Tag Archives for Centers for Medicare & Medicaid Services

Wake up call on spiraling brand-name drug prices 

Published in RINewsToday on August 14, 2023

By Herb Weiss

A new pharmaceutical drug price report that is both timely and overdue has been released by AARP’s Public Policy Institute, following on the heels of the Centers for Medicare & Medicaid Services (CMS) releasing in June, which revised guidance for the historic Medicare Drug Price Negotiation Program.  

This report details the list prices for the 25 brand-name drugs with the highest total Medicare Part D spending in 2021, noting that prices have increased by an average of 226%—or more than tripled—since they first entered the market. Those 25 drugs were responsible for $80.9 billion in total Medicare Part D spending in 2021, about 37% of the total spending, and were used by more than 10 million Part D enrollees.  It noted that, on average, nearly 60% of their current list price was due to price increases after the product entered the market.

The price of Enbrel, used to treat rheumatoid arthritis and psoriatic arthritis, has increased by 701% since coming to market in 1998, and the price of Januvia, used to treat diabetes, has increased by 275% since entering the market in 2006.

Overall, the lifetime price increases ranged from 20% to 739%, and all but one of the drugs’ lifetime price increases greatly exceeded the annual rate of inflation over the same period of time. 

Brand-name drug prices increase faster than inflation has – for decades

“Brand-name drug prices have increased dramatically faster than inflation for decades,” said Leigh Purvis, Prescription Drug Policy Principal, AARP Public Policy Institute, and author of the report.  “The median price of a new brand-name prescription drug is now approximately $200,000 per year, so even relatively small percentage price increases can translate into thousands of dollars and put life-saving medications out of reach of the patients who need them,” she said. 

“We know that there is lot of media attention on individual drug prices that take place year after year.  However, a lot less attention is paid to how those price increases are often building on top of a long line of price increases and how those relentless price increases add up over time,” says Purvis, during a press call to journalists scheduled on the day of the report’s release.

“These findings have huge implications for the people that AARP represents, many of whom need prescription drugs to help them stay well,” Purvis said. “People on Medicare prescription drug plans take on average of between 4 and 5 prescription drugs per month and their drugs are increasing covered using coinsurance where you pay a percentage of the drugs price instead of a flat co-pay.  In fact, across the country more and more people are facing cost sharing directly affected by drug price increases, whether it is by coinsurance or simply before they meet their deductible.  Millions of other people don’t have health coverage and are having to absorb the cost associated with growing drug prices on their own,” she said.

“Our analysis shows that drugs that have been on the market for twenty years or more have seen an average lifetime price increase of 592 percent.  In real terms this can be the difference of thousands of dollars for one person and enough to force the trade-offs that we often hear about, like choosing to put food on the table or being able to pay for gas,” notes Purvis.

“There is no justification for drug companies to engage in these type of price increases every year they are on the market, particularly increases that are so much higher than the price increases for other goods and services,”  adds Purvis. 

CMS releases revised guidance for negotiating with drug manufacturers 

Congress recently passed the Inflation Reduction Act (IFA), a federal law requiring drug companies to pay a penalty to Medicare if their drug’s price increases faster than the rate of inflation. The law will also give Medicare the ability to negotiate lower drug prices with drug companies for the first time. CMS is expected to announce the first 10 drugs selected for negotiation by September 1st, and the negotiated prices will become available in 2026.

“This historic law cracks down on the big drug companies and [will bring] real relief to millions of seniors who have been struggling with out-of-control prescription drug prices,” said Nancy LeaMond, AARP Executive Vice President and Chief Advocacy and Engagement Officer. “American families simply can’t afford to keep paying the highest prices in the world for the medications they need.”

Last March, CMS issued initial guidance to seek comments on its historic Medicare Drug Negotiation Program.  The agency received over 7,500 comments from consumer, patient groups, drug companies and pharmacies.  In June, CMS released its revised guidelines detailing the requirements and parameters of how the agency will oversee the new program.

“Issuing final guidance for the Medicare Drug Price Negotiation Program is an important “next step” in controlling spiraling high drug prices, says AARP’s LeaMond, noting that Medicare’s new buying power will get a better price for Medicare beneficiaries, saving the program billions of dollars and making prescription drugs more affordable.

