Congress Is Making Quiet Progress on Drug Costs

https://www.commonwealthfund.org/blog/2018/congress-making-quiet-progress-drug-costs?omnicid=EALERT1477719&mid=henrykotula@yahoo.com

Progress on drug costs

While the Trump administration has taken small steps to implement its blueprint to lower prescription drug prices, Congress has recently made quiet progress on some policies that could help lower drug costs for patients.

First, both the Senate and House advanced legislation to ban “gag clauses” that prevent pharmacists from telling patients that they can save money on medications by paying for them out of pocket. Certain prescription benefit managers (PBMs) have used gag clauses as part of their formulary design. While this is not a widespread industry practice, a 2016 survey of community pharmacists found that nearly 60 percent had encountered a gag clause in the previous 10 months. Two bills (S. 2553 and H.R. 6733) would prohibit private Medicare plans from instituting gag clauses. A third, related bill (S. 2554) — passed by the Senate on Monday with overwhelming support — prohibits private health insurance plans from using them. While they enable pharmacists to advise patients on how to spend less at the pharmacy counter, these bans won’t necessarily lower the prices of drugs.

Second, a lesser-known provision of S. 2554, added by the Senate Committee on Health, Education, Labor and Pensions (HELP), could help lower drug prices by shedding light on patent-settlement agreements between drug manufacturers. Brand-name manufacturers sometimes use these agreements to extend their monopolies and keep drug prices higher by directly and indirectly compensating generic manufacturers for voluntarily delaying generics from coming to market. The Congressional Budget Office has found that setting a standard to rein in these types of settlements would produce $2.4 billion in savings over 10 years.

The HELP committee provision would require manufacturers of biologics (large-molecule drugs) and biosimilars (nearly identical copies of original biologics) to report patent-settlement agreements to the Federal Trade Commission (FTC) — an important step in understanding and preventing abuse of what is sometimes referred to as “pay for delay.”

Pay-for-Delay Stalls Drug Competition, Costing Patients Billions

In 2003, Congress required patent-settlement agreements between brand-name and generic small-molecule drug manufacturers to be filed with the FTC for review after they are made. (Currently most drugs sold are small-molecule drugs, but the biologics market is growing rapidly.) Such agreements effectively delay the sale of lower-cost generic drugs by nearly 17 months longer than agreements without payments, according to a 2010 report by the FTC. These anticompetitive agreements cost taxpayers approximately $3.5 billion each year.

In 2012, the U.S. Supreme Court decided in FTC v. Actavis that a brand-name drug manufacturer’s payment to a generic competitor to settle patent litigation can violate antitrust law. After the Court’s decision, the number of pay-for-delay agreements declined two years in a row. With drug companies now required to report these settlements to the FTC, the agency has been able to act to protect patients from anticompetitive deals that delay cheaper, generic drug products from coming to market. The FTC reviews reported settlements and, if it determines an agreement violates antitrust law, the agency challenges the agreement in the courts.

For example, in 2008 the FTC sued Cephalon, Inc., for paying four generic companies $300 million to delay marketing of their generic versions of Cephalon’s sleep-disorder drug, Provigil, until 2012. In 2015, the FTC reached a settlement with Cephalon’s owner, Teva Pharmaceutical Industries, Ltd., which agreed to ending pay-for-delay agreements for all their U.S. operations. The company also paid $1.2 billion in compensation for Cephalon’s anticompetitive behavior.

FTC Reporting Requirement Does Not Apply to Biologic and Biosimilar Manufacturers

The FTC reporting requirement applies only to small-molecule drugs, however, and not to far more expensive biologics and biosimilars. The potential savings of having biosimilars available for sale are significant: even one biosimilar competing against a brand-name biologic can result in a 35 percent lower price for patients and payers. Without delays in competition with brand-name biologics, biosimilars could save $54 billion to $250 billion over 10 years.

