gov.

For more information, click here.

  1. Regulations Open for Comment

IRS, Treasury Release Proposed Rule on QHP Benchmarks

The IRS and Treasury Department, in a proposed rule released July 6, proposed to alter how qualified health plan (QHP) benchmarks are determined so that they account for the costs of pediatric dental benefits. If finalized, the rule would go into effect for the 2019 plan year.

Although pediatric dental care is one of the 10 “essential health benefits” that plans are required to cover under the Affordable Care Act (ACA), several plans do not include such coverage, and consumers instead buy stand-alone dental products. Meanwhile, the marketplace determines the amount of tax credits a family can receive to cover the cost of coverage based on the second-cheapest silver-level plan.

However, as the proposed rule said, “because qualified health plans that do not offer pediatric dental benefits tend to be cheaper than qualified health plans that cover all ten essential health benefits, the second lowest-cost silver plan (and therefore the premium tax credit) for taxpayers purchasing coverage through a Marketplace in which stand-alone dental plans are offered is likely to not account for the cost of obtaining pediatric dental coverage.”

Treasury and IRS added that the existing rules “frustrate” the goal of making all essential health benefits affordable to those receiving premium tax credits, so the administration wants to update its interpretation to ensure all 10 services are addressed.

“Consistent with this interpretation, the proposed regulations provide that for taxable years beginning after December 31, 2018, if an Exchange offers one or more silver-level qualified health plans that do not cover pediatric dental benefits, the applicable benchmark plan is determined by ranking (1) the premiums for the silver-level qualified health plans that include pediatric dental benefits offered by the Exchange and (2) the aggregate of the premiums for the silver-level qualified health plans offered by the Exchange that do not include pediatric dental benefits plus the portion of the premium allocable to pediatric dental benefits for stand-alone dental plans offered by the Exchange,” the proposal said.

The rule aims to create the ranking by adding the premium for the lowest-cost silver plan that does not include a pediatric dental benefit to the premium for the cheapest stand-alone dental plan, and the premium for the second-cheapest silver plan without pediatric dental benefits to that of the second-lowest stand-alone dental plan. The second-cheapest amount from this combined ranking would be the taxpayer’s applicable benchmark plan premium, the rule said.

CMS Releases Proposed Mandatory Bundled Payment Program

On July 25, CMS proposed new models to mandate bundled payments for cardiac care. This is the agency’s second program requiring providers to accept set payments for an episode of care. CMS also proposed extending its existing mandatory bundled payment initiative for hip replacements to other hip surgeries.

CMS clarified that under the new Medicare physician payment system starting in 2018, both mandatory bundled payment models could qualify as Advanced Alternative Payment Models, which would allow participating physicians to be excluded from a new proposed quality reporting program and instead receive a lump-sum payment from Medicare.

The agency also announced a new initiative to encourage hospitals to increase cardiac rehabilitation, in hopes of improving patient outcomes and reducing readmissions.

To see the proposed rule, click here. CMS will accept comments on the proposed rule until 5 p.m. on Oct. 3.

IRS Publishes Draft Regulations on Reporting of Catastrophic Health Coverage

The Internal Revenue Service (IRS) published new draft health coverage reporting regulations in the Federal Register on Aug. 2. The new draft regulations call for the health insurers that sell catastrophic medical insurance to report any catastrophic coverage they have provided to the enrollees and the IRS on Form 1095-B. The rule would first apply to the coverage in effect in 2017—issuers would then send out the first catastrophic plan 1095-B forms in early 2018.

Catastrophic plans are higher-deductible, lower-value plans that insurers can sell to people under 30, and to people of any age who earn too much to qualify for ACA exchange plan premium subsidies. The new draft regulations also call for the government agencies that offer Basic Health Plans—which are similar to managed Medicaid programs for people who earn too much to qualify for Medicaid—to report Basic Health Plan coverage to the IRS.

A third piece of the draft regulations clarifies that an employer providing two or more types of coverage that come under the minimum essential coverage rules would just have to report the richest form of coverage.

Comments on the draft regulations are due by Oct. 3.

