05 Nov November 5, 2018

CMS’ Final Payment Rules Smack HOPDs, 340B, Postpone E/M Changes

The Centers for Medicare and Medicaid Services late last week released two payment system rules that will have significant impact on payments to providers – the Hospital Outpatient Prospective Payment System the Medicare Physician Fee Schedule. Not listening to overwhelming opposition to cutting payments for clinic visits in off-campus provider based departments, CMS finalized the controversial proposal. However, CMS has scaled back the “blended rates” for the five levels of evaluation and management codes, pushing out the start date to 2021, and collapsing the codes to three levels instead of two. The American Hospital Association and the Association of American Medical Colleges have already announced an intention to challenge the site-neutral policy in court.

 

The OPPS Final Rule Includes:

• CMS is finalizing its proposal to applying the physician fee schedule-equivalent payment rate for the clinic visit when provided at an off-campus provider-based department that is paid under OPPS.
  • The rate will be implemented over a two-year phased-in approach with clinic visits paid at 70 percent of the OPPS rate for CY 2019 and transitioning to the full PFS rate for CY 2020.
• CMS is NOT finalizing its proposal regarding “clinical families of services” in this final rule but will continue to monitor the expansion of services in excepted off-campus provider based departments.
• CMS is finalizing its proposal to pay ASP minus 22.5% for 340B drugs in non-excepted off-campus provider-based departments.

Click here for the CMS Fact Sheet and here for the final rule.

 

The PFS Final Rule Includes:

• CMS is finalizing the reduction the Wholesale Acquisition Cost (WAC)-based drug payment add-on from the current 6 percent to 3 percent for new Part B drugs during the first quarter of sales when Average Sales Price (ASP) is unavailable.
• Instead of finalizing the blended rates for evaluation and management codes for CY 2019 and 2020, CMS is implementing changes to the documentation policy but maintaining the current payment structure. However, starting in CY 2021 and beyond, CMS will make the following change the payment structure –
  • Pay a single rate for E/M office/outpatient visit levels 2 through 4 for established and new patients while maintaining the payment rate for E/M office/outpatient visit level 5.
  • Allow for new add-on codes to reflect extra time needed with patients.
  • Allow practitioners to choose to document using medical decision-making or time, or continue using the current framework.
• CMS is finalizing its proposal to pay new telehealth and technology-based codes.
• Additional updates and changes to the Quality Payment Program.

Click here for the CMS Fact Sheet and here for the final rule.

 

Clinicians’ Quality Payment Program Sees Significant Changes in Final Rule

The PFS Final Rule also makes changes to the QPP that warranted a separate fact sheet from the Agency. Here are some key changes:

• Under the MIPS 2021 payment (2019 performance) year, Quality is measured at 45 percent, Cost at 15 percent, Improvement Activities at 15 percent and Promoting Interoperability at 25 percent.
• CMS maintains the low volume threshold of $90,000 or less in Part B charges or providing care for 200 or fewer Part B beneficiaries and adds a third criterion of performing 200 or less covered professional services under the PFS.
• Eligible clinician types include those from year 2, plus now also include – physical therapists, occupational therapists, qualified speech-language pathologists, qualified audiologists, clinical psychologists and registered dieticians or nutrition professionals.
• For clinicians in Advanced APMs, the CEHRT threshold is increased to require at least 75 percent of eligible clinicians in each APM Entity use CEHRT and the rule extends the 8 percent revenue-based nominal risk standard through 2024.
• In the all-payer combination option and other payer Advanced APMs, CMS will allow QP determinations at the TIN level in instances when all clinicians who bill under the TIN participate as a single APM Entity and all payer types to be included in the 2019 Payer Initiated Process for the 2020 QP Performance Period.
• Click here for the CMS QPP Fact Sheet.

 

CMS Makes Major Changes To Home Health, ESRD, and DME

As if PFS and OPPS were not enough, CMS also released final rules for the Home Health payment system along with payments for home infusion therapy and payment rules for Durable Medical Equipment and End-Stage Renal Disease programs.  Here are some key changes:

• The HHA rule moves the payment structure from 60-day episodes of care to 30-day periods of care and remove the therapy threshold requirements, both policies stemming from the Balanced Budget Act of 2018.
• Additionally, the rule includes a temporary payment system for home infusion therapy services for 2019 and 2020 until a new permanent benefit kicks in Jan. 1, 2021.
• Aside from the annual payment updates in the ESRD payment, CMS revised the drug designation process to allow all new renal dialysis drugs and biological products approved by the FDA on or after January 1, 2020, to increase patient choices without barriers.
• CMS finalized changes to bidding and pricing methodologies under the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program.
• For the Home Health final rule, click here, and CMS Fact Sheet, click here. For the ESRD/DME final rule, clickhere, and the CMS Fact Sheet, click here.

 

HRSA Moves Up 340B Ceiling Price Penalties Rule

The Health Resources and Services Administration has released a rule to change the effective date of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation from July 2019 to January 1, 2019. The final rule lays out how ceiling prices in the 340B drug discount program should be calculated, the so-called “penny-pricing policy” as part of the formula for calculating discounts, and civil monetary penalties for manufacturers who “knowingly and intentionally” overcharge providers. The effective date of the regulation, mandated in the Affordable Care Act, was subsequently delayed until July 1, 2019. Since the delay was announced, Committee Chairmen in the House and Senate sent a letter to HRSA urging the Administration to move forward with the rule quickly. Additionally, the American Hospital Association, Association of American Medical Colleges, America’s Essential Hospitals, 340B Health and three individual hospitals sued HHS for what they allege is an unreasonable delay of the rule. Click here for the latest notice and here for the final rule from January 2017. Click here for the Congressional letter, and here for the hospital lawsuit.