Opposition, of course

At press time, the Pharmaceutical Research and Manufacturers of America (PhRMA), the leading industry lobby group for pharmaceutical companies, along with a group of pharmaceutical companies and trade groups, are suing the U.S. Health and Human Services to block the implementation of the Medicare Drug Price Negotiation Program established by the Inflation Reduction Act enacted by President Biden last August. The U.S. Chamber of Commerce has also filed a lawsuit in a U.S. District Court in Ohio to ask for an injunction to keep the negotiations from going forward. The trade group is challenging the constitutionality of the IFA’s drug price negotiation program.   

It’s a very high lift and big burden to meet the standard to stop the law from being implemented,” noted Kelly Bagby, AARP’s Vice President at AARP Foundation Litigation, before AARP’s press call ended.

“It is entirely appropriate and is necessary and the public interest is so enormous in balancing of the government’s interest verses the pharmaceutical companies and Chamber’s interest in this case,” says Bagby,” stressing that beneficiaries have to win this case. “It’s so obvious that pharmaceutical companies are not the victims they are painting themselves to be, she adds, affirming her belief that beneficiaries and Medicare have the strongest argument.  

Bagby noted, “AARP is working to protect the integrity of whole Medicare program for everybody and to allow for older people to not have to make horrible choices about do I pay my rent or do I get to take my life saving drugs.” 

Reports a Wake-Up Call

Although PhRMA,  pharmaceutical companies and trade groups along with the U.S. Chamber are strongly opposed to CMS’s new program to negotiation drug prices, polls show that people aged 50 and over, view the lowering of the price of costly prescription drugs to be a very important policy issue to them. Purvis hopes that the recently released AARP report will serve as a wake-up call for every American who is skeptical about the importance of lowering prescription drug prices. “Higher government spending driven by drug price increases will affect all Americans in the form of higher taxes, cuts to public programs, or both,” she predicts.  

For a copy of AARP’s Medicare Part D Drug Price report, go to https://www.aarp.org/pri/topics/health/prescription-drugs/prices-top-medicare-part-d-drugs-tripled-since-entering-market.html.

CMS Moves to Strengthen Nursing Home Safety and Clarity of Consumer Info

Published in RINewsToday on January 23, 2023

To improve transparency of nursing home consumer information, the federal Department of Health and Human Services (HHS) through the Centers for Medicare & Medicaid Services (CMS), will now post Care Compare citations that are under dispute by nursing homes on its website.  CMS will also take steps to protect nursing home residents from being inappropriately diagnosed with schizophrenia which oftentimes leads to improper use of anti-psychotic medications to sedate and chemically restrain residents.

“We have made significant progress in decreasing the inappropriate use of antipsychotic medications in nursing homes, but more needs to be done,” said CMS Administrator Chiquita Brooks-LaSure, announcing the new guidance this week. “People in nursing homes deserve safe, high-quality care, and we are redoubling our oversight efforts to make sure that facilities are not prescribing unnecessary medications,” she says.

CMS’s actions advance President Biden’s goal of reinforcing safeguards against unnecessary medication use and treatments that was outlined in his State of the Union address to create an Action Plan for “Protecting Seniors by Improving Safety and Quality of Care in the Nation’s Nursing Homes.”

Tackling the inappropriate drugging of Nursing Home residents

Beginning this month, CMS will conduct targeted, off-site audits of nursing homes to determine whether facilities are accurately assessing and coding individuals with a schizophrenia diagnosis. Nursing home residents erroneously diagnosed with schizophrenia are at risk of receiving poor care and being prescribed inappropriate anti-psychotic medications. Anti-psychotic medications are especially dangerous to these residents due to their potential devastating side effects, including death.

According to the Washington, DC-based National Consumer Voice for Quality Long-Term Care, in 2008, CMS first introduced a quality measure in its Care Compare rating system that calculates the percentage of long-stay residents (over 100 days) that were receiving anti-psychotic medications. This quality measure was initially introduced to address the practice of some nursing homes of illegally using anti-psychotic medications to sedate residents with dementia or other increased patient care needs, rather than providing appropriate hands-on care interventions.