But there are concerns that manufacturers are entering into pay-for-delay agreements to keep prices for these drugs artificially high. Since 2015, when the biosimilar pathway was implemented, the FDA has approved 12 biosimilars, yet only three are currently available to patients — likely because of patent litigation and pay-for-delay agreements.

FTC Review Is Part of the Solution

In his remarks upon releasing the U.S. Food and Drug Administration’s Biosimilars Action Plan in July, FDA commissioner Scott Gottlieb noted the FTC’s key role in monitoring U.S. markets to protect consumers from anticompetitive behaviors, including those of prescription drug manufacturers. He also pointed out the patent litigation tactics manufacturers use to delay biosimilar competition.

As it does for the small-molecule drug market, the FTC can play a proactive role in monitoring what is happening in the biologic and biosimilar markets. At a workshop on drug pricing held last year, acting FTC chair Maureen Ohlhausen said that while her agency has been making progress in eliminating pay-for-delay agreements, it has not seen the last of them. She said they will remain a target. But to move forward, the FTC needs clearer authority to review patent settlements between biologic and biosimilar manufacturers.

With Senate passage of S. 2554 and its FTC reporting provision, Congress has taken an important step in encouraging a robust biosimilar market. (While the House has not passed a similar measure, the Senate bill could be added to a reconciliation of the House and Senate gag clause bills.) Engaging all the relevant market regulators — including the FTC, the U.S. Patent and Trademark Office, the Centers for Medicare and Medicaid Services, and the FDA — will inject needed competition into this nascent market and help lower drug prices for U.S. consumers.

 

Medicaid rolls set to be slashed under Trump-approved work rules

http://thehill.com/policy/healthcare/406624-medicaid-rolls-set-to-be-slashed-under-trump-approved-work-rules

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The thousands of people who lost Medicaid coverage this month in Arkansas for not following newly implemented work requirements may be a sign of what’s to come in other GOP-led states.

Indiana and New Hampshire are slated to implement their Medicaid work requirements next year, and a slew of other states are awaiting approval from the Trump administration.

Arkansas has served as a test case of sorts since it was the first state to implement work requirements, and this month it became the first state to kick off beneficiaries for not following them.

The state removed more than 4,000 people from the Medicaid rolls, with some estimates saying that number could climb to 50,000 when the requirements are fully implemented in 2019.

“I think other states should be thinking seriously about the warnings that Arkansas’ experience has for their states,” said Erin Brantley, a senior research associate at George Washington University’s Milken Institute of Public Health.

While many people in Arkansas’ program are exempt from reporting their activities to the state because they’re already working, others are not, meaning they need to file monthly reports through an online portal to show they are meeting the requirements.

Of those who lost coverage this month, about 95 percent didn’t file the necessary documents with the state. That led to their removal from Medicaid, though some may have been working working the required 80 hours a month.

It’s unclear why those participants didn’t file reports, especially if they were working, though some say it could be due to confusion, an inability to access a computer or general unawareness about the new requirements.

The state said it conducted “extensive” outreach that included sending more than 136,000 letters and emails and making more than 150,000 phone calls from April through August.

“It seems that [the state] is doing some outreach, but a lot of individuals still don’t know about the new requirements and are not setting up their accounts,” said Robin Rudowitz, associate director of the Kaiser Family Foundation’s program for Medicaid and the uninsured.

“There are many lessons to be learned about online reporting, and communication, and having individuals understand what the requirements are,” Rudowitz said. “The changes to these programs are difficult to communicate.”

In a report published in the journal Health Affairs this month, the author conducted interviews with 18 Medicaid recipients in northeast Arkansas and found that a dozen had not heard about the state’s new requirements.

Seema Verma, head of the U.S. Center for Medicare and Medicaid Services, which is responsible for reviewing state requests for work requirements, characterized Arkansas’ recent removal of Medicaid recipients as a positive step.