 

Will the New Part B Drug Pricing Proposal Impact 340B?

Following an influx of questions on the President’s new plan to lower payments for Part B drugs to the international market rate, including how it will impact 340B, HHS created a Q&A webpage.  HHS answers many questions about the impact of the proposal, including whether physicians will see payment cuts. Click here.

 

Congressional Diabetes Caucus Makes Recommendations to Lower Insulin Prices

The Bipartisan Diabetes Caucus has released a report based on a year-long investigation that offers recommendations “to increase price transparency, promote competition among insulin makers, and encourage the use of value-based contracts.”  Specifically, the investigation, led by co-chairs Reps. Tom Reed (R-N.Y) and Diana DeGette (D-CO), suggests:

• Requiring insulin companies, PBMs and insurers to disclose the rebates they receive on the drug and share savings with patients
• Eliminating rebates and replacing them with outcomes-based drug payment contracts
• Allowing generic companies to produce older forms of insulin.

The report was sparked by the fact that the price of insulin has doubled since 2012, following a nearly 300 percent rise between 2002 and 2013. To read the full report, click here.

• In a related development, The American Medical Association called on the FTC to take action against drug companies they say are contributing to high prices for insulin, click here.

 

Network for Excellence in Health Innovation Releases Roadmap for Reinventing Health Care

NEHI has released the report that calls for a series of steps in technology development, health care payment, regulations, workforce and other areas. Among other areas, the report calls for new payment models for use by Medicare, Medicaid, and private health insurers that would encourage, according to the authors, technology-enabled innovation in health care delivery that increases access and convenience; and training of health care workers to operate virtually and in multidisciplinary teams. The report has been published as an e-book and paperback on Amazon, click here for the executive summary.

 

Kaiser Puts Out Its Annual Insurance Calculator for 2019 ACA Plans

The Kaiser Family Foundation released the updated Health Insurance Marketplace Calculator last week to include data on all 2019 plans available through ACA marketplaces. The calculator provides estimates of health insurance premiums and subsidies for people purchasing insurance on their own in health insurance exchanges. People can enter their income, age, and family size to estimate their eligibility for subsidies and how much they could spend on health insurance. It also can estimate whether a person is eligible for Medicaid. Click here for the KFF Health Insurance Marketplace Calculator.

 

Hospital-Acquired Infections Declining

Researchers found a 16% decline in the risk of hospital-acquired infections between 2011 and 2015, with the largest decreases seen among urinary tract and surgical site infections, based on a survey of 199 hospitals across the US. The findings were published in The New England Journal of Medicine.  Click here for details.

 

FDA Releases Warning on “Do It Yourself” Genetic Tests

The Food and Drug Administration is now cautioning against relying on direct-to-consumer genetic tests for health care purposes, particularly when the test is used to connect a person’s genes to a drug’s effectiveness. This warning comes a day after the FDA approved a test by company selling these products, 23andMe, that links genetics with patients’ ability to metabolize some medications. The FDA states that they “have required that the test label make clear that it is not intended to provide information on a patient’s ability to respond to any specific medication.” Additionally, the Agency warns patients to be vigilant about tests that haven’t been cleared by the FDA, without calling out any specific companies. Click here for the FDA notice.

 

LabCorp Partners with Apple to Make Test Results Available in Apple Health App
LabCorp has announced that patients are now able to access test results as well as other medical information with the Apple Health app. Other medical information depends on participating healthcare organizations. The app connects to a LabCorp Patient account and all data is protected by passcode, Face ID, or Touch ID. LabCorp hopes that patients will have a holistic view of their health as well as be able to access and understand their information easier stating, “This feature will make it easy for LabCorp patients to access their LabCorp laboratory test results, along with other available medical data from multiple providers, whenever they choose.” For the LabCorp announcement, click here.

 

Premature Birth Rates on the Rise
According to the annual premature birth report card from March of Dimes, the rate of premature births across the U.S rose for the 3rd year in a row, 9.93% of births in 2017, up from 9.85% in 2016. The report card draws data from the CDC to further analyze who specifically has a higher risk of having a preterm baby. The researchers found that African-American woman are disproportionately affected and the state of Mississippi has the highest levels of premature birth. However, Iowa, Rhode Island, Wyoming, and Puerto Rico saw a lower pre-term birth rate in 2017. The report concludes that social and economic factors play a large role in driving the rise of premature birth rate. For the full report, clickhere.

 

First FDA-Approved Cannabis Drug Available for Prescription
The first FDA approved cannabis-based medication is now available for prescription in all 50 states. Epidiolex, made by GW Pharmaceuticals, is an oral therapy that can be used to treat two types of epileptic conditions, Dravet syndrome and Lennox-Gastaut syndrome, in patients 2 and older. After the FDA approved the drug in June, DOJ and the DEA classified it as a schedule V substance, allowing it to be legally prescribed by doctors. The three clinical trials found that Epidiolex resulted in about a 25%-28% drop in seizures. GW Pharmaceuticals will also launch a patient support program that offers patient education and helps lower out-of-pocket costs for those who have been prescribed this drug. Although the drug is currently only allowed for two rare seizures, it can be prescribed “off-label” for other conditions. Click here for the DEA statement on the drug, and here for FDA’s.

 

Research Shows Dogs Can “Sniff-Out” Malaria
A recent British study provided strong evidence that dogs can be trained to sniff out people with Malaria leading to the potential for dogs to assist malaria elimination campaigns. The dogs are trained to smell the malaria parasites on people’s clothing. The study utilized sniffing samples from socks worn briefly by children from a malaria endemic area of West Africa. More research and training need to be done to make a move towards implementing this strategy. However, these dogs could help stop the spread from country to country as well as help identify someone infected. For more on the study, click here.