The measure, excluding residents with certain diagnoses, including schizophrenia, Huntington’s disease, and Tourette’s syndrome, resulted in some nursing homes improperly diagnosing residents with schizophrenia, observed the Consumer Voice, a national organization representing consumers in issues related to long-term care, helping to ensure consumers are empowered to advocate for themselves.      

CMS’s new guidance acknowledges that there has been a steady rise in schizophrenia diagnoses since the quality measure was first introduced, charges the Consumer Voice, noting that it comes on the heels of a report issued by the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) which found that from 2015-2019 there was a 194% increase in the number of residents diagnosed with schizophrenia who did not have that diagnosis prior to admission to the nursing home.

“It is important to note that it is extremely rare for schizophrenia to suddenly occur in older people,” says the Consumer Voice, stating that the onset of schizophrenia generally occurs in someone’s late teens through their twenties.

CMS announced that it will begin to conduct audits of nursing homes with high rates of schizophrenia diagnoses and “examine the facility’s evidence for appropriately documenting, assessing, and coding a diagnosis of schizophrenia.” Facilities that have “inaccuracies” will have their Five-Star Quality Measure Rating adjusted. CMS will downgrade the facility’s Quality Measure ratings to one star, which would drop their Overall Star Rating as well. CMS will monitor each facility’s data to determine whether they have addressed the identified issues. After that, CMS will decide whether any downgrades should be reversed.

While Consumer Voice has expressed significant concern with the accuracy of CMS’s Quality Measure, it supports these actions. The Quality Measure rating often inflates a facility’s overall 5-Star rating on Care Compare. This action will help incentivize compliance and make sure the public is aware of these illegal practices in nursing homes, says the consumer advocacy group.

Increased transparency

Separately, CMS announced it plans to take a new step to increase the transparency of nursing home information provided to consumers by publicly displaying survey citations that facilities are disputing. Currently, when a facility disputes a survey deficiency, that deficiency is not posted to Care Compare until the dispute process is complete. This process usually takes approximately 60 days; however, some cases can take longer. 

Although the number of actual deficiencies under dispute is relatively small, they can include severe instances of non-compliance such as Immediate Jeopardy (IJ) citations. This level of citation occurs when the health and safety of residents could be at risk for serious injury, serious harm, serious impairment, or death. Displaying this information while it is under dispute can help consumers make more informed choices when it comes to evaluating and choosing a facility. This new information will begin appearing on Care Compare on January 25th. While citations will be publicly displayed, they will not be included in the Five-Star Quality Rating calculation until the dispute is complete. 

“We support anything that CMS can reasonably do to improve the health and safety of seniors in long-term care, especially those with cognitive impairment. When it comes to the nursing home industry’s concerns about new CMS rules, we think it’s best to err on the side of transparency. Seniors and their families need as much information as possible to make informed decisions about long-term care,” says a spokesperson for the Washington, DC-based National Committee to Preserve Social Security and Medicare, an advocacy group whose mission is to protect Social Security and Medicare.

Local reaction:  “You cannot un-ring a bell”

RI Health Care Association

“We fully support improving nursing home transparency, safety and quality, and accountability regarding our members’ service to the residents and patients entrusted to their care,” says John E. Gage, President and CEO of Rhode Island’s Health Care Association, representing 64 of the 80 nursing facilities in the state. “Eliminating any inappropriate use of psychotropic medications and ensuring the highest quality of care is a shared focus of both CMS and RIHCA,” notes Gage.

“We strongly disagree with CMS’ decision to post of deficiencies that are in the process of being disputed through established CMS policies, regardless of their scope and severity, says Gage. “Posting deficiencies that, in many instances, are incorrect, inaccurately cited or cited at an inappropriate level of scope and severity, during an approved appeals process is unfair and could damage a facility’s reputation unfairly,” he adds.

According to Gage, doing this is akin to convicting someone before their full trial, (prosecution and defense alike) before the verdict is announced. “You cannot “un-ring a bell,” he says.