“I’m excited by the partnerships that Arkansas has fostered to connect Medicaid beneficiaries to work and educational opportunities, and I look forward to our continued collaboration as we thoroughly evaluate the results of their innovative reforms,” Verma said in a tweet the same day that 4,000 recipients lost coverage.

The work requirements have prompted lawsuits in Kentucky and Arkansas by advocates who say they are harmful to those in need. The judge that blocked a similar program in Kentucky earlier this year will also preside over the Arkansas case.

The Trump administration says “able-bodied” adults on Medicaid should work if they’re able to. In all three states, the work requirements apply only to those who gained coverage through ObamaCare’s Medicaid expansion, which allowed for covering more low-income adults.

It’s unclear how the work requirements will impact beneficiaries in Indiana and New Hampshire when they are rolled out next year, but both states are planning to rescind coverage for those who don’t meet the new work rules.

Beneficiaries in Indiana will have to work at least eight months each year, and an 80-hour-a-month requirement will be gradually phased in over an 18-month period. Compliance with the requirements will be checked annually instead of monthly, like in Arkansas.

New Hampshire beneficiaries subject to the new requirements must work 100 hours a month beginning in January. Enrollees who don’t meet the threshold for one month will have their coverage suspended.

Some argue that the true purpose of Medicaid work requirements is to cut spending for the federal program, a priority of conservatives for years.

“This policy is clearly not designed to help people find work. It’s designed to take them off Medicaid,” said Joan Alker, executive director of the Center for Children and Families at the Georgetown University School of Public Policy, referring to the Arkansas policy.

“It’s nothing to do with promoting work, supporting work — it’s about creating red tape for folks who are not able to jump over these bureaucratic hurdles for one reason or another — no internet access, they may not know, may be homeless, may not get the letter,” she said. “Those are the ones that will lose coverage.”

 

 

Bundled Payment Program Does Not Drive Hospitals to Increase Volume

https://www.commonwealthfund.org/publications/journal-article/2018/sep/bundled-payment-program-does-not-drive-hospitals-increase?omnicid=EALERT1467649&mid=henrykotula@yahoo.com

Lower extremity joint replacement

The Issue

In 2013, the Centers for Medicare and Medicaid Services (CMS) introduced a voluntary program for hospitals called Bundled Payments for Care Improvement (BPCI). Under this alternative payment model, CMS makes a single, preset payment for an episode, or “bundle,” of care, which may include a hospitalization, postacute care, and other services. Evaluations of the program for lower extremity joint replacement surgery (e.g., a hip or knee replacement) have found that it reduced spending. But experts wonder if bundled payments could encourage hospitals to perform more surgeries than they would otherwise or to cherry-pick lower-risk patients. Commonwealth Fund–supported researchers explore these issues of volume and case mix in the Journal of the American Medical Association.The authors used Medicare claims data from before and after the launch of BPCI, comparing markets that did and did not participate in the program.

What the Study Found

3.8%

increase in mean quarterly market volume in non-BPCI markets after the program was launched

4.4%

increase in mean quarterly market volume in BPCI markets after the program was launched

  • Participation in the BPCI program was not significantly associated with an overall change in the volume of surgeries performed.
  • The mean quarterly market volume in non-BPCI markets increased 3.8 percent after the program was launched. For BPCI markets, the increase was 4.4 percent.
  • The analysis found only one change in case mix: patients who had previously used skilled nursing facilities were slightly less likely to undergo a lower extremity joint replacement surgery at a hospital participating in BPCI.

The Big Picture

Results from this study alleviate concerns that hospitals’ participation in voluntary bundles may increase the overall number of joint replacement surgeries paid for by Medicare. In particular, the savings per episode observed in prior BPCI evaluations are not diminished or eliminated by an increase in procedure volume. The findings do raise concerns: if patients with prior use of skilled nursing facilities are less likely to undergo procedures at BPCI-participating hospitals, perhaps it is because hospitals avoid them based on perceived risk. On the other hand, the authors note, these decisions could have been based on clinically appropriate factors, like risk of complications.