UNOS Proposes Changes to Liver Transplant Policies

The United Network for Organ Sharing (UNOS) is proposing changes to the geographic regions for liver transplants to better match organ supply with demand and make access more equitable. Currently, there exists a wide variation in a transplant candidate’s chance of receiving an organ in a timely way, based on where the patient lives and the location of the transplant hospital where they are listed. Some patients may not get organs until they are much sicker than are patients awaiting transplants in different regions.

HHS Proposes Updates to Title X Rules

On Sept. 2, HHS proposed to preclude Title X grant recipients from using criteria in their selection of family planning providers that are unrelated to the ability to deliver services effectively.

Since 2011, 13 states have attempted to restrict participation by family planning providers in Title X based on factors unrelated to their ability to provide services. The Title X program provides funding for certain family planning services, including STD screening and treatment, but funding is not used to pay for abortions. Although Planned Parenthood is not mentioned by name in the proposed rule, it has often been the subject of defunding actions by states and Congress.

In the proposed rule, HHS said the effects already felt by the restrictions in many states justify the department’s rulemaking. HHS said grant recipients that do not provide services directly would also be required to follow the updated standards when choosing subrecipients.

HHS also proposed that a tiered structure governing how funds are distributed would not be allowed unless it can be proven that a provider in a top tier delivers Title X services more effectively than a lower-tier provider. According to the Guttmacher Institute, a research organization that supports reproductive rights, four states have a priority system for distributing family planning funds, which often disadvantages family planning centers.

CMS Proposes Changes to Risk Adjustment in 2018 Marketplace Rules

On Aug. 29, CMS issued the proposed annual Notice of Benefit and Payment Parameters for 2018, which outlines additional steps to strengthen the Health Insurance Marketplace. CMS is issuing this rule earlier in the calendar year in order to provide more certainty to the Marketplace as it continues to mature.

Beginning in 2017, the proposed policies will take steps to strengthen the risk adjustment program. First, the rule proposes updates beginning in 2017 to better reflect the risk associated with enrollees who are not enrolled for a full 12 months. Second, beginning in 2018, the rule proposes to use prescription drug utilization data to improve the predictive ability of CMS’s risk adjustment models. Third, also beginning in 2018, the rule proposes to establish transfers that will help to better spread the risk of high-cost enrollees, a change that would improve the risk-sharing benefits of the program.

In addition to the improvements to risk adjustment, the proposed rule contains other provisions to improve the Marketplace consumer experience and strengthen the individual and small group markets as a whole. The proposed rule would give consumers additional tools for assessing the networks of competing plans; broaden availability of this year’s new standardized plan options by accommodating state cost-sharing rules; and create consumer protections for consumers enrolling through the direct enrollment channel. The proposed rule would also create multiple child age bands that address instances in which consumers could face large premium changes after turning age 21; amend the guaranteed renewability regulations to provide additional flexibility for issuers to remain in an insurance market in certain situations; and codify several special enrollment periods that are already available to consumers in order to ensure the rules are clear and to limit abuse. It also seeks information on a number of suggestions offered by issuers, consumers, providers and others on further improving the risk pool, such as additional changes to special enrollment period policies or outreach; clarifying coordination of benefit rules between Medicare, Medicaid and the Marketplace; and providing greater certainty on the amount of user fee revenue spent on education and outreach.

To see the proposed rule, click here.

  1. Reports

GAO: DOD Needs Further Analysis of the Size, Readiness and Efficiency of the Medical Force

On Sept. 21, GAO released a report finding the Department of Defense (DOD) needs further analysis of the size, readiness and efficiency of the medical force in its defense health care reform.

DOD initiated a study—the Report on Military Health System Modernization—to address perceived weaknesses within the Military Health System and to leverage advances in civilian business practices. The GAO report reviewed this study, and assesses, among other things, the extent to which it followed an approach that is consistent with relevant generally accepted research standards and utilized key practices for estimating cost savings.

GAO made six recommendations, which include that DOD conduct a new analysis of the required number of active-duty and civilian medical personnel that mitigates known limitations; identify and mitigate limitations regarding the standard for maintaining providers’ clinical skills; develop a strategy for achieving its goals for transferring health care to DOD facilities and increasing the productivity of active-duty providers; and, when considering proposed changes to facilities, include in any accompanying cost estimates an appropriate level of detail.

To see the full report, click here.