“As mentioned by CMS, we are just talking about a relatively small number of deficiencies,” states Gage. Rather than potentially posting erroneous deficiencies, he calls on CMS to speed up the process of conducting Informal Dispute Resolutions (IDRs) or Independent Dispute Resolutions (IIDRs) to no more than forty-five (45) days to ensure that accurate information is posted timely. IDRs and IIDRs are two different options from CMS that nursing homes can choose to appeal of cited deficiencies.

“As to the changes to the public reporting and the Five-Star Quality Rating System, we are disappointed that the Biden Administration and CMS have apparently made this determination administratively, without any comment period to allow for an opportunity for nursing homes and the public to provide feedback,” says Gage.

LeadingAge RI

“I appreciate CMS’s goal of increasing oversight of unnecessary antipsychotic medication use, although it should be noted that there has been a National Partnership to reduce the unnecessary use of antipsychotic drugs for years, so the industry has been very engaged in these efforts already,” notes James Nyberg, Executive Director of LeadingAge RI, a not-for-profit membership organization comprised of not-for-profit providers of aging services. 

Nyberg expresses concern about CMS posting deficiencies that are under dispute publicly. “That is taking a guilty before proven innocent approach, which is unfair and detrimental to providers. There is an existing process to resolve disputes over deficiencies, and this seems to short-circuit it, especially when deficiencies can be/and are overturned during the process.  One more blow to a beleaguered industry,” he says.

Long-Term Care Ombudsman

“The inappropriate use of antipsychotic medications in nursing homes has been an on ongoing issue for many years,” observes Kathleen Heren, Rhode Island’s Long-Term Care Ombudsman. “It takes a skilled practitioner who gives a battery of tests to diagnose someone with schizophrenia. This shouldn’t be determined by a hospital intern who spends 20 minutes with an agitated resident in a hospital emergency room,” she says.

According to Heren, schizophrenia has an early onset [about 4% of schizophrenia arise before the age of 15, and about 1% before the age of 10].  A 78-year -old resident does not become schizophrenic all of a sudden because he or she is agitated. “I can say that I have not seen many deficiencies given to Rhode Island nursing homes for overusing anti-psychotic medications,” she says, because of the efforts of  Health Care Centrics, Rhode Island’s Quality Assurance organization, that has provided in-depth staff training on the use of these drugs. The surveyors from the Rhode Island Department of Health (RIDoH) are very quick to cite facilities for not following guidelines in the inappropriate use of these drugs.

Heren says that there have been cases where RIDOH has rescinded a deficiency based on the input received by the survey team during the Informal Dispute Resolution process. “There are some facilities that are continually receiving deficiencies and that families should be able to see why a deficiency was given and a facilities response as to why it was considered unfair,” she says.

CMS Actions promote quality of care

RI Department of Health

“At the Rhode Island Department of Health (RIDoH), one of our major focus areas is monitoring and ensuring that nursing homes and other healthcare facilities provide the highest quality of care and services in a clean and safe environment, says Joseph Wendelken, RIDoH’s Public Information Officer. 

“We will continue to do everything we can to protect patients and residents, which includes following any new CMS protocols and partnering with CMS on new initiatives,” Wendelken says. 

Senior Agenda Coalition of RI

Adds Maureen Maigret, Policy Advisor for the Senior Agenda Coalition of RI, “Rhode Island nursing homes have generally provided good quality of care over the years,” acknowledging that improvements can always be made. “Both of these changes are intended to promote better quality care,” she says. “If people are erroneously coded as having schizophrenia, they may be subject to poorer care and harmed by being prescribed inappropriate medication. Posting inspection citations under dispute on Nursing Home Compare with a notation they are under dispute is important in that resolution of the dispute could take 60 days or longer and in the meantime the public remains unaware of what could be significant deficiencies which could impact their decisions,” states Maigret says.

The QSO memo — Updates to the Nursing Home Care Compare website and Five-Star Quality Rating System: Adjusting Quality Measure Ratings Based on Erroneous Schizophrenia Coding, and Posting Citations Under Dispute — is available here for review:

https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationgeninfo/policy-and-memos-states/updates-nursing-home-care-compare-website-and-five-star-quality-rating-system-adjusting-quality

Trustee Reports predict improved outlook for Social Security and Medicare

Published in RINewsToday on June 6, 2022

On June 2, 2022, following a meeting of the Social Security and Medicare Boards of Trustees, the Social Security Administration (SSA) – joined by the Departments of Health and Human Services and Labor, the Centers for Medicare & Medicaid Services, and the U.S. Department of Treasury — released a 275-page annual report giving us a snapshot of the financial health of the Social Security Trust Funds.