The Bottom Line

Hospital participation in a bundled care program did not change overall volume, thereby alleviating the risk of eliminating savings related to the program. In addition, participation was generally not associated with changes in case mix.

 

 

 

CHS faces investigation related to EHR incentive program

https://www.beckershospitalreview.com/legal-regulatory-issues/chs-faces-investigation-related-to-ehr-incentive-program.html

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Franklin, Tenn.-based Community Health Systems has received a civil investigative demand related to the company’s adoption of EHRs and adherence to the meaningful use program, according to CHS’ latest financial filing.

Under the meaningful use program, now called the promoting interoperability program, CMS distributed incentive payments to eligible providers for installing EHR systems and using them to engage patients and families and to improve care coordination.

In its financial filing, CHS said it is responding to a civil investigative demand related to its “adoption of electronic health records technology and the meaningful use program.”

Federal and state authorities issue these types of demands to collect records and information related to ongoing civil investigations, including False Claims Act cases.

CHS declined to comment on the investigative demand beyond what is included in the financial filing.

EHR incentive payments grabbed the attention of federal regulators after HHS’ Office of Inspector General released a report in 2017 that revealed Medicare made approximately $729.4 million in EHR incentive payments to medical providers who did not comply with federal requirements.

 

CMS allows Medicare Advantage plans to negotiate Part B drug prices, implement step therapy

https://www.fiercehealthcare.com/payer/cms-allows-medicare-advantage-plans-to-negotiate-part-b-drug-prices-implement-step-therapy?mkt_tok=eyJpIjoiWlRsak1qTmpPV0poTVRBeCIsInQiOiI4TVwvbjloekN1OGJxWlJVTUw1djE5YXZkNlhONEpUQ3pXVFpmN3hlckFBcFRhSFBVRURkcCtVSmhpbVF0NlZoYkVmNVpHczVKbjBLXC9ZbjkxUlwvQVYrdm9FemhcL0FId3BmWkYzelg0a2tcLytaUEpHZ2VlU0dScldoRGJhWXlwUDlzIn0%3D&mrkid=959610

The Centers for Medicare & Medicaid Services (CMS) is giving Medicare Advantage (MA) plans more power in how they pay for Part B drugs.

The agency will allow MA plans to negotiate Part B drug prices with manufacturers, as well as to implement step therapy for Part B drugs. Plans will be required to pass half of the savings generated through negotiation to patients.

Negotiating Part B drug prices will foster competition and allow MA plans to get a better deal for their enrollees, according to CMS. These negotiations may also lead to price decreases in traditional Medicare.

The move represents perhaps the most significant step in the administration’s push to reduce drug prices, offering a new lever to combat ever-increasing costs.

Step therapy is a form of prior authorization that requires patients to try a “preferred” drug—that is, a less-expensive biosimilar— before the plan will cover a different, more expensive one. CMS says this will reduce costs for plans and beneficiaries alike.

Under the Affordable Care Act, at least 85% of plans’ savings must go toward healthcare services and quality improvement activities.

Further, the new policy requires “more than half of the savings required to be passed on directly to patients,” CMS said in a press release. A memo (PDF) from the agency says the savings may come in the form of “gift cards or other items of value.”

It is “unique that Medicare Advantage has not done this,” said CMS administrator Seema Verma in a press call on Tuesday evening, noting that traditional Medicare and private insurance plans have long been allowed to implement a step therapy policy.

MA plans will not be required to implement step therapy. Those that decide to do so must inform beneficiaries before the next enrollment period in October.

Verma added that patients and doctors can appeal the step therapy requirement through the existing appeals process.

The Pharmaceutical Care Management Association (PCMA), a trade association representing pharmacy benefit managers (PBMs), called the move “an important step toward reducing costs for the program and beneficiaries,” adding that “some of the highest priced drugs are found in Medicare Part B.”

Opponents of step therapy, who sometimes call it “fail first,” say limiting medication options can have negative consequences for consumers.