Kaiser Family Foundation: Medicare EpiPen Spending Increased 1,151 Percent Since 2007

According to Kaiser Family Foundation, Medicare spending for the EpiPen increased from $7.0 million in 2007 to $87.9 million in 2014, an increase of 1,151 percent.

Medicare spending per EpiPen prescription increased from $71 in 2007 to $344 in 2014, an increase of 385 percent. This increase in spending by the federal health program is mostly attributable to the product’s skyrocketing price—since Mylan acquired the EpiPen in 2007, the company has increased the list price for a pack of two EpiPens nearly 550 percent, from $94 in 2007 to $609 in 2016.

EpiPens are often used to treat anaphylactic shock in children with serious food allergies, but they are also used by older adults and disabled people to treat severe allergic reactions. Lawmakers in both parties have asked HHS to assess what impact the price increases have had on federal spending.

For more information, click here.

GAO: Improved Oversight of Veterans’ Health Care Community Care Physicians’ Credentials Needed

On Sept. 19, GAO released a report finding that the Department of Veterans Affairs’ (VA) contractors successfully verified the credentials of physicians under one community care program, but were deficient in doing so under another program. GAO found that the contractors almost always verified and documented the credentials of physicians in the Veterans Health Administration’s (VHA) Patient-Centered Community Care (PC3) program consistent with the requirements of the contract. In contrast, the contractors did not always verify credentials of the physicians in the Veterans Choice Program (Choice) in a timely manner.

GAO recommended that VHA should develop a comprehensive oversight strategy that includes monitoring and evaluations of the contractors’ verification of PC3 and Choice physicians’ credentials, as well as VHA staff’s review of Choice physicians, and assess the risk of not verifying Choice physicians’ licenses under VHA Choice provider agreements.

To see the full report, click here.

JAMA Study on Bundled Payment

According to a new JAMA study, Medicare’s voluntary bundled payment program showed promise at reining in costs for an episode of care. However, one researcher warns that the program could be inadvertently encouraging unnecessary treatment. Researchers examined whether participants in the voluntary program for lower extremity joint replacements—mostly knees and hips—had reduced costs.

CDC Study Finds Increased Use of Broad-Spectrum Antibiotics in Hospitals

The study examined a period before a number of government and private efforts to encourage appropriate antibiotic prescribing starting in 2014. However, the authors said they don’t believe major changes in antibiotic use in acute care hospitals have occurred since then, based on a review of a smaller sample of data.

According to a new CDC study, U.S. hospitals are increasingly using broad-spectrum drugs that fight a range of disease-causing bacteria, which could signal increasing concern about infections caused by drug-resistant bacteria. The study, published in JAMA Internal Medicine, found that overall antibiotic use in hospitals changed little between 2006 and 2012. Just over 55 percent of patients received at least 1 dose of antibiotics during their hospital visit, according to the review of more than 34 million patients’ discharges from over 300 U.S. hospitals.

But the significant increase in the use of broad-spectrum antibiotics is “worrisome in light of the rising challenge of antibiotic resistance,” explained the authors from CDC. For example, researchers found a 37 percent increase in carbapenem, which is among a group of antibiotics often characterized as a “last resort” drug meant for very serious infections that are resistant to other types of antibiotics.

Researchers couldn’t determine whether the increased use of broad spectrum drugs was appropriate because the study did not examine why the antibiotics were prescribed.

MS Society Issues Recommendations to Improve Access to Drugs

The National Multiple Sclerosis Society (NMSS) on Sept. 22, issued a set of recommendations to improve access to drugs for the chronic disease.

NMSS calls for limiting price hikes on drugs that have been on the market “for a considerable time.” NMSS also advocates an out-of-pocket cap for prescription costs in Medicare and requirements that insurance companies not place all medicines for a disease on a specialty tier with coinsurance.

The group cited a 2015 study finding huge price increases for multiple sclerosis treatments in the past 20 years. The cost of first-generation drugs averaged $60,000 annually in 2013, up from $8,000 to $11,000 in the 1990s.

PhRMA spokeswoman Holly Campbell said the trade group agrees with some recommendations, but is “disappointed that they propose a number of recommendations which would undermine innovation in treatment for multiple sclerosis medicines rather than promote access and encourage development of new medicines.”

To see their recommendations click here.