The Trustee reports findings

According to this year’s Trustee Reports, “Social Security and Medicare both face long-term financing shortfalls under currently scheduled benefits and financing. Costs of both programs will grow faster than gross domestic product (GDP) through the mid-2030s primarily due to the rapid aging of the U.S. population. Medicare costs will continue to grow faster than GDP through the late 2070s due to projected increases in the volume and intensity of services provided.”

The Social Security Trustees report that the combined asset reserves of the Old-Age and Survivors Insurance and Disability Insurance (OASI and DI) Trust Funds, paying benefits to 65 million retirees, disabled people as well as survivors of deceased workers, are projected to become depleted in 2035, one year later than projected last year, with 80 percent of benefits payable at that time. The DI Trust Fund asset reserves are not projected to become depleted during the 75-year projection period.

“It is important to strengthen Social Security for future generations. The Trustees recommend that lawmakers address the projected trust fund shortfalls in a timely way to phase in necessary changes gradually,” says Kilolo Kijakazi, Acting Commissioner of Social Security in a statement announcing the released report. “Social Security will continue to be a vital part of the lives of 66 million beneficiaries and 182 million workers and their families during 2022,” she adds.   

The Medicare Board of Trustees note in its 263 page report that the projected depletion date for Medicare’s trust fund for inpatient hospital care (Part A), covering around 64 million retirees and disabled persons, moved from last year’s forecast of 2026 to 2028. At this time Medicare will only be able to pay 90% of the scheduled benefits when the fund is depleted.

“We are committed to running a sustainable Medicare program that provides high quality, person-centered care to older Americans and people with disabilities,” said CMS Administrator Chiquita Brooks-LaSure. In a statement “Medicare trust fund solvency is an incredibly important, longstanding issue and we are committed to working with Congress to continue building a vibrant, equitable, and sustainable Medicare program,” she says.

Thoughts from senior advocacy groups

In a statement, AARP CEO Jo Ann Jenkins said that this year’s Social Security and Medicare Trustee report sends this clear message to Congress: “The Social Security and Medicare Trustees’ reports should send this “clear message” to Congress: “Despite the short-term improvement, you must act to protect the benefits people have earned and paid into both now and for the long-term. The stakes are too high for the millions of Americans who rely on Medicare and Social Security for their health and financial well-being.”

“These reports also underscore the urgent need for Congress to pass legislation allowing Medicare to negotiate for lower prescription drug prices, which would result in billions of dollars of savings for seniors, the Medicare program, and taxpayers,” says Jenkins.

Jenkins also calls on Congress to increase funding to fix serious long-time Social Security customer service problems, which currently impede or keep seniors and people with disabilities from getting their benefits in a timely manner.

Following the release of the Trustees Report, Executive Director Alex Lawson, of the Washington, DC-based Social Security Works, (SSW) a social welfare organization that lobbies for Social Security Reforms, also issued a statement: “Today’s report shows that our Social Security system remains strong. Protecting and expanding benefits is a question of values, not affordability. That this year’s projections are even stronger than last year’s proves once again that Social Security is built to withstand times of crisis, including pandemics.”

We don’t have a Social Security crisis, but we do have a retirement income crisis. With prices rising, seniors and people with disabilities are struggling to afford food and medicine. The solution is to expand Social Security,” says Lawson. 

According to SSW, the 2020 Social Security Trustee’s Report reported that Social Security has an accumulated surplus of about $2.85 trillion.  It projects that, even if Congress took no action whatsoever, Social Security not only can pay all benefits and associated administrative costs until 2035, it is 90 percent funded for the next quarter century, 84 percent for the next half century, and 81 percent for the next three quarters of a century.  