Step therapy policies “dangerously intrude on patient safety” and “weaken the doctor/patient relationship by negating the healthcare plan that they created together,” according to patient advocacy organization Fail First Hurts.

Part B drugs are either generally administered by a physician, administered via durable medical equipment, or otherwise specified by statute.

 

 

CMS Reevaluates Stark Law in Response to Value-Based Care Initiatives

http://www.managedhealthcareexecutive.com/health-law-and-policy/cms-reevaluates-stark-law-response-value-based-care-initiatives?rememberme=1&elq_mid=2696&elq_cid=876742&GUID=A13E56ED-9529-4BD1-98E9-318F5373C18F

Image result for stark laws

 

On June 20, 2018, CMS and HHS issued a “request for information” (RFI) seeking input on strategies to reduce the burden of the federal physician self-referral law or “Stark Law,” including the law’s impact on the transition to value-based care.

In the RFI, CMS solicits information on the ways in which the Stark Law creates challenges for coordinated, value-based care, and the transition to alternative payment and delivery models; it also seeks ideas and input on how the Stark Law may be changed to facilitate these models.

What’s driving the RFI

The RFI is launched as part of the agency’s “Regulatory Sprint to Coordinated Care” led by HHS Deputy Secretary Eric Hargan, which is directed at addressing regulatory barriers to coordinated care.  As such, the Regulatory Sprint and the RFI represent the administration’s efforts to reduce regulatory burden, while also demonstrating a commitment to the transition to more value-based, coordinated care and risk-based payment.  In public statements, HHS and CMS officials have suggested that the Regulatory Sprint may support similar flexibility in other laws, including the Anti-Kickback Statute.

Although the agency does not commit to any specific regulatory changes in this document, it is notable that HHS issued a similar RFI in 2010 just before it issued sweeping waivers of the Stark Law and Anti-Kickback Statute for the Medicare Shared Savings Program.  While many of the questions focus on “Alternative Payment Models” under the Quality Payment Program, the RFI is not limited to these programs.  Instead, the RFI invites the public to propose new exceptions and revised interpretations of the statute to advance the goals of coordinated care.

What CMS wants to know

In the RFI, CMS poses twenty specific questions related to the Stark Law, Alternative Payment Arrangements, and delivery system innovation strategies. The topics and questions range from:

  • Requests for details on Alternative Payment Models and innovations considered or engaged in by healthcare delivery system participants, including details on the financial and operational details of the arrangements, such as financial risk;
  • Solicitation of ideas and input on additional and/or new exceptions to the Stark Law that would facilitate existing and innovative arrangements;
  • Thoughts on changes to existing provisions of the final rule implementing the Stark Law, such as definitions of “commercial reasonableness” and “fair market value,” and thoughts on other potential definitions and terms such as “Alternative Payment Model,” clinical and financial integration and others;
  • Comments on key concepts in the existing law including compensation formulas that do and do not take into account the volume or value of referrals or other business within the meaning of the Stark Law and other novel financial arrangements; an
  • Requests for information on the Stark Law’s compliance cost, the potential role of increased transparency to promote compliance and how CMS should assess the Stark Law’s effectiveness in achieving its underling policy goals related to improper financial incentives.

The RFI may represent an important opportunity for the healthcare industry to educate CMS on current experiences and challenges, and to shape the content of future rules implementing changes to the Stark Law, particularly in a time of industry integration across the continuum of care.  The RFI also offers tangible evidence of the administration’s commitment to continue a migration to value-based care, and potentially reflects an enhanced commitment and desire to migrate away from fee-for-service payment to arrangements involving financial risk.

 

 

SHORT-TERM HEALTH PLANS ALLOWED UP TO 3 YEARS

https://www.healthleadersmedia.com/finance/short-term-health-plans-allowed-3-years

A final rule expands access to non-ACA-compliant plans, which the Trump administration has touted as cheaper alternatives to full coverage.


KEY TAKEAWAYS

Only about 200,000 people are expected to exit the ACA exchange market as a result of the final rule.

Gross premiums for marketplace plans are expected to rise 1% next year attributable to this policy change.

The administration notes that ‘these products are not for everyone,’ so buyers should review their options carefully.

Beginning this fall, consumers will be allowed to buy short-term limited-duration health plans renewable for up to three years, the Trump administration announced Wednesday morning with a newly finalized rule.

The policy change expands access to lower-grade coverage options the Obama administration had restricted to three months, without a renewal option, in light of the Affordable Care Act. The looser rules finalized Wednesday allow terms up to 12 months, renewable up to 36 months.

While critics contend the short-term options will pull younger healthier beneficiaries out of ACA-compliant exchange plans, driving up premiums for sicker populations left behind, the administration says any negative effects will be minimal and outweighed by the market benefits of having more options.

James Parker, MBA, a former Anthem executive who serves as director of the Health and Human Services Office of Health Reform and as one of four key senior advisors to HHS Secretary Alex Azar, said the administration doesn’t expect a mass exodus from the ACA exchanges to these short-term options.

“What we do believe, however, is that there will be significant interest in these policies from individuals who today are not in the exchange and, in many cases, have been priced out of coverage as insurance premiums have significantly increased over the past four to five years,” Parker said during a call with reporters Tuesday evening.

Randy Pate, a deputy administrator of the Centers for Medicare & Medicaid Services who oversees individual and small-group markets as director of the Center for Consumer Information and Insurance Oversight, said the administration expects about 600,000 people to enroll in the short-term plans next year as a result of the expanded access. Only an estimated 200,000 will leave the exchange market as a result of the final rule, he said.

This shift is expected to increase gross premiums for marketplace plans by 1% next year, with net premiums decreasing by 6%, Pate said during the call.

  • The wrong direction? When the administration announced its plans earlier this year to expand access to short-term coverage options, American Hospital Association President and CEO Rick Pollack called it “a step in the wrong direction for patients and health care providers.” If consumers are unaware of the limits on their skimpy coverage, it could ultimately drive bad debt for hospitals, he said.
  • Disclosure requirements beefed up: The final rule includes additional language to make sure consumers know what they are buying, Pate said. “We fully recognize these products are not necessarily for everyone, but we do think they will provide an affordable option to many, many people who have been priced out of the current market under the Obamacare regulation,” he said.
  • There’s an opportunity for insurers. As consumers gain interest in their short-term options, insurers will have an opportunity to meet the rising demand. “The impact is going to vary depending on the insurer, whether this is a business they have been in in the past and whether they have been longing to get back into it when consumer interest reached an acceptable level,” Christopher Holt, director of healthcare policy with D.C.-based think tank American Action Forum, told HealthLeaders Media. “There also could be some who see it as a new opportunity to claim a share of the marketplace they’re not reaching.”
  • But insurers have some skepticism. Matt Eyles, president and CEO of America’s Health Insurance Plans, wrote a letter to HHS in April. “We are concerned that substantially expanding access to short-term, limited duration insurance will negatively impact conditions in the individual health insurance market, exacerbating problems with access to affordable comprehensive coverage for all individual market consumers,” Eyles wrote.
  • Trump administration boosters: Beyond simply opening a door to longer short-term plans, the Trump administration has touted these and other non-ACA-compliant options as viable rescue mechanisms for individuals squeezed by rising premiums. Navigators, who have been tasked in past years with helping people sign up for exchange coverage, will now be encouragedto provide information on short-term and association health plans as well.
  • States can block: The final rule released Wednesday addresses the federal government’s definition of short-term limited-duration health insurance, but states retain the authority to impose stricter regulations, Pate said. They can limit or even ban the plans altogether.

While lawmakers seem to have backburnered their aspirations for broad healthcare reform in the near-term, Parker said the administration will continue taking incremental steps to improve affordability of coverage.