“At the end of the century, in 2095, Social Security is projected to cost just 5.86 percent of the gross domestic product (“GDP”), less than most other wealthy countries spend on their counterpart programs,” says SSW.

Max Richtman, President and CEO of the Washington, DC-based National Committee to Preserve Social Security and Medicare (NCPSSM), throws in his two cents about this year’s Trustee Report. “The takeaway from the latest Social Security Trustees report is this:  Congress must strengthen the program’s finances without delay. The Trustees project that the combined Social Security retirement and disability trust fund will become depleted by 2035, one year later than projected in their previous report. At that point, every Social Security beneficiary will suffer a 20% cut to their benefits.”

“Seniors struggling to meet rising living expenses need Social Security to be boosted and strengthened. The pandemic, runaway inflation and devastating stock market losses serve to remind us how vital a robust Social Security program is to workers, retirees, the disabled and their families. The clock is running down. The time for fair, just, and equitable action that safeguards Social Security’s financial stability is now,” adds Richtman.   

While acknowledging that the trust fund insolvency date may fluctuate from year to year, the urgent need to boost the program’s financing and benefits remains consistent, says Richtman. 

NCPSSM’s Richtman says, over the years, the GOP has opposed the expansion and strengthening of Social Security and has called for raising the retirement age, privatization, and more recently, ‘sunsetting’ Social Security and Medicare every five years.  He calls for passage of Rep. John Larson’s Social Security 2100: A Sacred Trust legislation that would extend trust fund solvency by requiring high wage earners to contribute their fair share through an adjustment in the payroll wage cap. 

A Washington Insider says that House Speaker’s Nancy Pelosi (D-CA) policy staff are concerned about the cost of Larson’s Social Security fix legislation and are seeking a CBO cost estimate. At press time this measure has more than 200 Democratic cosponsors in the House. The Congressional Asian Pacific American Caucus (CAPAC), Congressional Black Caucus (CBC), the Congressional Hispanic Caucus (CHC), the Task Force on Aging and Families, and the Congressional Progressive Caucus have all called on Pelosi to bring the bill to the House floor for a vote.

“Thanks to the American Rescue Plan, our economic recovery has strengthened both the Social Security and Medicare Hospital Insurance Trust Funds and improved financial projections for these vital programs. But to ensure that every American worker, senior, child, and person with disabilities receives the necessary and earned benefits provided by both Social Security and Medicare, we need to act. That’s why I am an original cosponsor of legislation like Social Security 2100: A Sacred Trust, to not only enhance benefits for seniors and some of our most vulnerable neighbors, but to also guarantee access to these programs for generations to come,” said Congressman David Cicilline, (D-RI).  

Congress can step in to financially strengthen the Social Security and Medicare programs. A message from the Social Security and Medicare Boards of Trustees suggest Congress pass legislation to reduce or eliminate the long-term financing shortfalls in both the Social Security and Medicare. “Taking action sooner rather than later will allow consideration of a broader range of solutions and provide more time to phase in changes so that the public has adequate time to prepare,” say the Trustees.

Congress should look for “medium-term solvency” fixes to ensure that Social Security program can pay full benefits for several decades rather than for the full 75-year projection period, suggests Paul N. Van De Water, Senior Fellow at the Washington, DC-based Center for Budget and Policy Priorities, a nonprofit nonpartisan research organization and policy institute that conducts research on government policies and programs. “But shoring up the program’s financing for a substantial period of time is important for assuring both current and future beneficiaries that Social Security will be there for them in the years to come,” he says.

At a crossroad

NCPSSM’s Richtman believes Social Security’s future is now at a crossroads. “We can either cut benefits or expand benefits and pay for it by requiring the wealthiest to pay their fair share,” he says, calling on Congress to hold an up or down votes on Larson’s Social Security legislation.

Polling shows that voters support fixing Social Security and Medicare. Seniors may well go to the polls, sending a message with their vote that strengthening and expanding Social Security is important to them.   

For a copy of the 2022 Social Security Trustee Report, go to https://www.ssa.gov/OACT/TR/2022/tr2022.pdf. For a copy of the 2022 Medicare Trustee Report, go to https://www.cms.gov/files/document/2022-medicare-trustees-report.pdf